SWOG S0215: A phase II study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER2-positive, stage IV breast cancer

Robert B. Livingston, William E. Barlow, Joseph J. Kash, Kathy S. Albain, Julie R. Gralow, Danika L. Lew, Lawrence E. Flaherty, Melanie E. Royce, Gabriel N. Hortobagyi

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

SWOG trial S0102 showed significant activity of the combination of docetaxel and vinorelbine in HER2- negative metastatic breast cancer (MBC). For HER2- positive patients, additional benefit may occur with the addition of trastuzumab due to its synergy with docetaxel and vinorelbine. Patients with HER2-positive MBC, but without prior chemotherapy for MBC or adjuvant taxane, were eligible. Docetaxel (60 mg/m2) was given intravenously on Day 1, vinorelbine (27.5 mg/m2) intravenously on Days 8 and 15, and filgrastim (5 μg/kg) on Days 2-21 of a 21-day cycle. In addition, patients received weekly infusions of trastuzumab (2 mg/kg) after an initial bolus of 4 mg/kg. The primary outcome was 1 year overall survival (OS), with secondary outcomes of progression-free survival (PFS), response rate, and toxicity. Due to slow accrual (February 2003-December 2006), enrollment was stopped after 76 of 90 planned patients. There have been 32 deaths and 51 progressions among the 74 eligible patients who received treatment. The estimated 1 year OS was 93% (95% CI 84-97%) with a median of 48 months. One-year PFS was 70% (95% CI 58-79%) with a median of 20 months. Response rate for measurable disease was 84%. No deaths were attributed to treatment. Grade 4 toxicities were reported for 19% with neutropenia the most common (15%). The most common grade 3 toxicities (33%) were leucopenia (14%) and fatigue (10%). The combination of trastuzumab, docetaxel, and vinorelbine is effective as first-line chemotherapy in HER2-positive MBC with minimal toxicity. One-year survival estimates are among the highest reported in this population.

Original languageEnglish (US)
Pages (from-to)123-131
Number of pages9
JournalBreast Cancer Research and Treatment
Volume130
Issue number1
DOIs
StatePublished - Nov 1 2011

Keywords

  • Docetaxel
  • HER2-positive metastatic breast cancer
  • Trastuzumab
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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