First-line chemotherapy with fluorouracil-epirubicin-navelbine (FEN) combination in advanced breast cancer.
BACKGROUND
A phase II study was carried out to determine the safety and efficacy of the combination of vinorelbine, epirubicin and 5-fluorouracil (FEN) as first-line chemotherapy in advanced breast cancer (BC).


METHODS
Thirty-four women with advanced BC, aged 32-75 years (median 59), previously untreated for recurrence, were enrolled in the study. The treatment consisted of fluorouracil 600 mg/m2 on day 1, epirubicin 75 mg/m2 on day 1 and vinorelbine 25 mg/m2 on days 1 and 8, every 3 weeks, up to a maximum of 9 cycles.


RESULTS
The efficacy appeared favourable with 18 objective responses (3 complete and 15 partial) and 9 disease stabilizations, giving an overall response rate of 53% (95% CI: 36-70). The median progression-free and overall survival was 6 and 18 months, respectively (95% CI: 4.8-7.8 and 16.2-22.2, respectively). Toxicity was acceptable; the main grade 3/4 toxicity was alopecia in 94% of patients, neutropenia in 44% and less frequently gastrointestinal toxicity (9%), anaemia (6%), mucositis (6%), thrombocytopenia (3%) and diarrhoea (3%). No treatment-related death occurred,


CONCLUSIONS
Our results suggest that FEN, as first-line chemotherapy, is an active and well-tolerated treatment for patients with advanced breast cancer.
Ardavanis
A
A
First Department of Medical Oncology, St. Savas Anticancer Hospital, Athens, Greece. ardavanis@yahoo.com
Tryfonopoulos
D
D
Orphanos
G
G
Ioannidis
G
G
Karamouzis
M
M
Rigatos
G
G
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
D015251:Epirubicin; D014747:Vinblastine; D000077235:Vinorelbine; D005472:Fluorouracil