“Weekly docetaxel and gemcitabine as first line treatment for metastatic breast cancer: results of a multicenter phase II study”

Massimo Cajozzo, Sergio Palmeri, Vincenza Leonardi, Filippelli, Condemi, Francesco Ferraù, Andrea Mangiameli, Spada, Ferraù, De Cataldis, Leonardi, Bruno Massidda, Farris, Giuseppe Comella, Marco Danova, Misino, Laura Palmeri

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17 Citations (Scopus)

Abstract

Objectives: We conducted a multicenter phase II study to evaluate the clinical effi cacy, toxicity, and dose intensity of a new weekly schedule of docetaxel and gemcitabineas fi rst-line treatment of metastatic breast cancer patients. Methods: We enrolled 58 patients, 52% of whom had received a previous anthracycline-containing chemotherapy. The treatment schedule was: docetaxel35 mg/m 2 and gemcitabine 800 mg/m 2 i.v. on days 1, 8,15 every 28 days. Results: All patients were assessable for toxicity and 56 for effi cacy. Overall response rate was64.3% with 16.1% of complete responses and 48.2% of partial responses. Median survival was 22.10 months (95% CI: 15.53–28.67) and median time to tumor progression was 13.6 months (95% CI: 10.71–16.49). The most common hematological toxicity was neutropenia (no febrileneutropenia), which occurred in 28 patients (48.3%) but grade 3–4 in only 8 patients (14%). Alopecia, the most common nonhematological toxicity, occurred in 20 (34.5%) patients, but only 5 patients (8.6%) experiencedgrade 3 alopecia. Conclusion: The activity of docetaxel and gemcitabine in metastatic breast cancer is confirmed. The promising results of the employed schedule,in agreement with other published studies, need to befurther confirmed within a phase III study.
Original languageEnglish
Pages (from-to)438-445
JournalOncology
Volume68 (4-6)
Publication statusPublished - 2005

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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