Abstract
3554 Background: BV (Avastin™) increases overall survival from 15.6 to 20.3 months in pts with mCRC when added to first-line irinotecan, fluorouracil, and leucovorin. In a subsequent larger pooled analysis, adding BV to CT was found to increase the risk of arterial thromboembolic events (ATEs), particularly in pts ≥65 years old with a history of atherosclerosis (Genentech, Inc., DDL, Aug 2004). Low-dose ASA is a standard therapy for primary and secondary prophylaxis of ATEs in pts at high risk of such events, and use of ASA ≤325 mg daily has been permitted in BV trials. We explored the bleeding risk associated with ASA use in mCRC trials. Methods: Analyses of pts with mCRC pooled from 3 RCTs of BV with CT were performed to explore a potential relationship between ASA use and incidence of bleeding events. ASA users were defined in 2 ways: Group A, those who reported ASA use at study enrollment (N=108); Group B, those in Group A plus those who used ASA at any time on study (N=195). Bleeding event rates by NCI-CTC grade were calculated as percent incidence unadjusted for a pt’s duration of study treatment. Conclusion: In this analysis, the use of low-dose ASA by pts with mCRC who receive CT alone or in combination with BV does not appear to increase the risk of bleeding of any severity. An exploratory analysis of the treatment effect of ASA on ATE risk in mCRC will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech Genentech, GlaxoSmithKline, ImClone, Pfizer Genentech Genentech Genentech
Published Version
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