Bevacizumab (a monoclonal antibody to vascular endothelial growth factor) does not increase the incidence of venous thromboembolism when added to first-line chemotherapy to treat metastatic colorectal cancer

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Abstract
3529 Background: Venous thromboembolism has been reported as a potential risk of anti-angiogenic and anti-VEGF therapy. To clarify the true risk, studies of bevacizumab [Avastin (BV)] included special case report forms and “real-time” assessment of the incidence and characteristics of thromboembolism. An analysis was performed from two completed randomized, controlled, double-blind trials. Methods: Study AVF2107g was a large, randomized, controlled, double-blinded Phase III trial testing the efficacy and safety of adding BV to bolus-IFL as first-line chemotherapy for metastatic colorectal cancer. The addition of BV to IFL chemotherapy resulted in a prolongation of median survival from 15.6 mos to 20.3 mos (p=0.00004). Study AVF2192g was a randomized, controlled, double-blinded Phase II trial testing the efficacy and safety of adding BV to FU/LV as first-line chemotherapy in CRC for subjects who were not optimal candidates for first-line CPT- II. The addition of BV to FU/LV chemotherapy resulted in prolongation of median progression-free survival from 5.5 to 9.2 months (p=0.0002). Results: The incidences and types of thrombembolic events in the two trials is shown below: Conclusions: The addition of BV to either standard first-line chemotherapy was not associated with an increase in venous thromboembolism in either study AVF2107g or study AVF2192g. There may be a small increase in arterial thromboembolic events. These data emphasize the high background rate of thromboembolism associated with mCRC and standard chemotherapy.

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