The safety of long-term bevacizumab use: Results from the BRiTE observational cohort study (OCS)

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Abstract
4103 Background: Bevacizumab (BV) prolongs overall survival and progression-free survival when added to chemotherapy in 1st and 2nd line mCRC. BRiTE prospectively followed 1,953 1st line mCRC pts for safety and effectiveness of BV-containing treatment. Previous reports from BRiTE suggested BV-associated safety events (gastrointestinal perforation, arteriothromboembolic (ATE) events, bleeding) typically occur within 6 months (mo) of starting BV, whereas BV-associated hypertension (HTN) may be continuous over time. Data from BRiTE show that use of BV beyond 1st progression (BBP) is associated with increased survival and results in longer exposure. We report here the safety outcomes associated with long-term exposure to BV in a large, representative population of mCRC pts with up to 3 years of follow-up. Methods: Pts and methods for BRiTE have been described previously. For this analysis, pts were grouped based on their total duration of BV exposure. Long-term BV exposure was defined as >12 mo of cumulative administration. We report the rate of BV-targeted safety events that occurred before 12 mo in pts with 12 mo of exposure. Results: As of June 20, 2007 (median follow-up of 20.8 mo), the range of total exposure to BV for the overall population (1953 pts) was 0.03–36.3 mo; 557 pts had >12 mo BV. Most pts (78%) used BV continuously. The rates of BV-targeted safety events occurring >12 mo in pts that used BV >12 mo was low compared to the rates occurring < 12 mo in pts with <12 mo of BV (Table). In contrast, HTN in pts using BV ≥12 mo was greater (27.5%) than seen in pts with <12 mo of BV exposure (17.3%). Conclusion: In BRiTE, exposure to long-term BV did not increase the risk of serious BV-targeted safety events such as GIP, ATEs, and Gr 3–4 bleeding.

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