AIM: To investigate the efficacy and safety of cape-citabine plus irinotecan +/- 
bevacizumab in advanced or metastatic colorectal cancer patients.
METHODS: Forty six patients with previously untreated, locally-advanced or 
metastatic colorectal cancer (mCRC) were recruited between 2001-2006 in a 
prospective open-label phase II trial, in German community-based outpatient 
clinics. Patients received a standard capecitabine plus irinotecan (CAPIRI) or 
CAPIRI plus bevacizumab (CAPIRI-BEV) regimen every 3 wk. Dose reductions were 
mandatory from the first cycle in cases of > grade 2 toxicity. The treatment 
choice of bevacizumab was at the discretion of the physician. The primary 
endpoints were response and toxicity and secondary endpoints included 
progression-free survival and overall survival.
RESULTS: In the CAPIRI group vs the CAPRI-Bev group there were more female than 
male patients (47% vs 24%), and more patients had colon as the primary tumor 
site (58.8% vs 48.2%) with fewer patients having sigmoid colon as primary tumor 
site (5.9% vs 20.7%). Grade 3/4 toxicity was higher with CAPIRI than CAPIRI-Bev: 
82% vs 58.6%. Partial response rates were 29.4% and 34.5%, and tumor control 
rates were 70.6% and 75.9%, respectively. No complete responses were observed. 
The median progression-free survival was 11.4 mo and 12.8 mo for CAPIRI and 
CAPIRI-Bev, respectively. The median overall survival for CAPIRI was 15 mo (458 
d) and for CAPIRI-Bev 24 mo (733 d). These differences were not statistically 
different. In the CAPIRI-Bev, group, two patients underwent a full secondary 
tumor resection after treatment, whereas in the CAPIRI group no cases underwent 
this procedure.
CONCLUSION: Both regimens were well tolerated and offered effective tumor growth 
control in this outpatient setting. Severe gastrointestinal toxicities and 
thromboembolic events were rare and if observed were never fatal.