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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(2008). DNA Vaccines Targeting Tumor Antigens to B7 Molecules on Antigen-Presenting Cells Induce Protective Antitumor Immunity and Delay Onset of HER-2/Neu-Driven Mammary Carcinoma. Clin. Cancer Res.
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(2008). Antibodies targeted to TRAIL receptor-2 and ErbB-2 synergize in vivo and induce an antitumor immune response. Proc. Natl. Acad. Sci. USA
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(2008). Trends in Survival Over the Past Two Decades Among White and Black Patients With Newly Diagnosed Stage IV Breast Cancer. JCO
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(2008). Polysomy 17 in Breast Cancer: Clinicopathologic Significance and Impact on HER-2 Testing. JCO
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(2008). Antibody-Mediated Delivery of Interleukin-2 to the Stroma of Breast Cancer Strongly Enhances the Potency of Chemotherapy. Clin. Cancer Res.
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Cristofanilli, M., Morandi, P., Krishnamurthy, S., Reuben, J. M., Lee, B.-N., Francis, D., Booser, D. J., Green, M. C., Arun, B. K., Pusztai, L., Lopez, A., Islam, R., Valero, V., Hortobagyi, G. N.
(2008). Imatinib mesylate (Gleevec(R)) in advanced breast cancer-expressing C-Kit or PDGFR-{beta}: clinical activity and biological correlations. Ann Oncol
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(2008). Single-Agent and Combination Therapeutic Strategies to Inhibit Hepatocyte Growth Factor/MET Signaling in Cancer. Clin. Cancer Res.
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Simon, R.
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(2008). A Phase I-II Study of Combined Blockade of the ErbB Receptor Network with Trastuzumab and Gefitinib in Patients with HER2 (ErbB2)-Overexpressing Metastatic Breast Cancer. Clin. Cancer Res.
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Ryan, Q., Ibrahim, A., Cohen, M. H., Johnson, J., Ko, C.-w., Sridhara, R., Justice, R., Pazdur, R.
(2008). FDA Drug Approval Summary: Lapatinib in Combination with Capecitabine for Previously Treated Metastatic Breast Cancer That Overexpresses HER-2. The Oncologist
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Paul, B., Trovato, J. A., Thompson, J.
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Schmidt, M., Hasenclever, D., Schaeffer, M., Boehm, D., Cotarelo, C., Steiner, E., Lebrecht, A., Siggelkow, W., Weikel, W., Schiffer-Petry, I., Gebhard, S., Pilch, H., Gehrmann, M., Lehr, H.-A., Koelbl, H., Hengstler, J. G., Schuler, M.
(2008). Prognostic Effect of Epithelial Cell Adhesion Molecule Overexpression in Untreated Node-Negative Breast Cancer. Clin. Cancer Res.
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King, J., Waxman, J., Stauss, H.
(2008). Advances in tumour immunotherapy. QJM
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Puglisi, F., Cardellino, G. G., Crivellari, D., Di Loreto, C., Magri, M. D., Minisini, A. M., Mansutti, M., Andreetta, C., Russo, S., Lombardi, D., Perin, T., Damante, G., Veronesi, A.
(2008). Thymidine phosphorylase expression is associated with time to progression in patients receiving low-dose, docetaxel-modulated capecitabine for metastatic breast cancer. Ann Oncol
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Gravalos, C., Jimeno, A.
(2008). HER2 in gastric cancer: a new prognostic factor and a novel therapeutic target. Ann Oncol
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