title: Biweekly docetaxel and vinorelbine with granulocyte colony-stimulating factor support for patients with anthracycline-resistant metastatic breast cancer.
abstract: This phase II trial evaluated the efficacy and toxicity of vinorelbine 25 mg/m2 plus docetaxel 60 mg2/m administered on day 1, every 2 weeks with granulocyte colony-stimulating factor support (G-CSF, 5 microg/kg/day, days 3-7) as primary prophylaxis in patients with histologically confirmed metastatic breast cancer (MBC) and previously treated with anthracyclines in the adjuvant or in the first-line setting. A total of 48 patients received 352 cycles (median 8, range 2-10). All patients were included in the efficacy and safety evaluation on an intent-to-treat analysis. Eight patients (17%) showed a complete response and 14 patients (29%) showed a partial response. Overall response rate was 46% [95% confidence interval (CI) 33-60]. The median duration of response was 10.0 months. With a median follow-up of 18.0 months, the median time to progression was 11.9 months and the median overall survival was 27.1 months. The most frequently reported grade 3/4 hematological toxicity was neutropenia (19% of patients, 4% of cycles). Febrile neutropenia was reported in six patients (13%) and 7 cycles (2%), but no toxic deaths were reported. The most common grade 3/4 non-hematological toxicity was asthenia (17% of patients, 6% of cycles) and nail toxicity (15% of patients, 3% of cycles). In conclusion, biweekly docetaxel plus vinorelbine with G-CSF support is active and well tolerated as chemotherapy for patients with MBC resistant to anthracyclines. G-CSF support is recommended for lowering the incidence and severity of neutropenia and febrile neutropenia.
authors.affiliation: Servicio de Oncología, Hospital Universitario, 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: Amaya
authors.initials: A
authors.lastname: Olaverri
authors.forename: Alberto
authors.initials: A
authors.lastname: Arizcun
authors.forename: Teresa
authors.initials: T
authors.lastname: Martín
authors.forename: Cesar A
authors.initials: CA
authors.lastname: Rodríguez
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
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy* / Q000473:pathology; D018275:Carcinoma, Lobular / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006401:Hematologic Agents / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D018943:Anthracyclines; D006401:Hematologic Agents; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D014747:Vinblastine; D000077235:Vinorelbine