Biweekly docetaxel and vinorelbine in anthracycline-resistant metastatic breast cancer: a multicenter phase II study

Am J Clin Oncol. 2003 Apr;26(2):127-31. doi: 10.1097/00000421-200304000-00005.

Abstract

The aim of this study was to determine the efficacy and toxicity of a biweekly combination of docetaxel and vinorelbine in patients with metastatic breast cancer (MBC) previously treated with anthracyclines. Eligible patients (n = 49) with MBC received vinorelbine, 25 mg/m2, followed by docetaxel, 60 mg/m2. Cycles were repeated every 14 days for a total of 8 planned cycles. Response rate was evaluated every 4 cycles. All 49 patients were evaluable for safety and 44 for efficacy. Vinorelbine plus docetaxel resulted in an overall response rate of 45% (CI 95%: 31-60) with 2 (4%) complete responses and 18 (41%) partial responses. Patients with visceral metastasis achieved a lower response rate than those without (33% versus 60%, p = 0.044). Time to progression was 11.0 months (CI 95%: 8.6-13.5), and median overall survival was 12.7 months (CI 95%: 9.0-16.4). The most common grade III to IV hematologic adverse events was neutropenia (65% of patients). Febrile neutropenia was observed in 9 cycles (3%) and in 7 patients (14%). Grade III to IV nonhematologic toxicity was rare. Biweekly combination of docetaxel and vinorelbine is an effective and well-tolerated regimen in anthracycline-resistant MBC.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antibiotics, Antineoplastic
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Carcinoma, Ductal, Breast / drug therapy
  • Carcinoma, Ductal, Breast / secondary
  • Carcinoma, Lobular / drug therapy
  • Carcinoma, Lobular / secondary
  • Docetaxel
  • Drug Administration Schedule
  • Drug Resistance, Neoplasm
  • Female
  • Granulocyte Colony-Stimulating Factor / therapeutic use
  • Humans
  • Middle Aged
  • Paclitaxel / administration & dosage*
  • Paclitaxel / analogs & derivatives*
  • Survival Analysis
  • Taxoids*
  • Vinblastine / administration & dosage*
  • Vinblastine / analogs & derivatives*
  • Vinorelbine

Substances

  • Antibiotics, Antineoplastic
  • Taxoids
  • Granulocyte Colony-Stimulating Factor
  • Docetaxel
  • Vinblastine
  • Paclitaxel
  • Vinorelbine