Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer
Herbert Hurwitz, M.D., Louis Fehrenbacher, M.D., William Novotny, M.D., Thomas Cartwright, M.D., John Hainsworth, M.D., William Heim, M.D., Jordan Berlin, M.D., Ari Baron, M.D., Susan Griffing, B.S., Eric Holmgren, Ph.D., Napoleone Ferrara, M.D., Gwen Fyfe, M.D., Beth Rogers, B.S., Robert Ross, M.D., and Fairooz Kabbinavar, M.D.
Background Bevacizumab, a monoclonal antibody against vascularendothelial growth factor, has shown promising preclinical andclinical activity against metastatic colorectal cancer, particularlyin combination with chemotherapy.
Methods Of 813 patients with previously untreated metastaticcolorectal cancer, we randomly assigned 402 to receive irinotecan,bolus fluorouracil, and leucovorin (IFL) plus bevacizumab (5mg per kilogram of body weight every two weeks) and 411 to receiveIFL plus placebo. The primary end point was overall survival.Secondary end points were progression-free survival, the responserate, the duration of the response, safety, and the qualityof life.
Results The median duration of survival was 20.3 months in thegroup given IFL plus bevacizumab, as compared with 15.6 monthsin the group given IFL plus placebo, corresponding to a hazardratio for death of 0.66 (P<0.001). The median duration ofprogression-free survival was 10.6 months in the group givenIFL plus bevacizumab, as compared with 6.2 months in the groupgiven IFL plus placebo (hazard ratio for disease progression,0.54; P<0.001); the corresponding rates of response were44.8 percent and 34.8 percent (P=0.004). The median durationof the response was 10.4 months in the group given IFL plusbevacizumab, as compared with 7.1 months in the group givenIFL plus placebo (hazard ratio for progression, 0.62; P=0.001).Grade 3 hypertension was more common during treatment with IFLplus bevacizumab than with IFL plus placebo (11.0 percent vs.2.3 percent) but was easily managed.
Conclusions The addition of bevacizumab to fluorouracil-basedcombination chemotherapy results in statistically significantand clinically meaningful improvement in survival among patientswith metastatic colorectal cancer.
Source Information
From Duke University, Durham, N.C. (H.H.); Kaiser Permanente, Vallejo, Calif. (L.F.); Genentech, South San Francisco, Calif. (W.N., S.G., E.H., N.F., G.F., B.R., R.R.); Ocala Oncology, Ocala, Fla. (T.C.); Sarah Cannon Cancer Center, Nashville (J.H.); Hematology and Oncology Associates of Northeastern Pennsylvania, Scranton, Pa. (W.H.); Vanderbilt University, Nashville (J.B.); California Pacific Medical Center, San Francisco (A.B.); and the University of California at Los Angeles, Los Angeles (F.K.).
Address reprint requests to Dr. Hurwitz at the Department of Medical Oncology and Transplantation, Rm. 3802 Red Zone, Duke South Clinics, Box 3052, Duke University Medical Center, Durham, NC 27710, or at hurwi004{at}mc.duke.edu.
Bevacizumab in Colorectal Cancer
Sonpavde G., Sharieff W., Hurwitz H. I., Novotny W., Kabbinavar F., the Bevacizumab Study Team
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N Engl J Med 2004;
351:1690-1691, Oct 14, 2004.
Correspondence
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Sargent, D. J., Kohne, C. H., Sanoff, H. K., Bot, B. M., Seymour, M. T., de Gramont, A., Porschen, R., Saltz, L. B., Rougier, P., Tournigand, C., Douillard, J.-Y., Stephens, R. J., Grothey, A., Goldberg, R. M.
(2009). Pooled Safety and Efficacy Analysis Examining the Effect of Performance Status on Outcomes in Nine First-Line Treatment Trials Using Individual Data From Patients With Metastatic Colorectal Cancer. JCO
27: 1948-1955
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Au, H.-J., Karapetis, C. S., O'Callaghan, C. J., Tu, D., Moore, M. J., Zalcberg, J. R., Kennecke, H., Shapiro, J. D., Koski, S., Pavlakis, N., Charpentier, D., Wyld, D., Jefford, M., Knight, G. J., Magoski, N. M., Brundage, M. D., Jonker, D. J.
(2009). Health-Related Quality of Life in Patients With Advanced Colorectal Cancer Treated With Cetuximab: Overall and KRAS-Specific Results of the NCIC CTG and AGITG CO.17 Trial. JCO
27: 1822-1828
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Minor, D. R.
(2009). Risk of Venous Thromboembolism With Bevacizumab in Cancer Patients. JAMA
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Van Cutsem, E., Kohne, C.-H., Hitre, E., Zaluski, J., Chang Chien, C.-R., Makhson, A., D'Haens, G., Pinter, T., Lim, R., Bodoky, G., Roh, J. K., Folprecht, G., Ruff, P., Stroh, C., Tejpar, S., Schlichting, M., Nippgen, J., Rougier, P.
(2009). Cetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer. NEJM
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Chen, W.-L., Lin, C.-T., Lin, N.-T., Tu, I-H., Li, J.-W., Chow, L.-P., Liu, K.-R., Hu, F.-R.
(2009). Subconjunctival Injection of Bevacizumab (Avastin) on Corneal Neovascularization in Different Rabbit Models of Corneal Angiogenesis. IOVS
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Barros Costa, R. L.
(2009). Review Article: Targeted Therapy: Comprehensive Review. AM J HOSP PALLIAT CARE
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Reck, M., von Pawel, J., Zatloukal, P., Ramlau, R., Gorbounova, V., Hirsh, V., Leighl, N., Mezger, J., Archer, V., Moore, N., Manegold, C.
(2009). Phase III Trial of Cisplatin Plus Gemcitabine With Either Placebo or Bevacizumab As First-Line Therapy for Nonsquamous Non-Small-Cell Lung Cancer: AVAiL. JCO
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Kanate, A. S, Auber, M. L, Higa, G. M
(2009). Priorities and uncertainties of administering chemotherapy in a pregnant woman with newly diagnosed colorectal cancer. J Oncol Pharm Pract
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Ma, W. W., Adjei, A. A.
(2009). Novel Agents on the Horizon for Cancer Therapy. CA Cancer J Clin
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Ruan, J., Hajjar, K., Rafii, S., Leonard, J. P.
(2009). Angiogenesis and antiangiogenic therapy in non-Hodgkin's lymphoma. Ann Oncol
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Dallas, N. A., Xia, L., Fan, F., Gray, M. J., Gaur, P., van Buren, G. II, Samuel, S., Kim, M. P., Lim, S. J., Ellis, L. M.
(2009). Chemoresistant Colorectal Cancer Cells, the Cancer Stem Cell Phenotype, and Increased Sensitivity to Insulin-like Growth Factor-I Receptor Inhibition. Cancer Res.
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(2009). Intricacies of Bevacizumab-Induced Toxicities and Their Management. The Annals of Pharmacotherapy
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Sharma, A., Sharma, A. K., Madhunapantula, S. V., Desai, D., Huh, S. J., Mosca, P., Amin, S., Robertson, G. P.
(2009). Targeting Akt3 Signaling in Malignant Melanoma Using Isoselenocyanates. Clin. Cancer Res.
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Giusti, R. M., Cohen, M. H., Keegan, P., Pazdur, R.
(2009). FDA Review of a Panitumumab (VectibixTM) Clinical Trial for First-Line Treatment of Metastatic Colorectal Cancer. The Oncologist
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Chen, H., Campbell, R. A., Chang, Y., Li, M., Wang, C. S., Li, J., Sanchez, E., Share, M., Steinberg, J., Berenson, A., Shalitin, D., Zeng, Z., Gui, D., Perez-Pinera, P., Berenson, R. J., Said, J., Bonavida, B., Deuel, T. F., Berenson, J. R.
(2009). Pleiotrophin produced by multiple myeloma induces transdifferentiation of monocytes into vascular endothelial cells: a novel mechanism of tumor-induced vasculogenesis. Blood
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Cao, Y.
(2009). Positive and Negative Modulation of Angiogenesis by VEGFR1 Ligands. Sci Signal
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Chen, E., Jonker, D., Gauthier, I., MacLean, M., Wells, J., Powers, J., Seymour, L.
(2009). Phase I Study of Cediranib in Combination with Oxaliplatin and Infusional 5-Fluorouracil in Patients with Advanced Colorectal Cancer. Clin. Cancer Res.
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Hecht, J. R., Mitchell, E., Chidiac, T., Scroggin, C., Hagenstad, C., Spigel, D., Marshall, J., Cohn, A., McCollum, D., Stella, P., Deeter, R., Shahin, S., Amado, R. G.
(2009). A Randomized Phase IIIB Trial of Chemotherapy, Bevacizumab, and Panitumumab Compared With Chemotherapy and Bevacizumab Alone for Metastatic Colorectal Cancer. JCO
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Blanke, C. D.
(2009). Dual-Antibody Therapy in Advanced Colorectal Cancer: Gather Ye Rosebuds While Ye May. JCO
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Tol, J., Koopman, M., Cats, A., Rodenburg, C. J., Creemers, G. J.M., Schrama, J. G., Erdkamp, F. L.G., Vos, A. H., van Groeningen, C. J., Sinnige, H. A.M., Richel, D. J., Voest, E. E., Dijkstra, J. R., Vink-Borger, M. E., Antonini, N. F., Mol, L., van Krieken, J. H.J.M., Dalesio, O., Punt, C. J.A.
(2009). Chemotherapy, Bevacizumab, and Cetuximab in Metastatic Colorectal Cancer. NEJM
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Aranda, E., Valladares, M., Martinez-Villacampa, M., Benavides, M., Gomez, A., Massutti, B., Marcuello, E., Constenla, M., Camara, J. C., Carrato, A., Duenas, R., Reboredo, M., Navarro, M., Diaz-Rubio, E.
(2009). Randomized study of weekly irinotecan plus high-dose 5-fluorouracil (FUIRI) versus biweekly irinotecan plus 5-fluorouracil/leucovorin (FOLFIRI) as first-line chemotherapy for patients with metastatic colorectal cancer: a Spanish Cooperative Group for the Treatment of Digestive Tumors Study. Ann Oncol
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