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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[Abstract][Full Text]
Peoples, G. E., Holmes, J. P., Hueman, M. T., Mittendorf, E. A., Amin, A., Khoo, S., Dehqanzada, Z. A., Gurney, J. M., Woll, M. M., Ryan, G. B., Storrer, C. E., Craig, D., Ioannides, C. G., Ponniah, S.
(2008). Combined Clinical Trial Results of a HER2/neu (E75) Vaccine for the Prevention of Recurrence in High-Risk Breast Cancer Patients: U.S. Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Clin. Cancer Res.
14: 797-803
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Wang, Y., Ikeda, D. M., Narasimhan, B., Longacre, T. A., Bleicher, R. J., Pal, S., Jackman, R. J., Jeffrey, S. S.
(2008). Estrogen Receptor-Negative Invasive Breast Cancer: Imaging Features of Tumors with and without Human Epidermal Growth Factor Receptor Type 2 Overexpression. Radiology
246: 367-375
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Ortega-Paino, E., Fransson, J., Ek, S., Borrebaeck, C. A. K.
(2008). Functionally associated targets in mantle cell lymphoma as defined by DNA microarrays and RNA interference. Blood
111: 1617-1624
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Ramond, A., Sartorius, E., Mousseau, M., Ribuot, C., Joyeux-Faure, M.
(2008). Erythropoietin Pretreatment Protects Against Acute Chemotherapy Toxicity in Isolated Rat Hearts. Exp. Biol. Med.
233: 76-83
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Crump, M., Gluck, S., Tu, D., Stewart, D., Levine, M., Kirkbride, P., Dancey, J., O'Reilly, S., Shore, T., Couban, S., Girouard, C., Marlin, S., Shepherd, L., Pritchard, K. I.
(2008). Randomized Trial of High-Dose Chemotherapy With Autologous Peripheral-Blood Stem-Cell Support Compared With Standard-Dose Chemotherapy in Women With Metastatic Breast Cancer: NCIC MA.16. JCO
26: 37-43
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Revillion, F., Lhotellier, V., Hornez, L., Bonneterre, J., Peyrat, J.-P.
(2008). ErbB/HER ligands in human breast cancer, and relationships with their receptors, the bio-pathological features and prognosis. Ann Oncol
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Bird, B. R.J. H., Swain, S. M.
(2008). Cardiac Toxicity in Breast Cancer Survivors: Review of Potential Cardiac Problems. Clin. Cancer Res.
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[Abstract][Full Text]
Hayes, D. F.
(2008). Markers for Predicting and Evaluating Response to Therapy for Breast Cancer. Am Soc Clin Oncol Ed Book
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[Abstract][Full Text]
Suvarna, S K
(2008). Cardiac pathology of fatal trastuzumab therapy. J. Clin. Pathol.
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