Randomised phase-II trial of CAPIRI (capecitabine, irinotecan) plus bevacizumab vs FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) plus bevacizumab as first-line treatment of patients with unresectable/metastatic colorectal cancer (mCRC)

BACKGROUND: To compare the efficacy and safety of CAPIRI + bevacizumab (Bev) in comparison with FOLFIRI + Bev as first-line treatment for patients with metastatic colorectal cancer (mCRC). METHODS: Patients were randomised to receive either FOLFIRI plus Bev 5 mg kg(-1) every 2 weeks (Arm-A) or CAPIRI plus Bev 7.5 mg kg(-1) every 3 weeks (Arm-B). RESULTS: Three hundred thirty-three patients (Arm-A = 167; Arm-B = 166) were enrolled into the study. No difference was observed in median progression-free survival (PFS) (10.0 and 8.9 months; P = 0.64), overall survival (25.7 and 27.5 months; P = 0.55) or response rates (45.5 and 39.8.7%; P = 0.32) for FOLFIRI-Bev and CAPIRI-Bev, respectively. Patients treated with CAPIRI-Bev presented significantly higher incidence of diarrhoea (P = 0.005), febrile neutropenia (P = 0.003) and hand-foot skin reactions (P = 0.02) compared with patients treated with FOLFIRI-Bev. Treatment delays (P = 0.05), dose reduction (P < 0.001) and treatment discontinuation owing to toxicity (P = 0.01) occurred more frequently in the CAPIRI-Bev arm. CONCLUSION: The PFS of FOLFIRI-BEV is not superior to that observed with the CAPIRI-Bev regimen. CAPIRI-Bev has a less favourable toxicity profile, requiring dose reductions, in order to be considered as an option in first-line treatment of patients with mCRC. British Journal of Cancer (2012) 106, 453-459. doi: 10.1038/bjc.2011.594 www.bjcancer.com Published online 12 January 2012 (C) 2012 Cancer Research UK