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Journal of Clinical Oncology, Vol 21, Issue 1 (January), 2003: 60-65
© 2003 American Society for Clinical Oncology

Phase II, Randomized Trial Comparing Bevacizumab Plus Fluorouracil (FU)/Leucovorin (LV) With FU/LV Alone in Patients With Metastatic Colorectal Cancer

Fairooz Kabbinavar, Herbert I. Hurwitz, Louis Fehrenbacher, Neal J. Meropol, William F. Novotny, Grazyna Lieberman, Susan Griffing, Emily Bergsland

From the Division of Hematology-Oncology, University of California Los Angeles, Los Angeles, Hematology/Oncology Clinic, Kaiser Permanente, Vallejo, Genentech Inc, South San Francisco, and Division of Hematology/Oncology, University of California San Francisco, San Francisco, CA; Division of Hematology and Oncology, Duke University, Durham, NC; and Divisions of Medical Science and Population Science, Fox Chase Cancer Center, Philadelphia, PA.

Address reprint requests to Fairooz Kabbinavar, MD, UCLA School of Medicine, Division of Hematology/Oncology, 10945 Le Conte Ave, Ste 2338J, Los Angeles, CA 90095; email: fkabbina{at}mednet.ucla.edu.

Purpose: This phase II trial investigated the safety and efficacy of two doses of bevacizumab, a monoclonal antibody to vascular endothelial growth factor, plus fluorouracil (FU)/leucovorin (LV) versus FU/LV alone in patients with metastatic colorectal cancer.

Patients and Methods: One hundred four previously untreated patients with measurable metastatic colorectal cancer were randomly assigned to one of the following three treatment groups: 36 to FU (500 mg/m2)/LV (500 mg/m2) alone, 35 to FU/LV + low-dose bevacizumab (5 mg/kg every 2 weeks), and 33 to FU/LV + high-dose bevacizumab (10 mg/kg every 2 weeks). FU/LV was given weekly for the first 6 weeks of each 8-week cycle.

Results: Compared with the FU/LV control arm, treatment with bevacizumab (at both dose levels) plus FU/LV resulted in higher response rates (control arm, 17%, 95% confidence interval [CI], 7% to 34%; low-dose arm, 40%, 95% CI, 24% to 58%; high-dose arm, 24%, 95% CI, 12% to 43%), longer median time to disease progression (control arm, 5.2 months, 95% CI, 3.5 to 5.6 months; low-dose arm, 9.0 months, 95% CI, 5.8 to 10.9 months; high-dose arm, 7.2 months, 95% CI, 3.8 to 9.2 months), and longer median survival (control arm, 13.8 months; 95% CI, 9.1 to 23.0 months; low-dose arm, 21.5 months, 95% CI, 17.3 to undetermined; high-dose arm, 16.1 months; 95% CI, 11.0 to 20.7 months). After cross-over, two of 22 patients had a partial response to bevacizumab alone. Thrombosis was the most significant adverse event and was fatal in one patient. Hypertension, proteinuria, and epistaxis were other potential safety concerns.

Conclusion: The encouraging results of this randomized trial support further study of bevacizumab 5 mg/kg plus chemotherapy as first-line therapy for metastatic colorectal cancer.

Supported by Genentech, Inc, South San Francisco, CA.




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