Multimodality therapy for rectal cancer Carlo Aschele Oncologia Medica B Istituto Nazionale per la Ricerca sul Cancro - Genova Highlights in the management of gastrointestinal cancer Roma - May 21-22, 2010 LOCAL FAILURE AND SITE OF RECTAL CANCER tumor site odds ratio upper third 0.43 middle/ lower third 1.0 95% c.i. 0.24-0.77 p=0.004 Hermanek, 1995 EFFECT OF RT ON LOCAL FAILURE AND SITE OF RECTAL CANCER Dutch TME trial cm from anal verge 2-y LR, % RT+TME TME p 0-5 5.8 10 0.05 5-10 1.0 10.1 <0.001 10-15 1.3 3.8 0.17 NEJM, 2001 CHI? • SOTTO LA RIFLESSIONE PERITONEALE • ENTRO 12 CM DALLA RIMA ANALE INTERVENTO- RETTOSCOPIA (STR RIGIDO)-RMN età-sesso-altezza-peso-condizioni ginecologiche ed ostetriche (nord vs sud europa) anteriore vs posteriore Locally advanced rectal cancer • perirectal fat penetration • adjacent organ invasion • lymphnode infiltration • mesorectal fascia (CRM) involvement TRUS - CT scan - MRI Tx neoadiuvante del carcinoma del retto Patient selection - tumor location - tumor stage Standard treatment Chemotherapy – role (concomitant and adjuvant) – simplification / potentiation Surgery / pathology Standard vs selective approach Tx neoadiuvante del carcinoma del retto Patient selection - tumor location - tumor stage Standard treatment Chemotherapy – role (concomitant and adjuvant) – simplification / potentiation Surgery / pathology Standard vs selective approach IMPACT OF POST-OP CMT T3 and/or N+ local failure, % 5-y survival, % GITSG 7175 Mayo/NCCTG 79-47-51 86-47-51 11 INT 0114 14 64 NSABP R-02 9 62-65 Compared to surgery alone: ~ 50 ~ 15-25 14 9-11 54 53 60-70 (4-y) LOCALLY ADVANCED RECTAL CANCER. IMPACT OF ADJUVANT CMT ON SURVIVAL (NCCTG 794751, 864751; NSABP R01, R02; INT 0114. N=3791) Gunderson, L. L. et al. J Clin Oncol; 22:1785-1796 2004 Copyright © American Society of Clinical Oncology Post-op chemoradiation Compliance 46-76 % Acute toxicity (grade III-IV) Long-term toxicity 26-53 % 46-56 % NCCTG 79-4751 / 86-4751; GITSG 7175 ; NSABP R02; CAO/ARO/AIO 94 CAO/ARO/AIO-94 50.4 Gy CI FU TME FU x 4 cy TME 50.4 Gy CI FU FU x 4 cy R CAO/ARO/AIO-94 TME SURGERY 5-y outcome Post-op (n=394) Pre-op (n=405) p Survival % LF % 74 13 76 6 0.80 0.006 acute toxicity chronic toxicity 40 24 27 14 0.001 0.01 NEJM 2004 PRE-OP CHEMORADIATION: IMPACT ON SPHINCTER SAVING CAO/ARO/AIO-94 declared to require APR sphincter-saving surgery Post 78 19 % (15/78) Pre 116 39 % (45/116) p 0.004 NEJM 2004 Standard treatment of locally advanced rectal cancer T3-4 and/or N+ RT CT 45-50.4 Gy T M E Pre-op RT vs. surgery alone: Risk of local recurrence in phase III trials Role of chemotherapy PRE-OP RT +/- CONCOMITANT CT pCR, % RT RT + CT EORTC 5 14 FFCD 3 10 Bosset, NEJM 2006; Gerard, JCO 2006 Role of chemotherapy PRE-OP RT +/- CONCOMITANT CT 5-y LR, % RT RT + CT EORTC 17 8 FFCD 16 8 Bosset, NEJM 2006; Gerard, JCO 2006 NSABP R-04 RT + Capecitabine +/- oxaliplatin R S RT + CI 5-FU +/- oxaliplatin N=1460 STAR-01 R n=747 ypT0(N0) RT 50.4 Gy FU 225 mg/m2/day PVI 16% 6-8 wks RT 50.4 Gy FU 225 mg/m2/day PVI OXA 60 mg/m2 weekly x 6 T M E p=0.94 16% ACCORD R n=598 RT 45 Gy CAPE 1600 mg/m2/day 14% 6-8 wks RT 50 Gy CAPE 1600 mg/m2/day OXA 50 mg/m2 weekly x 5 T M E p=0.11 19% ASCO ‘09 Standard treatment of locally advanced rectal cancer T3-4 and/or N+ RT CT 45-50.4 Gy T M E Blunt dissection LR 20–40% TME 5–10% Fascial plane In mesorectum In/on muscularis Dataset for colorectal cancer (2° edition), RCOP, 2007 SURGERY QUALITY: EFFECT OF THE PLANE OF SURGERY ON LOCAL RECURRENCE Circumferential resection margin LOCAL RECURRENCE AND CRM Nagtegaal, I. D. et al. J Clin Oncol; 26:303-312 2008 Copyright © American Society of Clinical Oncology Standard treatment of locally advanced rectal cancer T3-4 and/or N+ RT CT 45-50.4 Gy T M E FU-based adjuvant chemotherapy in rectal cancer patients. QUASAR study (n=948). survival Effect of FU-based adjuvant chemotherapy in colon and rectal cancer patients. QUASAR study Recurrence n = 3239 Effect of adjuvant FU-based chemotherapy in rectal cancer patients included in the QUASAR study Recurrence at any time n = 948 Lancet 2008; 371: 1503 CAO/ARO/AIO-94 50.4 Gy CI FU TME FU x 4 cy TME 50.4 Gy CI FU FU x 4 cy R LOCALLY ADVANCED RECTAL CANCER. IMPACT OF ADJUVANT CMT ON SURVIVAL (NCCTG 794751, 864751; NSABP R01, R02; INT 0114. N=3791) + Adj Chemo Surg +/- RT Gunderson, L. L. et al. J Clin Oncol; 22:1785-1796 2004 ECOG 5204 * RT + bolus or CI FU ± LV, or Cape or NSABPR 04 Effect of adjuvant chemotherapy in pts with good and poor response to pre-op treatment DFS JCO, 2007 Tx neoadiuvante del carcinoma del retto Patient selection - tumor location - tumor stage Standard treatment Chemotherapy – role (concomitant and adjuvant) – simplification / potentiation Surgery / pathology Standard vs selective approach Standard treatment of locally advanced rectal cancer RT CT 45-50.4 Gy T M E Optimal for every LARC patient? n=188 (TRUS 130 / MRI 58) 22 % node + after pre-op CRT n 3-y LR 5-y LR routine pre 674 4% 5% selective post 676 11% 12 % HR=0.39 (95% CI 0.27-0.58); p<0.0001 •pT3<5mm, N any T2 and early T3 tumours <5mm have 85-90% 5 year cancer specific survival. MERKEL et al 2001 STANDARD vs SELECTIVE APPROACH • almeno 7-8 cm dalla rima anale • infiltrazione grasso < 5 mm (MERCURY) • non evidenza di linfonodi patologici • margine radiale atteso di almeno 2 mm • chirurgo dedicato • TME con mesoretto integro e CRM • pT3a-bN0 (almeno 12 linfonodi negativi) • G1-G2 patients’ preference Rectal cancer: adjuvant / neoadjuvant treatment STOMA THERAPIST NURSE RADIOTHERAPIST SURGEON CURE QOL RADIOLOGIST PATHOLOGIST MEDICAL ONCOLOGIST