Safety of bevacizumab (BV) among patients (pts) receiving first-line chemotherapy (CT) for metastatic colorectal cancer (mCRC): Preliminary results from a larger registry in the U.S

Abstract

3566 Background: In a phase III pivotal trial in pts with mCRC, BV (Avastin) increased overall survival when added to first-line irinotecan, fluorouracil, and leucovorin. Safety data from that trial have been described, and indicate that certain serious adverse events (SAEs, primarily gastrointestinal perforations [GI perfs]) occurred more often in pts who received CT with BV than those who received CT alone. Methods: To evaluate targeted safety events of BV in unselected pts, a surveillance registry was opened to enroll 2000 mCRC pts in the US receiving BV with first-line CT (choice of CT was at physician’s discretion). Eligibility criteria have been minimized to facilitate enrollment of a broad mCRC population. Data collected at baseline include history of hypertension, stroke or myocardial infarction, diabetes, hypercholesterolemia, atrial fibrillation, chronic anticoagulant or aspirin use, peptic ulcer disease, diverticulosis, and recent surgery or endoscopy. Pts are followed for up to 3 years, and clinical data (including survival, disease progression, changes in CT or BV regimen, interim surgery or endoscopy, and SAE occurrence) are collected every 3 months. Results: Through 11/10/04, 932 pts (male 54%; median age 63 [range 26–92]; PS 0–1 87%; primary colon 80%) have been enrolled from 267 sites in 49 states. The most common first-line CT regimens used with BV are FOLFOX (47.7%), FOLFIRI (15.3%), IFL (13.9%), and bolus 5FU/LV (8.2%). Four hundred fifty-two pts have had a 3-month follow-up assessment; 167 pts have had a 6-month assessment. From these 932 pts, 71 BV-related SAEs have been reported from 59 pts (6.3% of enrolled pts), including 16 GI perfs (1.7%) and 3 post-operative hemorrhage or wound-healing complications (0.3%); other reported SAEs include GI symptoms, infection, thromboembolic events, and non-surgical bleeding. Conclusions: In this large ongoing registry, the safety profile of BV in a broad population of mCRC pts receiving a variety of CT regimens appears consistent with that observed in the pivotal trial. Updated safety data (including additional SAEs) will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech Genentech, Sanofi-Synthelabo Genentech Genentech, Sanofi-Synthelabo Genentech Genentech

Keywords

Affiliated Institutions

• John Muir Health US
• Mayo Clinic in Florida US

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