Docetaxel plus epirubicin is a highly active, well-tolerated, first-line chemotherapy for metastatic breast cancer: results of a large, multicentre phase II study

• Published in: Cancer chemotherapy and pharmacology Vol. 53; no. 1; pp. 75 - 81
• Main Authors: MORALES, Serafin, LORENZO, Antonio, OLTRA, Amparo, FRAU, Adolfo, MACHENGS, Ignacio, GALAN, Antonio, BELON, Joaquin, LLORCA, Cristina, RAMOS, Manuel, BALLESTEROS, Pedro, MENDEZ, Miguel, ALMANZA, Concepcion, CASTELLANOS, Javier, MORENO-NOGUEIRA, José Andrés, CASAL, Joaquin, LIZON, José
• Format: Journal Article
• Language: English
• Published: Berlin Springer 2004
• Subjects: Adolescent; Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Chemotherapy; Disease-Free Survival; Drug Administration Schedule; Epirubicin - administration & dosage; Epirubicin - adverse effects; Female; France; Humans; Infusions, Intravenous; Italy; Medical sciences; Middle Aged; Neoplasm Metastasis; Pharmacology. Drug treatments; Taxoids - administration & dosage; Taxoids - adverse effects; France; Italy; Antineoplastic agent; Multicenter study; Docetaxel; Breast cancer; Metastasis; Malignant tumor; Induction treatment; Mammary gland diseases; First-line chemotherapy; Taxane derivatives; Phase II trial; Advanced stage; Metastatic breast cancer; Anthracyclins; Epirubicin; Antimitotic
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-003-0690-0

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. 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. 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. The combination of docetaxel and epirubicin was highly active as first-line treatment for MBC and showed a manageable toxicity profile.