Phase I, dose-finding study of capecitabine in combination with docetaxel and epirubicin as first-line chemotherapy for advanced breast cancer

M. Venturini, L. Del Mastro, O. Garrone, C. Angiolini, M. Merlano, M. Bergaglio, G. Tolino, A. Lambiase, A. Baldini, G. Canavese, R. Rosso

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Abstract

Purpose: Capecitabine is an oral fluoropyrimidine with considerable activity and minimal myelosuppression and alopecia. This phase I study evaluated the addition of capecitabine to epirubicin/docetaxel combination therapy as first-line treatment for advanced breast cancer. Patients and methods: Twenty-three female patients with advanced breast cancer received capecitabine (765-1060 mg/m2 twice daily on days 1-14 of a 3-week treatment cycle) in combination with epirubicin and docetaxel (75 mg/m2 i.v. on day 1). Results: The maximum tolerated dose of capecitabine was 985 mg/m2 and the principal dose-limiting toxicity was febrile neutropenia. No grade 3/4 anemia or thrombocytopenia occurred. There were no grade 4 non-hematological events and grade 3 events other than alopecia were rare. Alopecia occurred in all patients and treatment cycles, and asthenia occurred in all patients and in 84% of treatment cycles. Other frequent adverse events included nausea, vomiting, fever, paresthesia and elevated transaminase levels. An objective response to treatment was observed in 91% (95% confidence interval 72% to 99%) of patients. Conclusions: The addition of capecitabine to docetaxel/epirubicin combination therapy provides a well-tolerated and active first-line chemotherapy regimen in patients with advanced breast cancer, and merits phase II/III evaluation.

Original languageEnglish
Pages (from-to)546-552
Number of pages7
JournalAnnals of Oncology
Volume13
Issue number4
DOIs
Publication statusPublished - 2002

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Keywords

  • Advanced breast cancer
  • Capecitabine
  • Docetaxel
  • Epirubicin
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Venturini, M., Del Mastro, L., Garrone, O., Angiolini, C., Merlano, M., Bergaglio, M., Tolino, G., Lambiase, A., Baldini, A., Canavese, G., & Rosso, R. (2002). Phase I, dose-finding study of capecitabine in combination with docetaxel and epirubicin as first-line chemotherapy for advanced breast cancer. Annals of Oncology, 13(4), 546-552. https://doi.org/10.1093/annonc/mdf056