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  • Adjuvant trastuzumab in HER2-positive breast cancer
    Slamon, Dennis ...
    Background: Trastuzumab improves survival in the adjuvant treatment of HER-positive breast cancer, although combined therapy with anthracycline-basedregimens 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 followedby 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 amedian 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. (Abstract truncated at 2000 characters)
    Source: The New England journal of medicine. - ISSN 0028-4793 (Vol. 365, issue 14, 2011, str. 1273-1283)
    Type of material - article, component part
    Publish date - 2011
    Language - english
    COBISS.SI-ID - 29394393

source: The New England journal of medicine. - ISSN 0028-4793 (Vol. 365, issue 14, 2011, str. 1273-1283)
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