BACKGROUND: Triweekly capecitabine plus irinotecan (CAPIRI) was not a 
replacement for fluorouracil, leucovorin, and irinotecan (FOLFIRI) in the 
treatment of metastatic colorectal cancer (mCRC) because of the potential for 
greater toxicity. Recently, it has reported that mCAPIRI is well tolerated and 
non-inferior to FOLFIRI. In this study, we conducted a multicenter phase II 
trial to assess the efficacy and safety of biweekly CAPIRI plus bevacizumab as 
second-line chemotherapy for mCRC with reduced toxicity and preserved efficacy.
METHODS: Patients with mCRC who had received prior chemotherapy, including 
oxaliplatin-based regimens, were eligible for this study. The treatment protocol 
administered capecitabine at 1000 mg/m2 twice daily from the evening of day 1 to 
the morning of day 8, intravenous irinotecan at 150 mg/m2 on day 1, and 
bevacizumab at 10 mg/kg on day 1 every 2 weeks. Primary endpoints for this study 
were progression-free survival (PFS) and safety. Secondary endpoints were 
overall survival (OS), time to treatment failure, response rate (RR), and 
disease control rate (DCR).
RESULTS: Fifty-one patients were enrolled in this study. Median PFS was 
5.5 months [95% confidence interval (CI) 4.23-7.40 months], and median OS was 
13.5 months (95% CI 11.57-20.23 months). The RR was 14.6% (95% CI 6.5-28.4%), 
and the DCR was 66.7% (95% CI 51.5-79.2%). Hypertension was the most common 
Grade 3 adverse event (27.5%), followed by neutropenia (17.6%). Only two 
patients suffered from grade 3 hand-foot syndrome.
CONCLUSIONS: In mCRC patients, biweekly CAPIRI + bevacizumab appears effective 
and feasible as a second-line chemotherapy with relatively low toxicities, and 
has potential as a useful substitute for FOLFIRI + bevacizumab.