A phase II trial of capecitabine and docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) as preoperative treatment in women with stage II/III breast cancer

H. Jinno, M. Sakata, T. Hayashida, M. Takahashi, M. Mukai, T. Ikeda, Y. Kitagawa

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Capecitabine (X) and docetaxel (T) have demonstrated a synergistic effect in preclinical models and a survival benefit in metastatic breast cancer. This study's purpose was to determine the efficacy of X and T followed by 5-fluorouracil/epirubicin/cyclophosphamide (FEC) in the preoperative setting. Patients and methods: Patients with stage II/III breast cancer received four cycles of XT (capecitabine 1650 mg/m2 on days 1-14 and docetaxel 60 mg/m2 on day 8 every 3 weeks), followed by four cycles of FEC (5-fluorouracil 500 mg/m2, epirubicin 90 mg/m2, and cyclophosphamide 500 mg/m2 on day 1 every 3 weeks). Primary end points were the pathological complete response (pCR) rate and adverse drug reactions. Results: Seventy-four patients were enrolled and 71 patients were assessable for clinical and pathological responses. The overall response rate was 91.5%. The pCR rate was 14.1% (10 of 71). Grade 3/4 neutropenia was observed in 32.4% of patients. The most common grade 3/4 non-hematologic adverse event was hand-foot syndrome, observed in 11.3% of patients. With 29 months median follow-up, 2-year disease-free survival was estimated 85% for all patients. Conclusion: These data indicate that the sequential combination of XT followed by FEC is a well-tolerated, effective neoadjuvant treatment of stage II/III breast cancer.

Original languageEnglish
Pages (from-to)1262-1266
Number of pages5
JournalAnnals of Oncology
Volume21
Issue number6
DOIs
Publication statusPublished - 2009 Oct 23

Keywords

  • Breast cancer
  • Capecitabine
  • Docetaxel
  • Preoperative chemotherapy

ASJC Scopus subject areas

  • Hematology
  • Oncology

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