Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer Journal Article

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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.).
Journal Title: The New England journal of medicine
Volume: 372
Issue: 2
ISSN: 1533-4406; 0028-4793
Publisher: Unknown  
Journal Place: United States
Date Published: 2015
Start Page: 134
End Page: 141
Language: eng
DOI/URL:

10.1056/NEJMoa1406281
Notes: ClinicalTrials.gov/NCT00542451; JID: 0255562; 0 (Antibodies, Monoclonal, Humanized); 33069-62-4 (Paclitaxel); EC 2.7.10.1 (ERBB2 protein, human); EC 2.7.10.1 (Receptor, ErbB-2); P188ANX8CK (trastuzumab); ppublish