title: 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.
abstract: 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/m2, epirubicin 70 mg/m2, cyclophosphamide 500 mg/m2, every 3 weeks) followed by four cycles of paclitaxel (175 mg/m2 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.
authors.affiliation: Department of Internal Medicine, Section of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara, Turkey. ermanm@tr.net
authors.forename: Mustafa
authors.initials: M
authors.lastname: Erman
authors.forename: Esmen
authors.initials: E
authors.lastname: Baltali
authors.forename: Aziz
authors.initials: A
authors.lastname: Karaoglu
authors.forename: Huseyin
authors.initials: H
authors.lastname: Abali
authors.forename: Huseyin
authors.initials: H
authors.lastname: Engin
authors.forename: Yavuz
authors.initials: Y
authors.lastname: Ozisik
authors.forename: Nilufer
authors.initials: N
authors.lastname: Guler
authors.forename: Kadri
authors.initials: K
authors.lastname: Altundag
authors.forename: Gulten
authors.initials: G
authors.lastname: Tekuzman
authors.forename: I Lale
authors.initials: IL
authors.lastname: Atahan
authors.forename: Demirali
authors.initials: D
authors.lastname: Onat
authors.forename: Iskender
authors.initials: I
authors.lastname: Sayek
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D018299:Neoplasms, Ductal, Lobular, and Medullary / Q000188:drug therapy / Q000473:pathology / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage; D012449:Safety; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil