A multicenter phase II randomized trial of docetaxel/gemcitabine versus docetaxel/capecitabine as first-line treatment for advanced breast cancer: A gruppo oncologico italia meridionale study

P. Vici, F. Giotta, L. Di Lauro, D. Sergi, E. Vizza, L. Mariani, A. Latorre, L. Pizzuti, C. D'Amico, D. Giannarelli, G. Colucci

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To evaluate two docetaxel-based regimens as first-line treatment in advanced breast cancer patients. Methods: Patients were randomly assigned to docetaxel/gemcitabine (arm A: docetaxel 75 mg/m 2 on day 1, gemcitabine 1,000 mg/m 2 on days 1 and 8) or docetaxel/capecitabine (arm B: docetaxel 75 mg/m 2 on day 1, capecitabine 1,250 mg/m 2 twice daily on days 1-14); both chemotherapy regimens were repeated every 21 days. The primary objective of the study was to evaluate the response rate. Results: Seventy-two patients were enrolled (36 each in arms A and B). Responses according to intention-to-treat analysis were as follows: arm A, 41.7% [95% confidence interval (CI) 25.6-57.8]; arm B, 38.9% (95% CI 23-54.8). Median progression-free survival was 10.9 months (95% CI 8.1-13.7) in arm A and 10 months (95% CI 8.8-11.2) in arm B. Overall survival was 26 months (95% CI 22.0-30.0) in arm A and 28 months (95% CI 23.4-32.6) in arm B. Both treatments were well tolerated; myelosuppression was the dose-limiting toxicity, with grade 3-4 neutropenia in 13.8 and 19.4% of the patients in arms A and B, respectively. No relevant differences in other toxicities were observed in the two arms, except for diarrhea (13.9%) and hand-foot syndrome (11.1%), which occurred only in arm B. Conclusions: Both regimens were active and well tolerated in advanced breast cancer.

Original languageEnglish
Pages (from-to)230-236
Number of pages7
JournalOncology
Volume81
Issue number3-4
DOIs
Publication statusPublished - Dec 2011

Keywords

  • Advanced breast cancer
  • Capecitabine
  • Docetaxel
  • Gemcitabine
  • Phase II trial

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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