title: A phase II study of cisplatin and vinorelbine in patients with metastatic breast cancer.
abstract: BACKGROUND
  To evaluate the efficacy and safety of the combination of cisplatin and vinorelbine in metastatic breast cancer.
  
  
  METHODS
  Cisplatin (80 mg/m(2) day 1) and vinorelbine (25 mg/m(2) days 1 and 8) were administrated every 3 weeks to 52 patients (mean age 57 years; range 35-75 years) with metastatic breast cancer. Thirty-two patients were previously untreated for metastatic disease. Treatment was repeated for a maximum of six cycles.
  
  
  RESULTS
  Objective responses were obtained in 27 patients (52.9%; complete response 9.8%). The response rate was similar in pretreated and untreated patients (50% and 54.7%, respectively; P = 0.7). ECOG performance status was good (grade 0 or 1) in 55.7% of patients at baseline assessment and in 90.3% at the end of treatment (P = 0.0001). Median time to progression was 8.5 months (8.5 months in first-line and 8.7 months in second-line patients). Median survival was 16.6 months (21.2 months in first-line and 16.1 months in second-line patients). Grade 3/4 toxicity included neutropenia (44% in first-line, 60% in second-line patients), nausea (17.3%), anemia (17%), asthenia (3.8%) and thrombocytopenia (1.9%). There were no cases of febrile neutropenia or treatment-related deaths. Alopecia did not develop in any of the patients.
  
  
  CONCLUSIONS
  Cisplatin plus vinorelbine is active and tolerable in metastatic breast cancer, in untreated and pretreated patients.
authors.affiliation: Centro Oncologico, Azienda per i Servizi Sanitari 1, Università di Trieste, Trieste, Italy. co@ass.1sanita.fvg.it
authors.forename: G
authors.initials: G
authors.lastname: Mustacchi
authors.forename: M
authors.initials: M
authors.lastname: Muggia
authors.forename: S
authors.initials: S
authors.lastname: Milani
authors.forename: R
authors.initials: R
authors.lastname: Ceccherini
authors.forename: M L
authors.initials: ML
authors.lastname: Leita
authors.forename: C
authors.initials: C
authors.lastname: Dellach
mesh_terms: D000328:Adult; D000368:Aged; D000616:Aminoglutethimide / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001707:Biopsy, Needle; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary*; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary*; D019290:Megestrol Acetate / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D011336:Probability; D018570:Risk Assessment; D012983:Soft Tissue Neoplasms / Q000188:drug therapy / Q000556:secondary; D016019:Survival Analysis; D013629:Tamoxifen / Q000008:administration & dosage; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D013629:Tamoxifen; D000616:Aminoglutethimide; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D019290:Megestrol Acetate