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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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How Should We Pay the Piper When He's Calling the Tune? On the Long-Term Affordability of Cancer Care in the United States
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Chemotherapy with bevacizumab, irinotecan, 5-fluorouracil and leucovorin (IFL) associated with a large, embolizing thrombus in the thoracic aorta
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Multicenter Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
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Intravitreal Bevacizumab for Choroidal Neovascularization Caused by AMD (IBeNA Study): Results of a Phase 1 Dose-Escalation Study.
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The Present and Future of Angiogenesis-Directed Treatments of Colorectal Cancer
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Carcinogenesis, September 1, 2006; 27(9): 1729 - 1738.
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A phase II study of high-dose bevacizumab in combination with irinotecan, 5-fluorouracil, leucovorin, as initial therapy for advanced colorectal cancer: results from the eastern cooperative oncology group study E2200
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Preclinical evaluation of tumor microvascular response to a novel antiangiogenic/antitumor agent RO0281501 by dynamic contrast-enhanced MRI at 1.5 T.
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H. X. Chen, M. Mooney, M. Boron, D. Vena, K. Mosby, L. Grochow, C. Jaffe, L. Rubinstein, J. Zwiebel, and R. S. Kaplan
Phase II Multicenter Trial of Bevacizumab Plus Fluorouracil and Leucovorin in Patients With Advanced Refractory Colorectal Cancer: An NCI Treatment Referral Center Trial TRC-0301
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{blacktriangledown}Bevacizumab and {blacktriangledown}cetuximab for colorectal cancer
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Profile of Plasma Angiogenic Factors Before and After Hepatectomy for Colorectal Cancer Liver Metastases
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Blockade Of Endogenous Vascular Endothelial Growth Factor (VEGF) Reveals A Role For Endothelium In The Regulation Of Mammalian Glomerular Permeability
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Laminin {alpha}2 Chain-Positive Vessels and Epidermal Growth Factor in Lung Neuroendocrine Carcinoma: A Model of a Novel Cooperative Role of Laminin-2 and Epidermal Growth Factor in Vessel Neoplastic Invasion and Metastasis
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Comparison of Microvascular Permeability Measurements, Ktrans, Determined with Conventional Steady-State T1-Weighted and First-Pass T2*-Weighted MR Imaging Methods in Gliomas and Meningiomas.
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Review of the Effects of Anti-Angiogenic Compounds on the Epiphyseal Growth Plate
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F. F. Kabbinavar, J. Hambleton, R. D. Mass, and S. Sarkar
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OSI-930: A Novel Selective Inhibitor of Kit and Kinase Insert Domain Receptor Tyrosine Kinases with Antitumor Activity in Mouse Xenograft Models
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C. H. Smorenburg, G. J. Peters, C. J. van Groeningen, P. Noordhuis, K. Smid, A. M. G. H. van Riel, W. Dercksen, H. M. Pinedo, and G. Giaccone
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C. G. Willett, Y. Boucher, D. G. Duda, E. di Tomaso, L. L. Munn, R. T. Tong, S. V. Kozin, L. Petit, R. K. Jain, D. C. Chung, et al.
Surrogate Markers for Antiangiogenic Therapy and Dose-Limiting Toxicities for Bevacizumab With Radiation and Chemotherapy: Continued Experience of a Phase I Trial in Rectal Cancer Patients
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J. Tabernero, T. Macarulla, F. J. Ramos, and J. Baselga
Novel targeted therapies in the treatment of gastric and esophageal cancer
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C. Lam, K.-H. Lim, and S. A. Karumanchi
Circulating Angiogenic Factors in the Pathogenesis and Prediction of Preeclampsia
Hypertension, November 1, 2005; 46(5): 1077 - 1085.
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D. R. D'Adamo, S. E. Anderson, K. Albritton, J. Yamada, E. Riedel, K. Scheu, G. K. Schwartz, H. Chen, and R. G. Maki
Phase II Study of Doxorubicin and Bevacizumab for Patients With Metastatic Soft-Tissue Sarcomas
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