Primary chemotherapy with epirubicin and vinorelbine in women with locally advanced breast cancer.
BACKGROUND
To assess the activity and toxicity of primary chemotherapy with epirubicin (60 mg/m2 every other week) and vinorelbine (25 mg/m2, weekly) plus granulocyte colony-stimulating factor (G-CSF) for 12 weeks, in patients with locally advanced breast cancer in a multicenter setting.


METHODS
Patients with stage IIIA or IIIB breast cancer, not older than 70, were eligible. A two-stage phase II design was applied. Response was assessed clinically, instrumentally and pathologically.


RESULTS
Out of 48 enrolled patients, 87.5% received all planned cycles, with a median dose-intensity of 30 mg/m2/week for epirubicin and 23.8 mg/m2/week for vinorelbine. A clinical or instrumental objective response was reached in 42 patients (87.5%, exact 95% CI: 74.7-95.3); significant downstaging was reached in all but one patient; 6 cases had a pathological complete response in the breast, and 2 cases in the lymph nodes too (pathological complete response rate 4.2%, exact 95% CI: 0.5-14.2); a further 2 patients had only microscopic cancer foci at pathological examination of the breast. Radiological tests underestimated the treatment effect on the breast. Toxicity was mild, neutropenia being the most frequent (grade 3-4 in 47% of patients), but never complicated with fever or sepsis. Mild constipation (< or =grade 2) occurred in 35% of patients. Moderate to severe asthenia occurred in 12% of 6 patients. No cardiac toxicity was reported. At 3 years, disease-free survival was 68% and overall survival 81%.


CONCLUSIONS
Primary chemotherapy with epirubicin every other week, weekly vinorelbine and G-CSF support is highly active and well tolerated in patients with locally advanced breast cancer.
Nisticò
Cecilia
C
Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy. cnistico@ifo.it
De Matteis
Andrea
A
Rossi
Emanuela
E
Carnino
Flavio
F
Valenza
Roberto
R
Agostara
Biagio
B
Bria
Emilio
E
Farris
Antonio
A
Cremonesi
Marco
M
D'Ottavio
Anna Maria
AM
Vaccaro
Angela
A
Garufi
Carlo
C
Giunta
Salvatore
S
Botti
Claudio
C
Perrone
Francesco
F
Terzoli
Edmondo
E
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008408:Mastectomy; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D014747:Vinblastine; D000077235:Vinorelbine