The DOI matches its Crossref record; 42 of the 42 references it cites were found in a registry or an index.
Adjuvant Trastuzumab in HER2-Positive Breast Cancer
Open accessAbstract
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. (Funded by Sanofi-Aventis and Genentech; BCIRG-006 ClinicalTrials.gov number, NCT00021255.).
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1 retracted
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Cited by
Gianni, L., Pienkowski, T., Im, Y.-H., Roman, L., Tseng, L.-M., Liu, M.-C., Lluch, A., Staroslawska, E., de la Haba-Rodriguez, J., Im, S.-A., et al. (2012) · The Lancet Oncology · doi:10.1016/s1470-2045(11)70336-9 · Cited by 2,374
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Cardoso, F., Kyriakides, S., Ohno, S., Penault-Llorca, F., Poortmans, P., Rubio, I. T., Zackrisson, S., & Senkus, E. (2019) · Annals of Oncology · doi:10.1093/annonc/mdz173 · Cited by 2,214
Targeting HER2-positive breast cancer: advances and future directions
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Metadata
- Authors
- Slamon, D., Eiermann, W., Robert, N., Pienkowski, T., Martin, M., Press, M., Mackey, J., Glaspy, J., Chan, A., Pawlicki, M., Pinter, T., Valero, V., Liu, M.-C., Sauter, G., von Minckwitz, G., Visco, F., Bee, V., Buyse, M., Bendahmane, B., Tabah-Fisch, I., Lindsay, M.-A., Riva, A., & Crown, J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-10-06
- Volume
- 365
- Issue
- 14
- Pages
- 1273-1283
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2098775844
- Cited by
- 2,775
- References
- 42
- FWCI
- 76.38
- Type
- journal article
- Language
- en
- Open access
- bronze
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