Phase II study to evaluate efficacy and safety of irinotecan, capecitabine, and bevacizumab in patients with metastatic colorectal cancer (mCRC).

e13018 Background: XELIRIregimen (combination of capecitabineand irinotecan) is an active and well tolerated treatment for mCRC. However, data available on the combination of XELIRIregimen with bevacizumab(BVZ) in patients (pts) with mCRC are limited at present. Therefore the aim of this study is to evaluate the efficacy and safety of the biweekly (biw) scheme with XELIRIregimen, plus BVZ in pts with mCRC. Methods: A multicentric, prospective, open-label phase II trial. Treatment scheme: irinotecan(175mg/m2 iv infusion 90 min, day 1, every 2 weeks) + capecitabine(1,000mg/m2 bid oral, days 2-8; pts aged ≥65, max dose: 800mg/m2 bid) + bevacizumab(5mg/kg, iv, day 1, every 2 weeks).Safety results from an interim analysisare presented. Results: A total of 77 pts were evaluated (66.2%, male) with a median age of 65.1 yrs (41.1-81.1). ECOG PS was ≤1 in 96.1% of pts. Primary tumor locations were: colon (51.9%), rectum(31.2%) and rectum/colon (16.9%).Twenty-seven pts (35.1%) received adjuvant chemotherap...