Publication: Adjuvant trastuzumab in HER2-Positive breast cancer
Authors
Slamon, Dennis ; Eiermann, Wolfgang ; Robert, Nicholas ; Pienkowski, Tadeusz ; Martin, Miguel ; Press, Michael ; Mackey, John ; Glaspy, John ; Chan, Arlene ; Pawlicki, Marek ; Pinter, Tamas ; Valero, Vicente ; Liu, Mei-Ching ; Sauter, Guido ; Minckwitz, Gunter von ; Visco, Frances ; Bee, Valerie ; Buyse, Marc ; Bendahmane, Belguendouz ; Tabah-Fisch, Isabelle ; Lindsay, Mary-Ann ; Riva, Alessandro ; Crown, John ; Breast Cancer International Research Group
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Publisher
Massachusetts Medical Society
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DOI
https://doi.org/10.1056/NEJMoa0910383
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info:eu-repo/semantics/article
Description
© 2011 Massachusetts Medical Society. All rights reserved. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/. This document is the Published version of a Published Work that appeared in final form in New England Journal of Medicine. To access the final edited and published work see https://doi.org/10.1056/NEJMoa0910383
Abstract
Background: Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-based regimens has been associated with cardiac toxicity. We wanted to evaluate the efficacy and safety of a new nonanthracycline regimen with trastuzumab. Methods: We randomly assigned 3222 women with HER2-positive early-stage breast cancer to receive doxorubicin and cyclophosphamide followed by docetaxel every 3 weeks (AC-T), the same regimen plus 52 weeks of trastuzumab (AC-T plus trastuzumab), or docetaxel and carboplatin plus 52 weeks of trastuzumab (TCH). The primary study end point was disease-free survival. Secondary end points were overall survival and safety. Results: At a median follow-up of 65 months, 656 events triggered this protocol-specified analysis. The estimated disease-free survival rates at 5 years were 75% among patients receiving AC-T, 84% among those receiving AC-T plus trastuzumab, and 81% among those receiving TCH. Estimated rates of overall survival were 87%, 92%, and 91%, respectively. No significant differences in efficacy (disease-free or overall survival) were found between the two trastuzumab regimens, whereas both were superior to AC-T. The rates of congestive heart failure and cardiac dysfunction were significantly higher in the group receiving AC-T plus trastuzumab than in the TCH group (P<0.001). Eight cases of acute leukemia were reported: seven in the groups receiving the anthracycline-based regimens and one in the TCH group subsequent to receiving an anthracycline outside the study. Conclusions: The addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk–benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia.
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Citation
N Engl J Med 2011 365:1273-83
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