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Annals of Oncology Advance Access published online on October 23, 2009
Annals of Oncology, doi:10.1093/annonc/mdp428
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

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. Jinno1,*, M. Sakata1, T. Hayashida1, M. Takahashi1, M. Mukai2, T. Ikeda3 and Y. Kitagawa1

1 Department of Surgery, Keio University School of Medicine
2 Department of Pathology, Keio University School of Medicine
3 Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan

* Correspondence to: Dr H. Jinno, Department of Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo 160, Japan. Tel: +81-3-3353-1211; Fax: +81-3-3355-4707; E-mail: jinno{at}sc.itc.keio.ac.jp

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.

breast cancer, capecitabine, docetaxel, preoperative chemotherapy

Received for publication June 19, 2009. Revision received July 31, 2009. Accepted for publication July 31, 2009.


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