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., ...Daha Fazla

CANCER INVESTIGATION, cilt.23, sa.3, ss.215-221, 2005 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 23 Sayı: 3
  • Basım Tarihi: 2005
  • Doi Numarası: 10.1081/cnv-200055956
  • Dergi Adı: CANCER INVESTIGATION
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.215-221
  • Hacettepe Üniversitesi Adresli: Hayır

Özet

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.