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 : Official Journal of the European Society of Mastology
Matti AaproGustavo Villanova

Abstract

Single-agent paclitaxel and vinorelbine are recommended treatments for advanced breast cancer (ABC) non-responsive to hormone therapy and without visceral crisis. This phase II trial compared first-line oral vinorelbine versus weekly paclitaxel for ABC. Eligible female patients had measurable locally recurrent/metastatic estrogen receptor-positive HER2-negative breast cancer and had received prior endocrine therapy (any setting) but no chemotherapy for ABC. Patients were stratified by prior taxane and visceral metastases and randomized to either oral vinorelbine 80 mg/m2 (first cycle at 60 mg/m2, escalated to 80 mg/m2 in the absence of grade 3/4 toxicity) or intravenous paclitaxel 80 mg/m2 on days 1, 8, and 15 every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was disease control rate (DCR; confirmed complete or partial response, or stable disease for ≥6 weeks). The 131 randomized patients had received a median of 2 prior endocrine therapies; >70% had prior (neo)adjuvant chemotherapy and 79% visceral metastases. DCR was 75.8% (95% confidence interval: 63.6-85.5%) with vinorelbine and 75.4% (63.1-85.2%) with paclitaxel. The most common grade 3/4 adverse events were neutropenia (52%), fatigue (...Continue Reading

Citations

Jun 2, 2020·JCO Clinical Cancer Informatics·Gabrielle B RocqueAndres Azuero
Feb 13, 2020·Signal Transduction and Targeted Therapy·Zhuoran GongZhifei Dai
Feb 9, 2021·Future Science OA·Serafin Morales MurilloAntonieta Salud Salvia
Apr 17, 2020·Signal Transduction and Targeted Therapy·Zhuoran GongZhifei Dai
Apr 3, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Chuanxi ZhengChongqi Tu

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