Capecitabine and irinotecan with and without bevacizumab for advanced colorectal cancer patients

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 pro- spective open-label phase Ⅱ trial, in German commu- nity-based outpatient clinics. Patients received a stan- dard 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 sec- ondary 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 re- sponses were observed. The median progression-free survival was 11.4 mo and 12.8 mo for CAPIRI and CA- PIRI-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 under- went 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 out- patient setting. Severe gastrointestinal toxicities and thromboembolic events were rare and if observed were never fatal.