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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Garcia, A. A., Hirte, H., Fleming, G., Yang, D., Tsao-Wei, D. D., Roman, L., Groshen, S., Swenson, S., Markland, F., Gandara, D., Scudder, S., Morgan, R., Chen, H., Lenz, H.-J., Oza, A. M.
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Posner, M. C., Niedzwiecki, D., Venook, A. P., Hollis, D. R., Kindler, H. L., Martin, E. W., Schilsky, R. L., Goldberg, R. M., for the Cancer and Leukemia Group B,
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Calvani, M., Trisciuoglio, D., Bergamaschi, C., Shoemaker, R. H., Melillo, G.
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Kesari, S., Schiff, D., Henson, J. W., Muzikansky, A., Gigas, D. C., Doherty, L., Batchelor, T. T., Longtine, J. A., Ligon, K. L., Weaver, S., Laforme, A., Ramakrishna, N., Black, P. McL., Drappatz, J., Ciampa, A., Folkman, J., Kieran, M., Wen, P. Y.
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Van Cutsem, E., Siena, S., Humblet, Y., Canon, J.-L., Maurel, J., Bajetta, E., Neyns, B., Kotasek, D., Santoro, A., Scheithauer, W., Spadafora, S., Amado, R. G., Hogan, N., Peeters, M.
(2008). An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Ann Oncol
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Li, X., Liu, Y.-H., Lee, S.-J., Gardner, T. A., Jeng, M.-H., Kao, C.
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Claes, A., Wesseling, P., Jeuken, J., Maass, C., Heerschap, A., Leenders, W. P.J.
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Khorana, A. A., Liebman, H. A., White, R. H., Wun, T., Lyman, G. H.
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(2008). Prevention of Venous Thromboembolism in Patients with Cancer. Am Soc Clin Oncol Ed Book
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Pawlik, T. M., Schulick, R. D., Choti, M. A.
(2008). Expanding Criteria for Resectability of Colorectal Liver Metastases. The Oncologist
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Miller, K., Wang, M., Gralow, J., Dickler, M., Cobleigh, M., Perez, E. A., Shenkier, T., Cella, D., Davidson, N. E.
(2007). Paclitaxel plus Bevacizumab versus Paclitaxel Alone for Metastatic Breast Cancer. NEJM
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Kamat, A. A., Merritt, W. M., Coffey, D., Lin, Y. G., Patel, P. R., Broaddus, R., Nugent, E., Han, L. Y., Landen, C. N. Jr., Spannuth, W. A., Lu, C., Coleman, R. L., Gershenson, D. M., Sood, A. K.
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Little, R. F., Aleman, K., Kumar, P., Wyvill, K. M., Pluda, J. M., Read-Connole, E., Wang, V., Pittaluga, S., Catanzaro, A. T., Steinberg, S. M., Yarchoan, R.
(2007). Phase 2 study of pegylated liposomal doxorubicin in combination with interleukin-12 for AIDS-related Kaposi sarcoma. Blood
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Korita, P. V., Wakai, T., Shirai, Y., Sakata, J., Takizawa, K., Cruz, P. V., Ajioka, Y., Hatakeyama, K.
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Lyman, G. H., Khorana, A. A., Falanga, A., Clarke-Pearson, D., Flowers, C., Jahanzeb, M., Kakkar, A., Kuderer, N. M., Levine, M. N., Liebman, H., Mendelson, D., Raskob, G., Somerfield, M. R., Thodiyil, P., Trent, D., Francis, C. W.
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Gallagher, D. J., Capanu, M., Raggio, G., Kemeny, N.
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Ton, N.C., Parker, G.J.M., Jackson, A., Mullamitha, S., Buonaccorsi, G.A., Roberts, C., Watson, Y., Davies, K., Cheung, S., Hope, L., Power, F., Lawrance, J., Valle, J., Saunders, M., Felix, R., Soranson, J.A., Rolfe, L., Zinkewich-Peotti, K., Jayson, G.C.
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