title: Randomized phase III study of gemcitabine and vinorelbine versus gemcitabine, vinorelbine, and cisplatin in the treatment of advanced non-small-cell lung cancer: from the German and Swiss Lung Cancer Study Group.
abstract: OBJECTIVE
  To evaluate whether cisplatin-based chemotherapy (gemcitabine, vinorelbine, and cisplatin [GVP]) prolongs overall survival in comparison to cisplatin-free chemotherapy (gemcitabine and vinorelbine [GV]) as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Between September 1999 and June 2001, 300 patients with NSCLC stage IIIB with malignant pleural effusion or stage IV disease were randomly assigned to receive GV (gemcitabine 1000 mg/m(2) + vinorelbine 25 mg/m(2) on days 1 and 8 every 3 weeks) or GVP (gemcitabine 1000 mg/m(2) + vinorelbine 25 mg/m(2) on days 1 and 8 + cisplatin 75 mg/m(2) on day 2 every 3 weeks). Primary end point of the study was overall survival.
  
  
  RESULTS
  Two hundred eighty-seven patients (GV, 143 patients; GVP, 144 patients) were eligible for analysis. At the time of analysis, April 15, 2002, 209 patients (GV, 103 patients; GVP, 106 patients) of 287 patients had died (73%). No statistically significant difference was observed for overall survival (P =.73; median survival, 35.9 versus 32.4 weeks; 1-year survival rate, 33.6% versus 27.5%) as well as for event-free survival (P =.35; median time-to-event, 19.3 versus 22.3 weeks) between GV and GVP. Two hundred fourteen patients were assessable for best response. The overall response rates were 13.0% for GV versus 28.3% for GVP (P =.004; complete responders, 0% versus 3.8%; partial responders, 13.0% versus 24.5%). Hematologic and nonhematologic toxicity was significantly lower in the GV treatment arm compared with GVP. No statistically significant difference in quality of life was observed.
  
  
  CONCLUSIONS
  In this phase III study, the cisplatin-based GVP regimen showed no survival benefit as first-line chemotherapy in advanced NSCLC when compared with the cisplatin-free GV regimen, which was substantially better tolerated.
authors.affiliation: University Hospital Hamburg-Eppendorf, Department of Oncology and Hematology, Hamburg, Germany. laack@uke.uni-hamburg.de
authors.forename: E
authors.initials: E
authors.lastname: Laack
authors.forename: N
authors.initials: N
authors.lastname: Dickgreber
authors.forename: T
authors.initials: T
authors.lastname: Müller
authors.forename: A
authors.initials: A
authors.lastname: Knuth
authors.forename: J
authors.initials: J
authors.lastname: Benk
authors.forename: C
authors.initials: C
authors.lastname: Lorenz
authors.forename: F
authors.initials: F
authors.lastname: Gieseler
authors.forename: H
authors.initials: H
authors.lastname: Dürk
authors.forename: W
authors.initials: W
authors.lastname: Engel-Riedel
authors.forename: K
authors.initials: K
authors.lastname: Dalhoff
authors.forename: C
authors.initials: C
authors.lastname: Kortsik
authors.forename: U
authors.initials: U
authors.lastname: Graeven
authors.forename: M
authors.initials: M
authors.lastname: Burk
authors.forename: T
authors.initials: T
authors.lastname: Dierlamm
authors.forename: T
authors.initials: T
authors.lastname: Welte
authors.forename: I
authors.initials: I
authors.lastname: Burkholder
authors.forename: L
authors.initials: L
authors.lastname: Edler
authors.forename: D K
authors.initials: DK
authors.lastname: Hossfeld
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008875:Middle Aged; D011788:Quality of Life; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D000093542:Gemcitabine