Docetaxel plus epirubicin is a highly active, well-tolerated, first-line chemotherapy for metastatic breast cancer: results of a large, multicentre phase II study.
OBJECTIVE
In this multicentre phase II study, the efficacy and safety profile of the combination of docetaxel and epirubicin as first-line chemotherapy for metastatic breast cancer (MBC) were evaluated.


METHODS
Epirubicin (75 mg/m(2)) and docetaxel (75 mg/m(2)) were given intravenously once every 3 weeks for six cycles to 133 patients with MBC.


RESULTS
The overall clinical response rate was 67% (complete and partial responses were 23% and 44%, respectively). The median time to progression was 10.8 months (95% CI 9.7-12.6) and the median overall survival was 19.5 months. Granulocyte colony-stimulating factor support was administered to 32% of patients and in 22% of cycles. Grade 3/4 neutropenia occurred in 35% of patients and febrile neutropenia in 19%. The most frequent grade 3/4 non-haematological toxicities (as percent of patients) were asthenia (6%), vomiting (5%) and nausea (5%). No patients developed congestive heart failure.


CONCLUSIONS
The combination of docetaxel and epirubicin was highly active as first-line treatment for MBC and showed a manageable toxicity profile.
Morales
Serafín
S
Medical Oncology Service, Hospital Arnau de Vilanova, Avda Alcalde Rovira Roure, 80, 25198, Lleida, Spain. smorales@arnau.scs.es
Lorenzo
Antonio
A
Ramos
Manuel
M
Ballesteros
Pedro
P
Méndez
Miguel
M
Almanza
Concepción
C
Castellanos
Javier
J
Moreno-Nogueira
José Andrés
JA
Casal
Joaquín
J
Lizón
José
J
Oltra
Amparo
A
Frau
Adolfo
A
Machengs
Ignacio
I
Galán
Antonio
A
Belón
Joaquín
J
Llorca
Cristina
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005602:France; D006801:Humans; D007262:Infusions, Intravenous; D007558:Italy; D008875:Middle Aged; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin