Local Excision for early rectal cancer

Local Excision for early rectal cancer M. Trompetto, E. Ganio, G. Clerico, A. Realis Luc, RJ Nicholls Colorectal Eporediensis Centre Clinica S. Rita Vercelli Gruppo Policlinico di Monza

Mortality Morbidity Sexual and urinary dysfunctions Risk of stoma

Oncological results Functional results QoL

Risk of recurrence 5-y survival Depth of invasion Jass (1987) 97% Dukes A Hermanek (1989) 81% Muscolaris Mucosa Harrison (1994) 78% Submucosa 65% Intern Musc Layer 60% External Musc layer

Risk of recurrence sm1 sm2 Risk of local recurrence sm2 sm3 flat or ulcerated High risk of local recurrence and nodal invasion

Limph node metastasis T1 0-12 % T2 12-28% T3 36-79%

Risk of recurrence Limph + Limph- P Recurrence 36.4% 5,9% p < 0,005 5-y survival 72,7% 91,1% p < 0,05 10-y survival 45,5% 65,3% p < 0,05 Hase et al 1995

Selection criteria for local excision 1 Tumor not treatable with major surgery (frail patients,refusal) 2 - Tumor moderately or well differentiated, not mucinous 3 - Mobile at digital examination 4 ut1 or ut2 at ultrasound 5 No detectable limph nodes 6 Posterior or posterolateral localisation 6 Not occupying more than 35-40% of the rectal circumferentia Bailey 1998

High Risk Poor differentiation Mucinous ca Lymphovascular invasion Proper muscle invasion Positive margins

Rectal Cancer - Local treatment Elettrocoagulation Local radiotherapy Rectal Mucosectomy Excision via trans-sphinteric Transanal Excision TEM

TEM in Italy 34 TEM devices 17 actually used 1208 declared procedures ( 84% in 6 centres) Puglisi R, Trompetto M et al Chir Ital, 2007

TEM for adenomas Experience of six italian centres 882 TEM 588 adenomas No mortality Perforation 3 Minor complications 48 (8,2%) Major complications 7 (1,2%) Definitive hystology of adenomas 90,1% Recurrences 23 (4,3%) (20 re-tem, 3 AR) Guerrieri M, Trompetto M et al Dig Liv Dis, 2006

A predictive model for local recurrence after TEM for cancer 487 patients Validated model using measures of calibration and discrimination Cox regression model predicted local recurrence with a concordance index of 0,76 using age, depth of tumor invasion, tumor diameter, presence of limphovascular invasion, poor differentiation,and conversion to radical surgery after histopathological examination of the TEM specimen Bach SP et al Br J Surg, 2009

Recurrence Inadequate preop stadiation? Inadequate resection? Inadequate follow-up? Inadequate further treatment?

.. Local excision and TEM are likely to be curative in most patients with a primary tumor which is limited to the submucosa (T1), without high-risk features and in absence of metastatic disease. They allow for improved patients comfort, shorter hospital stay and earlier return to preop activity level. Once the tumor invades the muscularis propria (T2) radical resection is recommended.. Balch GC et al World J Gastroenterol 2006

.. pt1 rectal cancers treated by local excision have 3-5 fold higher risk of recurrence compared with patients treated by radical surgery. Local excision should be reserved for low-risk cancers in patients who accept an increased risk of tumor recurrence, prolonged surveillance and possible need for aggressive salvage surgery. Radical resection is the more definitive surgical treatment of T1 rectal cancers.. Bentrem DJ et al Ann Surg 2007

CEC Experience 1994-2008 237 local excisions 56 transanal 181 TEM adenocarcinomas 35 (29 ut1, 6 ut3) adenomas 194 carcinoids 8

Cec Experience 1994-2000 Postoperative hystological evaluation adenoca 78 pt1 56 pt2/pt3 pts have had postop RT pt2 14 pt3 8 11 pt2 and 11 pt1 pts have ben submitted to RR (4 N+)

Transanal Excision vs Radical resection

LE vs Radical Surgery 151 transanal excision (group A) 319 pts 168 radical resection (group B) Group B: Higher location Larger size Similar adverse hystology Fewer local recurrence Fewer distant mts Better recurrence-free survival Lymph node mts 18% Overall and disease-specific survival similar Bentrem DJ et al Ann Surg 2007

2124 pts 765 LE 1359 AR 601 T1 164 T2 493 T1 866 T2 LE AR 30-day morbidity 5,6% 14,6% p< 0,001 5-y pt1 local recurr 12,5% 6,9% p= 0,003 5-y pt2 local recurr 22,1% 15,1% p= 0,01 You YN, Nelson H et al Ann Surg 2007

Local excision/tem vs Radical resection 479 low-risk pt1 120 transanal approach/tem (group A) 359 radical resection (group B) group A group B General complications 7,5% 25,1% p< 0,001 Specific complications 9,2% 22,8% p< 0,001 Local recurr (F-U 44 M) 6% 2% p= o,49 Ptok H et al Arch Surg 2007

Salvage Surgery post LE Tumor differentiation Nodal status Interval between initial operation and recurrence (follow-up!) Pattern of recurrence

Immediate vs salvage surgery post LE 155 pts 91 local excision 44 snare-cautery 20 fulguration 21 APR/LAR immediately (group A) 21 APR/LAR for local recurrence /group B) Disease-free survival 94,1% (group A) p<0,05 55,5% (group B) Baron PL, Enker WE et al DCR 1995

pt2 Rectal Cancer Local excision 649 pts 44 pt2 Recurrences 20 reoperations ( within 4 weeks) group A R0 group B 22 no operation R1/G3- group C Group A 7% Group B 29% Group C 50% Borschitz T et al DCR 2007

Surgical Salvage post Transanal Excision 50 pts with previous transanal excision 31 abdominoperineal resections 11 low anterior resections 4 total pelvic exenterations 3 transanal excisions 1 stoma Weiser MR, Minsky BD et al DCR, 2005

Surgical Salvage- Results 27 pts (55%) required extended pelvic dissection with en bloc resection of: Pelvic sidewall 18 Coccyx or portion of sacrum 6 Prostate 5 Seminal vesicles 5 Bladder 4 Portion of vagina 3 Ureter 1 Ovary 1 Uterus 1 Weiser MR, Minsky BD et al» DCR, 2005

Surgical Salvage - Outcome R0 in 44 of 49 pts 29 pts recurred or died ( F-U 33 months) 53% of five-year specific survival Extended pelvic resections had worse outcome Weiser MR, Minsky BD et al DCR, 2005

..Pelvic recurrence following transanal excision of early rectal cancer is often locally advanced, requiring an extended pelvic dissection with en bloc resection of adjacent pelvic organs to achieve salvage. The long-term outcome in patients undergoing resection is less than expected, considering the early stage of their disease.. Weiser MR, Minsky BD et al DCR 2005

Conclusion Patient selection for local excision or TEM is frequently governed by fitness for radical surgery rather than suitable tumor biology A perfect hystological response is probably the most important factor to avoid a very bad oncological outcome Only a better aknowledgment of the biology of the tumor will allow us a local safer approach to rectal lesions.