3rd National Congress nd th · Journal of Radiotherapy & Medical Oncology, vol 22, 2016, Supplement...

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3 rd National Congress of the Federation of Romanian Cancer Societies The 26 nd Annual Congress of the Romanian Society for Radiotherapy and Medical Oncology (RSRMO) The 8 th National Congress of Romanian Radiotherapy Society PRESENT and FUTURE in the Management of Abdominal and Pelvic Cancers Bucharest, November 3-5, 2016 Crowne Plaza Hotel Organized by: Romanian Society for Radiotherapy and Medical Oncology Romanian Radiotherapy Society University of Medicine and Pharmacy “Carol Davila”, Bucharest University of Medicine and Pharmacy ”Iuliu Hatieganu” Cluj-Napoca ESMO and IAEA endorsed

Transcript of 3rd National Congress nd th · Journal of Radiotherapy & Medical Oncology, vol 22, 2016, Supplement...

Page 1: 3rd National Congress nd th · Journal of Radiotherapy & Medical Oncology, vol 22, 2016, Supplement 7 Thursday, November 3rd, 2016 09.00–17.10 HALL A – PRE CONGRESS COURSE 09.00–11.30

3rd National Congressof the Federation of Romanian Cancer Societies

The 26nd Annual Congress of the Romanian Society for Radiotherapy and Medical Oncology (RSRMO)

The 8th National Congress of Romanian Radiotherapy Society

PRESENT and FUTURE in the Management of Abdominal and Pelvic Cancers

Bucharest, November 3-5, 2016Crowne Plaza Hotel

Organized by:Romanian Society for Radiotherapy and Medical Oncology

Romanian Radiotherapy SocietyUniversity of Medicine and Pharmacy “Carol Davila”, Bucharest

University of Medicine and Pharmacy ”Iuliu Hatieganu” Cluj-NapocaESMO and IAEA endorsed

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Journal of Radiotherapy & Medical Oncology, vol 22, 2016, Supplement 3

Dear colleagues,

Welcome to the 3rd National Congress of Medical Oncology and Radiotherapy of the Federations of the Romanian Cancer Societies, which will be held from November 3rd to November 5th 2016 at the Crowne Plaza Hotel in Bucharest.

Being consistent with the objective of the first events from 2012 and 2014, the organizers of this congress, the Romanian Radiotherapy Society (SRR), The Romanian Society for Radiotherapy and Medical Oncology (SRROM), offer you the possibility of a direct dialogue to highlight the progress made by Romania in cancer care and to facilitate the communication with other societies and professional associations from this field, from Romania and abroad.

The chosen subject for this congress is “Present and future in the management of Abdominal and Pelvic Cancers” is centered on the importance of innovative treatments in oncology and it is addressed to all the specialists involved in spotting, diagnosing and treating oncologic diseases. The purpose of this congress is to locate ourselves among theoretic skills, practical opportunities of research and the real possibilities to apply and finance the personalized treatments in conjunction with the standard therapy.

Your attendance at this event as well as the presence of remarkable personalities in the field of international and national medical oncology, radiotherapy and surgery will definitely contribute to the future strategies elaboration.

We do hope to achieve a high–class scientific event. We consider that it is good to be together when discussing about modern oncology if we want to overlap the distance between what we know and what we can offer to our patients. We consider that it is good to be together as a general rule. Only this way we will be respected as medical professionals and be valued by our society.

With the highest consideration,

Prof. Dr. Rodica ANGHEL Assoc. Prof. Dr. Gabriel KACSÓPresident of the Romanian Radiotherapy President of the Romanian SocietySociety of Radiotherapy and Medical Oncology

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Organizing Committee:Prof. Dr. Rodica AnghelAssoc. Prof. Dr. Gabriel KacsóProf. Dr. Viorica NagyProf. Dr. Tudor-Eliade CiuleanuProf. Dr. Alexandru IrimieConf. Dr. Laurentia GalesAssoc. Prof. Dr. Laura RebegeaAssoc. Prof. Dr. Nicolae VergaSef Lucr. Dr. Xenia Bacinschi

Dr. Alexandru EniuDr. Adrian MogaDr. Claudia OrdeanuDr. Radu VidraFiz. Mihai DumitracheAs. Med. Pr. Steluta NicolaescuAs. Med. Dana SandaMatematician Dr. Nicolae Todor

Scientific Committee: Assoc. Prof. Dr. Gabriel KacsóProf Dr Rodica AnghelProf. Dr. Viorica NagyProf. Dr. Tudor Eliade CiuleanuProf. Dr. Lucian MironProf. Dr. Liana GheorgheProf. Dr. Ioana LupescuProf. Dr. Irinel PopescuProf. Dr. Ioan ComanProf. Dr. Zeno SparchezProf. Dr. Octavian DuliuAcad. Dr. Nicolae ManolescuAssoc Prof. Dr. Zsolt FeketeAssoc Prof.Dr. Gabriel GluckAssoc Prof. Dr. Adina CroitoruAssoc. Prof. Dr. Dana StanculeanuAssoc. Prof. Dr. Calin CainapAssoc. Prof. Dr. Dan EniuAssoc. Prof. Dr. Alin RanceaAssoc. Prof. Dr. Ovidiu CozaConf. Dr. Laurentia GalesAssoc. Prof. Dr. Laura RebegeaAssoc. Prof. Dr. Nicolae VergaSef Lucr. Dr. Xenia Bacinschi

Dr. Renata ZahuDr. Daniela GreceaDr. Stefan CurescuDr. Dragos MedianDr. Cristina CebotaruDr. Eugen BanuCP Dr. Iuliana GruiaCP Dr. Sabin CincaDr. Bogdan MoldovanDr. Dana IancuDr. Mircea DediuDr. Andrei UngureanuDr. Razvan CurcaDr. Adrian UdreaDr. Rares FilepDr. A. HalmaciuDr. Lucian MargineanDr. Andrei ManuFiz. Mihai DumitracheAs. Med. Pr. Steluta NicolaescuAs. Med. Dana SandaAs. Med. Pr. Valentin GrosuAs. Med. Pr. Giliola Dumitrascu

Invited international speakers: Prof. Dr. Alvaro MartinezProf. Dr. Anca GrosuProf. Dr. Cristoph ZielinskiProf. Dr. R GalalaeProf. Dr. Thomas BrodowiczDr. Kenneth RusselProf. Dr. Ufuk AbaciogluProf. Dr. Yoseph CaracoProf. Dr. Teresa Macarulla

Dr. Chiara CremoliniProf. Dr. Nuria JornetProf. Dr. Maria Mania AspradakisProf. Dr. Eduard GershkevitshProf. Dr. Marc PeetersProf. Dr. Siegfried SegaertDr. Nina TunariuProf. Dr. Manuela SchmidingerProf. Dr. Lucio Crino

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Faculty list:Abacioglu UfukAnghel RodicaAspradakis Maria ManiaBacinschi XeniaBanu EugenBrodowicz ThomasCainap CCaraco YosephCebotaru CristinaCinca SabinCiuleanu Tudor-EliadeComan ICoza OCremolini ChiaraCrino LucioCroitoru AdinaCurca RazvanCurescu StefanDediu MirceaDuliu OctavianDumitrache MihaiDumitrascu GiliolaEniu DanFekete ZsoltFilep RaresGalalae RGales LaurentiaGershkevitsh EduardGheorghe LianaGluck GabrielGrecea DanielaGrosu AncaGrosu Valentin

Gruia IulianaHalmaciu AIancu DanaJornet NuriaKacso GabrielLupescu IoanaMacarulla TeresaManolescu NicolaeManu AndreiMarginean LucianMartinez AlvarezMedian DragosMiron LucianMoldovan BogdanNagy VioricaNicolaescu StelutaPeeters MarcPopescu IrinelRancea ARebegea LauraRussel KennethSanda DanaSchmidinger ManuelaSegaert SiegfriedSparchez ZenoStanculeanu DanaTunariu NinaUdrea AUngureanu AndreiVerga NicolaeZahu RenataZielinski Cristoph

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Thursday, November 3rd, 201609.00–17.10 HALL A – PRE CONGRESS COURSE09.00–11.30 Oncologia medicala – calatorie de la Pamant la Luna09.00–09.05 Introducere – Prof. Dr. TE Ciuleanu (UMF Cluj-Napoca, IOCN)09.05–09.35 Imuno-oncologia “From bench to bedside”– Dr. Dana Iancu (IOCN)

09.35–10.20 Chimioterapia, tratamentele tintite sau imunoterapia in cancer: ce ne rezerva viitorul? – Dr. M. Dediu (Sanador, Bucuresti)

10.20–10.50 Dependenta de haos a epigenomului – Dr. A. Ungureanu (Amethyst Cluj)

10.50–11.30 Clasificarea tintelor si cailor moleculare, update (medicamente autorizate FDA, EMA, ANMDM) – Dr. R. Curca (Spitalul Judetean Alba Iulia)

11.30–11.45 Coffee break

11.45–14.15 Actualitati in terapia biologica a principalelor localizari tumorale (1)

11.45–12.15 Date noi in designul studiilor clinice in terapia biologica – Dr. A. Udrea (Medisprof Cluj)

12.15–12.45 Cancerele bronhopulmonare (NSCLC) – Prof. Dr. TE. Ciuleanu (UMF Cluj-Napoca, IOCN)

12.45–13.15 Cancerele bronhopulmonare (SCLC & Mezoteliom) – Prof. Dr. L. Miron (IRO Iasi)13.15–13.45 Tumorile digestive – Dr. Adina Croitoru (Institutul Clinic Fundeni, Bucuresti)13.45–14.15 Tumorile glandei mamare – Dr. Daniela Grecea (IOCN)

14.15–15.00 Lunch

15.00–17.10 Actualitati in terapia biologica a principalelor localizari tumorale (2)

15.00–15.30 Tumorile renale – Assoc. Prof. Dr. Dana Stanculeanu (Institutul Oncologic Bucuresti)

15.30–16.00 Tumorile prostatei si uroteliale – Assoc. Prof. Dr. G. Kacsó (UMF Cluj-Napoca, Amethyst Cluj)

16.00–16.30 Tumorile aparatului genital feminin – Prof. Dr. Viorica Nagy (UMF Cluj-Napoca, IOCN)

16.30–17.00 Tumorile cutanate, sarcoame – Assoc. Prof. Dr. C. Cainap (UMF Cluj-Napoca, IOCN)

17.00–17.10 Take Home Messages – Prof. Dr. TE. Ciuleanu (UMF Cluj-Napoca, IOCN)

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Thursday, November 3rd, 2016

08.00–13.30 HALL B Target volume delineation for the abdominal and pelvic cancers. Couse Director: Assoc. Prof. Dr. Gabriel KACSO

08.00–08.10 Obiectivele cursului (Assoc. Prof. Dr. G.Kacsó)08.10–08.30 ICRU 83/ Relatia DVH-TCP/NTCP/Quantec – Dr. Renata Zahu 08.30–09.30 Delimitarea volumelor tinta ganglionare/ principii – Dr. Renata Zahu

09.30–10.30 Volume tinta si organe critice in cancerele digestive sup – Assoc. Prof. Dr. G. Kacsó

10.30–10–45 Coffee break

10.45–11.45 Volume tinta si organe critice in cancerele digestive inferioare (Dr. R Zahu)11.45–12.45 Volume tinta si organe critice in cancerele ginecologice (Assoc. Prof. Dr. G.Kacsó)12.45–13.30 Volume tinta si organe la risc in cancerele urologice (Assoc. Prof. Dr. G.Kacsó)

13.30–14.00 Lunch

HALL B 15:00-18.40: RESIDENTS‘ AFTERNOON; Moderatori/ membrii juriului: Prof. Dr. R. Anghel, Prof. Dr. V. Nagy, Prof. Dr. T. Ciuleanu

15.00–15.10 Radiation therapy technique as a prognostic factor in prostate cancer, Corina Ionescu

15.10–15.20 Survival of breast cancer patients according to the presence or absence of HER2, Ionescu Radu Mihai

15.20–15.30 Long-term oncological outcomes of patients with urinary bladder after multimodality treatment, Fabiana Curea

15.30–15.40 Is robotic surgery a superior alternative in the multimodality treatment of advanced cervical cancer?, Cristina Orlov

15.40–15.50 Assessment of clinical outcomes in glioblastoma multiforme patients treated with intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy, Vanessa Moldoveanu

15.50–16.00 Clinical, paraclinical and histological considerations for the evolution of malignant melanoma, Ana Zamfirescu

16.00–16.10 Survival and tolerance to treatment of patients with testicular cancer, T. B. Buta16.10–16.20 Perioperative approach in resectable gastric cancer, I. Botnariuc16.20–16.30 Synchronous and metachronous tumors. What to expect?, Iulia Ristea

16.30–16.40 A retrospective observational study of melanoma patients treated in a single institution between 2011 and 2016, I. Voica

Coffee break

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17.00–17.10RISK ASSESSMENT OF DEVELOPING SECOND MALIGNANCIES AFTER LOW AND MEDIUM DOSES OF I131 TREATMENT IN PATIENTS WITH DIFFERENTIATED THYROID CARCINOMA, Andra Piciu

17.10–17.20 PARANEOPLASTIC PEMPHIGUS AS A FIRST SIGN OF A HYPOPHARYNX SQUAMOUS CELL CARCINOMA Ana Maria Stefan

17.20–17.30THE PROGNOSTIC AND PREDICTIVE VALUE OF SQUAMOUS CELL CARCINOMA ANTIGEN IN LOCALLY ADVANCED CERVICAL CANCER, Ardelean Simona Andreea

17.30–17.40LOCO-REGIONAL ADVANCED CERVICAL CANCER, RADIOCHEMOTHERAPY, SURGERY, STERILE PIECE, RELAPSED Mircia Alexandra Daniela

17.40–17.50 THE IMPORTANCE OF A MULTIDISCIPLINARY TEAM IN RECTAL CANCER MANAGEMENT Bochis Ovidiu Vasile

17.50–18.00 THE ROLE OF ADJUVANT CHEMOTHERAPY IN THE TREATMENT OF ENDOMETRIAL ADENOCARCINOMA Radulea Alexandra Maria

18.00–18.10 HISTOPATHOLOGY: FRIEND AND ENEMY OF MEDICAL ONCOLOGIST Vlad-Adrian Afrăsânie

18.10–18.20 CURRENT MANAGEMENT OF BRAIN TUMORS IN THE RADIOTHERAPY DEPARTMENT OF IRO IASI Diana Tanase

18.20–18.30POTENTIAL RISK OF COGNITIVE IMPAIRMENT DUE TO IRRADIATION OF NEURAL STRUCTURES IN LOCALLY ADVANCED NASOPHARYNGEAL CANCER TREATED BY CURATIVE RADIOTHERAPY C.C. Mirestean

18.30–18.40 CHITOSAN GOLD NANOPARTICLES WITH OR WITHOUT METFORMIN IN THE TREATMENT OF GLIOBLASTOMA, Mihaela Aldea

18.40–18.50 Q&A – Discutii

18.50–19.00 Coffee break

19.00–20.00 General Assembly of GRROM (Grupul rezidentilor de Radioterapie si Oncologie Medicala) Claudiu Hopirtean, Radu VidraORDINEA DE ZI: 1. RAPORT DE ACTIVITATE 2015-2016; 2. ALEGEREA NOULUI COMITET DE CONDUCERE; 3. NOI PERSPECTIVE; 4. DISCUTIIESMO YOUNG ONCOLOGISTS CORNER – VESALIUS TALK Teresa Amaral si Radu Vidra

HALL A1 ATELIERE PRACTICE de conturaj (cazuri clinice) – on line, asistate de Medic & Fizician (Prof. Dr. Nagy Viorica, Conf. Dr. Cernea Valentin, Sef. lcr. Coza Ovidiu, Sef. lcr. Fekete Zsolt, Dr. Muntean Alina, Dr. Zahu Renata, Dr. Dana Cernea, Fiz. Dan Dordai, Fiz. Noemi Schultes, Fiz. Andreea Eva, Fiz. Diana Trandafir, Fiz. Mihai Suditu, Fiz. Raducu Popa)Digestiv inferior Gine Digestiv superior Uro-oncologie

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Thursday, November 3rd, 201612.30–18.30 HALL C Bayer Symposium – Ridicand stacheta in CHC12.30– 12.50 Lunch for participants

Partea I (2 h) Moderatori Liana Gheorghe, Ioana Lupescu

12.50–13.10 Introducere, date epidemiologice in CHC – dr. Liana Gheorghe13.10–13.30 Impactul noilor terapii antivirale asupra riscului CHC – dr. Speranta Iacob13.30–13.50 Screeningul si supravegherea in CHC – cine, cum, cand? – dr. Liana Gheorghe 13.50–14.10 Rolul biomarkerilor in diagnosticul HCC – dr. Razvan Cerban

14.10–14.30 Diagnosticul imagistic si recomandari in evaluarea CT si IRM a CHC – dr. Ioana Lupescu

14.30–14.50 Rolul examenului histopatologic in diagnosticul CHC: cum putem creste acuratetea? – dr. Mona Dumbrava

14:50–15:10 Coffee break

Partea a II-a ( 2h) Moderatori Adina Croitoru, Irinel Popescu

15.10–15.25 Stadializarea CHC: impactul asupra managementului si prognosticului – dr. Ioana Luca

15.25–15.55 Analiza sistematica a terapiilor locoregionale in CHC – dr. Mugur Grasu

15.55–16.25 Chirurgia curativa a CHC: rezectia, radioablatia si transplantul hepatic – dr. Irinel Popescu, dr. Doina Hrehoreț

16.25–16.40 Supravietuirea indelungata si calitatea vietii cu sorafenib –profilul pacientului, factori predictivi – dr. Iulia Gramaticu

16.40–17.00 Terapiile moleculare in CHC – dr. Adina Croitoru

17.00–17.15 Coffee break Partea a III-a ( 1h) Moderatori Lectorii invitati

17.15–17.30 Prezentare caz clinic I – dr. Florina Buica17.30–17.45 Prezentare caz clinic II – dr. Ioana Dinu17.45–18.00 Prezentare caz clinic III 18.00–18.15 Prezentare caz clinic IV

18.15–18.30 Concluzii

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Thursday, November 3rd, 201608.30–17.30 HALL D Workshop IAEA

09.00–17.30 National Training Course on acceptance and commissioning of radiotherapy equipment. Practical approach for LINAC based equipment (3DCRT, IMRT, VMAT)

08.30–09.00 Registration09.00–09.45 Introduction and welcome Prof. Dr. Rodica Anghel, PhD Mihai Dumitrache

09.00–09.45 The transition from 2D to 3D and to IMRT – rationale and critical elements, PhD Eduard Gershkevitsh

09.45–10.30 The perspective of the National Regulatory Body CNCAN

10.30–11.00 Coffee break

11.00–12.00 Linear accelerators for RT and acceptance tests – an overview, PhD Nuria Jornet12.00–13.00 Commissioning tests of a LINAC (I), PhD Maria Mania Aspradakis

13.00–14.00 Lunch

14.00–15.00 Commissioning tests of a LINAC (II), PhD Maria Mania Aspradakis15.00–15.45 QA and QC of R&V systems, PhD Eduard Gershkevitsh

15.45–16.00 Coffee break

16.00–17.00 Commissioning and QA of Imaging equipment in RT, PhD Eduard Gershkevitsh17.00–17.30 Vendor session – the medical physicist perspective PTW

Friday, November 4th, 201609.00–09.30 HALL A (all) Opening

Ministry of Health President of National Health House CNCAN representative President of SRR President of SRROM

09.30–11.15 HALL A (all) KEYNOTE LECTURES

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GYNECOLOGICAL CANCERS – Moderators: Assoc. Prof. Dr. Eniu D (RO), Prof. Dr. Nagy V (RO), Assoc. Prof. Stanculeanu D/RO

09.30–10.00 State of the art: SURGERY (Assoc. Prof. Dr. Rancea A/ RO)10.00–10.30 State of the art: RT (Assoc. Prof. Dr. Coza O/ RO)10.30–11.00 State of the art: Systemic therapy (Prof. Dr. Nagy V/ RO)11.00–11.15 Discussions

11.15–11.30 Coffee break

11.30–13.00 11.30-13.00 Astra Zeneca Lynparza – Cancerul ovarian intr-o noua era a terapiei tintite

11.30 Welcome – Bianca Diamandopol AZ 11.35 AZ oncology commintment – Radu Rasinar AZ 11.45 Symposium Opening – Prof. Dr. Tudor Ciuleanu 11.50 Ovarian Cancer – a “Glocal” problem – Dr. Stefan Curescu

12.00 BRCA testing: From risk assessment to targeted treatment – Prof. Dr. Tudor Ciuleanu

12.20 PARP inhibition – the future in ovarian cancer treatment – Dr. Dragos Median 12.30 New standard targeted therapy in ovarian cancer – Dr. Dana Stanculeanu

12.50 From synthetic lethality concept to clinical practice – Prof. Dr. Lucian Miron

13.00 Event closing – Prof. Dr. Tudor Ciuleanu

13.00–14.00 Lunch

14.00–16.15 UROLOGIC CANCERS/ KEYNOTE LECTURES – Moderators: Assoc Prof. Dr. G. Gluck (RO); Prof. Dr. A. Martinez (USA), Dr. Cebotaru C (RO)

14.00–14.30 State of the art: SURGERY (Prof. Dr. I. Coman/ RO)14.30–15.00 State of the art: BRACHYTHERAPY (Prof. Dr. A. Martinez/ USA)15.00–15.30 State of the art: RADIOTHERAPY (Prof. Dr. R Galalae/ D)15.30–16.00 State of the art: SYSTEMIC THERAPY (Assoc. Prof. Dr. Kacsó/ RO)16.00–16.15 Discussions

16.15–16.30 Coffee break

16.30–17.45 Original presentations – Moderators: Prof. Dr. Coman I (RO), Prof. Dr. Miron L (RO), Dr. Burz C (RO)

A rare case of primary mediastinal germ cell tumor (Dr. Chira R/ RO)

Intraoperative radiation therapy – looking back to 4 years of experience at University Hospital in Bern, Switzerland (Dr. Ionescu C/ CH)

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The efficacy of palliative pelvic radiotherapy – the experience of radiotherapy department, “Sf. Ap. Andrei” Emergency clinical hospital Galati (Assoc. Prof. Dr. Rebegea L/ RO)

The psychological assistance of the prostate cancer patients (Dr. Hetea O/RO)

PRO’s (patient reported outcomes) in prostate cancer treatment (Dr. Manolescu V/ RO)

Acute toxicity of IMRT versus 3DCRT for post-prostatectomy irradiation (Dr. Bunta O/ RO)

17.45–19.15PELVIABDOMINAL TUMORS – Other hystologies/ SARCOMAS – Moderators: Prof. Dr. Anghel R (RO), Prof. Dr. Brodowicz (A), Assoc. Prof. Dr. Eniu D (RO)

17.45–18.15 State of the art: Radiation therapy in retroperitoneal sarcomas – Prof. Dr. Anghel R (RO)18.15–18.45 State of the art: SYSTEMIC THERAPY GIST and NET – Conf. Dr. Gales L (RO)

18.45–19.15 State of the art: SYSTEMIC THERAPY Abdominal Soft tissue sarcoma – Prof. Dr. Thomas Brodowicz (A)

19.15–19.30 Discussions

19.15–20.15 SRR General Assembly

20.30–22.00 Dinner

Friday, November 4th, 201609.30– 11.15 HALL B Pharma/ Companies Symposia

09.30–09.40 Caris Media Symposium (Dr. Kenneth Russel)09.40–10.20 Boehringer Symposium – Afatinib in spotlights (Dr. Mircea Dediu)

10.20–10.50 Neolife Symposium – Stereotactical radiotherapy in lung cancer (Prof. Dr. Ufuk Abacioglu)

10.50–11.20 ICCO Medical Symposium – Radiotherapy in urological cancer – update 2016

11.15–11.30 Coffee break

11.30–12.00 Hall B Multidisciplinary tumor board – Assoc Prof Dr Rancea A. (RO), Prof. Dr. Nagy V. (RO), Assoc Prof Coza O./RO

12.00–13.00 Hall B Original presentations – Moderators: Assoc. Prof. Dr. Ordeanu C. (RO), Dr. Curca (RO), Dr. Zahu (RO)

12.00–12.10 Long term outcome, clinical, serological and pathological prognostic factors in 110 patients with epithelial ovarian cancer (Prof. Dr. Anghel R/ RO)

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12.10–12.20 Shifting from open to laparoscopic surgery in gynecological cancers (Dr. Eniu D/RO)

12.20–12.30 Interstitial brachytherapy in locally advanced cervical cancer, the Amethyst Cluj preliminary results (Dr. Sipos A/RO)

12.30–12.40 Implementing image-guided brachytherapy for cervix cancer: our dosimetric data comparative analysis and clinical impact literature review (Dr. Georgescu M.T/ RO)

12.40–12.50 Dosimetric comparison of bone marrow-sparing vmat radiotherapy versus conventional technique for treatment of cervical cancer (Dr. Zahu R/ RO)

12.50–13.00 Reactive oxygen species in patients with ovarian adenocarcinoma treated with platinum based Chemotherapy (Dr. Trifanescu O/RO)

13.00–13.10 MALIGNANT GESTATIONAL TROPHOBLASTIC NEOPLASIA IN FEMALE ADOLESCENTS (Monica Desiree Dragomir/ RO)

13.10–14.00 Lunch

14.00–16.15 HALL B Pharma/ Companies Symposia

14.00–14.30 Roche Symposium – Original and biosimilar monoclonal antibodies: particularities in their licesing and use (Prof. Dr. Yoseph Caraco)

14.30–15.30

Sanofi Symposium – Aflibercept, capcana pentru factori angiogenici multipli, (Prof. Dr. Tudor Ciuleanu, I.O.C.N.); Locul și momentul chimioterapiei în tratamentul cancerului de prostată (Conf. Dr. Laurentia Gales, I.O.B.); The CMS classification: ready for daily clinical practice? (Teresa Macarulla, MD, PhD Vall d´Hebrón Unversity Hospital Barcelona)

15.30–16.10 Boehringer Symposium – Updates in the Setting of EGFR Mutant NSCLC (Prof. Dr. Tudor Ciuleanu)

16.15–16.30 Coffee break

16.30–18.30 HALL B Pharma/ Companies Symposia16.30–17.00 Novartis Symposium (Dr. Mircea Dediu, Dr. Cebotaru Cristina)

17.00–17.30 Roche Symposium – Challenging in MCRC-treatment approaches (Dr. Chiara Cremolini)

17.30–18.00 BMS Symposium (Prof. Dr. Tudor Ciuleanu)

18.00–18.20 Neolife Symposium – When to stop sustaining treatment and how to manage the remaning time (Prof. Dr. Micaela Berkowitz)

18.20–18.50 Eli Lilly Symposium – Controverse in tratamentul cancerului pulmonar (Dr. Razvan Curca, Dr. Serban Negru, moderator: Dr. Laura Mazilu)

19.00–20.30 HALL B SRROM General Assembly Report on 2016 activity New Board Elections

20.30–22.00 Dinner

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Friday, November 4th, 201609.00–17.30 HALL C Workshop IAEA

09.00–17.30 HALL C National Training Course on acceptance and commissioning of radiotherapy equipment. Practical approach for LINAC based equipment (3DCRT, IMRT, VMAT)

09.00–09.45 Dosimetry – basic concepts, Prof Dr. Octavian Duliu09.45–10.30 Uncertainties and action levels, PhD Nuria Jornet10.30–11.00 Coffee break

11.00–12.00 Calibration of photons and electrons – dosimetry codes of practice, PhD Maria Mania Aspradakis

12.00–13.00 Detectors for measurements – best choice for the, PhD Nuria Jornet

13.00–14.00 Lunch

14.00–15.00 Non-standard beams: small fields, out-of-field dose for TPS, PhD Maria Mania Aspradakis

15.00–15.45 Phantoms, PhD Maria Mania Aspradakis

15.45–16.00 Coffee break

16.00–17.00 Accidental exposures in radiotherapy related to TPS and lessons learned. IAEA activity in QA in RT, PhD Eduard Gershkevitsh

17.00–17.30 Vendor session – the medical physicist perspective SUN NUCLEAR

Friday, November 4th, 2016

09.00–13.00 HALL D Departamentul de cercetare – Noi biomolecule cu rol de markeri utilizate in diagnosticul si monitorizarea eficientei tratamentului in cancer

Markeri moleculari in cancerul colo-rectal, Dr. Mirela Dumitru, Dr. Liliana Puiu, Dr. S. Cinca

Rolul CTC in procesul de metastazare, Dr. Daniela Fratila

Metaloproteinazele in angiogeneza, progresia si metastazarea tumorala, Dr. Daniela Glavan

Colangiocarcinomul uman versul colangiocarcinomul murin transplantabil, Dr. Valentina Negoita

Caracterizarea biochimica a hepatomului experimental RS-1, Dr. Maria Iuliana Gruia

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Utilizarea imunocitochimiei in diagnosticul tumorilor hepatice la animalele de experienta, Dr. Ana Maria Coman

Cresterea indicelui therapeutic al citostaticelor cu potential fotodinamic pozitiv prin metode neconventionale de chimioterapie fotostimulata, Dr. R. Fumarel

Friday, November 4th, 201614.00–17.45 HALL E – ASISTENTI MEDICALI14.00–16.15 Curs precongres – Dr. Xenia Bacinschi

16.15–16.30 Coffee break

16.30–17.45 Moderator: Dumitrascu Giliola

16.30–16.40 Asistentul medical – profesionistul sanatatii; Autor: Joian Mihaela, Coautori: Gais Stela, Akin Rodica

16.40–16.50 Clasificarea cancerului dupa tipul histologic; Autor: Zamfir Vera, Coautori: Dumitrache Ana Maria,Bortea Ionela Loredana

16.50–17.00 Tratamentul lmfoamelor cutanate primare; Autor: Iagar Maria, Albu Maria, Fecioru Mariana, Chelu Florenta

17.00–17.10 Cancerul tiroidian; Autor: Ionescu Ioana

17.10–17.20 Neoplasmul hemibaza limba biopsiat; Autor: Nae Ana, Coautori: Nae Florenina Cristina, Florea Cristina Eliza

17.20–17.30 Indicatiile extractiilor dentare in chimioterapie; Autor: Neacsa Mirela, Birladeanu Cristina, Goleanu Mihaela

17.30–17.45 Transfuzia sanguina intr-un sistem „bolnav”; Autor: Buflea Mihaela, Coautori: Erezeanu Mariana, Dragu Gina

Saturday, November 5th, 2016

08.00–09.00 HALL A KEYNOTE LECTURES – Moderators: Prof. Dr. Ciuleanu (RO), Assoc. Prof. Dr. Kacsó (RO)

Prof. Dr. Anca Grosu (Germany) Imaging in targeted radiotherapy Prof. Dr. C. Zielinski (Austria) Immuno-therapy in Oncology

09.00–10.30LOWER GASTROINTESTINAL CANCERS (colo-rectal, anal). Keynote lectures Moderators: Prof. Dr. Chiricuta C/ RO, Assoc. Prof. Dr. Rancea A/ RO, Dr. Banu E/ RO

09.00–09.30 State of the art: Surgery (Assoc. Prof. Dr. Eniu D/ RO)09.30–10.00 State of the art: Radiotherapy (Dr. Fekete Z/ RO)

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10.00–10.30 State of the art: Systemic therapy (Dr. Croitoru A /RO)

10.30–10.45 State of the art: Interventional Oncology – focus on intraperitoneal chemotherapy (Dr. Moldovan B RO)

10.45–11.15 Discussions

11.15–11.30 Coffee Break

11.30–12.00 Multidisciplinary tumor board (Panel = all of the previous session speakers )

12.00–13.00 Original presentations – Moderators Dr . Ciurascu – Brasov/Ro, Dr. Filip – Baia Mare/Ro, Dr. Zahu R – Cluj/ RO

12.00–12.10 A multivariate analysis of some biomarkers as prognostic factors in metastatic colorectal cancers (Dr. Chereches G/ RO)

12.10–12.20Larger boost to primary rectal cancer could improve prognostic significance of complete remission of rectal cancer after neoadjuvant treatment (Prof. Dr. Chiricuta C/ RO)

12.20–12.30 Neo-adjuvant chemo-radiation with escalated dose in locally advanced rectal cancer (Dr. Sturzu D/ RO)

12.30–12.40 How much we can trust in the nccn recommendations for anal cancer patients to improve the local control rates? (Prof. Dr. Chiricuta C/ RO)

12.40–12.50 Radiotherapy for anal carcinoma – the Nottingham University Hospitals experience (Dr. Fekete Z/ RO)

12.50–13.00 Nutrition management for colorectal cancer patients (Dr. Mateies I/ RO)13.00–13.10 Rare cancer in children: Appendicular carcinoid (Monika Bădoi/ RO)

13.10–14.00 Lunch

14.00–16.30 UPPER GASTRO-INTESTINAL CANCERS – Moderators: Prof. Dr. Anghel (RO), Prof. Dr. Popescu I (RO), Prof. Dr. Sparchez S (RO)

14.00–14.30 State of the art: SURGERY (Prof. Dr. I. Popescu, Bucharest/RO) 14.30–15.00 State of the art: MEDICAL ONCOLOGY (Assoc. Prof. Dr. C. Cainap/ R)) 15.00–15.30 State of the art: RADIOTHERAPY (Conf. Dr. Laura Rebegea/ RO)

15.30–15.50 State of the art: interventional Oncology – focus on minimal invasive ablations (Prof. Dr. Sparchez Z/ RO)

15.50–16.10 Interventional Oncology – focus on chemoembolization (Dr. Filep R, Dr. Halmaciu A, Dr. Marginean L/ RO)

16.10–16.30 Discussions

16.30–16.45 Coffee break

16.45–17.15 MULTIDSICIPLINARY TUMOR BOARD (Panel = all of the previous session speakers)

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17.15–18.15 Original presentations – Moderators: Dr. Muntean A – Cluj/RO, Dr. Curescu S – Timisoara/RO, Dr. Barbu C – Bucharest/Ro

17.15–17.25 Using genomic alterations of cancer cells for systemic therapy in daily practice – the st. constantin hospital experience (Dr. Banu E/ RO)

17.25–17.35 Anti-angiogenic treatment and the reactive oxygen species in experimental RS-1 hepatocellular carcinoma (Dr. Gruia M.I/ RO)

17.35–17.45 Systemic treatment options in pancreatic adenocarcinoma (Dr. Ilie SM/ RO)

17.45–17.55 Computer-aided diagnosis of abdominal masses – preliminary results, (Dr. Dumitrescu I/ RO)

17.55–18.05 A parallel robotic system might increase brachytherapy availability and reproducibility – the Cluj CHANCE concept (Assoc. Prof. Dr. Kacsó G/ RO)

18.05–18.15 Software-aided reconstruction of liver volumetry (Dr. Dumitrescu I/ RO)

18.15–18.30 Evaluation forms/ Certificate of Attendance Delivery

18.30–19.00 Joint Board Meeting SRR & SRROM

Saturday, November 5th, 201609.00–13.00 HALL B Pharma/ Companies Symposia

09.00–09.30 Amgen Symposium – Metastatic Colorectal (Prof. Dr. Marc Peeters) Tratamentul de prima linie in cancerul colorectal metastatic cu gena RAS de tip salbatic

09.30–10.00 Amgen Symposium – Dermatology (Prof. Dr. Siegfried Segaert) Managementul reactiilor adverse cutanate la pacientii tratati cu anticorpi anti-EGFR

10:00–10:30 Roche Symposium – HER-2/NEU directed treatment in breast cancer (Prof. Dr. Cristoph Zielinski)

10.30–10:45 amenajare sala10.45–11.25 MSD Symposium (Prof. Dr. Cristoph Zielinski, Prof. Dr. Rodica Anghel)

11.30–12.00 Astra Zeneca Symposium – Terapia hormonală, prima „terapie ţintită” pentru cancerul mamar cu receptori hormonali prezenți – Dr. Dana Grecea; moderator: Dr. Mircea Dediu

12.00–12.30 Novartis Symposium – Malign Melanoma (Dr. Curca Razvan, Dr. Andrei Ungureanu)

12.30–13.00 A&D Pharma Symposium – Cystistat (Dr. Manu Andrei)

13.00–14.00 Lunch

14.00–14.30 Roche Symposium – Optimizing therapy in metastatic lung cancer (Prof. Dr. Tudor Ciuleanu)

14.30–15.00 Merck Symposium (Prof. Dr. Rodica Anghel)

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15.00–16.00 J&J Symposium Assoc. Prof. Dr. Gabriel Kacso (RO), Dr. Nina Tunariu (UK) – How can modern imaging impact treatment approaches in management of prostate cancer

16.30–16.45 Coffee break

16:45–17:30 Pfizer Symposium – Prof. Dr. Manuela Schmidinger – Treatment updates in MRCC17:30–17:45 Pfizer Symposium – Prof. Dr. Lucio Crino-Oncogene driven NSCLC

Saturday, November 5th, 201609.00–17.30 HALL C Workshop IAEA

09.00–17.30 HALL C National Training Course on acceptance and commissioning of radiotherapy equipment. Practical approach for LINAC based equipment (3DCRT, IMRT, VMAT)

09.00–09.45 TPS overview; Differences between treatment planning systems, PhD Maria Mania Aspradakis

09.45–10.30 IAEA TPS clinical commissioning protocol. Results of the IAEA project on TPS audit in Europe, PhD Eduard Gershkevitsh

10.30–11.00 Coffee Break

11.00–12.00 Acceptance tests of a TPS, PhD Nuria Jornet12.00–13.00 TPS Dose calculation algorithms, PhD Maria Mania Aspradakis

13.00–14.00 Lunch

14.00–15.00 Commissioning tests on a TPS (I), PhD Nuria Jornet15.00–15.45 Commissioning tests on a TPS (II), PhD Nuria Jornet

15.45–16.00 Coffee break

16.00–17.00 Preparatory work for practicals PhD Nuria Jornet/ PhD Maria Mania Aspradakis, PhD Eduard Gershkevitsh, PhD Mihai Dumitrache, PhD Alina Tanase

17.00–17.30 Vendor session – the medical physicist perspective IBA

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Saturday, November 5th, 2016 10.00–13.00 HALL D PHYSICS & RTT SESSION

10.00–10.15 ELECTRONIC PATIENT RECORD IN RADIOTHERAPY; Sipos Oana*, Demeter Daniel*, Negrean Silvia*, Zahu Renata*, Noemi Schultes* *Amethyst Radiotherapy Center Cluj

10.15–10.30

DAILY IMAGE GUIDANCE WITH CONE-BEAM COMPUTED TOMOGRAPHY FOR PROSTATE CANCER IMRT; Grosu Mirabela Emanuela*, Badiu Adina Madalina*, Sarca Irina Claudia*, Vitca Daniel Ioan*, Pirv Ovidiu Ioan*, Zahu Renata*, Eva Andrea*, Trandafir Diana*, Schultes Noemi*, Kacsó Gabriel*,** *Amethyst Radiotherapy Center Cluj, **University of Medicine and Pharmacy Cluj-Napoca

10.30–10.45

THE ROLE OF THE RTT IN DETECTING POSSIBLE ERRORS IN BRACHYTHERAPY; Sarca Irina Claudia*, Persa Daniela Raveca*, Grosu Mirabela Emanuela*, Lungu Alexandra*, Schultes Noemi*, Dordai Dan*, Zahu Renata*, Negrut Lavinia*, Bote Aurel*, Kacso Gabriel*,** *Amethyst Radiotherapy Center Cluj, **University of Medicine and Pharmacy Cluj-Napoca

10.45–11.00 EVALUATION OF AUTOMATED INVERS TREATMENT PLANNING FOR DIFFERENT LOCALIZATION D.L. Trandafir*, A. Eva*, N. Schultes*, D. Dordai* *Amethyst Radiotherapy Center Cluj

11.00–11.15

INTENSITY MODULATED RADIOTHERAPY VS 3D CONFORMAL IN BREAST IRADIATION; Ioana Scarlatescu*, Bogdan Ile*, Aurel Chis*, Marius Spunei*, Alin Tanase*, Ioana Lupse*, Noemi Besenyodi*, Anca Croitoru* *Asociatia OncoHelp Timisoara

11.15–11.45 Coffee Break

11.45–12.00 IMPACT OF MULTILEAF COLLIMATOR MODELS ON VMAT PROSTATE PLANS; A. Eva*, D. Dordai*, N. Schultes*, G. Kacso*,** *Amethyst Radiotherapy Center Cluj, **UMF ”Iuliu Hatieganu” Cluj

12.00–12.15

REPRODUCTIBILITY OF BLADDER VOLUME IN PELVIC RADIOTHERAPY; Aurel Bote*, Lavinia Negrut*, Renata Zahu*, Gabriel Kacso*,** Daniel Demeter*, Madalina Badiu*, Emanuela Grosu*, Silvia Negrean*, Claudia Sarca*, Alexandra Lungu* *Amethyst RTC Cluj; **UMF “Iuliu Hatieganu” Cluj

12.15–12.30 HIP PROSTHESES METAL INDUCED ARTIFACTS INFLUENCE IN PROSTATE CANCER RADIATION THERAPY; Suditu Mihai*, Barbu Cristian*, Ciocaltei Violeta*, Adam Daniela*, Popa Raducu* *Amethyst, Otopeni

12.30–12.45 PATIENT PREPARATION, IMMOBILIZATION AND IMAGING IN PROSTATE CANCER MODERN RADIATION THERAPY; Ianole Gigi*, Negrescu Elena* *Amethyst, Otopeni

12.45–13.00

12.45-13.00 CBCT USE FOR DOSIMETRIC IMPACT ANALYZE DURING BLADDER CANCER RADIATION THERAPY; Adam Daniela*, Barbu Cristian*, Suditu Mihai*, Violeta Ciocaltei*, Popa Raducu*, Duran Cristina* *Amethyst Radiology Therapeutic Center, Otopeni

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Saturday, November 5th, 201609.00–18.30 HALL E – ASISTENTI MEDICALI09.00–11.15 Moderator: Nicolaescu Steluta

09.00–09.10 Nobila profesie de asistent medical ieri si azi; Autor: Berdila Aurelia, Coautori: Croitoru Iulia, Mihai Liliana

09.10–09.20 Managementul emotiilor; Autor: Stroe Mariana, Coautori: Dragan Violeta, Stanciulescu Rodica

09.20–09.30 Importanta comunicarii in relatia asistent medical – pacient; Autor: Zamfir Vera, Coautori: Stancu Nela Daniela, Dragoescu Angela, Ioan Paul Bogdan

09.30–09.40 Mobbing vs. Bullying în sistemul sanitar; Autor: Alexe Viorica, Coautori: Gais Stela, Baicu Xenia

09.40–09.50 Radioprotectia personalului medical si a pacientilor in practica de medicina nucleara; Autor: Vasile Mihaela, Coautori: Nita Corina

09.50–10.00 Etapele medicale parcurse de pacient in afectiunile oncologice; Autor: Mariana Pirgaru, Coautori: Ichim Monica

10.00–10.10 Trairile emotionale ale pacientului oncologic; Autor: Dumitrascu Giliola, Coautori: Neacsu Daniela, Vizitiu Claudiu

10.10–10.20 Poveste unei picaturi de sange; Autor: Bortoloti Adelina, Coautori: Nicolaescu Steluta, Bonciu Alina

10.20–10.30 Modificări hematologice în cancer; Autor: Alexe Gheorghe, Marinov Ecaterina, Alexe Viorica Liliana

10.30–10.40 Markerii tumorali – indicații, limite, interferențe analitice; Autor: Alexe Viorica Liliana, Alexe Gheorghe, Forcos Mariana

10.40–10.50 Preventia in cancerul de san; Autor: Serban Meri, Coautori: Iordache Andreea, Poenaru Raluca

10.50–11.00 Rolul asistentului medical in cancerul mamar; Autor: Dragan Gabriela, Coautori: Vasile Oana

11.00–11.15 Mastita Carcinomatoasa; Autor: Baicu Xenia, Coautori: Soceanu Lenuta, Bota Violeta

11.15–11.30 Coffee Break

12.00–13.00 Moderator: Berdila Aurelia

12.00–12.10 Efectele adverse ale chimioterapiei in cancerul de san; Autor: Anghelus Nicoleta, Coautori: Berdila Aurelia, Vatu Alina Cristina

12.10–12.20 Rolul asistentei medicale in ingrijirea pacientilor oncologici cu infectii; Autor: Goleanu Mihaela, Coautori: Boeru Steliana, Neacsa Mirela

12.20–12.30 Ingrijirea plagilor operatorii; Autor: Marinica Nicoleta Eleonora, Coautori: Sima Mirela, Ioan Gabriela

12.30–12.40 Managementul participarii asistentului A.T.I. la -Intubatia orotraheala a pacientului din oncologie; Autor: Manolache Eugenia, Coautori: Alexandru Mariana, Trusca Veronica

12.40–12.50Rolul asistentului medical de anestezie in monitorizarea pacientului pentru inducerea somnului; Autor: Manolache Eugenia, Coautori: Bogdan Costinela, Catrinoiu Ioana

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13.00–14.00 Lunch

14.00–14.10 Acordarea primului ajutor in stopul cardio-respirator; Autor: Florescu Codrut, Coautori: Pana Doina, Glavan Elena

14.10–14.20 Cancerul ovarian; Autor: Cioara Ileana, Coautori: Boruga Mihaela, Ivan Mariana

14.20–14.30 Variatiile Markerului tumoral in cancerul ovarian; Autor:Bejinariu Isabela, Coautori: Lecea Alexandrina, Marin Adriana

14.30–14.40 Rolul tomografiei computerizate în stabilirea planului de tratament al cancerului de col uterin; Autor: Burcea Georgeta, Coautori: Zamfir Simona, Pana Teodor

14.40–14.50 Hemoragia digestiva superioara sau ulcerul gastric de stress; Autor: Dumitru Irina Daniela, Bragadireanu Mihaela, Ghinea Nicoleta

14.50–15.00 Ingrijirea pacientilor cu neoplasm gastric; Autor: Croitoru Iulia, Coautori: Anghelus Nicoleta, Lencsik Ioana Alina

15.00–15.10 Ingrijiri acordate pacientului oncologic in sectia radioterapie; Autor: Fratiloiu Mirela, Coautori: Serban Meri

15.10–15.20 Tehnici modern de radioterapie externa; Autor: Ene Steluta, Coautori: Alexe Lili, Reisler Carmen

15.20–15.30 Tratamentul radioterapeutic al tumorilor cerebrale; Autor: Colita Andrei, Coautori: Vasilica Catalina, Coraci Ileana

16.30–16.45 Coffee break

17.15–18.15 Moderator: Grosu Valentin

17.15–17.25 Iradierea 3d conformationala in tratamentul neoplasmului rectal; Autor: Grosu Valentin, Coautori: Albu Marcela, Grosu Angela

17.25–17.35 Brahiterapia; Autor: Ivasc Veronel, Coautori: Vasile Raluca, Iancu Florian

17.35–17.45 Reactii secundare precoce ale radioterapiei la copii; Autor: Mitu Daniela, Coautori: Dobre Nicoleta, Soare Constanta

17.45–17.55 Aspecte globale ale îngrijirii paliative la copilul cu boală oncologică; Autor: Rotariu Geanina, Coautori: Dobre Olguta, Olar Irina Loredana

17.55–18.05 Prevenția și tratamentul extravazărilor de citostatice; Autor : Albu Maria, Coautori: Iagar Maria, Moraru Mariana, Birladeanu Cistina

18.05–18.15 Ingrijirea cateterelor si camerelor implantabile; Autor: Stanciu Cristian, Coautori: Baciu Ionut, Dobrescu Mihaela

18.15–18.30 Evaluation forms/ Certificate of Attendance Delivery

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A B S T R A C T S

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1. COMPUTER-AIDED DIAGNOSIS OF ABDOMINAL MASSES - PRELIMINARY RESULTS

Iolanda Dumitrescu

Institute of Oncology „Prof. Dr. Alexandru Trestioreanu” Bucharest, Romania

Introduction: Computer-aided diagnosis (CAD) has become one of the major research subjects in medical imaging informatics and diagnostic radiology. A CAD system may act as a virtual „second reader” by highlighting suspicious situations for further review and evaluation by the physician.

Materials and method: Shape-based and region-based descriptors have been issued, assuring a good intraclass and interclass differentiation, and also representing or correlating with one or more clinical findings or purely technical image characteristics. Supervised classification has been used for pattern discrimination. Principal component analysis has been used to map the high-dimensional feature space into an orthogonal basis, the principal components, assuring an efficient classification. Clusters have been issued by k-means clustering. Images used for software development have been taken from international public image databases.

Results: The efficiency of clustering has been scored. Based on the classification data, a new sample is allocated to a class on a nearest neighbor basis. The features issued assure discrimination, reliability, independence, optimality. The performances of the k-nearest neighbors clustering solutions have been tested by issuing a cophenetic correlation coefficient, an inconsistency coefficient, and graphically imaged by a dendrogram and a silhouette plot showing how well-separated the resulting clusters are. In the classification step, different distance metrics have been tested. For any software technique to be used clinically, it should be able to process images at a rate clinically useful. Computation time is not a trivial matter, so we paid attention to that.

Conclusion: The potential of CAD schemes across imaging modalities in improving radiologist‘s performance and reducing intra- and inter-radiologist performance variability has been proved and well recognized. CAD assist radiologist by providing the computer output as a „second opinion” and accelerate the process of analysis. CAD techniques offer a cost-effective alternative to double reading as a means of reducing errors.

2. SOFTWARE-AIDED RECONSTRUCTION OF LIVER VOLUMETRY

Iolanda Dumitrescu

Institute of Oncology „Prof. Dr. Alexandru Trestioreanu” Bucharest, Romania

Introduction: Imaging and diagnosing abdominal organs request delineating and scoring them, but that can be sometimes demanding, because neighbored organs may have similar densities. A noninvasive, high spatial and high contrast resolution imaging modality is requested. Accurate, noninvasive liver volumetry is aimed for initial staging, planning liver interventions, but also in treatment follow-up. Software-aided reconstruction and measuring the liver volume have become a „second opinion” for the physician.

Materials and method: Iso-contours based delineation of the organs in the image and the interactive localization of the liver border, issued spline-interpolated contour points that for the volume analyzed issued surface patches. Indirect rendering or isosurface rendering have been used for three-dimensional recovery of the liver volume. The isosurface obtained indicate the material interface of the reconstructed liver. For measuring the liver volume, the contour points of the liver boundary in each slice were extracted. Applying the principles of the integral calculus and solid geometry, the area enclosed by the liver boundary in each slice and

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the whole volume has been issued. The medical images (MRI, CT) have been taken from international public image databases. Image data has been considered on a patient - study - series - images basis.

Results: The extent enclosed by each contour, the total area and the volume of the liver have been scored. We have compared our computerized volumetric results with those of the „gold-standard” manual volumetry. The results have been encouraging.

Conclusion: A software-aided delineation of the liver in abdominal images enabled the reconstruction and measurement of liver volumes. Efficient and accurate assessment of liver volumes can aid the physician for treatment planning and follow-up. Manual volumetry is time consuming as compared with software-aided volumetry. Three dimensional volume recovery contribute to diagnosis accuracy and a better treatment follow-up time-reference in the oncological clinic.

3.IMPLEMENTING IMAGE-GUIDED BRACHYTHERAPY FOR CERVIX CANCER: OUR DOSIMETRIC DATA COMPARATIVE ANALYSIS AND CLINICAL IMPACT LITERATURE REVIEW

Georgescu Mihai-Teodor1, Tanase Alina2, Dumitrache Mihai2, Ileanu Bogdan3, Anghel Rodica1,4

1) University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania; 2) Emergency Central Military Hospital “Carol Davila” Bucharest, Romania; 3) The Bucharest University of Economic Studies, Romania,4Institute of Oncology “Prof. Dr. Al. Trestioreanu” Bucharest, Romania

Purpose: We report the results of our analysis comparing cervix cancer CT based and conventional brachytherapy dosimetric data. Also, we are presenting a review of the most important literature data regarding the clinical impact of image-guided brachytherapy for cervix cancer and for the local organs at risk (OAR).

Materials and methods: Thirty-two patients diagnosed with cervix cancer and treated between September 2013 and January 2016 were enrolled in our study, resulting in 62 brachytherapy plans. All patients were treated using Ir192 HDR afterloading system and a Fletcher Tandem-ovoids applicator. On the CT images the target volumes and the organs at risk were contoured. Also, the ICRU38 points were marked. The dose was prescribed for point A. Dose-volume histogram(DVH) data were compared with conventional ICRU38 and sigmoid point dose results for both the target volumes (D90, D100) and the organs at risk (D0.1cc, D1cc, D2cc, D3cc, D5cc). For the literature review we included the data reported by 15 studies on cervix

cancer image guided-brachytherapy focusing on dose rates, brachytherapy technique, local control, overall survival and late associated toxicity.

Results: Mean D90 and D100 results were at least 25% lower than the pointA prescribed dose. For the OAR’s D2cc mean doses were determined on the DVH to be with more than 100cGy higher than the ICRU reference point doses. Literature data report median local control and overall survival rates of 89.5% (+/-10.5%), 85% (+/-11%) respectively. Also in none of these studies grade 3 toxicity exceeded 10%.

Conclusion: Besides other advantages our study data confirm that compared to conventional planning, image-guided brachytherapy improves tumor coverage while decreasing the dose to the critical organs. Also, literature clinical data results confirm that these patients will benefit by significant improvement in local control and overall survival, without significant influence on their quality of life.

4. A MULTIVARIATE ANALYSIS OF SOME BIOMARKERS AS PROGNOSTIC FACTORS IN METASTATIC COLORECTAL CANCERS

Gabriela Chereches1, Otilia Barbos1, R. Buiga1, O.Balacescu1, Dana Iancu1, N. Todor1, Loredana Balacescu1, N. Miron3, Simona Ilcu-Slaniceanu4, T.E.Ciuleanu1,2

1) Oncologycal Institute „I. Chiricuta” Cluj-Napoca; 2) UMF “Iuliu Hatieganu” Cluj; 3) Gastroenterology Institute, Cluj-Napoca, Romania; 4) Santomar Oncodiagnostic Laboratory, Cluj-Napoca, Romania

Purpose: The aim of this study is to investigate new biomarkers for the follow-up of patients with colorectal cancers (CRC) receiving combined therapy. The biomarkers chosen to be studied are circulating tumor cells (CTCs) and serum biomarkers as: transthyretin (TRT), α-enolase (NNE), β2- microglobuline , B cell activating factor ( BAFF) which are not yet included in any official guideline for CRC follow-up.

Materials and methods: 72 patients with metastatic colorectal cancer (mCRC) were recruited in the period 21.02.2012-20.07.2015, blood samples were taken before chemotherapy. The molecular biomarkers were determined by ELISA technique. A manual method was used for the identification of CTCs, involving hemolysis followed by cytospin centrifugation and immunocytochemical staining for pan-citokeratin. Statistical analysis was reported at 24 months follow-up using Kaplan-Meier method and cut-off values were proposed for each marker.

Results: Patients with higher than cut-off values for transthyretin-TRT (400 mg/L) and α-enolase -NNE (40ng/ml) had a higher survival rate (SV24) at 24 months (p<0.01).

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β2-microglobuline levels lower than cut-off (3,7 mg/L) were significant (p<0.01) and had a negative impact on prognostic. Patients with B cell activating factor-BAFF marker levels lower than cut-off (1385pg/ml) had also a poor survival rate (p<0.01). A cut-off value of 1 CTC/1 ml of whole blood (6 CTCs/6 ml) was chosen for the correlation with SV24 and PFS. SV24 was 74 % in patients under the cut-off value and 64% in those over this cut-off value, p=0.15, NS .PFS was 66 % and 50% respectively, also without statistically significance p=0.19, NS.

Conclusions: Although multivariate analysis was retained only for β2- micro, we cannot deny the significance of individual biomarkers. A negative correlation was observed between the number of CTCs and the therapeutic outcome (SV24 and PFS), but this relationship didn’t reached the level of significance.

Acknowledgements: This work was supported by the PN-II-ID-PCE-2011-3- 0753 UEFISCDI and 137/2014 (CTC-Videoscope) PN-II-PT-PCCA-2013-4-2289 grants

5. CHITOSAN GOLD NANOPARTICLES WITH OR WITHOUT METFORMIN IN THE TREATMENT OF GLIOBLASTOMA

Mihaela Aldea1, Olga Soritau2, Ioana Brie1,2, Monica Potara3, Gabriel Kacso1,4

1) UMF „Iuliu Hatieganu” Cluj,Romania; 2) Institutul Oncologic „Prof Dr Ion Chiricuta” Cluj; 3) UBB, Institutul de Cercetari Interdisciplinare In Bio-Nano-Stiinte; 4) RTC Amethyst Cluj

Introduction: Glioblastoma is the most aggressive brain cancer, with a dismal prognosis of nearly 15 months despite multimodal treatments. Nano-therapies appear as an appealing strategy, as they could overcome natural barriers and increase drug delivery. Moreover, gold nanoparticles could be efficient as they may enhance the radiotherapy response of glioma cells.

Materials and methods: Here, we report our pilot study in glioblastoma cell cultures in which we synthetise novel gold nanoparticles (GNPs) for radiosensitization. Chitosan GNPs were developed and loaded with metformin. Their size, zeta potential and stability were characterised and their internalisation within tumor cells was assayed through dark field microscopy. Three primary glioblastoma cell lines were treated with GNP loaded chitosan and metformin and free drugs, followed by irradiation in three fractions of 1 and 2 Gy. The effect was evaluated through cell viability tests with MTT and tripan blue-based counting.

Results: Chitosan-based gold nanoparticles and metformin-loaded were 25 nm in size, with a nearly neutral zeta potential and superior cell internalisation compared to simple GNPs. Cell viability proved to be mostly affected

by the 80yM metformin-loaded and chitosan GNPs, while remaining unaffected by metformin and minimally affected by simple GNP used in similar concentrations. Intriguingly, all three glioblastoma cell lines were radioresistant and the combined treatment of GNP and radiotherapy was cytotoxic only due to drug-loaded GNPs.

Conclusion: The novelty of this study is the successful synthesis of chitosan GNPs with a higher MET loading and this formulation exhibited better targeted delivery as well as increased regression activity than free MET in GBM cells. Surprisingly, GNP-chitosan and metformin-loaded GNP were highly cytotoxic to glioma cell lines irrespective of irradiation.

Acknowledgements:This work is supported by UEFISCDI, Romania: The “ENERGY” Project (PNII-RU-TE-2014-4-0225) entitled « Nanotechnology guided Anti-angiogenic Radiotherapy – a new approach for Glioblastoma » .

6. LARGER BOOST TO PRIMARY RECTAL CANCER COULD IMPROVE PROGNOSTIC SIGNIFICANCE OF COMPLETE REMISSION OF RECTAL CANCER AFTER NEOADJUVANT TREATMENT

Chiricuta Ion Christian

AMETHYST, Otopeni

Introduction:The status of downstaged pathologic stage after neoadjuvant chemoradiation is an important factor for oncologic outcomes. However, to date, few studies have investigated oncologic outcomes according to postirradiated, postoperative pathologic stages and clinical factors affecting survival in locally advanced and fixed rectal cancer.

Therefore, the purpose of our presentation is to report on the oncologic outcomes according to pathologic stages and the clinical factors affecting survival in patients who underwent neo-adjuvant chemo-radiotherapy with larger boost dose followed by curative resection local advanced rectal cancer.

Material and method: Chemotherapy was administered during the radiotherapy. Radiation treatment was administered with a 6MV photon linear accelerator using the VMAT technique. The total radiation dosage was 50 – 50,4 Gy in 25 - 28 fractions with a simultaneous boost of 6 - 10 Gy delivered in 2,0 - 2,3 Gy over 5 - 6 weeks. The clinical target volume included the mesorectum, the primary tumor and the pelvic lymphatics with the upper margin was 1.5 cm above the sacral promontory (L5 level), lateral margin was 1.5 cm laterally from the pelvic lateral wall, and lower margin was 3 cm below the lower margin of the tumor.

Results: Neo-adjuvant chemo-radiotherapy is a safe multimodality treatment of fixed, locally advanced rectal

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cancer. We present our cases with down-staging and complete pathological response. Patients who showed pathologic complete remission had an excellent prognosis.

Conclusion: For better oncologic outcomes additional treatment modalities enhancing the down-staging should be investigated for locally advanced rectal cancer.

7. HOW MUCH WE CAN TRUST IN THE NCCN RECOMMENDATIONS FOR ANAL CANCER PATIENTS TO IMPROVE THE LOCAL CONTROL RATES?

Chiricuta Ion Christian

AMETHYST Radiotherapy Center

The treatment of cancer of the anal canal has changed significantly over the past several decades.

A therapeutic paradigm shift occurred with the seminal work of Nigro, who reported that anal canal cancer could be treated with definitive chemo-radiation, with APR reserved for salvage therapy only. This remains an attractive approach for patients and physicians alike and the standard of care in this disease.

Now, nearly four decades later, a similar approach continues to be utilized, albeit with higher radiation doses; however, this strategy remains fraught with considerable treatment-related morbidities and high local recurrence rates larger than 20%.

With the advent of intensity-modulated radiation therapy (IMRT), many oncologists are beginning to utilize this technology in the treatment of anal cancer in order to decrease these toxicities while maintaining similar treatment efficacy.

We present the relevant literature and our own data leading up to the modern treatment of anal canal cancer and discuss IMRT-related toxicity and disease-related outcomes in the context of outcomes of conventionally treated anal cancer.

Despite of improving radiotherapy irradiation techniques the total dose is limited to less than 60 Gy/2 Gy/ fraction to the primary tumor. The local recurrence rate is higher than 20%.

From our own experience for T3 and T4 primaries and for involved lymphatic areas larger total dose than that the NCCN recommended is necessary to improve the local control rate.

8. STATE OF THE ART: RADIOTHERAPY IN GYNECOLOGICAL CANCERS.

Ovidiu Coza1,2

1) University of Medicine and Pharmacy „Iuliu Hatieganu”; 2) The Oncology Institute „Ion Chiricuta”

Gynecologic cancers represent a significant cause of death in women worldwide, coming in second place after breast cancer both in incidence and mortality.

Radiotherapy (RT) is considered as a corner stone of cancer treatment, and more than 50% of cancer patients will experiment RT at least once during their treatment. The standard-of-care treatment for primary and recurrent gynecologic malignancies consists of external-beam radiation followed by brachytherapy. Technical innovation in radiation therapy such as stereotactic irradiation, intensity modulated RT, image-guided RT, and brachytherapy using remote controlled after-loading system, have made it possible to deliver ideally distributed radiation dose to the target with great accuracy, while sparing the adjacent organs at risk. As a result, tumor control rate by RT improved markedly and became excellent alternative to surgery in early stages. In locally advanced disease, randomized controlled trials established chemo-radiation as a standard treatment option for cervical cancer.

Intensity modulated whole pelvic radiation therapy (IM-WPRT) shows great promise in the treatment of gynecological malignancies by delivering therapeutic doses of irradiation with significantly greater sparing of normal tissues. Early studies show lower incidences of morbidities than for conventional 3D-CRT for patients treated for uterine and cervical cancer in the adjuvant setting and for uterine cancer in the definitive setting. For patients being treated definitively for cervical cancer, IM-WPRT should be used only as part of a clinical trial. Current trials will hopefully provide more evidence as to its feasibility, efficacy, and toxicity profile.

9. A RARE CASE OF PRIMARY MEDIASTINAL GERM CELL TUMOR.

Chira Romeo Ioan1, Florea Alina Silvia2, Crisan Doinita3, Popovici Bogdan Ioan4

1) 1st Medical Clinic Cluj Napoca, “Iuliu Hatieganu” University of Medicine and Pharmacy Cluj-Napoca, Romania; 2) The Oncology Institute “Prof. Dr. Ion Chiricuţă; 3) Clinical Emergency Hospital- Pathology Department- Cluj-Napoca; 4) Clinical Hospital of Pneumology- Thoracic Surgery Department, „Leon Daniello”, Cluj-Napoca

Background: Extragonadal germ cell tumors (GCTs) are relatively uncommon and represent 1% to 5% of all germ cell tumors. Their morphology varies widely and includes mature teratoma, immature teratoma, seminoma, yolk sac tumor, embryonal carcinoma, choriocarcinoma, and mixed GCTs . Extragonadal GCTs typically arise in midline locations. In adults, the most common sites, in order of frequency, are the anterior mediastinum, retroperitoneum, and the pineal and suprasellar regions . Primary mediastinal nonseminomatous

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germ cell tumors are uncommon neoplasms and clinically and biologically distinct from other germ cell tumors . Most extragonadal GCTs are diagnosed based upon a needle or open biopsy. The tissue sample is needed for diagnosis before initiating treatment. About 40% of these patients can envisage long-term survival with modern therapy that includes cisplatin-based chemotherapy followed by surgical resection of residual masses.

Case presentation: A 31 year-old man was referred to our hospital for US guided fine-needle trans-thoracic biopsy to establish the histological origin of a left anterior mediastinal tumor. The voluminous mass was in tight contact to main structures of the anterior mediastinum such as the pericardium, aorta or left pulmonary artery, accompanied by massive pleural effusion causing left lung atelectasia. Symptoms such as progressive dyspnea, fever and asthenia were the ones leading to further investigations. The biopsy fragment turned out to be part of a mediastinal Yolk sac tumor, one of the non-seminomatous GCT with extragonadal location. An elevated value of the highly specific tumor marker AFP enhanced the diagnostic. After a complete pre-evaluation, with a ECOG performance scale=1, our patient began first line chemotherapy (BEP protocol) for primary mediastinal nonseminomatous GCT, followed by VEIP protocol as second line chemotherapy. At the present moment, our patient has underwent surgical resection of the residual mass still present in the mediastinum after chemotherapy completion, with a favorable evolution.

Conclusion: Extragonadal GCTs remain uncommon, rare findings in our everyday practice. Diagnostic and treatment are the result of several medical specialties working together, biological and imagistic investigations leading to US guided fine needle biopsy, a precise histological result followed by oncological, even surgical treatment. Details and attention are especially required in such rare cases, as information regarding mediastinal Yolk sac tumors is available from several case reports, not extensive data.

10. SYSTEMIC TREATMENT OPTIONS IN PANCREATIC ADENOCARCINOMA

SM Ilie1,2, RM Anghel1,2

1) Institute of Oncology Prof Dr.Alexandru Trestioreanu Bucharest; 2) University of Medicine Carol Davila Bucharest

Background:For 95% of pancreatic cancer represented by adenocarcinoma, Gemcitabine is the corner stone of systemic treatment, since 1997. Standard recommendations are recently in favor of 5FU –Oxaliplatin –Irinotecan combination, either in adjuvant or metastatic setting. To date, immunotherapy or targeted therapies are disappointing. Thus, five year survival rate remains below 5%. As

cytotoxics remain the only valid therapeutic option, it is questionable which the best sequence in systemic treatment strategy is.

Material and method: We did a general review regarding pancreatic adenocarcinoma new and future therapeutic options.

Results: In borderline resectable disease, FOLFIRINOX regimen showed an objective rate of 30-45%; nevertheless Gemcitabine induction followed by chemo-radiation seems promising. The results of a phase III study, assessing the triple association against standard adjuvant 6 cycles of Gemcitabine are pending. Platinum based adjuvant chemotherapy is an option in BRCA mutation carriers. ESPAC 4 trial results showed a 12% improvement in 5 year estimated survival rate, by adding Capecitabine to standard treatment with more common reported severe diarrhea.

Even though the standard of care in locally non resectable advanced disease remains Gemcitabine centered, 5FU –Oxaliplatin –Irinothecan gains ground in ECOG 0-1 population, in metastatic setting too. Due to a poor PS prevalence in metastatic stage, nab-Paclitaxel-Gemcitabine less toxic combination has been assessed, showing a 2 months gain. In Gemcitabine refractory disease, Oxaliplatine containing regimens might be considered. In spite of PDL-1 expression in 40% pancreatic cancer cells, tumor environment being highly immune suppressive, single agent immune checkpoint blockade proved to be ineffective. Rare MSI bearing condition might respond to Pembrolizumab. Several phase I/II studies, assessing combinations with others immune checkpoint blockers or standard anticancer agent, giving close attention to high immune- and myelotoxicties, are on-going.

Conclusions: Nowadays, there is a tendency toward recommending 5FU triplet chemotherapy in fit patient with limited availability of head-to-head comparative trial with Gemcitabine containing regimens, in any stage of disease. Single agent Gemcitabine remains the option for poor performance status patients. Several ongoing studies are searching for efficacy of immunotherapy. The best treatment approach is still to be established.

11. INTRAOPERATIVE RADIATION THERAPY - LOOKING BACK TO 4 YEARS OF EXPERIENCE AT UNIVERSITY HOSPITAL IN BERN, SWITZERLAND

Codruta Ionescu1, Christina Lössl1, Daniel Aebersold1

1) Department of Radiation Oncology, University of Bern, Switzerland

Purpose: Intraoperative Radiation Therapy (IORT) offers the opportunity to apply a „eye-guided“ boost directly

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in the tumor bed, right after tumor has been removed. The IORT offers the biological advantages of a highly effective single high dose in a biological favorable environment, without hypoxia and cell repopulation. Our aim was to check feasibility of this procedure and after that implementation in our department.

Method: In 2012 we build up the technical infrastructure – operation room in accordance to radiation protection regulations, HDR-Brachytherapy using an afterloading device and Freiburg Flaps- also we defined the logistical back up and work flow for the complex collaboration between surgeons, radiation oncologists, anesthetists, physicists and radiotherapist.

Results: During the past 4 years 94 patients have been treated with IORT: 50 women and 45 men, aged 18 to 84 years, mean 62 . The indications were: sarcomas (62%), including extremity (ES), superficial trunk (TS) and retroperitoneal (RPS): 33%, 18% and 11% respectively and others 38%, including recurrence of rectum carcinoma, pancreas carcinoma and gynecological tumors after previous radiation therapy. Among sarcomas, 50% were treated in neoadjuvant setting; 32% were outpatients after „Whoops“ R1/R2 resections, who received IORT during the re-resection. After completing treatment patients are followed up every 3 months. Median time after treatment was 22 months. 84 Patients are alive, 1 patient with RPS died peri-operatively because of mesenteric vein thrombosis, 8 died of disease progression (systemic), 1 was lost in the follow up. 72 patients are free of disease, 9 are alive with systemic progression, 1 with systemic and local progress, who needed amputation. There were no grade 3 or 4 complications due to IORT.

Conclusion: IORT is feasible and now has been integrated into our standard treatment for sarcomas. The results are encouraging but long time follow up is needed to evaluate the outcome and late effects of this method.

12. A PARALLEL ROBOTIC SYSTEM MIGHT INCREASE BRACHYTHERAPY AVAILABILITY AND REPRODUCIBILITY- THE CLUJ CHANCE CONCEPT

Gabriel Kacso1,2, Edina Dordai3, Bogdan Petrut1,3, Zeno Sparchez1,4, Nicolae Crisan1,5, Doina Pisla5, Ina Maria Kacso1,6

1) UMF „Iuliu Hatieganu” Cluj, Romania; 2) RTC Amethyst Cluj; 3) Institutul Oncologic „Prof Dr Ion Chiricuta” Cluj; 4) IRGH „Octavian Fodor” Cluj; 5) Universitatea Tehnica Cluj Napoca; 6) Clinica Nefrologie „Mihai Manasia” Cluj

Introduction: Interstitial brachytherapy has many indications as standard treatment in oncology, in curative

or palliative setting. Its’ current use is however limited, due to lack of specialist and decreasing training during the residency program.

Material & methods: In a trans- disciplinary consortium we analyzed the optimal characteristics of a robot to be implemented in the medical environment. Various models -regarding size, degree of freedom (DOF), interface, sensors, and kinematics - were tested in several virtual medical scenarios having real interstitial brachytherapy indications (head and neck, breast, lung, liver, kidney, prostate, ano-rectal cancers). We tested the accuracy of positioning as well as reproducibility of hitting a predefined target while avoiding vicinity structures, at different depths.

Results: A 5-DOF parallel robot was constructed, fitting in the CT gantry, with universal ability of needle placement (biopsy or interstitial brachytherapy). The one axis accuracy in air was below 2 mm at less than 5 cm depth but increased above the 3 mm predefined threshold of needed precision in moulds at 5 cm depth in tridimensional scale. Needle grip rigidity and real-time tracking and adjustments are needed to improve the in depth needle deviation.

Conclusion: Robotic brachytherapy might increase brachytherapy availability and reproducibility.

This work is supported by UEFISCDI, Romania ( the “CHANCE” Pro jec t no . 173 /2012 , PN-II-PCCA-2011-3.2-0414, entitled „Robotic assisted brachytherapy, an innovative approach of inoperable cancers”).

13. STATE OF THE ART IN GYNECOLOGIC CANCERS CHEMOTHERAPY

Viorica Magdalena Nagy1

1) UMPh „Iuliu Hatieganu”, Institute of Oncology „Prof Dr Ion Chiricuta” Cluj-Napoca

Significant recent developments and trends in chemotherapy for major gynecologic malignancies, i.e., ovarian cancer, endometrial cancer, uterine sarcomas and cervical cancer are presented. In ovarian cancer, chemotherapeutic options for early, advanced and recurrent disease are in the adjuvant setting as well as in the neoadjuvant setting are explored. For uterine cancer, adjuvant chemotherapy is employed for high risk epithelial subtypes with early disease, such as uterine papillary serous carcinomas, uterine carcinosarcomas and leiomyosarcomas, advanced stage cases, as well as recurrent disease. Chemotherapy is utilized in cervical cancer as neo-adjuvant therapy prior to surgery or radiation, as a sensitizer concomitantly with radiation therapy or for the treatment of advanced and recurrent disease.

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14. INTERSTITIAL BRACHYTHERAPY IN LOCALLY ADVANCED CERVICAL CANCER, THE AMETHYST CLUJ PRELIMINARY RESULTS

Sipos Anamaria1, Catalin Iacob1, Dan Dordai1, Noemi Schultes1, Gabriel Kacso1,2

1) Amethyst Radiotherapy Center Cluj, Cluj-Napoca; 2) University of Medicine and Pharmacy “Iuliu Hatieganu” , Cluj-Napoca.

Purpose: Concurrent chemo-radiation (CRT) including brachytherapy (BT) is the cornerstone in primary treatment of locally advanced cervical cancer. For tumors with parametrial involvement, the Fletcher applicator may not provide adequate dosimetric coverage of the high risk clinical target volume (HR CTV) in the parametrial region. Combined intracavitary and interstitial BT, using Utrecht applicator with interstitial needles placed in the parametrial residual disease, improves target coverage.

Material and method: Between Jan and June 2016, in Amethyst Radiotherapy Center Cluj , 17 patients with stage IIB-IV(FIGO) cervical cancer were treated with combined intracavitary and interstitial BT. Five patients received 3 or 4 cycles of neo-adjuvant chemotherapy (NACT). All were treated with IMRT/VMAT to a total dose(TD) of 45-50,4Gy/25-28fr, 1,8-2Gy/fr on the pelvis and 54 – 62Gy/25- 29fr boost(sequentially or SIB) on the CT/ MRI pathological lymph nodes . Concomitant chemotherapy was added using Cisplatin or Carboplatin. Pelvis MRI was performed before EBRT also in the last week of EBRT, before BT, to evaluate the residual local disease. The TD given by BT was 27-28Gy/4fr (BT/EQD2 37,8-39,7Gy), 2fr/week. Utrecht applicator and usually 1 to 3 interstitial needles on each side were used in mild anesthesia. CT – scan was performed for every application. Treatment plan optimization was done with the Oncentra Brachy TPS (Elekta ). The HR CTV (the residual GTV), IR CTV and OAR, were contoured according to guidelines (GEC and GEC-ESTRO). The HR CTV received a TD between 84 - 89.2 Gy EQD2 (EBRT+BT).

Results: Combined intracavitary and interstitial BT achieved better dosimetric coverage, allowing the HR CTV to be above 84 Gy and improving local control . Patients with locally advanced cervical cancer and who remained with parametrial residual disease post CRT would benefit the most from interstitial cervical brachytherapy, without increasing the toxicity for OAR.

Conclusion: The intracavitary and interstitial cervical BT should be the preferred method for patients with residual parametrial disease post CRT, given the superior dosimetric coverage translating into higher local control rates.

15. NEO-ADJUVANT CHEMO-RADIATION WITH ESCALATED DOSE IN LOCALLY ADVANCED RECTAL CANCER

Daniela Sturzu1, Renata Zahu1, Catalin Iacob1, Anamaria Sipos1, Ovidiu Bunta1, Dan Dordai1, Noemi Schultes1, Andrea Eva1, Gabriel Kacso1,2

1) RTC Amethyst Cluj; 2) UMF „Iuliu Hatieganu” Cluj, Romania

Purpose: To assess the impact of escalated dose of neo-adjuvant radiotherapy (RT) on the circumferential resection margins (CRM) in patients with locally advanced rectal cancer.

Material and method: From 2015 to 2016, at RTC Amethyst Cluj, all patients with MRI staged T3/T4 and or N+ rectal cancer and threatened CRM were treated with preoperative intensified RT associated to concurrent chemotherapy with Capecitabine. A total dose of 50.4 Gy was delivered to the entire mesorectum and the boost (sequential or simultaneous) up to 54-56Gy on the tumor areas in contact/ close proximity(<5 mm) to the mesorectal fascia (MRF). A positive CRM was defined as tumor < 1mm from the margin on the final pathological report of the radical surgery.

Results: Ten patients fulfilled the criteria. This assessment includes both cancer deposits within a lymph node as well as direct tumor extension. All patients completed the intended treatment. Of them, 80% were clinical T3 and 20% were T4, whereas 60% were N2 and 40% N1. On the pre-treatment pelvic MRI, 70% of patients had infiltrated MRF and 30% had tumor/ lymph nodes less than 5 mm from it. Down-staging was achieved in half of the patients. There were no severe GU or GI acute toxicities. All patients underwent radical surgery with 90% “Ro” resections (a single R1, for a T4 case- at prostate level of invasion).

Conclusions: an 10 % increased of RT dose to risk areas in proximity/ contact with the mesorectal fascia/ improves the probability of “Ro” resections.

16. DOSIMETRIC COMPARISON OF BONE MARROW-SPARING VMAT RADIOTHERAPY VERSUS CONVENTIONAL TECHNIQUE FOR TREATMENT OF CERVICAL CANCER

Renata Zahu1, Gabriel Kacso1,2, Catalin Iacob1, Andrea Eva1, Noemi Schultes1, Diana Trandafir1, Dan Dordai1

1) Amethyst Radiotherapy Center Cluj; 2) Univerisity of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj

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Purpose:To compare bone marrow-sparing volume modulated arc therapy (BMS-VMAT) with no intention to spare bone marrow VMAT (No-BMS-VMAT) plans versus conventional (four-field box ) techniques in the treatment of cervical cancer.

Material and method: The data from 5 cervical cancer patients treated with concurrent chemotherapy and pelvic radiotherapy were analyzed We have created VMAT plans with and without the intention to spare de bone marrow and compared the dosimetric data using four-field box. All plans were normalized to cover the planning target volume with the 98% isodose line. The clinical target volume consisted of the pelvic and presacral lymph nodes, uterus and cervix, upper vagina, and parametrial tissue. Normal tissues included bowel, bladder, and pelvic bone marrow (PBM), which comprised the lumbosacral spine , the iliac, ischial and pubic bone as well as the proximal femora (lower pelvis bone marrow). Dose-volume histograms for the planning target volume and normal tissues were compared for BMS-VMAT, No-BMS-VMAT vs. four-field box.

Results: For each of the 5 patients, BMS-VMAT treatment plans demonstrated a reduction of the volume of BM receiving >40% (18 Gy) of the prescription dose (45 Gy) compared with both No BMS-WPRT and four-field treatment. While the difference in dose reduction was not large for No BMS-VMAT, it was significant compared to conventional technique. VMAT plans were superior to the four-field box technique in reducing the dose to small bowel, rectum, and bladder.

Conclusion: BMS-VMAT reduced irradiation of pelvic bone marrow compared with the four-field box technique, therefore BMS-VMAT might reduce acute hematologic toxicity.

17. THE EFFICACY OF PALLIATIVE PELVIC RADIOTHERAPY.THE EXPERIENCE OF RADIOTHERAPY DEPARTMENT, “SF. AP. ANDREI” EMERGENCY CLINICAL HOSPITAL GALATI

Laura Rebegea1,2, Mihaela Dumitru1, Dorel Firescu3,4, Diana Craita1

1) “Sf. Ap. Andrei”- Emergency Clinical Hospital Galati, Radiotherapy Department; 2) “Dunarea de Jos” Galati University, Faculty of Medicine and Pharmacy, Medical Clinical Department; 3) “Dunarea de Jos” Galati University, Faculty of Medicine and Pharmacy, Surgical Clinical Department; 4) “Sf. Ap. Andrei” Emergency Clinical Hospital Galati, IInd Surgery Clinic

Introduction: The incidence of colorectal neoplasms, prostate and bladder cancer is growing due to continued

growth in the expectancy of life, access to various methods of treatment (hormone therapy, biological, chemotherapy) in patients with advanced disease, may be obtained survive for several months or years. The palliative pelvic radiotherapy is indicated for pain, bleeding, urethral obstruction and improve quality of life. The study objective was to assess the short and medium term palliative radiotherapy efficacy in patients with inoperable locally advanced disease because the present symptoms.

Material and method: In this study had been included 86 patients, median age was 68.5 years (range 46-88 years) diagnosed with cancer of the prostate (13.95%), bladder (19.77%) and rectum (66.28%) that performed pelvic palliative radiotherapy from January 2011 to December 2015 in Radiotherapy Department of “Sf. Ap. Andrei”- Emergency Clinical Hospital Galati. The patients were predominantly male in 76% of cases. In 24.42% of cases was presented hematuria, 36.05% rectal bleeding, 23 patients (30.23%) urethral obstruction and 39.35% painful pelvic syndrome. Palliative radiotherapy was performed with the Theratron Elite 100 unit. Fractionation schemes used were DT = 30 Gy / 10fr, d / fr = 3Gy in 43 of cases (50% of cases), DT = 40 Gy / 20fr, d / fr = 2Gy in 6 of cases with RC (6,98%), DT=50Gy/25fr, d/fr=2Gy in 23 of the cases with RC (26,74%) and 14 patients(16,28%) were conducted incomplete radiotherapy.

Results: Symptom control was assessed 4 weeks after completion of radiation therapy. Eight patients were lost to follow-up after therapy. Median follow-up therapy was 42 months (range 10-60 months). Overall survival was 29% at 1 year. Pain control was achieved in 76.47% of cases. Pain recurrence occurred in 30% of cases. At 85.71% was obtained controlling hematuria, and 4 patients have manifested hematuria recurrence. For 82.35% of the cases rectal bleeding was controlled and in 2 cases this symptom recurred. For 73.91% of the cases of urethral obstruction was achieved good palliation and in 39.13% of cases manifested recurrence of urethral obstruction.

Conclusions: Pelvic palliative radiation therapy is a therapeutic option that allows advanced pelvic tumor control symptoms (bleeding, obstruction, pain) in patients who are not candidates for surgery, treatment with an acceptable toxicity profile. Long-term toxicity is difficult to quantify so more studies still need to be proceeded in order to define optimal doses, fractionation regimens.

18. THE PSYCHOLOGICAL ASSISTANCE OF THE PROSTATE CANCER PATIENTS

Oana Hetea1, Renata Zahu1, A. Ungureanu1, V. Manolescu1, C. Iacob1, G. Kacso1,2

1) RTC Amethyst Cluj-Napoca; 2) UMF “Iuliu Hatieganu” Cluj-Napoca

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Prostate cancer patients can go through negative emotional states, of a multifactor nature, both psychological and social or spiritual. This emotional distress can interfere with the patients’ ability to cope with the cancer, the physical symptoms and even the treatment.

The present paper intends to show the effects of the psychotherapeutic intervention in diminishing the emotional distress in patients with prostate cancer and implicitly in the preservation of the quality of life at a high level.

The research is an experimental one, of the pre-testing/post-testing type with a control group. 50 patients (average age, 62) participated into the study, all suffering from prostate cancer in treatment at the Amethyst Radiotherapy Centre in Cluj. They completed specific psychological tests before and after the treatment. The efficacy of the psychological intervention was checked by comparing the scores obtained before the intervention with the scores obtained after the intervention.

The results show a significant difference in the scores obtained by patients after the psychological intervention in the sense that the emotional distress was significantly reduced and implicitly the quality of life significantly increased.

19. PROS (PATIENT REPORTED OUTCOMES) IN PROSTATE CANCER TREATMENT

Vlad Alexandru Manolescu1, Oana Hetea1, Irina Mateies1, Gabriel Kacso1,2

1) RTC Amethyst Cluj-Napoca; 2) University of Medicine and Pharmacy“Iuliu Hatieganu” Cluj

Background: The value of PROs (patient reported outcomes) has been recently pointed out by oncology quality of life studies. Oncologists either miss or underestimate various symptoms or treatment related side effects experienced by the patients.

Material and methods: “Quality of Life Project” is a online application developed in order to transfer and analyze weekly PRO questionnaires (QLQ-C30 +QLQ-PR25) completed by patients with early prostate cancer treated in Amethyst Radiotherapy Center Cluj, during radiation therapy with curative intent. Data from 26 patients enrolled in the initial phase of the project were collected between August 2015 and July 2016.

Results: The interim analysis was performed in August 2016 in order to identify strengths of the observational prospective study and possible barriers and methods of improvement. The identified strong points were: better and earlier detection of clinical symptoms compared to those identified during regular medical visits and improvement

of psycho-emotional status of the patient during treatment period. The median number of questionnaires completed by one patient during radiotherapy for prostate cancer was 7. Median time for completion of one questionnaire by the patient was 15 minutes; median online data transfer time by study nurse was 3 minutes. Median decisional analysis and intervention design time for one questionnaire was 15 minutes. The identified weak points are: time consuming method and involvement of many of the clinics’ resources: front desk personnel, study nurses, doctors, psychologist and nutritionist.

Conclusion: “Quality of Life Project” facilitates collection of patient filtered data, essential for better symptom management. Although aspects that need to be reviewed were identified; this application improves patient-doctor communication.

20. NUTRITION MANAGEMENT FOR COLORECTAL CANCER PATIENTS

Mateies Ioana Irina

Amethyst Radiotherapy Center Cluj-Napoca

Cancers of the colon and rectum are one of the most common tumor types worldwide. Cancer cachexia syndrome is highly prevalent among patients with colorectal cancer, has a large impact on morbidity and mortality and on patient quality of life. Early nutritional intervention has been shown to halt malnutrition and may improve outcome in some patients.

This paper discusses the nutritional management of the commonly experienced symptoms, as a result of the combined modality of treatment for colorectal cancer patient and the diet and lifestyle recommendations for the colorectal cancer survivors.

The goals of nutritional support in patients with colorectal cancer are to improve nutritional status to allow initiation and completion of anticancer therapies and improve quality of life. Nutritional support, as part of the multimodal treatment of the oncological patient, should begin at the time of diagnostic and continue throughout the treatment period. The strategies for nutritional support include nutritional advice, diet modification, oral nutritional supplements, enteral and parenteral nutrition.

The colorectal cancer patients undergoing various cancer treatment regimens face many nutrition related problems. The dietary interventions planned for them should be adequate enough to prevent nutritional complications during each step of the treatment and the food habits should be under check, so that we can help the patient maintain or improve his nutritional status, quality of life and possibly, the clinical outcome.

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21. HISTOPATHOLOGY: FRIEND AND ENEMY OF MEDICAL ONCOLOGIST

Vlad-Adrian Afrăsânie1, Eva Cojocaru1, Simona Costin1, Lucian Miron1,2

1) Medical Oncology Department, Regional Institute of Oncology, Iaşi, Romania; 2) “Grigore T. Popa” University of Medicine and Pharmacy, Iaşi, Romania

Residents in oncology / Oral presentation

Introduction: The pathologic diagnosis has an overwhelming importance in oncology, with great impact over prognostic, treatment and survival of the patient. Although, the accuracy of this method is very high, diagnostic errors can be present in 5-10% of cases.

Case presentation: We present the case of a 71 years old man, heavy smoker, who was diagnosed in March 2015 with squamous cell carcinoma of the lung. The thoraco-abdominal CT scan described a tumor in the right lobe of the lung of 50/60/50 mm. Subsequently, a right inferior lobectomy was performed and the histopathological examination confirmed the diagnosis and revealed a pT2N0G2 stage . Vascular, perineural and visceral pleura invasion also were described. In April 2015, we initiated adjuvant chemotherapy with Cisplatin and Vinorelbine. Four cycles were administered from April 2015 to July 2015. After 14 months, in May 2016, the thoracic CT scan described multiple pulmonary nodules and a laryngeal tumor. A laryngoscopy with biopsy was performed and the pathologic exam diagnosed a secondary lesion of squamous cell carcinoma. Despite of the histopathologic diagnosis, we considered the laryngeal tumor a second cancer not a metastasis. Our decision was based on the fact that laryngeal metastasis in patients with stage IV lung cancer are extremely rare – only 1%. Also, the patient is a heavy smoker and this secondary cancer can be explained with the concept called field cancerization. For these reasons, we asked a second opinion from another pathologist who confirmed our hypothesis. In June 2016 we initiated chemotherapy with Carboplatin and Paclitaxel. In September the thoracic CT scan indicated us a partial response of the disease.

Conclusions: In some cases histopathological examination can misdiagnose cancer. Medical oncologists play an essential role in error reduction because they can correlate the clinical information with the histopathologic findings.

22. THE PROGNOSTIC AND PREDICTIVE VALUE OF SQUAMOUS CELL CARCINOMA ANTIGEN IN LOCALLY ADVANCED CERVICAL CANCER

Ardelean Simona Andreea1, Marita Andreea1, Carpov Domnica1, Todor Nicolae1, Nagy Viorica1,2

1) ”Prof.Dr. Ion Chiricuta” Oncology Institute, Cluj-Napoca; 2) ”Iuliu Hatieganu” University of Medicine and Pharmacy

Residents in oncology / Oral presentation

Purpose/Objective: Squamous cell carcinoma antigen is the most commonly used serum tumor marker for squamous cell cervical cancer. The clinical importance of SCCAg is still being disputed.The aim of this study is to reveal the prognostic and predictive value of squamous cell carcinoma antigen in locally advanced cervical cancer by correlating the pre and post-therapeutic value of AgScc with general survival and disease free survival.

Material & methods: In this study were included 85 patients with locally advanced squamous cell cervical cancer, treated between January 2011 - December 2013 at the Oncology Institute “Prof.Dr. Ion Chiricuta” Cluj-Napoca . The median age at diagnosis was 52 years old (22-73), 25 patients had stage IIB disease, 31 patients had stage IIIA and 29 patients had stage IIIB disease. The pre-therapeutic dimension of the tumor had a median of 4 cm(1,5 cm-7cm). 52 patients were treated with neoadjuvant chemotherapy, concomitant radiochemotherapy and brachytherapy, 32 patients with neoadjuvant chemotherapy, concomitant radiochemotherapy, brachytherapy and surgery, 1 patient treated with radiotherapy and brachytherapy. The median follow up was 49,5 months(30,6-65,4). The squamous cell carcinoma antigen levels were tested before treatment and periodically after treatment.

Results: The median value of pre-therapeutical SCCAg was 3,44[0,23-54,32]. 61% of patients had SCCAg above 2,7 ng/ml and 39% below 2,7 ng/ml. Overall survival(OS) was 96% for stage IIB, 83% for IIIA, 60% for IIIB (p=0,08). OS for patients with pre-therapeutic SCCAg<2,7 ng/ml was 94% vs 69% with SCCAg>2,7 ng/ml (p=0,05). Disease free survival was 88% for those with pre-therapeutic SCCAg<2,7ng/ml vs 52% with SCCAg>2,7 ng/ml (p=0,02). Locally recurrence free survival was 90% for patients with SCCAg<2,7% vs 80% with SCCAg>2,7 ng/ml (p=0,2). Metastasis free survival was 94% for patients with SCCAg<2,7% vs 61% with SCCAg>2,7 ng/ml (p=0,03). Recurrence free survival for patients with post-therapeutic SCCAg<2,7ng/ml was 92% vs 63% with SCCAg>2,7ng/ml (p<0,01). Metastasis free survival for patients with post-therapeutic SCCAg<2,7ng/ml was 93% vs 42% with SCCAg>2,7ng/ml (p<0.01).

Conclusion: In this study SCCAg was proved to have both prognostic and predictive value. Elevated pre-therapeutic levels of SCCAg have a prognostic value and are associated with lower OS and a predictive value for

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recurrence and metastasis. Higher post-therapeutic levels of SCCAg are associated with a low recurrence and metastasis free survival.

23. THE IMPORTANCE OF A MULTIDISCIPLINARY TEAM IN RECTAL CANCER MANAGEMENT

Bochis Ovidiu Vasile1,2, Fekete Zsolt1,2, Vlad Catalin1,2, Fetica Bogdan1, Leucuta Daniel Corneliu2, Busuioc Constantin Ioan2, Irimie Alexandru1,2

1) Institute of Oncology „Prof.Dr. Ion Chiricuta”, Cluj-Napoca, Romania; 2) University of Medicine and Pharmacy „Iuliu Hatieganu”, Cluj-Napoca, Romania

Residents in oncology / Oral presentation

Introduction:The aim of this study was to evaluate the impact of the interval between surgery and adjuvant treatments regarding the overall survival and recurrence free-survival, for patients from a developing country. For the stage II and III rectal cancer, international guidelines recommend neoadjuvant chemoradiotherapy (CRT) regardless of the tumor location. The developing countries have a lack of radiotherapy centers, specialists, and a long waiting list for radiotherapy. These problems might lead to protocol deviations.

Material & methods:We conducted a retrospective study of 161 patients with rectal cancer treated with surgery, postoperative CRT and with or without chemotherapy for a total of 6 months, at The Oncology Institute Cluj-Napoca between 2006- 2010. All patients had 5 years of follow-up.

Results:A total of 161 patients were enrolled in this study. The majority of patients were locally advanced stages (89.44%). The well known prognostic factors, such as TNM stage, performance status, CEA serum level, perineural, vascular and lymphatic invasion, and node capsular effraction have statistically significant influenced overall survival. In 21.12% of patients the first adjuvant treatment was started in the first 4 weeks after surgery. Only 13.04% of patients started the concomitant CRT in the limit of 6 weeks after surgery. Concerning the time between surgery and CRT, we didn’t observe a statistically significantly difference in OS if the radiotherapy started after the first 6 weeks (p=0.701). The OS rate for locally advanced rectal cancer patients was 69.44%.

Conclusions:In rectal cancer, the importance of the first therapeutical act is crucial. Following international guidelines provides a survival advantage and a better quality of life. In case of adjuvant treatment, is recommended to start this treatment as soon as the local infrastructure allow.

24. LOCO-REGIONAL ADVANCED CERVICAL CANCER - THE INSTITUTE OF ONCOLOGY CLUJ RESULTS WITH A MULTIMODAL APPROACH

Mircia Alexandra Daniela1, Nagy Viorica1,2, Todor Nicolae1, Ordeanu Claudia1,2

1) Oncology Institute “Prof. Dr. Ion Chiricuta “ Cluj-Napoca; 2) University of Medicine and Pharmacy “ Iuliu Hatieganu” Cluj Napoca

Residents in oncology / Oral presentation

Background and purpose: This study was conducted in „Prof. Dr. Ion Chiricuta” Cluj - Napoca , is a retrospective study in which we analyzed the cause of failure in patients with advanced locoregional cervical cancer , neoadjuvant chemotherapy , radiochemotherapy and surgery.

Material & methods: In this study we included 251 patients with locoregional advanced cervical cancer who were treated in the IOCN between January 2010 - December 2014. The patients received neoadjuvant chemotherapy cycles 1-3 : Carboplatin + Paclitaxel or Cisplatin + Topotecan followed by concurrent radiochemotherapy to total dose ( TD ) of 46 Gy / 23 fr + boost technique to TD of 10-14 Gy in to 5-7 fr or brachytherapy MDR / HDR 14 Gy in to 2 fr , followed by clinical evaluation and surgery.

Results: Baseline characteristics. Median age at diagnosis was 49.5 years ( 22-73 years); 195 (77.70%) patients had stage II B, 56 (22.30%) patients had stage III A;83 ( 33 % ) patients neoadjuvant chemotherapy conducted concurrent radiochemotherapy and 168 (67 %) patients had concomitant radiochemotherapy conducted

Of the 251 patients operated 149 ( 59.3 %) had a negative histopathologic response and 102 (40.7 %) were histologically positive result; 11 (52.4 %) patients had distant metastase, 10 (47.6%) patients had regional metastases

Specific 5-year survival, tumor size 97% <5 cm and 90% tumor size> = 5 cm (p = 0.03). Hemoglobin level <12 mg / dl had a specific survival at 5 years 88% as opposed to a hemoglobin level> 12 mg / dl that has a specific 5-year survival of 96% (p <0.01). Specific survival at 5 years, 97% to 89% respectively negative histopathology results for histopathological positive results (p= 0.02).

Disease free survival at 5 years, 93% to 79% respectively result negative histopathology for histopathological positive results (p<0.01). For the 149 patients with histopathologically negative result of disease free survival at 5 years, 96% of tumors with a size <5 cm and 85% tumor size> 5 cm (p = 0.01), and treatment failure in 149 patients with sterile piece was 6.7% (N=10 ), of which 80% was the failure distance, 20% being represented by local failure.

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We analyzed risk factors that lead to metastasis and local recurrence and outcome that chemotherapy schedule neoadjuvant, total dose of RTE + boost, total dose brachytherapy, answer histopathological and nodal invasion were statistically significant which showed that they had a role in causing the failure remotely but not locally.

Multivariate analysis showed that tumor size, hemoglobin and histopathological result, are prognostic factors influencing survival.

Conclusion: It has been shown that patients who had sterile piece after treatment had a decreased risk of developing therapeutic essay compared with those who experienced relics histopathological outcome. Also our multivariate analysis confirmed that tumor size, hemoglobin and histopathological results are prognostic factors influencing survival.

25. POTENTIAL RISK OF COGNITIVE IMPAIRMENT DUE TO IRRADIATION OF NEURAL STRUCTURES IN LOCALLY ADVANCED NASOPHARYNGEAL CANCER TREATED BY CURATIVE RADIOTHERAPY

C.C. Mirestean1, G.C.Mihaila1, O.N.Pagute1, C.Safta1, Elena Manea1, C.Buzea1, Mihaela Oprea1, Catalina Ursache1, Anisoara Anghelache1, D.T. Iancu1,2

1) Regional Institute of Oncology, Iasi; 2) ”Grigore T Popa” University of Medicine and Pharmacy, Iasi

Residents in oncology / Oral presentation

Brain radionecrosis is one of the underevaluated, but potentially fatal, late toxicities in radiotherapy for locally advanced nasopharyngeal cancer. Radioinduced dementia associated with temporal lobe radionecrosis and irradiation of hippocampus with high doses can cause severe deterioration of the quality of life. For 10 patients with locally advanced nasopharyngeal cancer treated with curative intent by 3D-CRT technique, alternative plans using IMRT and VMAT techniques were proposed, running on VARIAN planning system Eclipse 13.3. Using Lyman-Kutcher-Burman and Gay-Niemierko radiobiological models, risk of cerebral radionecrosis was predicted for all three irradiation techniques. Subsequently, temporal lobes and hippocampus were delineated as organs at risk, for which Dmax, Dmin and Dmean were evaluated. IMRT and VMAT techniques increase the dose received and the risk of neural radionecrosis, but offer better outlining of the target volume and a reduction in dose to other OAR. The assessment of doses received by temporal lobes (highest values for Dmax) associated the 3D-CRT technique with highest risk

of radionecrosis in this region. The mean dose over 10 Gy received by hippocampus through VMAT technique can justify the delineation of hippocampus as organ at risk in cancers of cavum and also optimization of irradiation plans for hippocampus sparing.

26. RISK ASSESSMENT OF DEVELOPING SECOND MALIGNANCIES AFTER LOW AND MEDIUM DOSES OF I131 TREATMENT IN PATIENTS WITH DIFFERENTIATED THYROID CARCINOMA

Andra Piciu1,3, Claudiu Pestean2,3, Elena Barbus2,3, Maria Iulia Larg2,3, Doina Piciu2,3

1) Medical Oncology Department „Prof. Dr. Ion Chiricuta” Institute of Oncology, Cluj-Napoca, Romania; 2) Nuclear Medicine Department „Prof. Dr. Ion Chiricuta” Institute of Oncology, Cluj-Napoca, Romania; 3) ”Iuliu Hatieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania

Residents in oncology / Oral presentation

Background and aim: Thyroid carcinoma is the most frequent endocrine tumor, with a very important rising incidence in the Institute of Oncology “Prof. Dr. Ion Chiricuta” Cluj-Napoca (IOCN) of 5 up to 10 times in the last 10 years. The aim of this study is to determine the possible risk of a patient with differentiated thyroid carcinoma (DTC) treated with low and medium radioiodine activity to develop a second primary malignancy.

Material & methods: 1990 patient form the database of IOCN between 1970 and 2003 were investigated. All patients were treated for DTC, consisting also radioiodine adjuvant therapy. The mean long-term follow-up period was 182 months and the overall survival rate at 10 years wes 94.7%.

Results: The mean dose of the radioiodine I-131 that was administrated for the patient enrolled in the study was of 63.2 mCi. Among the patient examined, 93 of them had a second primary malignancy and only one patient had two associated malignancies apart of the DTC, breast and cervical carcinoma. 29 of these patients developed the second malignancy after the treatment of the DTC. The relative risk of development of a second malignancy in DTC patients was increased (p<0.0001) for the breast, uterine and ovarian cancers compared with the general population.

Conclusions: The presence of DTC was related to the overall risk of developing a second primary malignancy, without any relation with the adjuvant therapy consisting in low and medium dose of radioiodine.

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27. THE ROLE OF ADJUVANT CHEMOTHERAPY IN THE TREATMENT OF ENDOMETRIAL ADENOCARCINOMA

Radulea Alexandra Maria1, Nagy Viorica1,2, Ordeanu Claudia1, Todor Nicolae1

1) Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; 2) Universitatea de Medicina si Farmacie „Iuliu Hatieganu” Cluj Napoca

Residents in oncology / Oral presentation

Background and aims: This study conducted in IOCN evaluated the results obtained by adjuvant chemotherapy in endometrial adenocarcinoma primary operated, in terms of overall survival and disease free survival.

Material & methods: It was a retrospective study, in which we included 53 patients diagnosed with endometrial adenocarcinoma and treated at the IOCN during January 10th 2010- December 31st 2014. All patients were operated in prime time, and then received adjuvant chemotherapy. The chemotherapy regimen was Paclitaxel 175 mg / mp + Carboplatin AUC 5 q21d.

Results: Baseline characteristics: median age at diagnosis was 57.3 years (29-74 years); median follow-up was 39.8 months. 36 patients had stage FIGO III (70%), 8 patients had stage FIGO II (15%), 7 patients stage FIGO I and 2 patients stage FIGO IV. Regarding the histopathologic type, 48 cases (90.6%) were endometrioid endometrial adenocarcinoma and 5 cases (9.4%) were clear cell endometrial adenocarcinoma. 10 showed a high degree of differentiation, 24 cases moderate, 15 cases low grade, and 4 cases had not stated the degree of differentiation. 48 patients (90.6%) received surgery followed by radiotherapy and adjuvant chemotherapy, only 5 patients (9.4%) had adjuvant chemotherapy after surgery without radiation therapy. All patients received the same chemotherapy regimen: Paclitaxel 175 mg / m2 + Carboplatin AUC 5 q21d. Overall survival was 76% and disease-free survival of 54%. Patients who received 6 cycles of chemotherapy had an overall survival of 79% compared to 74% for those with less than 6 cycles of chemotherapy. Surgical treatment was hysterectomy and bilateral salpingoophorectomy ± pelvic and para-aortic lymphadenectomy. Of the 36 patients with FIGO stage III, 15 had pelvic lymphadenectomy, which resulted in an overall survival of 86% compared with 73% for patients without lymphadenectomy (p=0.07). At the end of treatment, 40 patients (75.5%) had controlled disease, and 13 (24.5%) were either stationary illness or disease evolution. Analyzing this data we can state that adjuvant chemotherapy brings an improvement in overall survival and disease free for advanced endometrial adenocarcinoma.

Conclusions: Although the survey data did not result in a statistically significant difference between survival for

patients who were given less than 6 cycles of chemotherapy and those who were administered 6 cycles of chemotherapy, there is an overall survival increase if we administer 6 cycles of chemotherapy. A long-term follow-up and a larger group of patients will likely strengthen the results obtained in this study.

28. PARANEOPLASTIC PEMPHIGUS AS A FIRST SIGN OF A HYPOPHARYNX SQUAMOUS CELL CARCINOMA

Ana Maria Stefan1, Laura Rebegea2,3, Iuliana Ivan4

1) ”Prof.Dr. Al. Trestioreanu „ Oncological Institute Bucharest; 2) ”Sf. Ap Andrei „ Emergency Clinical Hospital Galati, Radiotherapy Department; 3) ”Dunarea de Jos „ University of Galati. Clinical Medical Department; 4) ”Sf. Ap Andrei „ Emergency Clinical Hospital Galati, Oncology Department

Residents in oncology / Oral presentation

Introduction:Paraneoplastic pemphigus is a rare autoimmune disease of the skin associated with neoplasm. It is mostly associated with lymphoproliferative disorders (nearly 84 % of all cases are found in hematologic neoplasms). The underlying pathogenesis is believed to be triggered by altered immune system in response to underlying neoplasm. The manifestations can predate, occur at the same time or after the diagnosis of cancer. Males between 40 and 70 years are most frequently affected. The prognosis of PNP is generally poor, and the disease is often fatal. The occurrence of PNP with squamous cell carcinoma is rare.

We have chosen to present this case because paraneoplastic pemphigus is a very rare paraneoplastic manifestation (in literature were described less than 500 cases) with a poor prognosis. The association of hypopharynx squamous cell carcinoma with is not commonly seen.

Case presentation: We present the case of 67 years old male with paraneoplastic pemphigus associated with squamous cell carcinoma of the hypopharynx. The patient presented to Otolaryngology department of “Sf. Ap Andrei” Emergency Clinical Hospital Galati with dispneea and disphonia. Otolarygeal examination revealed a vegetant tumour mass that narrows the glotic space and causes respiratory insufficiency. On the clinical examination the patient presented vesicles with clear liquid and painful sores on the trunk, arms and legs that appeared a few weeks earlier the respiratory symptoms. A biopsy was performed and the result was a low grade squamous cell carcinoma of the hypopharynx. A tracheostomy was performed. The patient started radiotherapy with concomitant chemotherapy (Cisplatin 100 mg/m2 day 1, 22 and 43 of treatment) in the

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Radiotherapy Department of “Sf. Ap Andrei” Emergency Clinical Hospital Galati. He presented vesicles in different stages of evolution and painful sores. Concomitant the patient received symptomatic treatment with corticoids, proton pump inhibitors. A skin biopsy was performed.

Conclusion: We observed an amelioration of the pemphigoid skin lesions during the specific antineoplastic treatment. Nevertheless the radiotherapic treatment was delayed because the skin lesions were in the field of radiation and the patient developed grade 3 radiodermatitis.

29. CURRENT MANAGEMENT OF BRAIN TUMORS IN THE RADIOTHERAPY DEPARTMENT OF IRO IASI

Diana Tanase1, Alexandra Stoicescu1, Alina Rogojanu2, Silvana Ojica2, Mihaela Oprea2, Manuela Oprisan2, Ana-Maria Constantin2, Irina Butuc2, A. Zara2, Andreea Marinca1

1) Radiotherapy Department, Iasi Regional Oncology Institute; 2) Physics Department, Iasi Regional Oncology Institute

Residents in oncology / Oral presentation

Background: The current standard treatment for newly diagnosed glioblastoma patients is surgical resection, followed by radiotherapy plus concomitant and adjuvant temozolomide chemotherapy.

Material & method: We performed a prospective evaluation of the efficacy and safety of radio-chemotherapy with temozolomide in newly diagnosed glioblastoma patients. We identified 90 patients with glioblastoma multiforme treated in the Radiotherapy Department of the Iasi Regional Oncology Institute, from April 2011 to September 2016. Only the newly diagnosed, histologically confirmed patients, treated with radiotherapy plus concomitant and adjuvant temozolomide chemotherapy were selected for the present analysis. All patients had a general and neurological examination, evaluation of ECOG performance status, Mini Mental Status Evaluation (MMSE), and a contrast-enhanced brain MRI or CT-scan. Radiotherapy consisted of fractionated focal irradiation to a total dose of 60 Gy in 30 fractions. Concomitant temozolomide chemotherapy (75 mg/m2) was administered daily during radiotherapy. The first cycle of adjuvant temozolomide was initiated 28 days after completion of radio-chemotherapy, at a dose of 150 mg/m2, increased to 200 mg/m2 beginning with the second cycle. Evaluations were performed at 4 weeks after completion of radio-chemotherapy, and at 3 months intervals afterwards, using the same parameters.

Results: Of the 90 patients evaluated in the Radiotherapy Department of IRO Iasi who were treated with radiotherapy plus concomitant temozolomide chemotherapy, we obtained

preliminary results on overall survival, toxicity and progression free survival.

Conclusions: Our results compare favorably with those already published. Even in this small number of patients, RPA classes retain their prognostic significance.

30. CBCT USE FOR DOSIMETRIC IMPACT ANALYZE DURING BLADDER CANCER RADIATION THERAPY

Adam Daniela1, Barbu Cristian1, Suditu Mihai1, Violeta Ciocaltei1, Popa Raducu1, Duran Cristina1

1) Amethyst Radiology Therapeutic Center, Otopeni

Medical physics / Oral presentation

Background & aim: Bladder volume changes have an important impact during bladder cancer radiation therapy. The study aim was to evaluate the dosimetric impact of target volume variation by using daily cone beam computed tomography (CBCT).

Material & method: For analyze, we selected five patients with bladder cancer where planning CT images were acquired with empty bladder. All plans were done with volumetric modulated arc therapy (VMT) using Pinnacle treatment planning system and Elekta Synergy linear accelerator. Set-up errors corrections and target volume verifications were performed daily with Elekta XVI CBCT system. The target delineation based on daily CBCT images, were used for comparative analysis of dose distribution between original plan and recalculated plan.

Results: The dosimetric differences observed during the treatment indicate that patient’s preparation and use of daily volumetric images verification is crucial for treatment delivery accuracy in bladder cancer.

Conclusion:The most important impact was the under-dosage of the target volume in the sessions where the bladder volume was larger than the volume used for planning.

31. REPRODUCIBILITY OF BLADDER VOLUME IN PELVIC RADIOTHERAPY

Aurel Bote1, Lavinia Negrut1, Renata Zahu1, Gabriel Kacso1,2, Daniel Demeter1, Madalina Badiu1, Emanuela Grosu1, Silvia Negrean1, Claudia Sarca1, Alexandra Lungu1

1) RTC Amethyst Cluj; 2) University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj

Medical physics / Oral presentation

Introduction: Bladder filling is a variable parameter in

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the radiotherapy treatment of pelvic malignances. In case of prostate cancer because of the high doses to the target volume (74-78 Gy) important bladder volume can receive high doses, which can increase toxicity. The variable bladder volume can also cause shifts in the position of the prostate. In case of cervical cancer, bladder filling will influence the position of the uterine body and the position of bowel loops.

The aim of this study was to assess the reproducibility of bladder filling with our current protocol.

Material and methods: Our bladder filling protocol consists of administering 500 ml of water with 35 minutes before simulation. Patients are asked to empty their bladder before starting drinking water. Before each RT session patients are asked to repeat the protocol.

We have analyzed 30 patients with different pelvic malignances (prostate, cervix, rectum).We used a mathematical formula to calculate/approximate the bladder volume on axial and sagital CT slices. [(maximum bladder dimension on Z axis * maximum bladder dimension on X axis * maximum bladder dimension on Y axis)/2 ].The exact bladder volume was established using Pinnacle Planning System on manual segmentation. The reproducibility of the bladder was assessed on weekly CBCTs using the same formula as on the initial planning CT.

We compared the measurements for each patient and diagnostic subgroups, the reference volume being the one calculated on the TPS.

Results: 24 patients were able to obtain a bladder volume above 150 cc, which was considered the ideal minimum. Our mathematical formula was able to approximate the real bladder volume with a mean 29 % error. Bladder volumes on weekly CBCT’s were compared to planning volume. Reproducibility was not satisfactory for prostate cancer patients and showed a trend in decreasing bladder volumes through the 8 week treatment.

Conclusions: Our present bladder filling protocol was successful to obtain ideal volume for planning and to fulfill DVH criteria but the reproducibility during treatment is difficult for most of the patients. Therefore, better consistency or adaptation is needed during treatment. CBCT is indispensable to verify the position of targets like prostate or uterus with high precision radiotherapy.

32. IMPACT OF MULTILEAF COLLIMATOR MODELS ON VMAT PROSTATE PLANS

A. Eva1, D. Dordai1, N. Schultes1, G. Kacso1,2

1) Amethyst Radiotherapy Center Cluj; 2) UMF”Iuliu Hatieganu” Cluj

Medical physics / Oral presentation

Objective: The aim of this study is to compare the dosimetric outcomes of prostate VMAT plans optimized with the Agility (Elekta, Stockholm, Sweden) multileaf collimator (leaf width 0.5 cm) versus the MLCi2 (leaf width 1 cm ), both attached to an Elekta 6MV linac.

Material & method: For fifteen patients VMAT plans were generated with the MLCi2 and the Agility head in Pinnacle 9.10 using the Auto-Planning (AP) module with no further optimization. Same beam geometry and dose constraints were used. The prescription dose was 70 Gy for the prostate and 56 Gy for the seminal vesicles in 28 fractions. Critical structures were assessed based on QUANTEC criteria. The plans were compared in terms of doses to organs at risk (OAR), PTV coverage, Homogeneity Index (HI), Conformity Index (CI), moreover, treatment times and monitor units/plan.

Results: Differences occurred concerning the MU and the treatment delivery time. We managed to obtain clinically acceptable plans in both cases but depends on the patient medical history and on the final decision of the physician.

Conclusion: the Agility MLC improved the homogeneity and conformity index while reducing the total MU.

33. DAILY IMAGE GUIDANCE WITH CONE-BEAM COMPUTED TOMOGRAPHY FOR PROSTATE CANCER IMRT

Grosu Mirabela Emanuela1, Badiu Adina Madalina1, Sarca Irina Claudia1, Vitca Daniel Ioan1, Pirv Ovidiu Ioan1, Zahu Renata1, Eva Andrea1, Trandafir Diana1, Schultes Noemi1, Kacso Gabriel1,2

1) Amethyst Radiotherapy Center Cluj; 2) University of Medicine and Pharmacy “Iuliu Hatieganu”Cluj

Medical physics / Oral presentation

Introduction: Curative radiotherapy of prostate cancer needs doses above 70 Gy, usually 76-78Gy, in 38-39fr. IMRT/VMAT is characterized by steep dose gradients. Such dose gradients need very precise patient positioning. Our aim is to assess the magnitude and impact of set-up errors in prostate RT using CBCT as IGRT method.

Material & methods: We have analyzed 150 patients with prostate carcinoma. CT simulation was done with an established bladder filling protocol. All patients were treated with VMAT. Patient positioning was verified with CBCT. We have used an offline e-NAL protocol (CBCT on day 1, 2, 3 then weekly) for patients with errors <3mm. For patients with errors >3mm we have used an online protocol with daily CBCTs.

Results: A total of 2022 CBCTs were analyzed. 14 patients were verified with an online protocol, 136

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patients were checked with an offline protocol. We have calculated the mean set-up errors for each patient, the population systematic error and the population random error component. Mean set-up population error were for X Y Z, 0.01, 0.07 respectively 0.01. The systematic error for the population were X= 1.6 mm, Y=1.4 mm and Z=1.5 mm. The population random error were X= 1.8mm, Y=1.6 mm and Z= 1.8mm.

Conclusion:CBCT allows for precise positioning in pelvic RT and is also useful to detect daily changes in rectal and bladder volume.

34. THE ROLE OF THE RTT IN DETECTING POSSIBLE ERRORS IN BRACHYTHERAPY

Sarca Irina Claudia1, Persa Daniela Raveca1, Grosu Mirabela Emanuela1, Lungu Alexandra1, Schultes Noemi1, Dordai Dan1, Zahu Renata1, Negrut Lavinia1, Bote Aurel1, Kacso Gabriel1,2

1) Amethyst Radiotherapy Center Cluj; 2) University of Medicine and Pharmacy “Iuliu Hatieganu” Cluj

Medical physics / Oral presentation

Introduction: HDR-Afterloading brachytherapy is used in the treatment of prostate, gynecological, rectal, breast, thoracic, otorhinolaryngological cancers and others. The role of the radiotherapy technician is to inform the patient about the procedure he is to be submitted to, his preparation before the treatment and to fulfill some technical aspects in the administration of the treatment. The purpose of the paper is to analyze the possible errors that may occur during brachytherapy and the role of the RTT to reduce or avoid these errors.

Material & methods: We have analyzed all the stages of brachytherapy, starting from the preparation of the patient, mounting necessary applicators, the acquisition of the images, performing the irradiation and the post-procedure care in the case of gynecological BT (utero-vaginal or a cylinder) and urological BT (prostate).

Results: There were identified the following sources of errors: incorrect patient identification and preparation, positioning, emptying the rectum, improper filling of the bladder, errors in the identification of the instruments, incorrect CT scanning, bad imaging quality, errors in connecting the tubes, improper positioning of the tubes, wrong measurement of the catheter lengths, suboptimal staff training in emergency procedures.

Conclusion: The role of the RTT is very important in the chain of procedures from receiving the patient in the ward and until the brachytherapy treatment is complete. Errors can be reduced by properly training the staff in practicing

brachytherapy, in creating an adequate working environment and by keeping vigilance staff.

35. INTENSITY MODULATED RADIOTHERAPY VS 3D CONFORMAL IN BREAST IRADIATION

Ioana Scarlatescu1, Bogdan Ile1, Aurel Chis1, Marius Spunei1, Alin Tanase1, Ioana Lupse1, Noemi Besenyodi1, Anca Croitoru1

1) Asociatia OncoHelp Timisoara

Medical physics / Oral presentation

Aim: One of the top issues still remaining in external beam radiotherapy is linked to breast cancer and the technique that is used for treatment. Is it the new technology always better?

Material and method: The machine that we use for treatment is a Unique Performance from Varian with the energy of 6 MV with the treatment planning system Eclipse. All the patients were simulated in the supine position with both hands up using the Q-fix chest board with the Siemens Somatom CT.We choose different patients and created treatment plans using 3D conformal and IMRT. We compared the treatment plans according to the dose distribution in the planning target volume (PTV) and dose limitations for the organs at risk following the guidelines offered by RTOG and QUANTEC. We considered all the cases that we encountered in radiotherapy: whole breast, chest wall, with or without lymph nodes.

Conclusions: The protocol for irradiation of breast cancer that we use today is the result of the numerous treatment plans made with the two major techniques used today: IMRT and 3D conformal. For each case we choose the best treatment plan for the patient according to the patients history and the expected results.

36. ELECTRONIC PATIENT RECORD IN RADIOTHERAPY

Sipos Oana1, Demeter Daniel1, Negrean Silvia1, Zahu Renata1, Noemi Schultes1

1) Amethyst Radiotherapy Center Cluj

Medical physics / Oral presentation

Introduction: Technical innovations have revolutionized the practice of radiotherapy in the last years. Different softwares are now employed in the treatment planning, Linac manipulation, image acquisition and clinical data record.

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The objective of this study is to present the workflow in our clinic, which is based on an electronic patient record.

Materials and methods: Since January 2015 we have switched from paper-based medical records to a paperless electronic patient record. All the radiotherapy data regarding patient positioning, dose prescription, field geometry, different supportive treatments are stored in an electronic format.

Results: We are presenting the chain of radiotherapy and all the software we use in-house from the RTE indication to patient treatment. Clinical and medical data are stored in AMS- in-house developed software. Radiotherapy data are imported from this AMS software and from TPS (Pinnacle) into Mosaiq the record and verifying system. We also present how our system is linked to the national health insurance funds RT reimbursement module.

Conclusions:Electronic patient data handling is a viable and practical tool to replace paper -based records.In our clinical experience, using the above mentioned software have improved the workflow and the time management and also have reduced errors.

37. HIP PROSTHESES METAL INDUCED ARTIFACTS INFLUENCE IN PROSTATE CANCER RADIATION THERAPY

Suditu Mihai1, Barbu Cristian1, Ciocaltei Violeta1, Adam Daniela1, Popa Raducu1

1) Amethyst Radiology Therapeutic Center, Otopeni

Medical physics / Oral presentation

Modern treatment planning systems use computed tomography images and calibrated scales of tissue associated CT numbers to electron density for inhomogeneity corrections. The presence of a high density metal in the scanned volume causes induced artifacts that influence tissue associated CT numbers and introduce errors in the dose distribution calculation. Also, CT images metal induced artifacts can affect the delineation of the interest anatomical structures by affecting the images quality.

To evaluate how the artifacts affect the treatment planning process, three prostate cancer patients with unilateral hip prostheses implants and one patient with bilateral hip prostheses were selected and the corresponding CT images sets in original form and reconstructed using the Metal Artifact Reduction algorithm (Philips - O-MAR) were used for target volumes and organs at risk delineation and dose calculation.

For each images set plans were made with different radiation therapy treatment techniques, step and shot intensity modulated radiation therapy, 360 degree dual-arc volumetric modulated arc therapy (VMAT) and short arcs

VMAT. All the plans were generated with Pinnacle version 9.10 treatment planning system and Elekta Synergy MLCi2 linear accelerator. Evaluation of artifacts influence was made by using dose volume histogram and dose distribution analyze.

In both planning steps- contouring process and plan generation, images artifacts induced significant differences.

38. EVALUATION OF AUTOMATED INVERS TREATMENT PLANNING FOR DIFFERENT LOCALIZATION

D.L. Trandafir1, A. Eva1, N. Schultes1, D. Dordai1

1) Amethyst Radiotherapy Center Cluj

Medical physics / Oral presentation

Aim: The purpose of this study is to evaluate the clinical implementation of an automated inverse treatment planning option, Pinnacle Auto-Planning (AP). For this we have compared automatically generated plans with manually optimized plans for prostate, breast and rectum cancer patients.

Material & method: Since its beginning the objective in radiotherapy has always been to deliver maximum dose to the target volume homogeneously, while avoiding dose to the normal surrounding structures. Progress made in last few decades has allowed Radiotherapy Treatment Planning to become increasingly complex as treatments become more precisely targeted. In order to produce the ‘best’ plan in an acceptable amount of time, manufacturers are starting to develope tools to aid automation of both contouring and treatment planning.

Patients with prostate, breast and rectum cancer that were initially planned with IMRT or VMAT, depending on tumour localization, were re-planned with Pinnacle AP version 9.10 and evaluated using Score Cards. Only one single cycle of plan optimization was used for AP. The prescription dose were 50 Gy in 25 fraction for breast cases, 50.4 Gy in 28 fraction for rectum cases and 50.4 Gy in 28 fraction for prostate cases. The dose to the planning target volumes (PTV’s), the organs at risk (OAR’s), conformity index (CI) and homogeneity index (HI) were evaluated.

Results: Comparison with manually created plans showed no significant differences but in order to meet the clinical acceptance criteria, plans produced by the AP had to be manually “tweaked”, with dose constraints slackened in some cases and tightened in others.

Conclusion:The evaluated automated planning treatment plans achieved consistent and good quality treatment plans with potentially clinically relevant OAR’s sparing. The overall message is that using this automated planning tool an acceptable clinical treatment plan can be achieved.

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39. PATIENT PREPARATION, IMMOBILIZATION AND IMAGING IN PROSTATE CANCER MODERN RADIATION THERAPY

Ianole Gigi1, Negrescu Elena1

1) Amethyst RTC, Otopeni

Medical Physics/ Oral presentation

Radiation therapy is one of most common treatment technique for prostate cancer. The aim of radiation therapy is to deliver with high accuracy the prescribed dose to the target volume with sparing of healthy tissues.

In modern radiation therapy techniques, like intensity modulated radiation therapy, patient positioning have an important role for treatment delivery accuracy. Use of appropriate immobilization devices that provide reproducibility of the patient position during treatment and patient comfort is critical.

For prostate cancer treatment, because of high influence of rectum and bladder volume changes on target position, good preparation of patients before treatment planning images acquisition and every treatment session is mandatory.

Modern linear accelerator are equipped with imaging systems that allow check of patient positioning and anatomical changes, like portal imaging (PI) and cone beam computed tomography (CBCT). Volumetric images acquisition by using CBCT improves set-up errors corrections by matching not only bones anatomy like PI, but also soft tissues. Another practice used during last period for better prostate localization accuracy is use of fiducial markers. CBCT used on a daily practice help radiation therapist and radiation oncologist to verify the correlation between patient position and anatomical structures matching, to evaluate the impact of these on treatment delivery and to decide if other procedures are necessary before treatment start.

40. URINARY SYMPTOMATOLOGY OF IRRADIATED PROSTATE CANCER PATIENTS

Mihaela Roman1, Oana Hetea1, Renata Zahu1, Gabriel Kacso1,2

1) RTC Amethyst Cluj; 2) UMF „Iuliu Hatieganu” Cluj

Nursing / Oral presentation

Background/ Aim: Prostate cancer is associated with urinary dysfunction because the prostate surrounds urethra. Therefore, the changes within the gland affect directly

the urinary function. These symptoms include: frequent urination, nocturia, with the difficult start of urination and maintaining a continuous flow of urine, dysuria and hematuria.

The purpose of this paper is to emphasize the effects of external beam radiation therapy on urinary symptoms in patients with prostate cancer.

Material & methods: For 126 patients (49 to86 years) treated in 2015 with RT for prostate cancer in the RTC Amethyst, we monitored the changes of urinary symptoms during external beam radiation therapy using specific questionnaires (IPSS – International Prostate Symptom Score). The questionnaires were self filled in by patients, weekly from onset to completion of therapy.

Results: The study shows that during radiotherapy about half of patients had worsening in urinary symptoms, 30% marked improvement in urinary symptoms, 13% of the patients remained with unchanged urinary symptoms from onset to end of treatment and 5% complained of urinary incontinence.

Conclusion: This procedure ensures accurate assessment of urinary symptoms during radiotherapy and allows comparison of pre- and post irradiation urinary function for acute and late urinary toxicity evaluation.

41. RADIATION THERAPY TECHNIQUE AS A PROGNOSTIC FACTOR IN PROSTATE CANCER

Corina Ionescu1, Rodica Anghel1,2

1) Institute of Oncology Buchraest; 2) University of Medicine and Pharmacy „Carol Davila”, Bucharest

Residents in oncology / Oral presentation

Introduction: In 2012 reported worldwide were 14.1 million new cases of cancer incidence is 25% higher among males.

Objectives: This is a comparative study between external radiotherapy 3D conformational (3D-CRT) and modulated imaging (IMRT) in terms of both certain epidemiological indicators, such as overall survival (OS) and survival without signs of progression (PFS) and from the point of view of treatment-related toxicity.

Materials and methods: For this study were evaluated retrospectively medical records and plans of external radiotherapy of 65 patients diagnosed with prostate cancer who have completed Radiation Therapy through one of two techniques in 2011-2013. Therapeutic toxicity evaluation was performed according to the tables Radiation Therapy and Oncology Group (RTOG) during radiotherapy 1 and 6 months after treatment. OS and PFS indicators were assessed at 1 year and 3 years after completion of radiotherapy.

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Results: The histopathological examination was in all cases of adenocarcinoma. Gleason score <7 was in 39.02% cases, 7th in 24.01% cases and> 7 in 36.87% cases. In 49.97% of cases surgical intervention was the primary treatment in 38.66% cases was conducted as local radiation therapy and bone metastases irradiation was performed in 11.36% cases.

Making a comparison with 3D technology, it has been observed that in cases where radiotherapy was applied with IMRT between 70-80 Gy total dose, toxicity to the rectum and bladder was significantly lower.

Conclusions: The analysis we conclude that the data obtained using 3D-CRT technique irradiation dose of radiation administered was lower than that given by IMRT, which has reduced local control of the disease. Thus, 3D-CRT technique, PSA and PSA PFS were lower than for IMRT technique, most often this difference is true for OS.

In addition, although the total dose of radiation administered IMRT target volume was significantly higher, by using the technique „reverse planning” to healthy tissues dosimetric values were lower and default tolerance of patients to treatment was better.

42. SURVIVAL OF BREAST CANCER PATIENTS ACCORDING TO THE PRESENCE OR ABSENCE OF HER2

Ionescu Radu Mihai1, Rodica Anghel1,2

1) Institute of Oncology Bucharest; 2) University of Medicine and Pharmacy „Carol Davila”, Bucharest

Residents in oncology / Oral presentation

Introduction: Breast cancer is the leading cause of mortality among women. About 1off 8 women is diagnosed with breast cancer during their lives. The survival rate of patients increased in the last two decades due to discoveries in the field of oncology and the use of personalized treatments. One of the main factors in breast cancer survival is the presence / absence of HER2 mutation. A HER2-positive status correlates with a worse prognosis of evolution.

Objectives: The main objective of this study was to correlate the survival rate of breast cancer according to the presence or absence of HER2.

Material & methods: This is a retrospective study of breast cancer patients hospitalized in the Oncology Institute of Bucharest, between 2009-2014. Methods for conducting this retrospective study are the patients follow up bulletins and they’re HP and IHC reports about the existence of HER2 mutation. Then the survival rate was correlated with the presence or absence off HER2 mutation. In this study where included a total of 50 patients. Among them 20% have shown positive HER2 and 80 have shown negative HER2

Results: The survival rate on 5 years was 80% for patients with HER2 negative mutation while for patients with HER2 positive mutation the survival rate was 60% on a 5 years period.Median age at diagnostic was 52,4 years. Stage distribuition was: 24% of the patients discovered the disease in stage I, 42% in stage IIA, 30% in stage IIB, and 4% discovered the disease in stage III.

Conclusions: The treatment of breast cancer, and survival rate are closely correlated with the presence or absence of HER2 mutation. IHC testing is also mandatory for diagnosis and appropriate treatments to personalized breast cancer treatments.

43. LONG-TERM ONCOLOGICAL OUTCOMES OF PATIENTS WITH URINARY BLADDER AFTER MULTIMODALITY TREATMENT

Fabiana Curea1, Inga Botnariuc, Cristina Orlov, Oana Trifanescu, Gales Laurentia, Rodica Anghel1,2

1) Institute of Oncology Bucharest; 2) University of Medicine and Pharmacy „Carol Davila”, Bucharest

Residents in oncology / Oral presentation

Introduction/ Objective: Bladder cancer is the sixth most common cancer, being three times more prevalent in men than in women. It is a complex disease associated with high morbidity and mortality rates if not treated optimally.

We aimed to asses the results obtained in bladder cancer patients treated using various treatment sequencing.

Materials and methods: We conducted a retrospective analysis of 178 urinary badder cancer patients, followed between 2003- 2015 in our clinic. The median age at diagnosis was 65 years (range: 19-87 years). Disease free survival (DFS) for patients with complete tumor resection receiving adjuvant treatment and progression free survival (PFS) for patients with post-operative residual disease were estimated.

Results: Stage disease’s distribution was: 32.2% stage II, 30.3% stage III, 37.4% stage IV. Radical cystectomy was performed in 72 patients (40.1%), while 106 patients (59.9%) underwent repeated transurethral resection of the urinary bladder tumor (TURBT). Postoperative treatment included multimodal therapy in 63 patients (35.4%) (chemotherapy and external beam radiation), external beam radiation alone in 59 patients (33.1%) and chemotherapy alone [methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or gemcitabine+platinum (GC) in 56 patients (31.4%)]. After a median follow-up of 35 months (range:3-79 months), 54 patients (30.6%) presented local recurrence, 38 patients (21%) distant recurrence (metastases), 18 patients (9.6%) both local and distant recurrence, and 68 patients

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(38.6%) were free of disease. Median duration until progression was 27 months.

Conclusion: Althought multimodality treatments were evaluated in clinical trials, no gold standards exists in what involves bladder cancer and the optimal treatment sequencing for achieving the best disease free survival still needs to be validated.

44. IS ROBOTIC SURGERY A SUPERIOR ALTERNATIVE IN THE MULTIMODALITY TREATMENT OF ADVANCED CERVICAL CANCER?

Cristina Orlov1, Fabiana Curea1, Inga Botnariuc1, Luiza G. Serbanescu1,2, Oana G. Trifanescu1,2, Rodica M. Anghel1,2

1) Alexandru Trestioreanu Institute of Oncology; 2) Carol Davila University of Medicine and Pharmacy, Bucharest

Residents in oncology / Oral presentation

Background/ Objective: Pelvic radiotherapy with concurrent cisplatin containing chemotherapy +/- brachytherapy is the standard treatment of advanced cervical cancer today, but because persistent disease is usually suspected/found on post treatment imaging, a third component of the treatment is often proposed: surgery. It is widely accepted that robotic surgery is superior to classical alternatives regarding post-operative recovery, hospital stay, social reintegration, but can it also have oncological advantage?

The aim of the present study was to compare the outcome of three modality treatment (robotic surgery vs laparotomy/laparascopy) and to determine if the robotic approach provides superior disease free survival (DFS) , overall survival rate (OS), local relapse rate (RR) and metastasis rate .

Material & methods: We retrospectively analised the cases of pacients with advanced cervical cancer, who received multimodality treatment (n= 43 – robotic radical hysterectomy, bilateral adnexectomy and pelvic lymphadenectomy and n=46 – who underwent the same surgical procedure, but laparoscopically or open) between 2008-2014.

Results: There were no diferences between the 2 groups regarding age, tumor hystology, radiation therapy dosage, concurrent chemotherapy or TNM stage.

DFS was superior in the robotic surgery group (75% at 2 years and 73% at 3 years vs 67.4% at 2 years and 58.7% at 3 years).

Local relapse rate was lower in the robotic surgery group (18.6% vs 30.3%). OS rates were comparable in the robotic surgery group (84.1% at 2 years, 81.2% at 3 years) vs the classical surgery group( 89% at both 2 and 3 years). Metastasis rate was similar (6,9% vs 8,6%).

Conclusion: Robotic surgery is a valid option after chemo-radiotherapy in the multimodal approach for cervical cancer with oncological results that can be compared with open surgery but with the advantages of minimally invasive surgery.

45. ANTI-ANGIOGENIC TREATMENT AND THE REACTIVE OXYGEN SPECIES IN EXPERIMENTAL RS-1 HEPATOCELLULAR CARCINOMA

Maria Iuliana Gruia, Antonela Busca, Marieta Panait, Valentina Negoita, Mirela Dumitru, Oana Trifanescu, Rodica Anghel1,2

1) Alexandru Trestioreanu Institute of Oncology; 2) Carol Davila University of Medicine and Pharmacy, Bucharest

Introduction: Angiogenesis plays an important role in progression and metastases of solid tumors and the main pro-angiogenic factor, the vascular endothelial growth factor (VEGF) is a potent cytokine that induce mitosis and regulates the permeability of endothelial cells. Reactive oxygen species (ROS) function as signaling molecules in many aspects of growth factor-mediated responses including angiogenesis. The aim of this study was to identify ROS production in hypoxic conditions and their role in angiogenesis signaling process.

Material and methods: RS-1 hepatoma cells were treated with Bevacizumab, in different dose levels (7.5 µg/ml, 100 µg/ml, or 150µg/ml). RS-1 hepatoma cells were induced with 200μM pyocyanin (general ROS inducer) and analyzed using flow cytometry. Untreated cells were used as control. The intracellular ROS production was quantified. In animal models treatment with bevacizumab was performed once a week during 3 month, 5 mg/kg body weight. Lipid peroxides, total –SH (tiol) and total antioxidant activity were measured.

Results: RS-1 hepatoma cells decreases to half at 24 hours after the treatment with Bevacizumab in different concentrations, but at 48 and 72 hours the number of cell recovered. The production of oxidative stress (%) at first concentration was 56%, at second concentration 42% and at the third concentration was 21%. The apoptosis rate measured ”in vivo” in the control group increase during the normal tumor growth from 14.30% to 29.86%. During the anti-VEGF treatment the increase of apoptosis is between 14.79% and 59.72%

The lipid peroxides level is not significantly modified by the administration of Bevacizumab, but we registered an increase of the antioxidant activity that suggests the self-defense system activation as a result of oxidative stress installation.

Conclusions: ROS have been identified as important signaling molecules in many cell types and have been

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associated with endothelial cell proliferation and new vessel formation. An increase of the antioxidant activity and apoptosis in tumoral cells during the anti-angiogenic treatment was demonstrated.

46. LONG TERM OUTCOME, CLINICAL, SEROLOGICAL AND PATHOLOGICAL PROGNOSTIC FACTORS IN 110 PATIENTS WITH EPITHELIAL OVARIAN CANCER

Rodica Anghel1,2, Laurentia Gales, Maria Iuliana Gruia, Luiza Serbanescu1,2, Inga Botnariuc, Cristina Orlov, Fabiana Curea, Oana Trifanescu1,2

1) Alexandru Trestioreanu Institute of Oncology; 2) Carol Davila University of Medicine and Pharmacy, Bucharest

Introduction: Ovarian cancer (OC) is the second most common gynecological malignancy, yet it has the highest case-fatality ratio of all gynecologic malignancies. The aim of this study was to evaluate the results of multimodality treatment (chemotherapy, surgery, radiotherapy) in patients with OC and to assess the impact of significant clinico-pathological prognostic factors on progression free survival and overal survival rates.

Material & method: Medical files of 110 consecutive patients with OC, presented between 2004 -2015 were retrospectively review. Treatment consisted in primary debulking and adjuvant chemotherapy (n=76, 69.0%) or neo-adjuvant chemotherapy and interval debulking surgery (n=21, 19.0%) or palliative chemotherapy after biopsy (n=13, 12,0%). First line platinum based chemotherapy (at least 4 cycles) was administered in all patients. Radiotherapy was administered in 15 patients (13.6%).

Results: Median age was 52 years (range, 18-74); most tumors were serous (76%) and mucinous (19.3%) and advanced stage (III/IV, 75.4%). More than 80% had elevated levels of CA125 mean value 475 IU/mL) The three-year progression free survival rate was 65% for stage II, 18% for stage III-IV, and 31% for all stages. Progression free survival (PFS) for stage IIIc and IV was 21 and 13 months. After a median follow up of 46 months median overall survival (OS) for all patients was 66 months,3 years OS 65%.

Clinical prognostic factors identified were performance status 0 vs 1 (HR=2.4, p=0.029) and extrem BMI (lower then 18 or higher than 30 HR=1.9, p=0.04). Patients diagnosed with well differentiated tumor G1 had a better survival rate compare with G2 and G3 tumors HR=1.8, p=0.05. The results of sequence surgery-chemotherapy or neoadjuvant chemotherapy-surgery were not different HR=1.3, p=0.112. The most important prognostic factor was residual disease. Patients with residual disease had an increased risk of recurrence, and death (HR=6.39, p=0.0001 and HR=5.36, p=0.02.

Conclusions: Effort must be made in order to ameliorate the prognostic of patients with OA. The most important independent prognostic factor identify were residual tumor volume, stage, performance status, grading.

47. REACTIVE OXYGEN SPECIES IN PATIENTS WITH OVARIAN ADENOCARCINOMA TREATED WITH PLATINUM BASED CHEMOTHERAPY

Oana Trifanescu, Fabiana Curea, Cristina Orlov, Inga Botnariuc, Maria Gruia, Rodica Anghel1,2

1) Alexandru Trestioreanu Institute of Oncology; 2) Carol Davila University of Medicine and Pharmacy, Bucharest

Introduction: Ovarian cancer (OC) is the most lethal of gynecologic tumors because women generally present with advanced stage disease. Platinum-based chemotherapy plays a pivotal role in OC treatment. The aim of the study was to assess the effects of platinum based chemotherapy on blood redox status in patients with ovarian cancer.

Material and methods: Seventeen patients with advanced ovarian adenocarcinoma stage IIIc and IV FIGO were included. Blood sample were collected before treatment, at 21 days (second cycle of chemotherapy) and at 42 days (3rd cycle of chemotherapy) with a platinum salt (cisplatin or carboplatin). The activity of antioxidant enzymes, the intensity of lipid peroxidation, the level of oxidative modification of proteins (OMP) were evaluated.

Results: Median age at diagnosis was 52 years, and 47% of patients presented with stage IIIc and 53% with stage IV. Nine patients received for the first time platinum based chemotherapy and 8 received multiple lines of chemotherapy. Lipid peroxides, SH thiol-albumin groups and total antioxidants were increased at baseline in 40% of patients. The evolution of these reactive oxygen species were monitored during chemotherapy cycles. If locally (in tumor cell increase oxidative stress is beneficial, the problem is related to migration and remote of ROS and their attack on essential biomacromolecule in normal tissues.

Conclusions: Platinum based chemotherapy in patients with ovarian cancer with FIGO stage III-IV induces radical formation and changes the homeostasis of the patient. The lipid peroxidation and antioxidant system in plasma move to a higher level of functioning which increased the oxidative stress.

48. ASSESSMENT OF CLINICAL OUTCOMES IN GLIOBLASTOMA MULTIFORME PATIENTS TREATED WITH INTENSITY-MODULATED RADIOTHERAPY VERSUS THREE-

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DIMENSIONAL CONFORMAL RADIOTHERAPY

Vanessa Moldoveanu1, Rodica Anghel1,2, M.T. Georgescu2

1) Institute of Oncology Bucharest „Prof. Dr. Al. Trestioreanu”; 2) University of Medicine and Pharmacy „Carol Davila” Bucharest

Residents in oncology / Oral presentation

Background: Despite the current multimodal treatment glioblastoma multiforme continues to be the most frequent and aggressive brain tumor, and is also associated with poor prognosis.

A small number of studies reviewed the data comparing clinical outcomes of intensity-modulated radiotherapy (IMRT) and three-dimensional conformal radiotherapy (3D-CRT) in the treatment of glioblastoma multiforme (GBM) patients . The purpose of this study is to determine whether IMRT improves 1-year and 2-year overall survival (OS) and progression free survival (PFS) compared with 3D-CRT in patients with GBM.

Material & methods: We evaluated the medical charts and radiotherapy treatment plans of 84 patients diagnosed with glioblastoma that underwent postoperative IMRT or 3D-CRT with concurrent and adjuvant Temozolomide from 2011-2014.

Results: Eighty-four patients were included in this study, 46 were treated with 3D-CRT and 38 with IMRT technique. The median age at diagnosis was 58 years (range 35-78), and the most frequent tumor location was in the frontal lobe (46%). The 1-year and 2-year overall survival rate (OS) for 3D-CRT group was 71, 7%, and 28, 9% respectively, whilst for the IMRT treated patients it was 73, 5%, and 30, 4% respectively. The median PFS was 7, 8 months for 3D-CRT group and 8, 2 months for the IMRT patients, predominantly with a local pattern of failure.

Conclusion: The results do not confirm a substantial survival benefit for the IMRT technique. Although IMRT allows better sparing of organs at risk (OAR) than 3D-CRT, the increased costs of this treatment force us to assess each case individually from different points of view such as tumor location and proximity to healthy tissues, in order to rationalize the use IMRT treatment delivery.

49. CLINICAL, PARACLINICAL AND HISTOLOGICAL CONSIDERATIONS FOR THE EVOLUTION OF MALIGNANT MELANOMA

Ana Zamfirescu, Anca Zamfirescu, Rodica Anghel1,2

1) Institute of Oncology Bucharest „Prof. Dr. Al. Trestioreanu”; 2) University of Medicine and Pharmacy „Carol Davila” Bucharest

Residents in oncology / Oral presentation

Introduction/ Objective: Malignant melanoma is one of the most dangerous types of cancer. Its incidence has grown at an alarming pace in the last decades, mainly affecting younger patients (under 50 years old). The most documented cause of melanoma is exposure to ultraviolet light. Although melanoma only accounts for approximately 2% of all skin cancers, it is responsible for the most deaths. The survival rate is high (over 98% 5 year survival) for a localized disease; however, its aggressive nature quickly leads to distant metastases if left undiagnosed. Presently, studies have shown the best indicator of tumor staging is vertical tumor thickness (in mm) – known as the Breslow depth.

We aimed to analyse the epidemiological data collected from a group of patients diagnosed with malignant melanoma, assessment of the clinical appearance of the disease, tumor stage, histopathological aspect, sentinel lymph node biopsy and treatment undergone; finding correlations between the data collected and the development of distant metastases or overall survival.

Material & method: The study group comprises 250 patients diagnosed with cutaneous malignant melanoma, between the years 2007-2016. All of the participants have undergone sentinel lymph node biopsy, have been treated and kept under observation through imaging tests. The data collected includes: gender, age, localization, macroscopic appearance, Breslow depth, tumor stage, sentinel lymph node biopsy, disease free survival, distant metastases, overall survival rate and other associated disease.

Results: The most common localization was the anterior thorax (24.5%), without any ulceration (55.6%). Low dose Interferon treatment was administered to every patient with ulcerative lesions. Out of 250 patients, 43 had tumor stage T1 (Breslow depth <0.76 mm), 46 had T2 (0.76-1.5 mm), 104 had T3 (1.5-4 mm) and 53 had T4 (>4 mm). Sentinel lymph node was positive for 18 patients, who as a result had regional lymphatic dissection and received high dose Interferon treatment. Of the 250 patients, 41 (16.4%) developed distant metastases in the following 5 years. The 5 year survival rate is 13.2% in the study group.

Conclusions: The majority of the patients have been diagnosed in an advanced stage, therefore the 5 year survival rate is quite low. The sentinel lymph node was positive without any correlation to tumor staging. The study shows the importance of constant observation in overall survival.

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50. SURVIVAL AND TOLERANCE TO TREATMENT OF PATIENTS WITH TESTICULAR CANCER

T.B. Buta1, R. Anghel1,2

1) Institutul Oncologic “Prof. Dr. Alexandru Trestioreanu” Bucuresti; 2) UMF. “Carol Davila” Bucuresti

Residents in oncology / Oral presentation

Introduction/ Objective: Testicular cancer is the most common neoplastic pathology in young adult males (aged 15-40 years in the area), which is otherwise rare malignancy compared to all males neoplastic pathologies. The incidence is 5 / 100,000 men / year in Europe, with a mortality of 0.35 / 100,000 men / year. The main types of testicular cancer are seminoma and nonseminoma. The cause is not fully known, whites are more predisposed to this pathology from the rest. Long term prognosis is very good, but complications are more pronounced psychological than physical. Survival at 5 years is generally higher in younger men (98%) and decreases with increasing age.

In this study we follow a descriptive analysis of cases with testicular cancer and treatment effectiveness.

Material & methods: This study included 25 patients with testicular cancer, treated in Institute of Oncology Bucharest in 2006-2016, aged between 22-52 years (mean age 34 years) with histologically confirmed diagnosis.

Results: Patients come in approximately equal proportions from urban areas (48%) and rural (52%) with mean age of 34 years. All patients underwent surgery as primary treatment, then 48% (12 patients) received adjuvant chemo-radiotherapy and 52% (13 patients) only adjuvant chemotherapy. There were no cases of developing cancer in the contralateral testicle. At the time of diagnosis 28% of patients (7 patients) had metastases. During treatment, 20% (5 patients) were registered with evolution of the disease through metastasis. The survival rate in patients without metastases was 100%. The mortality rate was 32% (8 patients), of which 20% (5 patients) had metastases at time of diagnosis.

Conclusions: Patients with testicular cancer generally responds well to treatment with a high success rate of the treatment.

51. PERIOPERATIVE APPROACH IN RESECTABLE GASTRIC CANCER

Botnariuc I1,Trifanescu O1,2, Ilie S2, Serbanescu L1, Bacinschi X1,2,Curea F1, Orlov C1,Anghel R1,2

1) Institutul Oncologic “Prof. Dr. Alexandru Trestioreanu” Bucuresti; 2) UMF “Carol Davila” Bucuresti

Residents in oncology / Oral presentation

Background: Gastric cancer is a highly aggressive malignancy and surgery alone does not provide cure even in early stages. There is no consensus for the best treatment approach in resectable disease. Several strategies are validated: perioperative chemotherapy, sequential adjuvant chemo-irradiation or even concomitant chemo-radiotherapy. We aimed to assess the impact on survival of different adjuvant treatment modalities.

Material & method: Of 75 files of gastric cancer patients addressed to Institute of Oncology Bucharest for surgical treatment between 2010 and 2014, 30 were excluded due to metastatic stage and 17 by missing data. Twenty eight cases were finally included in our analysis. The outcome of interest was disease free survival, time from surgery to any relapse, patients being categorized according adjuvant treatment: concomitant chemo-radiotherapy versus other complementary therapies.

Results: The median age was 61 years, with a range between 25 and 78 years, men were more affected than women (60% vs 40%), the majority of the patients bearing locally advanced disease (64%) and poor differentiated carcinoma (58%). Diffuse and intestinal histological subtypes were almost equally distributed (24% versus 27%, respectively) and 5% of cases were of mixed histology. Majority (96%) had undergone primary gastric resection followed by adjuvant therapy. For a median follow up of 27 months, median DFS was 48 months [95% CI 2.07-93.92] with the worst survival in stage III of disease (median DFS 12 months, log rank p=0.002). Median DFS in patients undergoing adjuvant chemotherapy or radiotherapy alone was 15 months ([95% CI 0-54.4], p=0.162), compared to patients treated by concurrent chemo-radiotherapy whose median DFS was not reached. Stage III of disease seems to benefit mostly from chemo- and radiotherapy concomitance (median DFS 48 mo vs 12 mo, log rank p= 0.022).

Conclusion: In our small sample, chemo-radiotherapy results in better disease-free survival in locally advanced, primary resected, gastric cancer. The results are still to confirm after definitive analyses of entire cohort.

52. SYNCHRONOUS AND METACHRONOUS TUMORS: WHAT TO EXPECT?

Iulia Ristea1, Ioana Voica1, Luiza Serbanescu1, Rodica Anghel1,2

1) Institutul Oncologic “Prof. Dr. Alexandru Trestioreanu” Bucuresti; 2) UMF “Carol Davila” Bucuresti

Residents in oncology / Oral presentation

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Objective: To evaluate the occurrence of synchronous and metachronous malignant tumours, to find the most frequent hystological tumour types, the age group and the relationship to the treatment received.

Methods: A retrospective study of previously diagnosed first primary tumour cases experiencing a synchronous or metachronous tumour, observed at the Bucharest Institute of Oncology between January 2006 to October 2016 . The cases were analyzed for morphology and histology of the first primary tumour, gender and age of patient, treatment received for the first tumour, time interval between the first and the second primary tumour, morphology and histology of the second tumour and the treatment received for the second tumour.

Results: We identified 36 cases presenting synchronous and metachronous tumours in 20 females and 16 men. The age range was 35-80 years (median 57).The time to the second primary tumour was 2-120 months. The most frequent primary tumours were gastrointestinal, breast, lung and melanoma. The patients received surgery, radiotherapy, chemotherapy, imunotherapy and hormonal therapy alone or as multimodality treatment for the first tumours. The most frequent second tumours were breast, lung, prostate and gastrointestinal.

Conclusions: It is of the utmost importance that patients diagnosed with a primary malignant tumour should be thoroughly and regularly followed. Cancer screening, risk evaluation, genetic counseling, and chemoprevention must be taken into consideration. Every new occurring tumour should be biopsied. The interaction between the first tumour and the second tumour or vice versa is still not entirely understood and there is still much to be explored.

53. A RETROSPECTIVE OBSERVATIONAL STUDY OF MELANOMA PATIENTS TREATED IN A SINGLE INSTITUTION BETWEEN 2011 AND 2016

Voica I.1, Serbanescu L1, Ristea I1, Trifanescu O1, Gales L1,2, Anghel R1,2

1) Institutul Oncologic “Prof. Dr. Alexandru Trestioreanu” Bucuresti; 2) UMF “Carol Davila” Bucuresti

Residents in oncology / Oral presentation

Objective:The aim of our study was to analyze prognostic factors, effect of treatment and survival outcome of a contemporary cohort of melanoma patients treated in a single institution.

Patients and methods: We retrospectively analyzed the data from 79 patients who were treated for melanoma between 2011 and 2016 at the Bucharest Institute of

Oncology. The patients received surgery, radiotherapy, chemotherapy, immunotherapy and targeted therapy, either alone or as a multimodality treatment. The current vital status was ascertained for all patients and survival was calculated from the date of diagnosis to the date of death or last follow-up.

Results: The patients included ranged in age from 22 to 79 years at the time of diagnosis, with a median age of 55. The most common site for the malignant melanoma was the trunk (51%), followed by extremities (34%), head and neck region (5%), eye (3%) and ano-rectal (1%). The percentage of patients diagnosed with stage II and III melanoma was similar (36% and 37% respectively), while 21% of patients presented metastatic disease at the diagnosis. The most common metastatic site was to the lymph nodes (60%). Seven patients (8%) underwent treatment for another primary tumour prior to the diagnosis of melanoma. The results of DFS and OS were according to those presented in the literature.

Conclusions: In the era of molecular profiling, management of malignant melanoma remains a challenge because of a paucity of active treatment modalities.

54. ACUTE TOXICITY OF IMRT VERSUS 3DCRT FOR POST-PROSTATECTOMY IRRADIATION

Bunta Ovidiu1, Nastase Ioana2, Marita Andreea3, Iacob Catalin1, Zahu Renata1, Kacsó Gabriel1,2

1) RTC Amethyst Cluj; 2) UMF Iuliu Hateganu Cluj; 3) Institute of Oncology „Prof Dr Ion Chiricuta” Cluj-Napoca, Romania

Objective: To assess the acute toxicities after 3D-CRT and IMRT in prostate cancer patients who underwent surgical treatment.

Material & methods: In the postprostatectomy setting for prostate cancer, we analysed a matched pair cohort of 30 patients treated with salvage or adjuvant 3D-CRT at the Institute of Oncology „Prof Dr Ion Chiricuta” Cluj-Napoca and 30 patients treated with salvage or adjubvant IMRT at RTC Cluj, from 2014 to 2016.

Results: Fiftyone patients (85%) underwent salvage radiotherapy and only 9 (15%) adjuvant radiotherapy. In the 3DCRT arm 47% of patients had no hormonal treatment before RT and 33% from the IMRT arm, respectively. Of all, 92% had at least G1 urinary toxicity. Acute urinary retention was present in 10% (3p) from the 3DCRT arm and 3% (1p) in the IMRT arm, respectively. Hematuria was present in 10% (3p) from the 3DCRT arm and 3% (1p) in the IMRT arm, respectively. 6p (20%) who underwent 3DCRT had rectal bleeding vs 5p (16,5%) after IMRT, but there was no G3 rectal bleeding in IMRT arm compared to 3 cases in

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3DCRT arm. In the 3DCRT arm we registered more diareea episodes, 46% vs 33% in IMRT arm. G3 erectile disfunction was present in 30% of the cases in both arms.

Conclusions: IMRT is better tolerated by the patients with less acute toxicities than 3D conformal radiotherapy. G3 acute toxicities were more present in the 3DCRT. G2 or less were more in the IMRT group.

55. ENDOVASCULAR TREATMENT OF MALIGNANT LIVER TUMORS

Filep R., Halmaciu A., Marginean L.

Department Radiology and Imaging – SCJU Tg. Mures

Malignant liver tumors are one of the main causes of oncologic related mortality world-wide; liver metastases and hepatocellular carcinoma occupy the first two places epidemiologically.

Surgical resection is the first-line treatment option, offering the best curative chance in patients with limited tumor spread, unfortunately more than 2/3 of cases are ineligible for this treatment.

The fact that malignant liver tumors are almost exclusively fed by the hepatic artery, made it possible to develop ways of reaching them trans-arterially, which combined with technologic advances made in the last 20 years, led to the development of a endovascular arsenal dedicated for oncologic patients. Interventional treatment options include: transarterial chemo-infusion (TACI), transarterial chemo-embolization (TACE) with lipiodol/drug-eluting particles/bioresorbable particles combined with different chemotherapeutic agents and radio-embolization.

The efficacy of all these possibilities is proven by multicentric randomized trials, showing a significant benefit in survival.

We present our experience on 56 cases treated in our department with some of the above mentioned interventional options and their effects in terms of survival.

56. RARE CANCER IN CHILDREN: APPENDICULAR CARCINOID

Monika Bădoi , Oana Iaru, Codruţa Comşa, Olivia Drăgnescu, Monica Dragomir

Institute of Oncology “Prof. Dr. Al. Trestioreanu”, Pediatric oncology Department

Background and aims: Carcinoid tumors are epithelial tumors located in different anatomical structures: intestinal tract, bronchi, pancreas and ovaries. The appendicular carcinoid is discovered during the histopathological analysis

of the appendicular tissue obtained after appendectomy. The clinical presentation is usually represented by acute abdominal pain located in right iliac fossa leading to the diagnosis of appendicitis. The carcinoid syndrome (recurrent abdominal pain, diarrhea, wheezing, facial flushing) usually diagnosed in adults, is rare in children. The treatment consist in surgical intervention (appendectomy). The prognostic is very good, with very rare cases of metastatic tumors.

The aim of the study was to evaluate the epidemiological characteristics of children having this diagnosis admitted in our unit.

Methods: We performed a retrospective study that included patients diagnosed with appendicular carcinoid, admitted in the Pediatric Oncology department from 2006 until 2016.

Results: 7 patients were evaluated (6 girls and 1 boy) aged between 10 and 15 years. The clinical presentation was with acute abdominal pain in 5 cases; nausea and vomiting in 4 cases and chronic abdominal pain (recurrent episodes of pain localised mainly in right iliac fossa) for 2 patients. Although 4 of our patients were initially diagnosed with urinary tract infection, gastritis or chronic abdominal pain, in evolution all patients had appendicitis and appendectomy was performed (one case associated peritonitis). No patient had metastatic disease (CT thorax and abdomen) and investigations for carcinoid syndrome were negative.

Conclusions: Our patients have the features mentioned in the literature: clinical diagnosis of appendicitis, accidental histopathological discovery after surgery, absence of carcinoid syndrome and metastatic disease.

The appendicular carcinoid represents a rare tumor in children with very

57. MALIGNANT GESTATIONAL TROPHOBLASTIC NEOPLASIA IN FEMALE ADOLESCENTS

Monica Desiree Dragomir, Codruta Comsa, Monika Badoi, Oana Iaru, Olivia Dragnescu

Institute of Oncology „Prof. Dr. Al. Trestioreanu”, Pediatric Oncology Department, Bucharest, Romania

Background: Gestational trophoblastic neoplasia (GTN) encompass a spectrum of neoplastic disorders that arise from placental trophoblastic tissue after abnormal fertilization and account for less than 1 % of malignancies in women.

Purpose: retrospective study (Jan.2001-March 2015) which evaluates clinical presentation, risk factors, response to treatment and the accuracy of the serum tumor marker (hCG) .

Patients and method: 9 patients(pts.) between 13-17 year old were evaluated; one out of them has AIDS discovered

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at the same time with malignant GTN. 8/9 patients reported vaginal bleeding at presentation and/or abdominal pain; the ninth patient (with AIDS) had uterine wall perforation with haemoperitoneum at diagnosis. Pretreatment hCG level was elevated: > 100.000 mUI/ml in 2/9 pts . Stages (FIGO): I (5 pts), III (4 pt- lung metastases). Histological types: invasive mole (3), choriocarcinoma (1), malignant hydatidiform mole (3), non-mole trophoblastic neoplasia (1), placental site trophoblastic tumor (1). Tratment: consisted in surgery (sucction curettage-8 and conservative surgery for perforation-1) followed by chemotherapy- 3 cycles after a normal level of serum marker is obtained or until the lung

metastases disappeared. Patients were followed-up for least 1 year after completion the treatment.

Results: All patients belong to the „low risk” group. Complete remission (CR) in all cases. Disease free survival till now, including the patients with metastasis/AIDS.

Conclusions: 1. The findings confirm data from literature available for adult women: high rate of cure, including cases with lung metastasis. 2. GTN is treated efficiently with conservative surgery and chemotherapy. 3. hCG is an essential tumor marker for diagnosis, risk group stratification, choosing therapy, monitoring the response to the treatment and follow up.

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MELANOM avansat*1

NSCLC scuamos avansat**2

NSCLC non-scuamos avansat**3

RCC avansat***4

SG la 1 AN

73%vs. 42% DTIC

RR: 0,42, P<0,001#

SG la 1 AN

42%vs 24% docetaxelRR: 0,59, P<0,001

SG la 1 AN

51%vs 39% docetaxelRR: 0,73, P<0,002

SG MEDIANĂ

+5,4 lunivs everolimus

RR: 0,73, P=0,002

*nerezecabil sau metastatic; **după tratamentul anterior cu chimioterapie; ***după terapie anterioară; #la pacienţi cu status mutaţional BRAF negativPD-1: programmed death; SG: supravieţuire generală; NSCLC: cancer bronho-pulmonar altul decât cel cu celule mici (non-small cell lung cancer); DTIC: dacarbazină; RCC: carcinom renal (renal cell carcinoma)Referinţe: 1. Robert et al. NEJM 2015;372:320-30; 2. Brahmer et al. NEJM 2015; 373:123-35; 3. Borghaei et al. NEJM 205; 373:1627-39; 4. Motzer et al. NEJM 2015; 373:1803-13.

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Acest material este destinat profesioniștilor din domeniul sănătăţii. © 2016 Bristol-Myers Squibb Company. Toate drepturile rezervate.1506RO16PR07549-01. Data aprobării materialului: Iunie 2016Opdivo® este marcă înregistrată Bristol-Myers Squibb și se eliberează pe bază de prescripţie medicală restrictivă.

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Consultaţi Rezumatul Caracteristicilor Produsului (RCP) înainte de prescriere. Compoziţia calitativă şi cantitativă: Fiecare ml de concentrat conţine nivolumab 10 mg. Indicaţii terapeutice: Melanom OPDIVO este indicat în monoterapie sau în asociere cu ipilimumab pentru tratamentul melanomului în stadiu avansat (nerezecabil sau metastazat) la adulţi. În comparație cu monoterapia cu nivolumab, o creștere a supraviețuirii fără progresia bolii (SFP) pentru asocierea nivolumab cu ipilimumab este stabilită numai la pacienții cu expresie tumorală redusă a PD-L1. Cancerul bronho-pulmonar altul decât cel cu celule mici (NSCLC) OPDIVO este indicat pentru tratamentul cancerului bronho-pulmonar altul decât cel cu celule mici (NSCLC, non‑small cell lung cancer) local avansat sau metastazat, după tratamentul anterior cu chimioterapie, la adulți. Carcinom renal (RCC) OPDIVO este indicat ca monoterapie pentru tratamentul carcinomului renal după terapie anterioară, la adulți. Doze şi mod de administrare: OPDIVO în monoterapie: Doza recomandată de OPDIVO este de 3 mg/kg nivolumab administrată intravenos pe durata a 60 de minute la fiecare 2 săptămâni. OPDIVO în asociere cu ipilimumab: Doza recomandată este de 1 mg/kg nivolumab administrată sub formă de perfuzie intravenoasă pe durata a 60 de minute la fiecare 3 săptămâni pentru primele 4 doze în asociere cu 3 mg/kg ipilimumab administrat intravenos pe durata a 90 de minute. Aceasta este apoi urmată de o a doua fază în care doza de 3 mg/kg nivolumab este administrată sub formă de perfuzie intravenoasă pe durata a 60 de minute la fiecare 2 săptămâni. Tratamentul cu OPDIVO, fie sub formă de monoterapie fie în asociere cu ipilimumab, trebuie continuat atât timp cât se observă beneficii clinice sau până când nu mai este tolerat de pacient. Nu se recomandă creșterea sau reducerea dozei. Poate fi necesară amânarea sau oprirea administrării tratamentului în funcţie de profilul individual de siguranţă și tolerabilitate. Recomandările detaliate pentru gestionarea reacţiilor adverse mediate imun sunt descrise la pct. 4.4. Pacienților tratați cu OPDIVO trebuie să li se înmâneze Cardul de atenționare pentru pacient și să li se aducă la cunoștinţă riscurile administrării OPDIVO (vezi, de asemenea, prospectul). Atunci când OPDIVO este administrat în asociere cu ipilimumab, dacă se întrerupe temporar administrarea dozei oricăruia dintre medicamente, se va întrerupe temporar și administrarea dozei din celălalt medicament. Copii şi adolescenţi: Siguranţa și eficacitatea OPDIVO la copii cu vârsta sub 18 ani nu au fost încă stabilite. Pacienţi vârstnici: Nu este necesară ajustarea dozelor la pacienţii vârstnici (≥ 65 de ani). Cancerul bronho-pulmonar altul decât cel cu celule mici Datele provenite de la pacienţi cu vârsta de 75 de ani sau peste sunt prea limitate pentru a permite formularea unor concluzii referitoare la această grupă de pacienţi.Cancerul bronho‑pulmonar altul decât cel cu celule mici Pacienții cu un scor al performanței Eastern Cooperative Oncology Group (ECOG) ≥ 2 au fost excluși din studiile clinice pentru NSCLC (vezi pct. 4.4 și pct. 5.1). Mod de administrare: OPDIVO este numai pentru administrare intravenoasă. OPDIVO nu trebuie administrat intravenos rapid sau în bolus. Când se administrează în asociere cu ipilimumab, OPDIVO trebuie administrat primul urmat de administrarea ipilimumab în aceeași zi. Pentru fiecare perfuzie se vor utiliza pungi și filtre pentru perfuzie diferite. Pentru instrucţiuni privind manipularea medicamentului înainte de administrare, vezi pct. 6.6 din RCP. Contraindicaţii: Hipersensibilitate la substanţa activă sau la oricare dintre excipienţii enumeraţi la pct. 6.1. Atenţionări şi precauţii speciale pentru utilizare: Atunci când nivolumab este administrat în asociere cu ipilimumab, se va consulta RCP-ul pentru ipilimumab înainte de iniţierea tratamentului. Reacţiile adverse mediate imun au survenit cu o frecvenţă mai mare atunci când nivolumab a fost administrat în asociere cu ipilimumab comparativ cu utilizarea nivolumab în monoterapie. Majoritatea reacţiilor adverse mediate imun s-au ameliorat sau s-au remis prin conduită terapeutică adecvată, inclusiv iniţierea corticoterapiei și ajustarea tratamentului (vezi pct.  4.2). S-au raportat, de asemenea, evenimente adverse cardiace și embolie pulmonară cu terapie asociată. Pacienţii trebuie monitorizaţi continuu pentru depistarea reacţiilor adverse cardiace și pulmonare, dar și a semnelor clinice, simptomelor și rezultatelor anormale ale testelor de laborator sugestive pentru dezechilibre electrolitice și deshidratare înainte de iniţierea tratamentului și periodic pe durata acestuia. Tratamentul cu nivolumab în asociere cu ipilimumab trebuie oprit în cazul reacțiilor adverse cardiace și pulmonare care pun viața în pericol sau severe recurente. Pacienţii trebuie monitorizaţi continuu (timp de cel puțin 5  luni după administrarea ultimei doze) deoarece o reacţie adversă la tratamentul cu nivolumab sau la cel cu nivolumab administrat în asociere cu ipilimumab poate apărea în orice moment în timpul sau după oprirea terapiei. În funcţie de severitatea reacţiei adverse, tratamentul cu nivolumab sau cu nivolumab administrat în asociere cu ipilimumab trebuie întrerupt temporar și administraţi corticosteroizi. Reducerea rapidă a dozei poate duce la agravarea sau recurența reacţiei adverse. Se va adăuga terapie cu rol imunosupresor diferită de corticoterapie în cazul în care se constată o agravare sau nu se observă nicio ameliorare în pofida utilizării corticosteroizilor. Tratamentul cu nivolumab sau cu nivolumab administrat în asociere cu ipilimumab trebuie oprit definitiv în cazul reapariţiei oricărei reacţii adverse severe mediată imun cât și în cazul unei reacţii adverse mediată imun ce pune viaţa în pericol. Utilizarea nivolumab la pacienții cu melanom care progresează rapid: Medicii trebuie să ia în considerare debutul întârziat al efectului nivolumab, înainte de inițierea tratamentului la pacienții cu afecțiune care progresează rapid (vezi pct. 5.1). Utilizarea nivolumab în NSCLC nonscuamos: Medicii trebuie să ia în considerare debutul întârziat al efectului nivolumab, înainte de inițierea tratamentului la pacienții cu caracteristici de prognostic rezervat și/sau cu boală agresivă. A fost observat un număr ridicat de decese la nivolumab, comparativ cu docetaxel, pe parcursul a 3  luni. Pneumonită mediată imun: În cazul tratamentului cu nivolumab în monoterapie sau cu nivolumab administrat în asociere cu ipilimumab, s-au observat cazuri severe de pneumonită sau afecțiune pulmonară interstiţială, inclusiv decese (vezi pct.  4.8). Colită mediată imun: În cazul tratamentului cu nivolumab în monoterapie sau cu nivolumab în asociere cu ipilimumab, s-au observat cazuri severe de diaree sau colită (vezi pct. 4.8). Hepatită mediată imun: În cazul tratamentului cu nivolumab în monoterapie sau cu nivolumab în asociere cu ipilimumab, s-au observat cazuri de hepatită severă (vezi pct. 4.8). Nefrită şi disfuncţie renală mediate imun: În cazul tratamentului cu nivolumab în monoterapie sau cu nivolumab administrat în asociere cu ipilimumab, s-au observat cazuri de nefrită severă și de disfuncţie renală severă (vezi pct. 4.8). Endocrinopatii mediate imun: În cazul tratamentului cu nivolumab în monoterapie sau cu nivolumab în asociere cu ipilimumab, s-au observat endocrinopatii severe, inclusiv hipotiroidism, hipertiroidism, insuficienţă suprarenală, hipofizită, diabet zaharat și cetoacidoză diabetică (vezi pct.  4.8). Tratamentul cu nivolumab sau cu nivolumab în asociere cu ipilimumab trebuie oprit definitiv în cazul insuficienței suprarenale severe (grad 3) sau care pune viața în pericol (grad 4). Erupții cutanate mediate imun: S-au observat erupții cutanate severe în cazul tratamentului cu nivolumab în asociere cu ipilimumab și, mai puţin frecvent, în cazul nivolumab utilizat în monoterapie (vezi pct. 4.8). Reacții legate de administrarea perfuziei: În cazul unei reacții severe sau care pune viața în pericol legată de administrarea perfuziei, trebuie oprită perfuzia cu nivolumab sau cu nivolumab în asociere cu ipilimumab și administrat tratamentul medical adecvat. Melanom: În comparație cu monoterapia cu nivolumab, o creștere a supraviețuirii fără progresia bolii (SFP) pentru asocierea nivolumab cu ipilimumab este stabilită numai la pacienții cu expresie tumorală redusă a PD-L1. Înainte de iniţierea tratamentului asociat, medicii sunt sfătuiţi să evalueze cu atenție caracteristicile individuale ale pacientului și ale tumorii, luând în considerare beneficiile observate și toxicitatea terapiei asociate comparativ cu utilizarea nivolumab în monoterapie (vezi pct. 4.8 și 5.1). Interacţiuni cu alte medicamente şi alte forme de interacţiune: Nivolumab este un anticorp monoclonal uman, astfel încât nu s-au efectuat studii privind interacţiunile farmacocinetice. Fertilitatea, sarcina şi alăptarea: Sarcina: Nu există date privind utilizarea nivolumab la femeile gravide. Alăptarea: Nu se cunoaște dacă nivolumab se excretă în laptele uman. Fertilitatea: Nu s-au efectuat studii privind efectul nivolumab asupra fertilităţii. Efecte asupra capacităţii de a conduce vehicule şi de a folosi utilaje: Pacienţilor trebuie să li se recomande precauţie atunci când conduc vehicule sau folosesc utilaje până în momentul în care au certitudinea că tratamentul cu nivolumab nu are un impact negativ asupra lor. Reacţii adverse Rezumatul profilului de siguranţă: În setul de date cumulat provenit din administrarea nivolumab 3 mg/kg ca monoterapie pentru multiple tipuri de tumori, cele mai frecvente reacţii adverse (≥ 10%) au fost fatigabilitatea (34%), erupţia cutanată (19%), pruritul (14%), diareea (13%), greaţa (13%) și scăderea apetitului alimentar (10%). Majoritatea reacţiilor adverse au fost de intensitate ușoară până la moderată (grad 1 sau 2). În setul de date cumulat provenit din administrarea nivolumab în asociere cu ipilimumab la pacienţi cu melanom, cele mai frecvente reacţii adverse (≥ 10%) au fost erupţia cutanată tranzitorie (51%), fatigabilitatea (43%), diareea (42%), pruritul (35%), greaţa (25%), febra (19%), scăderea apetitului alimentar (15%), hipotiroidismul (15%), vărsăturile (14%), colita (14%), durerea abdominală (13%), artralgia (11%) și cefaleea (11%). Majoritatea reacţiilor adverse au fost de la ușoare până la moderate (de grad 1 sau 2). În rândul pacienţilor trataţi cu nivolumab în asociere cu ipilimumab (48%) au avut primul debut al reacţiilor adverse de grad 3 sau 4 pe durata fazei iniţiale de administrare asociată.Pentru informaţii complete privind reacţiile adverse, vezi pct. 4.8 din RCP. Raportarea reacţiilor adverse suspectate: Profesioniștii din domeniul sănătăţii sunt rugaţi să raporteze orice reacţie adversă suspectată la: Agenţia Naţională a Medicamentului și a Dispozitivelor Medicale, Str. Aviator Sănătescu nr. 48, sector 1, București 011478- RO, Tel: + 4 0757 117 259, Fax: +4 0213 163 497, e-mail: [email protected] Supradozaj: În studiile clinice, nu au fost raportate cazuri de supradozaj. Lista excipienţilor: vezi pct. 6.1 din RCP. Incompatibilităţi: OPDIVO nu trebuie perfuzat concomitent în aceeași linie intravenoasă cu alte medicamente. Perioada de valabilitate: Flacon nedeschis: 2 ani După deschidere: Din punct de vedere microbiologic, după deschidere, medicamentul trebuie perfuzat sau diluat și perfuzat imediat. După pregătirea soluţiei perfuzabile: Dacă nu poate fi administrat imediat, stabilitatea fizico-chimică în timpul utilizării OPDIVO a fost demonstrată pentru un interval de 24 de ore la temperaturi de 2ºC până la 8ºC, protejat de lumină, și timp de maxim 4 ore la temperaturi de 20ºC până la 25ºC și în condiţiile de iluminare a camerei. Precauţii speciale pentru păstrare: A se păstra la frigider (2ºC–8ºC). A nu se congela. A se păstra în ambalajul original pentru a fi protejat de lumină. Pentru condiţiile de păstrare ale medicamentului după pregătirea soluţiei perfuzabile, vezi pct. 6.3 din RCP. Natura şi conţinutul ambalajului: 4 ml sau 10 ml de concentrat în flacon a 10 ml (sticlă de tip I) cu dop (butil-cauciuc) și capac de siguranţă detașabil de culoare albastru închis/gri (aluminiu). Cutie cu 1 flacon. Precauţii speciale pentru eliminarea reziduurilor şi alte instrucţiuni de manipulare: Pregătirea trebuie efectuată de personal instruit în conformitate cu regulile de bună practică, în special în ceea ce privește condiţiile aseptice. Calcularea dozei: Doza prescrisă pentru pacient este exprimată în mg/kg. Pe baza acestei doze prescrise, se calculează doza totală care trebuie administrată. Vezi secțiunea Pregătire şi administrare din RCP. Deţinătorul autorizaţiei de punere pe piaţă: Bristol-Myers Squibb Pharma EEIG, Uxbridge, Business Park, Sanderson Road, Uxbridge Ub8 1dh, Marea Britanie. Numărul autorizaţiei de punere pe piaţă: EU/1/15/1014/001-002. Data primei autorizări: 19 Iunie 2015 Data revizuirii textului: Mai 2016. Informaţii detaliate privind acest medicament sunt disponibile pe site-ul agenţiei europene pentru medicamente http://www.ema.europa.eu.

OPDIVO® - Informaţii esenţiale din rezumatul caracteristicilor produsului

Page 53: 3rd National Congress nd th · Journal of Radiotherapy & Medical Oncology, vol 22, 2016, Supplement 7 Thursday, November 3rd, 2016 09.00–17.10 HALL A – PRE CONGRESS COURSE 09.00–11.30
Page 54: 3rd National Congress nd th · Journal of Radiotherapy & Medical Oncology, vol 22, 2016, Supplement 7 Thursday, November 3rd, 2016 09.00–17.10 HALL A – PRE CONGRESS COURSE 09.00–11.30