Gynecologic Cancer InterGroup

GCIG Group Experiences:

AGO-Austria

Christian Marth

GCIG Education Symposium, November 2017, Vienna

Frauenheilkunde Innsbruck

Area 0,56 ‰

Population 1,2 ‰

Frauenheilkunde Innsbruck

1849-1919 1864 -1920

Key Points: We Need To Work Together…

• …since international collaboration in cancer

treatment trials has become increasingly important

from a scientific perspective.

• … to overcome regulatory and logistical barriers to

greater international collaboration.

• … to strengthen financial, regulatory, and logistic

support from government, academia, and local

institutions for academic clinical trials.

• … to induce and perform academic clinical trials in

complement to those run by pharmaceutical

companies.

Why Is International Collaboration in Cancer Clinical Trials Important?

1. More effective treatment for cancer

2. We need larger sample sizes in our trials to identify further improvements or to determine similar efficacy of a less-toxic regimen.

3. Molecular biology to help determine eligibility for trials. We must cast a wider net to find patients with the appropriate molecular classification.

4. To study rare diseases and less common cancers, we need global collaboration.

5. To evaluate the large number of promising new treatments, we need to complete definitive clinical trials rapidly.

6. Conduct of large trials across many countries permits us both to determine whether our clinical trial results are generalizable and to facilitate the introduction of new effective therapy into standard practice globally.

Only by Active Teamwork Will You Reach the Top of Your Dreams

Du Bois A, et al. Int J Gynecol Cancer. 2005;15(2):183-191.

Clinical Trials: Pattern of Care and Impact of Participation in Clinical Studies on the Outcome in Ovarian Cancer

2002 - First AGO Trial

AGO 04 Caelyx Gemzar(Edgar Petru)

January 2002 – June 2004

Random. phase II trial

Caelyx + Gemzar vs. Caelyx mono in platinum-refractory and platinum-resistant epithelial

ovarian, fallopian tube and peritoneal cancer

AGO TrialsAGO 01 Xeloda (n.d.)

AGO 02 NeoRecormon

Protokoll1 (n.d.)

AGO 03 NeoRecormon

AGO 04 Caelyx Gemzar

AGO 05 Campto

AGO 06 Topotecan

AGO 07 Mamma3

AGO 08 Calypso

AGO 09 Tarceva

AGO 10 MyocetGemzar

Random

AGO 11 Ovar Protektion (n.d.)

AGO 12 FAME-Endo

AGO 13 Desktop II

AGO 14 Cervix1

AGO 15 Myocet

AGO 16 IP-Therapie

AGO 17 Hector

AGO 18 Braun (n.d.)

AGO 19 CAMYLA (n.d.)

AGO 20 Vectibix

AGO 21 VEG Pazopanib /

AGO Ovar 16

AGO 22 PALIDO

AGO 23 REACT (n.d.)

AGO 24 BIBF / AGO Ovar 12

AGO 25 LION

AGO 26 Desktop 3

AGO 27 HPV (n.d.)

AGO 28 Trinova 2

AGO 30 Trinova 3

AGO 32 EN-ov8 Catumaxomab

(n.d.)

AGO 33 PenelopeAGO 35 LAB-SLN011AGO 36 SHAPEAGO 37 ITIC2AGO 38 ThromboseAGO 39 Ovar 2.21AGO 40 NOVA

AGO 41 MILOAGO 42 PITVINAGO 43 GANNET53AGO 44 Expression IVAGO 45 LUSTICAGO 46 INOVATYON

AGO 47 PAOLA-1AGO 48 Corail

AGO R01 Breastcancer duringpregnancy

Medicinal product Surgical

Questionnaire Other

Registry /retrospective n.d.=not done

50th AGO Trial in 2016

Frauenheilkunde Innsbruck

Study center of the Austrian AGO

32 Active collaborating centers

1 Med Uni Innsbruck

2 Med Uni Wien

3 Med Uni Graz

4 BHS Linz

5 BB Graz

6 BHS Ried i.I.

12 KH Oberpullendorf

13 Univ . Klinikum Salzburg

14 KH Hallein

15 BKH Kufstein

16 LK Neunkirchen

22 KA Rudolfstiftung

23 LK St. Pölten

24 LK Korneuburg

25 BKH Lienz

26 AKH Linz

27 BKH Hall

28 LK Mistelbach

Study centers17 Kaiser Franz Josefspital Wien

18 LK Wiener Neustadt

19 Hanuschkrankenhaus Wien

20 KH Elisabethinen Linz

21 LK Krems

7 Klinikum Wels-

Griesskirchen

8 Wilhelminenspital

Wien

9 KH Hietzing

10 LKH Leoben

11 LKH Klagenfurt

Most Austrian Sites per Trial

AGO 09Tarceva

AGO 12FAME-Endo

AGO 38Thrombose

19 17 16

Questionnaire

Registry

Medicinal product

Enrollment in AGO-Trials

0 100 200 300 400 500 600 700

MUW

MUI

MUG

SALK

LKH Klagenfurt

Ordensklinikum BHS Linz

BB Graz

KH Hietzing

KH Leoben

WSP Wien

AKH Linz/LFKK/Kepler

Klinikum Wels-Grieskirchen

KH Wr. Neustadt

BHS Ried i. I.

KH Kufstein

BKH Lienz

BB Wien

KA Rudolfstiftung

LKH St. Pölten

KH Neunkirchen

KH Oberpullendorf

LK Korneuburg

Privatklinik Villach

Kaiser-Franz-Josef Wien

LK Krems

LK Mistelbach

KH Hallein

Elisabethinen Linz

KH Oberwart

Zwettl

Hanuschkrankenhaus

BKH Hall

Number of patients

48%

50% of patients from 10% of the sites

AGOGRAMM

Latest report on current

and planned AGO Trials

International Collaboration

• GCIG (28 trial groups, worldwide)

• ENGOT (19 trial groups from 15 Europ. countries)

International trials, exchange of knowledge

https://www.i-med.ac.at/mypoint/news/677590.html

Christian Marth

– ENGOT ChairRegina Berger

– ENGOT Admin Chair

AGO Austria as Leading Group

AGO 28 Trinova 2 (ENGOT-ov6) phase III, randomized, double-blind trial of PLD +

AMG386/placebo in recurrent partially platinum-sensitive or

resistant epithelial ovarian cancer

• Coordination of large international trial with 6 trial

groups

7th Framework EU Grant

AGO 43 GANNET53two-part, multicentre, international phase I and II trial assessing the safety+ efficacy of Hsp90 inhibitor ganetespib in combination with paclitaxelweekly in high-grade serous / endometrioid or undifferentiated platinum-resistant epithelial ovarian cancer

• EU project (7th Framework Programme): 4 European

countries, €6 Mio. grant

• Sponsor & trial management: Medical University of Innsbruck

Currently 2597 Patients in AGO Trials

60

87

93

119

209

250

1028

AGO 08 Calypso

AGO 37 ITIC2

AGO 09 Tarceva

AGO 03 NeoRecormon

AGO 38 Thrombose

AGO 44 Expression IV

AGO 12 FAME-Endo

Questionnaire & registry

Medicinal product

Highest recruiting trials:

Publications

• In total 31 publications of AGO trials

• Most publications: AGO 08 CalypsoA multi-national, randomized, phase III, GCIG Intergroup study comparing

pegylated liposomal doxorubicin (CAELYX®) and carboplatin vs. paclitaxel

and carboplatin in patients with epithelial ovarian cancer in late relapse (> 6

months)

14 publicationse.g. Journal of Clinical Oncology, British Journal of Cancer, Gynecologic Oncology,

Journal of the National Cancer Institute, Annals of Oncology, European Journal of

Cancer

Future Impact of Ongoing

Surgical AGO Trials

• Efficiency of systematic pelvic and para-aortic lymph-adenectomy in patients with advanced ovarian cancerand intra-abdominal complete debulking (AGO 25 LION)

• Improved OS through tumour debulking surgery in addition to chemotherapy after recurrence ofplatinum-sensitive ovarian cancer (AGO 26 Desktop III)

• Non-inferiority of simple hysterectomy and pelvic nodedissection to treatment with radical hysterectomy andpelvic node dissection in terms of pelvic relapse-freesurvival in cervical cancer stage Ia2 (AGO 36 SHAPE)

Current situation

2014: First time that a total of 13 trials were

open for accrual simultaneously, enabling patients to

receive innovative, state of the art treatment

Today: 12 trialsare open for accrual

Why Is an International Cooperation in Clinical Trials Successful?

Frauenheilkunde Innsbruck