Unknown

Dataset Information

0

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


ABSTRACT: 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.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.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.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.).

SUBMITTER: Tolaney SM 

PROVIDER: S-EPMC4313867 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

altmetric image

Publications


<h4>Background</h4>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.<h4>Methods</h4>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 receiv  ...[more]

Similar Datasets

| S-EPMC6550431 | biostudies-literature
| S-EPMC5654518 | biostudies-literature
| S-EPMC3268553 | biostudies-literature
| S-EPMC9482917 | biostudies-literature
| S-EPMC5538020 | biostudies-literature
| S-EPMC7587424 | biostudies-literature
| S-EPMC4968930 | biostudies-literature
| S-EPMC3608861 | biostudies-other
| S-EPMC5955803 | biostudies-literature
| S-EPMC4828117 | biostudies-literature