A phase II study on the safety and efficacy of 5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by paclitaxel in the adjuvant treatment of breast cancer

Erman M., Baltali E., Karaoglu A., Abali H., Engin H., Ozisik Y., ...More

CANCER INVESTIGATION, vol.23, no.3, pp.215-221, 2005 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 23 Issue: 3
  • Publication Date: 2005
  • Doi Number: 10.1081/cnv-200055956
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.215-221
  • Hacettepe University Affiliated: No


The incorporation of a taxane into an anthracycline-containing regimen in the adjuvant treatment of breast cancer is a promising approach. In this study, we aimed to evaluate the safety and efficacy of four cycles of FEC (fluorouracil 500 mg/m(2), epirubicin 70 mg/m(2), cyclophosphamide 500 mg/m(2), every 3 weeks) followed by four cycles of paclitaxel (175 mg/m(2) every 3 weeks) in the adjuvant treatment of node-positive and other high-risk breast cancer patients. A total of 88 female patients were enrolled. Mean age (± SD) of the patients was 47 ± 10 (min: 24; max: 71). The patients were followed for a median of 48 months ( min: 20; max: 64). The most common side effects were nausea-vomiting ( grade I-II: 91%; grade III: 2%), as well as hematological toxicity ( grade I-II: 70%; grade III: 3%). Although all patients experienced some degree of toxicity, it was severe enough to be classified as grade III or IV in only 10 (11%) of the cases. Of note, six (8%) patients had grade I and only one (1%) had grade II cardiotoxicity. No grade III or IV cardiotoxicity was observed. The full eight cycles of study treatment could be administered to 75 patients (85%). Side effects necessitated the reduction of the doses of FEC and paclitaxel in one ( 1%) and three patients ( 3%), respectively. Median overall ( OS) and disease-free survival (DFS) have not yet been reached. Five-year OS and DFS have been estimated to be 78% and 61%, respectively. We conclude that FEC followed by paclitaxel is a well-tolerated and feasible regimen in the adjuvant treatment of early breast cancer. Its efficacity is comparable with other commonly used regimens and merits evaluation in a phase III study.