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)

J Souglakos, N Ziras, S Kakolyris, I Boukovinas, N Kentepozidis, P Makrantonakis, S Xynogalos, Ch Christophyllakis, Ch Kouroussis, L Vamvakas, V Georgoulias, A Polyzos, J Souglakos, N Ziras, S Kakolyris, I Boukovinas, N Kentepozidis, P Makrantonakis, S Xynogalos, Ch Christophyllakis, Ch Kouroussis, L Vamvakas, V Georgoulias, A Polyzos

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00469443.

Conflict of interest statement

The authors declare no conflict of interest.

Registration number:

Figures

Figure 1
Figure 1
CONSORT diagram of the study.
Figure 2
Figure 2
(A) Progression-free survival of patients treated with FOLFIRI+Bev or CAPIRI+Bev. (B) Overall survival of patients treated with FOLFIRI+Bev or CAPIRI+Bev. (C) Forest plots of PFS of patients treated with FOLFIRI+Bev or CAPIRI+Bev. (D) Forest plots of OS of patients treated with FOLFIRI+Bev or CAPIRI+Bev.

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