title: Gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell lung cancer: a phase III trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group.
abstract: OBJECTIVE
  Platinum-containing chemotherapy regimens are the standard treatment for patients with advanced non-small-cell lung cancer (NSCLC), although toxicity is common and may significantly affect the patient's quality of life (QoL). This trial aimed to assess whether a combination of gemcitabine and vinorelbine had benefits in terms of QoL, without influencing negatively on survival, compared with cisplatin-containing regimens.
  
  
  METHODS
  Patients with stage IIIB (effusion and supraclavicular nodes) or IV documented NSCLC who were younger than 70 years of age were randomly assigned gemcitabine plus vinorelbine (GemVin) or either gemcitabine plus cisplatin or vinorelbine plus cisplatin (cisplatin-based). European Organization for Research and Treatment of Cancer scales were used for QoL analysis.
  
  
  RESULTS
  Five hundred one patients were randomly assigned to treatment. The median age was 62 years. There were no significant differences in global QoL scores between the two arms after 2 months of treatment. However, worsening scores for appetite, vomiting, and alopecia were significantly more common in the cisplatin-based arm. Median survival was 38 v 32 weeks and median progression-free survival was 23 v 17 weeks in the cisplatin-based versus GemVin arms, respectively. For the GemVin arm the hazard ratio for death was 1.15 (90% confidence interval [CI], 0.96 to 1.37) and the hazard ratio for progression was 1.29 (90% CI, 1.10 to 1.52). Grade 3 or 4 myelosuppression, vomiting, alopecia, and ototoxicity were significantly more frequent with cisplatin-based treatment.
  
  
  CONCLUSIONS
  Global QoL is not improved with GemVin, although advantages in some components of QoL were apparent. GemVin is less toxic than standard cisplatin-based chemotherapy. There is a nonsignificant slight survival advantage with cisplatin-based chemotherapy. GemVin could be offered to advanced NSCLC patients who express concern about toxicity.
authors.affiliation: Clinical Trials Unit, National Cancer Institute, Via M Semmola, 80131 Naples, Italy. cgridelli@libero.it
authors.forename: Cesare
authors.initials: C
authors.lastname: Gridelli
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
authors.forename: Frances A
authors.initials: FA
authors.lastname: Shepherd
authors.forename: Alfonso
authors.initials: A
authors.lastname: Illiano
authors.forename: Francovito
authors.initials: F
authors.lastname: Piantedosi
authors.forename: Sergio Federico
authors.initials: SF
authors.lastname: Robbiati
authors.forename: Luigi
authors.initials: L
authors.lastname: Manzione
authors.forename: Santi
authors.initials: S
authors.lastname: Barbera
authors.forename: Luciano
authors.initials: L
authors.lastname: Frontini
authors.forename: Enzo
authors.initials: E
authors.lastname: Veltri
authors.forename: Brian
authors.initials: B
authors.lastname: Findlay
authors.forename: Silvio
authors.initials: S
authors.lastname: Cigolari
authors.forename: Robert
authors.initials: R
authors.lastname: Myers
authors.forename: Giovanni P
authors.initials: GP
authors.lastname: Ianniello
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Giampietro
authors.initials: G
authors.lastname: Gasparini
authors.forename: Sergio
authors.initials: S
authors.lastname: Fava
authors.forename: Vera
authors.initials: V
authors.lastname: Hirsh
authors.forename: Andrea
authors.initials: A
authors.lastname: Bezjak
authors.forename: Lesley
authors.initials: L
authors.lastname: Seymour
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002170:Canada; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007558:Italy; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D000093542:Gemcitabine