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.