Résumé
Abstract only 389 Background: The main end point of this trial was pathological response and published in 2010. We present the main clinical outcome after 3 years follow up. Methods: A total of 598 patients were included by 56 different French institutions between 2005 and 2008. Inclusion criteria were: resectable rectal adenocarcinoma accessible to digital examination and staged T3,4 Nx M0. Low anterior T2 were also eligible.Two neoadjuvant treatments were compared: CAP 45 (Radiotherapy 45 Gy/5 weeks with concurrent chemotherapy: capecitabine 1 600 mg/m2/day) versus CAPOX 50 (RT 50 Gy/5weeks with the same capecitabine plus oxaliplatin 50 mg/m2 /q week). Adjuvant chemotherapy was given to 253 patients and well balanced between both arms. All patients were analysed according to the intent to treat principle. Results: With a median follow up time of 36 months the main clinical results are presented in the table . There was no significant difference in local control, survival, toxicity and functional results. In an exploratory analysis, clinical complete response (24 pts) before surgery and pathological complete response (92 pts) were associated with an excellent disease free survival at 3 years respectively 92% and 90%. These results must be interpreted in reference with 3 other recent randomized trials involving the same patients: STAR 01 (Italy) NSABP R 04 (USA) (Table) CAO/ARO 04 (Germany). Conclusions: It is possible to conclude from this trial and the 3 other trials that: (1) oxaliplatin should not be included in the protocol (increased early toxicity and no effect on the pCR rate) (2) capecitabine is as efficient as fluorouracil (3) RT dose escalation to 50 Gy is improving pCR without increasing toxicity. A “CAP 50” regimen appears as safe and efficient in this neoadjuvant situation. [Table: see text]