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Article: Adjuvant Trastuzumab in HER2-Positive Breast Cancer

TitleAdjuvant Trastuzumab in HER2-Positive Breast Cancer
Authors
Issue Date2011
PublisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/
Citation
New England Journal of Medicine, 2011, v. 365, p. 1273-1283 How to Cite?
AbstractBACKGROUND: 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. (Funded by Sanofi-Aventis and Genentech; BCIRG-006 ClinicalTrials.gov number, NCT00021255.).
Persistent Identifierhttp://hdl.handle.net/10722/251815
ISSN
2017 Impact Factor: 79.26
2015 SCImago Journal Rankings: 14.619
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorSlamon, D-
dc.contributor.authorEiermann, W-
dc.contributor.authorRobert, N-
dc.contributor.authorPienkowski, T-
dc.contributor.authorMartin, M-
dc.contributor.authorPress, M-
dc.contributor.authorMackey, J-
dc.contributor.authorGlaspy, J-
dc.contributor.authorChan, A-
dc.contributor.authorPawlicki, M-
dc.contributor.authorPinter, T-
dc.contributor.authorValero, V-
dc.contributor.authorLiu, EC-
dc.contributor.authorSauter, G-
dc.contributor.authorvon Minckwitz, G-
dc.contributor.authorVisco, F-
dc.contributor.authorBee, V-
dc.contributor.authorBuyse, M-
dc.contributor.authorBendahmane, B-
dc.contributor.authorTabah-Fisch, I-
dc.contributor.authorLindsay, MA-
dc.contributor.authorRiva, A-
dc.contributor.authorCrown, J-
dc.contributor.authorKwong, A-
dc.date.accessioned2018-03-19T07:01:42Z-
dc.date.available2018-03-19T07:01:42Z-
dc.date.issued2011-
dc.identifier.citationNew England Journal of Medicine, 2011, v. 365, p. 1273-1283-
dc.identifier.issn0028-4793-
dc.identifier.urihttp://hdl.handle.net/10722/251815-
dc.description.abstractBACKGROUND: 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. (Funded by Sanofi-Aventis and Genentech; BCIRG-006 ClinicalTrials.gov number, NCT00021255.).-
dc.languageeng-
dc.publisherMassachusetts Medical Society. The Journal's web site is located at http://content.nejm.org/-
dc.relation.ispartofNew England Journal of Medicine-
dc.rightsNew England Journal of Medicine. Copyright © Massachusetts Medical Society.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.titleAdjuvant Trastuzumab in HER2-Positive Breast Cancer-
dc.typeArticle-
dc.identifier.emailKwong, A: avakwong@hku.hk-
dc.identifier.authorityKwong, A=rp01734-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1056/NEJMoa0910383-
dc.identifier.hkuros284570-
dc.identifier.volume365-
dc.identifier.spage1273-
dc.identifier.epage1283-
dc.identifier.isiWOS:000295578700004-
dc.publisher.placeUnited States-

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