title: Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to three additional courses of the same combination or gemcitabine alone.
abstract: BACKGROUND
  This randomised phase III study investigated if in responsive and stable disease (SD) stage IV patients after two courses of cisplatin and gemcitabine, single-agent gemcitabine (experimental arm) was not inferior in terms of overall survival (OS) to cisplatin-gemcitabine (standard arm).
  
  
  METHODS
  Noninferiority was defined as an increase in the hazard of death (HR) < or = 1.33 in the experimental arm. From January 2001 to February 2004, 340 patients were registered and 250 were randomised. Cisplatin was administered on day 1 at 75 mg/m2 and Gemcitabine on days 1 and 8 at 1250 mg/m2 every 3 weeks.
  
  
  RESULTS
  Response rate after two courses was 29%. The 1-year progression-free survival was 13% in both arms. One-year survival was 52% in the standard and 42% in the experimental arm for an HR of 1.21 [90% confidence interval (CI) 0.97-1.51]. Postprogression survival was in favour of the standard arm (HR 1.30, 95% CI 0.99-1.70, P = 0.051). Grades 3-4 toxicity favoured in the experimental arm.
  
  
  CONCLUSIONS
  In responsive and SD patients with stage IV non-small-cell lung cancer it was not possible to demonstrate that three courses of gemcitabine alone are not inferior, in terms of OS, to the standard approach of three courses of cisplatin-gemcitabine.
authors.affiliation: Department of Clinical and Biological Sciences, Thoracic Oncology Unit, San Luigi Hospital, University of Turin, Orbassano, Turin, Italy. silvia.novello@unito.it
authors.forename: S
authors.initials: S
authors.lastname: Novello
authors.forename: P
authors.initials: P
authors.lastname: Bruzzi
authors.forename: C
authors.initials: C
authors.lastname: Barone
authors.forename: R
authors.initials: R
authors.lastname: Buosi
authors.forename: A
authors.initials: A
authors.lastname: Masotti
authors.forename: G
authors.initials: G
authors.lastname: Michetti
authors.forename: M
authors.initials: M
authors.lastname: Fioretti
authors.forename: S
authors.initials: S
authors.lastname: Barbera
authors.forename: M
authors.initials: M
authors.lastname: Spatafora
authors.forename: L
authors.initials: L
authors.lastname: Garetto
authors.forename: P
authors.initials: P
authors.lastname: Mazzanti
authors.forename: V
authors.initials: V
authors.lastname: Dongiovanni
authors.forename: G
authors.initials: G
authors.lastname: Selvaggi
authors.forename: L
authors.initials: L
authors.lastname: Crinò
authors.forename: G V
authors.initials: GV
authors.lastname: Scagliotti
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology*; D002945:Cisplatin / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine