title: Biweekly docetaxel and vinorelbine in anthracycline-resistant metastatic breast cancer: a multicenter phase II study.
abstract: The aim of this study was to determine the efficacy and toxicity of a biweekly combination of docetaxel and vinorelbine in patients with metastatic breast cancer (MBC) previously treated with anthracyclines. Eligible patients (n = 49) with MBC received vinorelbine, 25 mg/m2, followed by docetaxel, 60 mg/m2. Cycles were repeated every 14 days for a total of 8 planned cycles. Response rate was evaluated every 4 cycles. All 49 patients were evaluable for safety and 44 for efficacy. Vinorelbine plus docetaxel resulted in an overall response rate of 45% (CI 95%: 31-60) with 2 (4%) complete responses and 18 (41%) partial responses. Patients with visceral metastasis achieved a lower response rate than those without (33% versus 60%, p = 0.044). Time to progression was 11.0 months (CI 95%: 8.6-13.5), and median overall survival was 12.7 months (CI 95%: 9.0-16.4). The most common grade III to IV hematologic adverse events was neutropenia (65% of patients). Febrile neutropenia was observed in 9 cycles (3%) and in 7 patients (14%). Grade III to IV nonhematologic toxicity was rare. Biweekly combination of docetaxel and vinorelbine is an effective and well-tolerated regimen in anthracycline-resistant MBC.
authors.affiliation: Hospital Universitario de Salamanca, Salamanca, Spain. amaliagomez@terra.es
authors.forename: Amalia
authors.initials: A
authors.lastname: Gómez-Bernal
authors.forename: Juan Jesús
authors.initials: JJ
authors.lastname: Cruz
authors.forename: Andrés
authors.initials: A
authors.lastname: García-Palomo
authors.forename: Alberto
authors.initials: A
authors.lastname: Arizcun
authors.forename: Eduardo
authors.initials: E
authors.lastname: Pujol
authors.forename: Pilar
authors.initials: P
authors.lastname: Diz
authors.forename: Germán
authors.initials: G
authors.lastname: Martín
authors.forename: Emilio
authors.initials: E
authors.lastname: Fonseca
authors.forename: Pedro
authors.initials: P
authors.lastname: Sánchez
authors.forename: César
authors.initials: C
authors.lastname: Rodríguez
authors.forename: Elvira
authors.initials: E
authors.lastname: del Barco
authors.forename: Yolanda
authors.initials: Y
authors.lastname: López
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy / Q000556:secondary; D018275:Carcinoma, Lobular / Q000188:drug therapy / Q000556:secondary; D000077143:Docetaxel; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D016019:Survival Analysis; D043823:Taxoids; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D000903:Antibiotics, Antineoplastic; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine