London SPECC Sun Myint Course March 2016
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Transcript of London SPECC Sun Myint Course March 2016
Contact radiotherapy (Papillon)for rectal cancer
Arthur Sun MyintLead clinician (Papillon)Hon. Professor in GastroenterologyThe University of Liverpool
The Friend’s House, Euston Road, London 9th March 2016
Background• Surgery is the Standard of care • TME is recommended for upper and mid
rectal cancer• APR is necessary for low rectal cancer• For early rectal cancer this approach is an
over treatment • We should not offer the same standard of
care for all patients with rectal cancer
WHY? - Personalised treatment• There is increase in ageing population • There is recognition of harm from surgery
especially in elderly patients• Earlier staged cancers are been
increasingly diagnosed through National bowel cancer screening programme.
• Disease stage is changing, therefore, the concepts for management of rectal cancer management should changed to reduce the harm from surgery.
UK’s ageing population on the rise
www.statistics.gov.uk (2008)
2.8 m 5.8 m
Mortality & morbidity in the Elderly
Rutten HJ et al. Lancet Oncol 2008;9(5): 494-501.
Mortality 14 - 25%Morbidity 40 - 50%
Medical co-morbidity
Obese
Fiaz O et al . Colorectal Disease (2011) 14: 1175-1182
Worse with higher ASA grades
Courtesy of Mr Simon Bach
Stage A - polyp22%
Stage A26%
Stage B25%
Stage C26%
Stage D1%
Screen Detected Tumors by Stage
Dukes A 48%Dukes A 48%
NBCS data
Started 2009
North West screening dataCourtesy of Prof Paul O’Toole
Polyp cancer 22%
This is a reality and not a dream
Rectal Cancer
• T1 /T2 /T3a• N0 /M0 • <3cm• Mobile
polyp
• T3b <5mm • N1 /M0• >3cm• CRM(-)ive
The Good The Bad• T3c + /T4• N2 /M0• >3cm• CRM (+)ive
The Ugly
Pre-op CRT Surgery
Not all pts suitable for surgery
Early rectal cancerAdvanced rectal cancer
The standard of CareSURGERY
So, what is the alternative option?
Contact X-ray Brachytherapy (Papillon)
Minimally invasive topical radiotherapyProf Jean Papillon - Lyon (1914-1993)
Selection Criteria
• Rectal adenocarcinoma (early cancer) low risk• Stage cT1 or cT2 (cT3a) confine to bowel wall• <3cm (one third of circumference or less)• Histologically- well to mod. differentiated• Clinically - Mobile exophytic tumour• Within 12cm from anal verge• Staging- MRI (rT1/T2/T3a) / uT1(EUS) • No suspicious lymph nodes (N0)
Patients not suitable for surgery or refuse surgery
Exclusion Criteria
• Poorly differentiated adenocarcinomas• Lympho vascular invasion - LVI(+)• Suspicious lymph nodes
Patients not suitable for radical curative radiotherapy
Contact RT delivers low energy, high dose (30Gy) small volume targeted radiation directly on the rectal tumour and kill cancer cells layer by layer at each treatment sessions every 2 weeks X 3
Why it works
Minimally invasive Low Energy (50KV)High Dose (30Gy)Small Volume (5cc)
Targeted Directly
Select responders after treatment
08.11.05 (Day 0) 22.11.05 (D 14) 06.12.05 (D 28)
10.01.06 ( D 62)
Good responders - No residual - Wait & Watch
Partial responders - Small residual - TEMS
Poor responder - Residual disease - TME
Sun Myint et al Clin Oncol Vol. 19 No 9 Nov 2007
No useful molecular bio predictive markers identified yetUniversity of Liverpool ‘Translational research’- genetic profile / proteonomics
Side Effects2009-2011(n=100)
Acute• Proctitis (2 patients has pain)• Radiation ulcer (27%)Late• G1/G2 Bleeding-38% (Argon 10%)• Stenosis 0% (1% in initial cohort)• Fistula 0% ( 1% in initial cohort)• No treatment related mortalitySun Myint A et al. Colorectal Disease (2013) PosterNICE – Interventional Procedure Guidance IPG 532 (2015)
(heals in 3- 6mths)
Papillon scar
Institution N° Pts Age pTis pT1 pT2 Loc Rec 3y
Nice2010-2014 12 73 1 9 2 0 95%
Clatterbridge2009-2012 123 70 0 99 24 3 67%
Hull2011-2014 18 71 0 9 9 0 100%
Guilford2014 4 68 0 3 1 0 100%
Nottingham2014 6 72 1 4 1 1 93%
Mâcon2011-2014 0 0 0 0 0 0 NA
Villeurbanne2011-2014 3 76 0 3 0 1 100%
TOTAL 166 72 2 137 37 3% 98%
Malignant Polyp local excision + post op PapillonResults
ICONE Group (CONTEM data base)
T2-T3 cancers : Papillon + EBRT(CRT)Institution N° Pts Age T2 T3 cCR Loc Rec Org pres 3yS
Nice2010-2014 16 84 10 6 16 1 15(93%) 70%
Clatterbridge2009-2012 128 71 57 71 81 11 104(81%) 72%
Hull2011-2014 35 78 30 5 32 3 32(91%) 91%
Guilford2014 26 75 18 8 23 1 23(88%)
Nottingham2014 20 76 6 14 16 1 17(85%)
Mâcon2011-2014 14 70 6 8 10 3 9(64%) 78%
Villeurbanne2011-2014 8 75 6 2 8 1 7(87%) 87%
TOTAL 247 75 133 114 87% 11% 81% 78%
ICONE Group (CONTEM data base)
Results
Tumour control probability (EBCRT vs EBCRT +CXB)
Study n Initial response
Organpreservation
Regrowth
Habr Gama(2014) 1
183 49% 38% 31%
Apelt(2015) 2
55 73% 73% 26%
Renahan(2015)
3 129 50% 75% 34%
Sun Myint(2015) 4
200 68% 80% 11%
1. Habr Gama et al. Int J Rad Oncol Bio Phys (2014); 88(4):822- 828 2. Apelt et al. Lancet Oncology (2015);16(8):919- 9273. Renehan et al Lancet Oncology (2015) in press4. Sun Myint et al. (in preparation)
OPERA (phase II randomised trial)
Mid /Low rectal cancer
EBCRT+EBRT boost
EBCRT+Papillon boost
Assessment at 14 weeks
End pointOrgan preservation(3yrs)
cCR ‘Watch & Wait’ TEMS for PR TME for NR
cT2/cT3a/cT3b No /N1 Size <5cm
Arm A Arm B
Hypothesis -20% difference in organ preservation between Arm A and Arm B
Inclusion
We need evidence
UK NCRI Rectal Trials Portfolio
Rectal Cancer
T1/T2/ N0 <3cm T3cCRM(-) N1 T3/T4CRM(+) N2
TREC COPERNICUS BACCUS
ARISTOTLE
The Good The Bad The Ugly
OPERA (<5cm T2/T3a T3b N0 /N1)
Multi disciplinary team meeting
“No decisions about me without me”
MDTDoctors Knows BestNo patient involvement
Shared decision making with patients
Treatment Options
Benefits HarmCureSurvival
RecurrenceDeathComplications
2cmT2 N1M0
MDT
It is another fine balance - Life changing
Patient’s Choice
Surgery
Must learn to think outside the box• Training• Governance• Guidelines• Protocols
Advances in Technology
New Innovations
New Concepts in treatment
Change in stage of disease 50% early stage (25% polyps)
Minimally invasive - Less Harm
Standard of Care
TEMSPapillon
The Future
An International Consensus MeetingChampalimaud Foundation February 2014 Lisbon
Rectal Cancer - “When not to operate”
October 2014 MilanMarch 2015
Heald et al. Consensus statement. Colorectal Disease(2014);16:334-36
Evolving concepts in rectal cancer management
NICE IP Guidance 532(2015)
1.1 Clinician’s Choice1.2 Patient’s Choice NICE IP Guidance 532(2015)
NICE Care pathway for Stage 1 rectal cancer
NICE Colorectal Guidelines (2016)
Non surgical option
NICE Care pathway for Stage 1 rectal cancer
NICE Colorectal Guidelines (2016)
Patient should have the opportunity to make informed decision about their care and treatment in partnership with their health care professionals.
Patient centred Care
NICE Colorectal Guidelines (2016)
Colorectal guidelines
Proposal for Contact radiotherapy• Low risk early rectal cancer (<6cm)
cT1/cT2/cT3a • Small mobile cancers (<3cm)• Elderly patients (80+ years)• Younger patients with high surgical risk (CPX)• No suspicious Lymph nodes• Discuss at early rectal cancer MDT• Offer patient treatment options after MDT
www.clatterbridgecc/professionals/papillon training course
Malignant polyp care pathway Low rectal cancer cT1/cT2 <3cm
MDT
Non Surgical option Surgical option
CXB X3
EBRT
cCR PR NR
W+W TEMS TME
TEMS TME
CXB
Malignant polyp care pathway Low rectal cancer cT1/cT2cT3a >5cm
MDT
Non Surgical option Surgical option
EBRT
CXB
cCR PR NR
W+W TEMS TME
TEMS TME
CXB
TEMS preferred
• No proof of malignancy in a polyp• Patient’s preference• Surgeon’s preference• Residual mucosal abnormality after Papillon
TEMS for residual mucosal abnormality
Histology – adenoma
Papillon preferred over TEMS
• Patients not fit for GA• Large malignant ulcerated polyps• Very low rectal malignant polyps • High anterior malignant polyps
Indications for Papillon after TEMS
Elderly patients not fit for radical surgery (NICE)Younger patients refusing stoma (trial)• Resection margins <1mm• Unexpected T2 polyp cancers • Extramural venous invasion EMVI(+)
Centres with Papillon facility in the UK
Clatterbridge 1993Hull 2010Guildford 2014Nottingham 2014LondonWolverhamptonDevonCardiffColchester Newcastle
Clatterbridge Papillon training courses started 2010 and runs annually in October
Hull team started 2010
Take home message• Avoid extirpative surgery in elderly patients
with early rectal cancer. Consider Papillon first. • Consider contact X-ray brachytherapy boost
for low rectal cancer in patients who responded well (cCR) following EBCRT to improve local control.
• Patients prefer to avoid surgery and a stoma if they have a choice
Arthur Sun MyintLead clinicianHon. ProfessorThe University of Liverpool
The Friend’s House, Euston Road, London 6th November 2015
Thank You