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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Laurie, S. A., Gauthier, I., Arnold, A., Shepherd, F. A., Ellis, P. M., Chen, E., Goss, G., Powers, J., Walsh, W., Tu, D., Robertson, J., Puchalski, T. A., Seymour, L.
(2008). Phase I and Pharmacokinetic Study of Daily Oral AZD2171, an Inhibitor of Vascular Endothelial Growth Factor Tyrosine Kinases, in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small-Cell Lung Cancer: The National Cancer Institute of Canada Clinical Trials Group. JCO
26: 1871-1878
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Adam, R., Wicherts, D. A., de Haas, R. J., Aloia, T., Levi, F., Paule, B., Guettier, C., Kunstlinger, F., Delvart, V., Azoulay, D., Castaing, D.
(2008). Complete Pathologic Response After Preoperative Chemotherapy for Colorectal Liver Metastases: Myth or Reality?. JCO
26: 1635-1641
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Seiwert, T. Y., Haraf, D. J., Cohen, E. E.W., Stenson, K., Witt, M. E., Dekker, A., Kocherginsky, M., Weichselbaum, R. R., Chen, H. X., Vokes, E. E.
(2008). Phase I Study of Bevacizumab Added to Fluorouracil- and Hydroxyurea-Based Concomitant Chemoradiotherapy for Poor-Prognosis Head and Neck Cancer. JCO
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Frei, B. L., Soefje, S. A.
(2008). A Review of the Cardiovascular Effects of Oncology Agents. Journal of Pharmacy Practice
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Kobayashi, H., Sugihara, K., Uetake, H., Higuchi, T., Yasuno, M., Enomoto, M., Kuramochi, H., Lenz, H.-J., Danenberg, K. D., Danenberg, P. V.
(2008). Messenger RNA Expression of Vascular Endothelial Growth Factor and Its Receptors in Primary Colorectal Cancer and Corresponding Liver Metastasis. Ann. Surg. Oncol.
15: 1232-1238
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Hsu, A. R., Chen, X.
(2008). Advances in Anatomic, Functional, and Molecular Imaging of Angiogenesis. JNM
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Jaissle, G. B., Ulmer, A., Henke-Fahle, S., Fierlbeck, G., Bartz-Schmidt, K. U., Szurman, P.
(2008). Suppression of Melanoma-Associated Neoangiogenesis by Bevacizumab. Arch Dermatol
144: 525-527
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Bianciotto, C., Shields, C. L., Kang, B., Shields, J. A.
(2008). Treatment of Iris Melanoma and Secondary Neovascular Glaucoma Using Bevacizumab and Plaque Radiotherapy. Arch Ophthalmol
126: 578-579
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Italiano, A., Massard, C., Bahleda, R., Vataire, A.-L., Deutsch, E., Magne, N., Pignon, J.-P., Vassal, G., Armand, J.-P., Soria, J.-C.
(2008). Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy. Ann Oncol
19: 787-792
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Benesch, M., Windelberg, M., Sauseng, W., Witt, V., Fleischhack, G., Lackner, H., Gadner, H., Bode, U., Urban, C.
(2008). Compassionate use of bevacizumab (Avastin(R)) in children and young adults with refractory or recurrent solid tumors. Ann Oncol
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Tol, J., Koopman, M., Rodenburg, C. J., Cats, A., Creemers, G. J., Schrama, J. G., Erdkamp, F. L. G., Vos, A. H., Mol, L., Antonini, N. F., Punt, C. J. A.
(2008). A randomised phase III study on capecitabine, oxaliplatin and bevacizumab with or without cetuximab in first-line advanced colorectal cancer, the CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG). An interim analysis of toxicity. Ann Oncol
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Picchio, M., Beck, R., Haubner, R., Seidl, S., Machulla, H.-J., Johnson, T. D., Wester, H.-J., Reischl, G., Schwaiger, M., Piert, M.
(2008). Intratumoral Spatial Distribution of Hypoxia and Angiogenesis Assessed by 18F-FAZA and 125I-Gluco-RGD Autoradiography. JNM
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Brostjan, C., Gebhardt, K., Gruenberger, B., Steinrueck, V., Zommer, H., Freudenthaler, H., Roka, S., Gruenberger, T.
(2008). Neoadjuvant Treatment of Colorectal Cancer with Bevacizumab: The Perioperative Angiogenic Balance Is Sensitive to Systemic Thrombospondin-1 Levels. Clin. Cancer Res.
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Meyer-Losic, F., Nicolazzi, C., Quinonero, J., Ribes, F., Michel, M., Dubois, V., de Coupade, C., Boukaissi, M., Chene, A.-S., Tranchant, I., Arranz, V., Zoubaa, I., Fruchart, J.-S., Ravel, D., Kearsey, J.
(2008). DTS-108, A Novel Peptidic Prodrug of SN38: In vivo Efficacy and Toxicokinetic Studies. Clin. Cancer Res.
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