Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer Journal Article
| Authors: | Tolaney, S. M.; Barry, W. T.; Dang, C. T.; Yardley, D. A.; Moy, B.; Marcom, P. K.; Albain, K. S.; Rugo, H. S.; Ellis, M.; Shapira, I.; Wolff, A. C.; Carey, L. A.; Overmoyer, B. A.; Partridge, A. H.; Guo, H.; Hudis, C. A.; Krop, I. E.; Burstein, H. J.; Winer, E. P. |
| Article Title: | Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer |
| Abstract: | BACKGROUND No single standard treatment exists for patients with small, node-negative, human epidermal growth factor receptor type 2 (HER2)-positive breast cancers, because most of these patients have been ineligible for the pivotal trials of adjuvant trastuzumab. METHODS We performed an uncontrolled, single-group, multicenter, investigator-initiated study of adjuvant paclitaxel and trastuzumab in 406 patients with tumors measuring up to 3 cm in greatest dimension. Patients received weekly treatment with paclitaxel and trastuzumab for 12 weeks, followed by 9 months of trastuzumab monotherapy. The primary end point was survival free from invasive disease. RESULTS The median follow-up period was 4.0 years. The 3-year rate of survival free from invasive disease was 98.7% (95% confidence interval [CI], 97.6 to 99.8). Among the 12 relapses seen, 2 were due to distant metastatic breast cancer. Excluding contralateral HER2-negative breast cancers and nonbreast cancers, 7 disease-specific events were noted. A total of 13 patients (3.2%; 95% CI, 1.7 to 5.4) reported at least one episode of grade 3 neuropathy, and 2 had symptomatic congestive heart failure (0.5%; 95% CI, 0.1 to 1.8), both of whom had normalization of the left ventricular ejection fraction after discontinuation of trastuzumab. A total of 13 patients had significant asymptomatic declines in ejection fraction (3.2%; 95% CI, 1.7 to 5.4), as defined by the study, but 11 of these patients were able to resume trastuzumab therapy after a brief interruption. CONCLUSIONS Among women with predominantly stage I HER2-positive breast cancer, treatment with adjuvant paclitaxel plus trastuzumab was associated with a risk of early recurrence of about 2%; 6% of patients withdrew from the study because of protocol-specified adverse events. (Funded by Genentech; ClinicalTrials.gov number, NCT00542451.) |
| Keywords: | chemotherapy; oncogene; safety; women; efficacy; disease; monoclonal-antibody; overexpression; trials; metastatic breast |
| Journal Title: | New England Journal of Medicine |
| Volume: | 372 |
| Issue: | 2 |
| ISSN: | 0028-4793 |
| Publisher: | Massachusetts Medical Society |
| Date Published: | 2015-01-08 |
| Start Page: | 134 |
| End Page: | 141 |
| Language: | English |
| ACCESSION: | WOS:000347443300008 |
| DOI: | 10.1056/NEJMoa1406281 |
| PROVIDER: | wos |
| PMCID: | PMC4313867 |
| PUBMED: | 25564897 |
| Notes: | Article -- Source: Wos |
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