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Randomized phase II study evaluating weekly oral vinorelbine versus weekly paclitaxel in estrogen receptor-positive, HER2-negative patients with advanced breast cancer (NorBreast-231 trial)

The Breast Apr 30, 2019

Aapro M, et al. - In this phase 2 trial, researchers assessed first-line oral vinorelbine vs weekly paclitaxel in estrogen receptor-positive, HER2-negative patients with advanced breast cancer (ABC). Eligible female patients had quantifiable locally recurrent/metastatic receptor-positive HER2-negative breast cancer and had previous endocrine therapy but no chemotherapy for ABC. Patients were stratified by previous taxane and visceral metastases and randomly allocated to either oral vinorelbine 80 mg/m2 or intravenous paclitaxel 80 mg/m2 on days 1, 8, and 15 every 3 weeks until disease progression or unacceptable toxicity. According to findings, comparable disease control rates were found in oral vinorelbine and paclitaxel (∼75%). Different safety profiles and, together with route and convenience of administration, may influence the choice of treatment. The most common grade 3/4 adverse events with vinorelbine were neutropenia, fatigue, and vomiting, and with paclitaxel they were neutropenia, dyspnea, hypertension, and peripheral sensory neuropathy. In 2% of vinorelbine-treated and 34% of paclitaxel-treated patients, grade 2 alopecia was seen.

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