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

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e13018 Background: XELIRI regimen (combination of capecitabine and irinotecan) is an active and well tolerated treatment for mCRC. However, data available on the combination of XELIRI regimen 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 XELIRI regimen, 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 analysis are 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 chemotherapy. Mean time to primary tumor diagnosis was 16.3±30.3 months. Metastases were detected in liver (63.6%), lung (51.9%), nodes (14.3%), and peritoneum (11.7%). Surgery of metastatic disease was performed in 7.8% of pts. The most frequent grade 3-4 toxicities registered were: diarrhea (15.6%), asthenia (13%) and neutropenia (9.1%). The frequency of occurrence for the most frequently AEs related to BVZ were 2.6% hypertension, 1.3% proteinuria; while for the least frequent AEs: 3.9% intestinal perforation, 6.5% pulmonary embolism, 2.6% thrombosis and 1.3% DVT. A total of 59 pts discontinued the study treatment, being the most common reasons: AEs (16.9%), disease progression (14.3%) and surgery (14.3%). Twelve pts (15.6%) died during the study due to disease progression (7 pts), AEs (4 pts), or unknown reason (1 patient). Three of the 4 AEs causing pts’ death occurred as a result of toxicity (2 cases of multi-organ failure and 1 case of intestinal perforation). Conclusions: These preliminary results show that biw scheme with XELIRI regimen, plus BVZ has a feasible and manageable safety profile for the treatment of pts with mCRC. Further analysis will be necessary to confirm these results.

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