title: Vinorelbine and paclitaxel as first-line chemotherapy in metastatic breast cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of a combination of vinorelbine (VNB) and paclitaxel (PTX) as first-line chemotherapy in metastatic breast carcinoma (MBC).
  
  
  METHODS
  Between August 1995 and August 1997, 49 patients with untreated MBC received a regimen that consisted of VNB 30 mg/m2 in a 20-minute intravenous (IV) infusion on days 1 and 8 and PTX 135 mg/m2 in a 3-hour IV infusion (starting 1 hour after VNB) on day 1. Cycles were repeated every 28 days. The median age of the patients was 52 years, and 59% of patients were postmenopausal. Median performance status was 1. Dominant sites of disease were soft tissue in 6%, bone in 29%, and viscera in 65%.
  
  
  RESULTS
  Objective responses were recorded in 27 of 45 assessable patients (60%; 95% confidence interval, 46% to 74%). Complete remissions occurred in three patients (7%), and partial remissions occurred in 24 patients (53%). No change was recorded in 12 patients (27%), and progressive disease occurred in six patients (13%). The median time to treatment failure was 7 months, and median survival duration was 17 months. The limiting toxicity was myelosuppression, mainly leukopenia in 49 patients (100%) (grade 1 to grade 2, four patients; grade 3, 30 patients; and grade 4, 15 patients). Neutropenia was observed in 100% of patients (grade 1 to grade 2, three patients; grade 3, 11 patients; grade 4, 35 patients). Two treatment-related deaths due to febrile neutropenia were observed in patients with massive liver involvement. Peripheral neurotoxicity developed in 33 patients (67%) (grade 1, 25 patients; grade 2, eight patients); there were no grade 3 or grade 4 episodes.
  
  
  CONCLUSIONS
  The combination of VNB-PTX showed significant activity as first-line chemotherapy for patients with MBC. Myelosuppression was the dose-limiting side effect, whereas neurotoxicity was mild to moderate.
authors.affiliation: Grupo Oncológico Cooperativo del Sur, Argentina.
authors.forename: L
authors.initials: L
authors.lastname: Romero Acuña
authors.forename: M
authors.initials: M
authors.lastname: Langhi
authors.forename: J
authors.initials: J
authors.lastname: Pérez
authors.forename: J
authors.initials: J
authors.lastname: Romero Acuña
authors.forename: M
authors.initials: M
authors.lastname: Machiavelli
authors.forename: J
authors.initials: J
authors.lastname: Lacava
authors.forename: C
authors.initials: C
authors.lastname: Vallejo
authors.forename: A
authors.initials: A
authors.lastname: Romero
authors.forename: H
authors.initials: H
authors.lastname: Fasce
authors.forename: E
authors.initials: E
authors.lastname: Ortiz
authors.forename: S
authors.initials: S
authors.lastname: Grasso
authors.forename: S
authors.initials: S
authors.lastname: Amato
authors.forename: R
authors.initials: R
authors.lastname: Rodríguez
authors.forename: M
authors.initials: M
authors.lastname: Barbieri
authors.forename: B
authors.initials: B
authors.lastname: Leone
mesh_terms: 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; D018450:Disease Progression; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine