Use of Chemotherapy plus a Monoclonal Antibody against HER2 for Metastatic Breast Cancer That Overexpresses HER2
Dennis J. Slamon, M.D., Ph.D., Brian Leyland-Jones, M.D., Steven Shak, M.D., Hank Fuchs, M.D., Virginia Paton, Pharm.D., Alex Bajamonde, Ph.D., Thomas Fleming, Ph.D., Wolfgang Eiermann, M.D., Janet Wolter, M.D., Mark Pegram, M.D., Jose Baselga, M.D., and Larry Norton, M.D.
Background The HER2 gene, which encodes the growth factor receptorHER2, is amplified and HER2 is overexpressed in 25 to 30 percentof breast cancers, increasing the aggressiveness of the tumor.
Methods We evaluated the efficacy and safety of trastuzumab,a recombinant monoclonal antibody against HER2, in women withmetastatic breast cancer that overexpressed HER2. We randomlyassigned 234 patients to receive standard chemotherapy aloneand 235 patients to receive standard chemotherapy plus trastuzumab.Patients who had not previously received adjuvant (postoperative)therapy with an anthracycline were treated with doxorubicin(or epirubicin in the case of 36 women) and cyclophosphamidewith (143 women) or without trastuzumab (138 women). Patientswho had previously received adjuvant anthracycline were treatedwith paclitaxel alone (96 women) or paclitaxel with trastuzumab(92 women).
Results The addition of trastuzumab to chemotherapy was associatedwith a longer time to disease progression (median, 7.4 vs. 4.6months; P<0.001), a higher rate of objective response (50percent vs. 32 percent, P<0.001), a longer duration of response(median, 9.1 vs. 6.1 months; P<0.001), a lower rate of deathat 1 year (22 percent vs. 33 percent, P=0.008), longer survival(median survival, 25.1 vs. 20.3 months; P=0.046), and a 20 percentreduction in the risk of death. The most important adverse eventwas cardiac dysfunction, which occurred in 27 percent of thegroup given an anthracycline, cyclophosphamide, and trastuzumab;8 percent of the group given an anthracycline and cyclophosphamidealone; 13 percent of the group given paclitaxel and trastuzumab;and 1 percent of the group given paclitaxel alone. Althoughthe cardiotoxicity was potentially severe and, in some cases,life-threatening, the symptoms generally improved with standardmedical management.
Conclusions Trastuzumab increases the clinical benefit of first-linechemotherapy in metastatic breast cancer that overexpressesHER2.
Source Information
From the Division of Hematology and Oncology, UCLA School of Medicine, Los Angeles (D.J.S., M.P.); the Department of Oncology, McGill University, Montreal (B.L.-J.): Medical Affairs, Genentech, South San Francisco, Calif. (S.S., V.P., A.B.); IntraBiotics, Mountain View, Calif. (H.F.); the Department of Biostatistics, University of Washington, Seattle (T.F.); the Department of Obstetrics and Gynecology, Frauenklinik vom Roten Kreuz, Munich, Germany (W.E.); the Department of Oncology, Rush–Presbyterian–St. Luke's Medical Center, Chicago (J.W.); the Department of Oncology, Hospital General Universitari Vall d'Hebron, Barcelona, Spain (J.B.); and the Department of Medical Oncology, Memorial Sloan-Kettering Cancer Center, New York (L.N.).
Address reprint requests to Dr. Slamon at UCLA School of Medicine, Division of Hematology/Oncology, 11-244 Factor Bldg., 10833 Le Conte, Los Angeles, CA 90095-1678, or at dslamon{at}mednet.ucla.edu.
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Agadjanian, H., Ma, J., Rentsendorj, A., Valluripalli, V., Hwang, J. Y., Mahammed, A., Farkas, D. L., Gray, H. B., Gross, Z., Medina-Kauwe, L. K.
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Gong, Y., Sweet, W., Duh, Y.-J., Greenfield, L., Fang, Y., Zhao, J., Tarco, E., Symmans, W. F., Isola, J., Sneige, N.
(2009). Chromogenic In Situ Hybridization Is a Reliable Method for Detecting HER2 Gene Status in Breast Cancer: A Multicenter Study Using Conventional Scoring Criteria and the New ASCO/CAP Recommendations. Am J Clin Pathol
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Barros Costa, R. L.
(2009). Review Article: Targeted Therapy: Comprehensive Review. AM J HOSP PALLIAT CARE
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(2009). Utility of Serum HER2 Extracellular Domain Assessment in Clinical Decision Making: Pooled Analysis of Four Trials of Trastuzumab in Metastatic Breast Cancer. JCO
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Leary, A. F., Hanna, W. M., van de Vijver, M. J., Penault-Llorca, F., Ruschoff, J., Osamura, R. Y., Bilous, M., Dowsett, M.
(2009). Value and Limitations of Measuring HER-2 Extracellular Domain in the Serum of Breast Cancer Patients. JCO
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Gori, S., Sidoni, A., Colozza, M., Ferri, I., Mameli, M. G., Fenocchio, D., Stocchi, L., Foglietta, J., Ludovini, V., Minenza, E., De Angelis, V., Crino, L.
(2009). EGFR, pMAPK, pAkt and PTEN status by immunohistochemistry: correlation with clinical outcome in HER2-positive metastatic breast cancer patients treated with trastuzumab. Ann Oncol
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Lee, J. H., Rosen, E. L., Mankoff, D. A.
(2009). The Role of Radiotracer Imaging in the Diagnosis and Management of Patients with Breast Cancer: Part 1--Overview, Detection, and Staging. JNM
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(2009). Design, Synthesis, Radiolabeling and In Vitro and In Vivo Characterization of Tumor-antigen- and Antibody-derived Peptides for the Detection of Breast Cancer. Anticancer Res
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Wong, K.-K., Fracasso, P. M., Bukowski, R. M., Lynch, T. J., Munster, P. N., Shapiro, G. I., Janne, P. A., Eder, J. P., Naughton, M. J., Ellis, M. J., Jones, S. F., Mekhail, T., Zacharchuk, C., Vermette, J., Abbas, R., Quinn, S., Powell, C., Burris, H. A.
(2009). A Phase I Study with Neratinib (HKI-272), an Irreversible Pan ErbB Receptor Tyrosine Kinase Inhibitor, in Patients with Solid Tumors. Clin. Cancer Res.
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Ross, J. S., Slodkowska, E. A., Symmans, W. F., Pusztai, L., Ravdin, P. M., Hortobagyi, G. N.
(2009). The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti-HER-2 Therapy and Personalized Medicine. The Oncologist
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Sheu, J. J.-C., Hua, C.-H., Wan, L., Lin, Y.-J., Lai, M.-T., Tseng, H.-C., Jinawath, N., Tsai, M.-H., Chang, N.-W., Lin, C.-F., Lin, C.-C., Hsieh, L.-J., Wang, T.-L., Shih, I.-M., Tsai, F.-J.
(2009). Functional Genomic Analysis Identified Epidermal Growth Factor Receptor Activation as the Most Common Genetic Event in Oral Squamous Cell Carcinoma. Cancer Res.
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Ignatiadis, M., Desmedt, C., Sotiriou, C., de Azambuja, E., Piccart, M.
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Harrington, K. J., El-Hariry, I. A., Holford, C. S., Lusinchi, A., Nutting, C. M., Rosine, D., Tanay, M., Deutsch, E., Matthews, J., D'Ambrosio, C., Turner, S. J., Pandeshwara, J. S., Bourhis, J.
(2009). Phase I Study of Lapatinib in Combination With Chemoradiation in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck. JCO
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Anton, A., Ruiz, A., Segui, M. A., Calvo, L., Munoz, M., Lao, J., Sancho, F., Fernandez, L.
(2009). Phase I clinical trial of liposomal-encapsulated doxorubicin citrate and docetaxel, associated with trastuzumab, as neo-adjuvant treatment in stages II and IIIA, HER2-overexpressing breast cancer patients. GEICAM 2003-03 study. Ann Oncol
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Saad, E. D., Katz, A.
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