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.

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/m(2) on days 1-14 and docetaxel 60 mg/m(2) on day 8 every 3 weeks), followed by four cycles of FEC (5-fluorouracil 500 mg/m(2), epirubicin 90 mg/m(2), and cyclophosphamide 500 mg/m(2) 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.

• Authors: H Jinno, M Sakata, T Hayashida, M Takahashi, M Mukai, T Ikeda, Y Kitagawa
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 21 Issue 6 Pg. 1262-1266 (Jun 2010) ISSN: 1569-8041 [Electronic] England
• PMID: 19854722 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Taxoids
• Deoxycytidine
• Docetaxel
• Epirubicin
• Capecitabine
• Cyclophosphamide
• Fluorouracil

Topics

• Adult
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Breast Neoplasms (drug therapy, pathology, surgery)
• Capecitabine
• Carcinoma in Situ (drug therapy, pathology, surgery)
• Combined Modality Therapy
• Cyclophosphamide (administration & dosage, adverse effects)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Docetaxel
• Drug Administration Schedule
• Epirubicin (administration & dosage, adverse effects)
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives)
• Humans
• Mastectomy, Segmental
• Middle Aged
• Neoadjuvant Therapy
• Neoplasm Staging
• Preoperative Period
• Taxoids (administration & dosage, adverse effects)
• Treatment Outcome