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Previous Volume 350:2335-2342 June 3, 2004 Number 23 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Mayer, R. J. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Bevacizumab, a monoclonal antibody against vascular endothelial growth factor, has shown promising preclinical and clinical activity against metastatic colorectal cancer, particularly in combination with chemotherapy.

Methods Of 813 patients with previously untreated metastatic colorectal cancer, we randomly assigned 402 to receive irinotecan, bolus fluorouracil, and leucovorin (IFL) plus bevacizumab (5 mg per kilogram of body weight every two weeks) and 411 to receive IFL plus placebo. The primary end point was overall survival. Secondary end points were progression-free survival, the response rate, the duration of the response, safety, and the quality of life.

Results The median duration of survival was 20.3 months in the group given IFL plus bevacizumab, as compared with 15.6 months in the group given IFL plus placebo, corresponding to a hazard ratio for death of 0.66 (P<0.001). The median duration of progression-free survival was 10.6 months in the group given IFL plus bevacizumab, as compared with 6.2 months in the group given IFL plus placebo (hazard ratio for disease progression, 0.54; P<0.001); the corresponding rates of response were 44.8 percent and 34.8 percent (P=0.004). The median duration of the response was 10.4 months in the group given IFL plus bevacizumab, as compared with 7.1 months in the group given IFL plus placebo (hazard ratio for progression, 0.62; P=0.001). Grade 3 hypertension was more common during treatment with IFL plus bevacizumab than with IFL plus placebo (11.0 percent vs. 2.3 percent) but was easily managed.

Conclusions The addition of bevacizumab to fluorouracil-based combination chemotherapy results in statistically significant and clinically meaningful improvement in survival among patients with 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.

Full Text of this Article

Related Letters:

Bevacizumab in Colorectal Cancer
Sonpavde G., Sharieff W., Hurwitz H. I., Novotny W., Kabbinavar F., the Bevacizumab Study Team
Extract | Full Text | PDF  
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 [Abstract] [Full Text]  
• 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 [Abstract] [Full Text]  
• Minor, D. R. (2009). Risk of Venous Thromboembolism With Bevacizumab in Cancer Patients. JAMA 301: 1434-1434 [Full Text]  
• 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 360: 1408-1417 [Abstract] [Full Text]  
• 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 50: 1659-1665 [Abstract] [Full Text]  
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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 27: 1227-1234 [Abstract] [Full Text]  
• 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 15: 5-8 [Abstract]  
• Ma, W. W., Adjei, A. A. (2009). Novel Agents on the Horizon for Cancer Therapy. CA Cancer J Clin 59: 111-137 [Abstract] [Full Text]  
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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. 69: 1951-1957 [Abstract] [Full Text]  
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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. 15: 1674-1685 [Abstract] [Full Text]  
• 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 14: 284-290 [Abstract] [Full Text]  
• 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 113: 1992-2002 [Abstract] [Full Text]  
• Cao, Y. (2009). Positive and Negative Modulation of Angiogenesis by VEGFR1 Ligands. Sci Signal 2: re1-re1 [Abstract] [Full Text]  
• 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. 15: 1481-1486 [Abstract] [Full Text]  
• 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 27: 672-680 [Abstract] [Full Text]  
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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 360: 563-572 [Abstract] [Full Text]  
• 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 20: 251-257 [Abstract] [Full Text]