Bevacizumab does not increase bleeding in patients with metastatic colorectal cancer receiving concurrent anticoagulation

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Abstract
3528 Background. Bevacizumab (BV, Avastin), a recombinant, humanized monoclonal antibody directed against VEGF, improves survival in combination with chemotherapy for first line treatment of metastatic colorectal cancer (CRC). The addition of BV to irinotecan/5-FU/leucovorin (IFL) resulted in a significant improvement in survival compared with IFL alone (p=0.00004; median survival increased from 15.6 to 20.3 months). Experience with BV in phase II studies, particularly in NSCLC, suggested that bleeding might be a safety signal. Therefore, patients receiving full-dose anticoagulation (FDAC) were excluded from the phase III CRC study. This analysis assesses the outcomes of patients with metastatic CRC who had a thrombotic event while receiving study treatment (BV or placebo), and remained on study while receiving FDAC. Methods. Patients with previously untreated metastatic CRC were randomized to IFL plus placebo (Arm 1) versus IFL plus BV (5 mg/kg; Arm 2). Thrombotic complications, including deep venous thrombosis, pulmonary embolus, and arterial events, and treatment were analyzed. FDAC was achieved with warfarin. Results.The overall rate of arterial and venous thromboembolic events was 16.2% in Arm 1 and 19.4% in Arm 2. Arterial events, such as myocardial infarction and stroke, were rare: 1% Arm 1 and 3.3% in Arm 2. Venous event rates were similar; 15.2% in Arm 1, 16.6% in Arm 2. Of those patients with a thrombotic event treated with FDAC, 30 patients (54.5%) in Arm 1 and 53 patients (82.8%) in Arm 2 continued on study drug. Grade 3/4 bleeding rates for those on FDAC and study drug are shown in Table 1. Conclusion. Use of concomitant full-dose anticoagulation therapy with Bevacizumab in combination with chemotherapy does not appear to increase the risk of hemorrhagic complications in patients with metastatic colorectal cancer.

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