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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, Arlene
dc.contributor.authorPawlicki, M.
dc.contributor.authorPinter, T.
dc.contributor.authorValero, V.
dc.contributor.authorLiu, M.
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, M.
dc.contributor.authorRiva, A.
dc.contributor.authorCrown, J.
dc.contributor.authorBreast, C.
dc.identifier.citationSlamon, D. and Eiermann, W. and Robert, N. and Pienkowski, T. and Martin, M. and Press, M. and Mackey, J. et al. 2011. Adjuvant trastuzumab in HER2-positive breast cancer.. The New England journal of medicine. 365 (14): pp. 1273-1283.

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. 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. 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. 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.

dc.titleAdjuvant trastuzumab in HER2-positive breast cancer.
dc.typeJournal Article
dcterms.source.titleThe New England journal of medicine
curtin.departmentCentre for Population Health Research
curtin.accessStatusFulltext not available

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