Final efficacy results for bevacizumab plus standard first-line chemotherapies in patients with metastatic colorectal cancer: First BEAT

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Abstract
4025 Background: Bevacizumab (BEV) significantly extends overall (OS) and/or progression-free survival (PFS) when combined with standard first-line chemotherapy (CT) regimens in patients (pts) with metastatic colorectal cancer (mCRC). First BEAT is an international prospective observational study evaluating the safety and efficacy profile of BEV when combined with a variety of CT regimens in a general pt population with mCRC Methods: Eligible pts were treated with first-line CT (physician’s choice) plus BEV 5mg/kg q2w (5- fluorouracil [5-FU]-based CT) or 7.5mg/kg q3w (capecitabine [cap]-based CT) until disease progression. Disease progression was assessed by investigators. Main trial endpoints included safety, PFS and OS. Results: 1,965 pts were enrolled across 41 countries between June 2004 and February 2006, of which 1,914 were evaluable by 2 August 2007 (male 58%; median age 59 years, 33% ≥65 years; ECOG PS 0/1 65%/34%). Most commonly used CT regimens in combination with BEV included FOLFOX (29%), FOLFIRI (26%), XELOX (18%) and 5-FU/cap monotherapy (15%). Median follow-up was 21.4 months; 60-day mortality was 2.5%; 52% pts were treated until progression. Grade 3–5 adverse events or SAEs of special interest included bleeding (3.2%), gastrointestinal perforation (1.8%), arterial thromboembolism (1.3%), hypertension (5.1%), proteinuria (1.0%) and wound-healing complications (1.0%). Overall median PFS was 10.8 months (95% CI: 10.4–11.3, based on 1,396 events) Updated analyses based on the final data cut off (November 2007), including first report of median OS, will be presented at the meeting. Conclusions: In this large community-based study, the safety and efficacy of first-line BEV with the most common chemotherapy regimens for mCRC in daily clinical practice is consistent with that observed in randomized phase III clinical trials.

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