title: A phase II study of intravenous navelbine and doxorubicin combination in previously untreated advanced breast carcinoma.
abstract: OBJECTIVE
  The combination of vinorelbine and doxorubicin, two very active drugs in metastatic breast cancer, has demonstrated impressive results in terms of efficacy, at the price of cardiac toxicity (10% grades 2-4) due to the cumulative dose of doxorubicin delivered. This study was designed to divide the dose of doxorubicin into two administrations (day 1 and 8) in order to reduce the toxicity profile, while keeping the same level of efficacy.
  
  
  METHODS
  Thirty-eight chemotherapy-naïve metastatic breast cancer patients entered into the study and were treated with vinorelbine, 25 mg/m(2), and doxorubicin, 25 mg/m(2), both on days 1 and 8, every 3 weeks. Thirty-seven patients were evaluable for efficacy and 38 for tolerance; 71% of the patients presented with visceral metastases.
  
  
  RESULTS
  Patients received a median of seven cycles and 94.9% of the intended dose intensity of both drugs. Grade 3-4 neutropenia was reported in 10% of cycles. Alopecia was reported in 89.5% of the patients, and grade 2 nausea/vomiting in 9.3% of the cycles. Grade 1-2 cardiac toxicity was noted in 23.7% of the patients. The objective response rate of the patients was 78.4% (nearly 81% for patients with visceral metastases); the median duration of response was 11.6 months, the median survival 21.6 months, and the 1-year survival 75.2%.
  
  
  CONCLUSIONS
  This schedule of vinorelbine/doxorubicin represents an active and well-tolerated combination.
authors.affiliation: Medical Oncology Department, Cancer Institute, Krakow, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Pawlicki
authors.forename: J
authors.initials: J
authors.lastname: Rolski
authors.forename: J
authors.initials: J
authors.lastname: Zaluski
authors.forename: P
authors.initials: P
authors.lastname: Siedlecki
authors.forename: C
authors.initials: C
authors.lastname: Ramlau
authors.forename: P
authors.initials: P
authors.lastname: Tomzak
mesh_terms: D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018567:Breast Neoplasms, Male / Q000188:drug therapy* / Q000473:pathology; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D014839:Vomiting / Q000139:chemically induced
chemical_list: D014747:Vinblastine; D004317:Doxorubicin; D000077235:Vinorelbine