Chemoradiation (CRT) followed by surgery and adjuvant capecitabine plus oxaliplatin (CAPOX) compared with induction CAPOX followed by concomitant CRT and surgery for locally advanced rectal cancer: Results of the Spanish GCR-3 randomized phase II trial after a median follow-up of 5 years.

Cancers of the Colon and Rectum
Session Type and Session Title: 
General Session 8: Reassessing the Role of Radiation Therapy in Rectal Cancer
General Poster Session C: Cancers of the Colon and Rectum
Abstract Number: 
J Clin Oncol 32, 2014 (suppl 3; abstr 383)
Carlos Fernandez-Martos, Carles Pericay, Jorge Aparicio, Maria Jose Safont, Antonia Salud, Bartomeu Massuti, Vicente Alonso, Ruth Vera, Pilar Escudero, Marta Martin-Richard, Carlos Bosch, Juan Maurel; Medical Oncology Department, Fundacion Instituto Valenciano De Oncologia, Valencia, Spain; Hospital de Sabadell, Corporació Sanitària Parc Taulí, Institut Oncològic del Vallès, Sabadell, Spain; Hospital La Fe Oncologia Medica, Valencia, Spain; Hospital General de Valencia, Valencia, Spain; University Hospital Arnau De Vilanova, Lerida, Spain; Hospital General de Alicante, Alicante, Spain; Hospital Universitario Miguel Servet, Zaragoza, Spain; Service of Medical Oncology, Hospital de Navarra, Pamplona, Spain; Hospital Clínico, Universitario Lozano Blesa, Zaragoza, Spain; Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Hospital Doctor Peset, Valencia, Spain; Hospital Clinic i Provincial, Barcelona, Spain

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures


Background: In locally advanced rectal cancer in contrast with the conventional approach the administration of chemotherapy prior to chemoradiation (CRT) and surgery allow most patients receive planned treatment with better toxicity profile without compromising the pCR and complete resection rates, as we previously demonstrated. (J Clin Oncol 28:859-865, 2010). We now report on the 5-year outcomes of this randomized trial. Methods: Patients with distal or middle third, T3-T4 and/or N+ rectal adenocarcinoma selected by Magnetic Resonance +/- endorectal ultrasound, were randomly assigned to arm A—preoperative CRT followed by surgery and four cycles of postoperative adjuvant capecitabine and oxaliplatin (CAPOX)—or arm B— four cycles of CAPOX followed by CRT and surgery. The following five-year outcomes were assessed: the cumulative incidence of local-regional (LRF) and distance failure (DF), disease-free (DFS) and overall (OS) using the Kaplan-Meier method. Results: Of 108 patients accrued, 52 were randomly assigned to arm A and 56 to arm B. According to intention-to-treat analysis with a median follow-up time of 69.5 months, the 5-years DFS rates were 64.3% (95% CI, 49% to 76%) in arm A and 60.7% (95 CI, 46% to 72%) in arm B (P=0.73). The 5-year cumulative incidences of local relapse were 1.9 % and 7.1% in A and B arms respectively (P= 0.36). No significant differences were detected for 5-year cumulative incidence of distant metastases (21.1% and 23.2%; P = 0.80) and 5-years overall survival (77.9% and 74.7%; P= 0.64). Conclusions: Both approaches yield similar 5-y outcomes. Because of the associated acute toxicity sparing and better compliance with induction CT compared with adjuvant CT, integrating effective systemic therapy prior to CRT and surgery may well be the next step in phase III testing versus the standard strategy to capture meaningful differences in DFS.