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Gastrointestinal Cancer

Clinical Outcomes Associated with Bevacizumab-Containing Treatment of Metastatic Colorectal Cancer: The BRiTE Observational Cohort Study

^aIngalls Hospital, Harvey, Illinois, USA; ^bEpidemiology and Public Health, Yale University School of Medicine, New Haven, Connecticut, USA; ^cDivision of Hematology & Oncology, Vanderbilt Ingram Cancer Center, Nashville, Tennessee, USA; ^dMinnesota Oncology Hematology, PA, Minneapolis, Minnesota, USA; ^eDivision of Hematology & Oncology, Department of Medicine, University of California at Los Angeles, Los Angeles, California, USA; ^fGenentech, Inc., South San Francisco, California, USA; ^gMayo Clinic College of Medicine, Rochester, Minnesota, USA; ^hUniversity of Chicago, Chicago, Illinois, USA; ⁱEpiSource, Hamden, Connecticut, USA

Key Words. Registry • Systemic therapy • Antiangiogenesis • VEGF inhibition • Biologics • GI perforation

Correspondence: Mark Kozloff, M.D., Ingalls Hospital, 71 W. 156 Street, Suite 401, Harvey, Illinois 60426, USA. Telephone: 708-339-4800; Fax: 708-339-4814; e-mail: mfkozloff{at}aol.com

Received April 6, 2009; accepted for publication August 4, 2009; first published online in THE ONCOLOGIST Express on September 2, 2009.

Disclosures: Mark Kozloff: Consultant/advisory role: Genentech; Honoraria: Genentech, Roche; Marianne Ulcickas Yood: Other: BriTE Advisory Board Member; Jordan Berlin: Consultant/advisory role: Genentech; Patrick J. Flynn: Consultant/advisory role: Genentech, Sanofi; Honoraria: Genentech, Sanofi (Speaker's Bureau); Fairooz F. Kabbinavar: Honoraria: Genentech, Roche; David M. Purdie: Employment/leadership position: Genentech; Mark A. Ashby: Employment/leadership position: Genentech; Ownership interest: Genentech; Wei Dong: Employment/leadership position: Genentech; Ownership interest: Genentech; Mary M. Sugrue: Employment/leadership position: Genentech; Ownership interest: Genentech; Axel Grothey: Consultant/advisory role: Genentech, Roche, CALGB.

This article discusses bevacizumab (Avastin®; Genentech).

The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias. No financial relationships relevant to the content of this article have been disclosed by the independent peer reviewers.

Background. The Bevacizumab Regimens' Investigation of Treatment Effects (BRiTE) study is a prospective, observational cohort study designed to elucidate safety and effectiveness outcomes associated with bevacizumab combined with chemotherapy as used in clinical practice for first-line treatment of metastatic colorectal cancer (mCRC).

Patients and Methods. Baseline characteristics, prespecified bevacizumab-related adverse events, and effectiveness data were collected from 1,953 mCRC patients who were receiving first-line treatment including bevacizumab at 248 U.S. sites.

Results. At database lock, the median follow-up was 20.1 months. At baseline, 46% of patients were aged 65 years and 49% had an Eastern Cooperative Oncology Group performance status score 1. Fluorouracil, leucovorin, and oxaliplatin was the most common first-line chemotherapy regimen (56%). Overall rates of bevacizumab-related adverse events in the BRiTE study, such as gastrointestinal perforation (1.9%), arterial thromboembolic events (2%), grade 3–4 bleeding (2.2%), and de novo hypertension requiring medication (22%), were consistent with those reported in randomized clinical trials (RCTs) of bevacizumab in first-line mCRC treatment. The median progression-free survival (PFS) and overall survival (OS) times were 9.9 (95% confidence interval [CI], 9.5–10.3) months and 22.9 (95% CI, 21.9–24.4) months, respectively.

Conclusion. The median PFS and OS durations and safety profile of bevacizumab in the BRiTE study were similar to those in RCTs of bevacizumab plus chemotherapy in first-line mCRC patients. The observations from the BRiTE study complement and expand upon RCT data, providing clinical information in a large cohort of bevacizumab-treated patients and subgroups such as the elderly.