title: Vinorelbine-gemcitabine in advanced non-small-cell lung cancer (NSCLC): an AASLC phase II trial. Austrian Association for the Study of Lung Cancer.
abstract: OBJECTIVE
  The purpose of the present phase 11 trial was to determine the efficacy and toxicity of vinorelbine-gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  From December 1997 to February 1999, 78 chemotherapy-naive patients (median age 60 years, Karnofsky performance status of 100, 90, 80 and 70 present in 5%, 41%, 36% and 18% of the patients, respectively) with stage IIIB (17%) or IV (83%) NSCLC (65% adenocarcinomas, 22% squamous-cell carcinomas, 10% large-cell carcinomas, 3% mixed-cell carcinomas) received 25 mg/m2 vinorelbine and 1200 mg/m2 gemcitabine on days 1, 8 and 15 of a four-week cycle.
  
  
  RESULTS
  In an intent-to-treat analysis, partial responses were seen in 19% of the patients. The median duration of response was 4.4 months. The median survival time was seven months and the one-year survival rate was 32%. Myelosuppression was the main side effect with WHO grade 3/4 neutropenia and thrombocytopenia in 35% and 11% of the patients, respectively. Other side effects were usually mild to moderate.
  
  
  CONCLUSIONS
  Vinorelbine-gemcitabine is active, well tolerated and easy to administer on an outpatient basis in advanced NSCLC. Thus a randomized comparison of this combination with platinum-based protocols is warranted in patients with advanced NSCLC.
authors.affiliation: Department of Internal Medicine, University of Vienna, Austria.
authors.forename: G
authors.initials: G
authors.lastname: Krajnik
authors.forename: A
authors.initials: A
authors.lastname: Mohn-Staudner
authors.forename: J
authors.initials: J
authors.lastname: Thaler
authors.forename: R
authors.initials: R
authors.lastname: Greil
authors.forename: S
authors.initials: S
authors.lastname: Schmeikal
authors.forename: F
authors.initials: F
authors.lastname: Marhold
authors.forename: J
authors.initials: J
authors.lastname: Deutsch
authors.forename: P
authors.initials: P
authors.lastname: Preiss
authors.forename: R
authors.initials: R
authors.lastname: Malayeri
authors.forename: C
authors.initials: C
authors.lastname: Schäfer-Prokop
authors.forename: W
authors.initials: W
authors.lastname: Wein
authors.forename: H
authors.initials: H
authors.lastname: Huber
authors.forename: R
authors.initials: R
authors.lastname: Pirker
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine