Original Article

Cancer Chemotherapy and Pharmacology

, 65:457

First online:

Sequential administration of dose-dense epirubicin/cyclophosphamide followed by docetaxel/capecitabine for patients with HER2-negative and locally advanced or node-positive breast cancer

  • Yago NietoAffiliated withDepartment of Medical Oncology, Clínica Universitaria de NavarraUT MD Anderson Cancer Center Email author 
  • , José Manuel AramendíaAffiliated withDepartment of Medical Oncology, Clínica Universitaria de Navarra
  • , Jaime EspinósAffiliated withDepartment of Medical Oncology, Clínica Universitaria de Navarra
  • , Susana De la CruzAffiliated withDepartment of Medical Oncology, Clínica Universitaria de Navarra
  • , Oscar Fernández-HidalgoAffiliated withDepartment of Medical Oncology, Clínica Universitaria de Navarra
  • , Marta SantistebanAffiliated withDepartment of Medical Oncology, Clínica Universitaria de Navarra
  • , Leyre ArbeaAffiliated withDepartment of Radiation Oncology, Clínica Universitaria de Navarra
  • , Javier AristuAffiliated withDepartment of Radiation Oncology, Clínica Universitaria de Navarra
  • , Rafael Martínez-MongeAffiliated withDepartment of Radiation Oncology, Clínica Universitaria de Navarra
    • , Marta MorenoAffiliated withDepartment of Radiation Oncology, Clínica Universitaria de Navarra
    • , Luis PinaAffiliated withDepartment of Radiology, Clínica Universitaria de Navarra
    • , Josu SolaAffiliated withDepartment of Pathology, Clínica Universitaria de Navarra
    • , Gerardo ZornozaAffiliated withDepartment of Breast Surgery, Clínica Universitaria de Navarra
    • , Fernando Martínez RegueiraAffiliated withDepartment of Breast Surgery, Clínica Universitaria de Navarra

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Abstract

Purpose

Capecitabine is effective against metastatic breast cancer (MBC). We hypothesized that sequential treatment with dose-dense epirubicin/cyclophosphamide (EC) and docetaxel/capecitabine would be active and tolerable in the adjuvant/neoadjuvant setting.

Methods

In this prospective phase II clinical trial patients with HER2-negative and node-positive or locally advanced tumors were eligible to receive four cycles of EC (100/600 mg/m2) every 2 weeks with G-CSF on days 3–10, followed by four cycles of docetaxel/capecitabine (75/1,000 mg/m2 b.i.d., days 1–14) every 3 weeks.

Results

Fifty-five patients were enrolled with median age of 49, and 80% had hormone receptor-positive disease. The median tumor size was 2.5 cm, with a median of two axillary nodes involved. Seventy-five percent of the first 20 patients had grade 2/3 hand-foot syndrome (HFS). Dose reduction of capecitabine to 800 mg/m2 reduced the grade 2/3 HFS incidence to 31% in the remaining patients. No grade 4/5 toxicities were observed. All 20 patients treated preoperatively responded, with 5 (25%) pathologic complete responses and 3 additional pT0N1 tumors. At a median follow-up of 48 (range 28–60) months, the event-free and overall survival rates are 91 and 98%, respectively.

Conclusions

Sequential treatment with dose-dense EC followed by docetaxel/capecitabine, using a lower capecitabine dose than that approved for MBC, has an acceptable toxicity profile and encouraging activity when used as neoadjuvant or adjuvant treatment of breast cancer.

Keywords

Phase II trial Capecitabine Docetaxel Adjuvant Neoadjuvant Breast cancer