Bevacizumab plus infusional 5-FU, leucovorin and irinotecan (FOLFIRI) for advanced colorectal cancer that progressed after oxaliplatin and irinotecan chemotherapy: A pilot study

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14593 Background: The humanized monoclonal antibody bevacizumab inhibits angiogenesis, and improves survival when combined with chemotherapy for advanced colorectal cancer. The purpose of this trial is to evaluate the combination of bevacizumab with infusional 5-FU, leucovorin and irinotecan (FOLFIRI) in patients with advanced colorectal cancer pretreated with combination regimens including 5-fluorouracil (5- FU), leucovorin (LV) and irinotecan or 5-FU, LV and oxaliplatin. Methods: A total 14 patients (median age 56 years) with advanced colorectal cancer, all of them had progressed after oxaliplatin and irinotecan based combination chemotherapy, were enrolled in this study. Patients were treated with 2 hour infusion of irinotecan 150 mg/m2 on day 1, plus bevacizumab 5 mg/kg iv infusion for 90 minute on day 2, intravenous (iv) injection of leucovorin 20 mg/m2 followed by a bolus of 5-FU 400 mg/m2 and then 22 hour continuous infusions of 600 mg/m2 given on 2 consecutive days every 14 days. Results: The median cycles of chemotherapy were six (range 3 to 12). The response rate was 28.5%, one patient (7.1%) had a complete response, and three patients (21.4%) had a partial response. Eight patients (57.1%) had stable disease, and two patients (14.3%) progressed. The median time to progression was 3.9 months (95% confidence interval (CI) 2.0–8.7 months), and the median overall survival was 10.9 months (95% CI 9.6–12.1 months). Grade 3/4 neutropenia occurred in 5 patients, among them 2 patients developed neutropenic fever. Grade 3 hematuria and hematochezia occurred in one patient. Grade 2 proteinuria occurred in two patients. However, hypertension, bowel perforation or thromboembolic events were not occurred in total 90 cycles. Conclusions: Bevacizumab with FOLFIRI is well tolerated and improves survival in heavily treated advanced colorectal cancer patients. Further studies are needed to confirm these results. No significant financial relationships to disclose.

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