title: Clinical assessment of patients with advanced non-small-cell lung cancer eligible for second-line chemotherapy: a prognostic score from individual data of nine randomised trials.
abstract: OBJECTIVE
  Knowledge of prognostic factors for advanced non-small-cell lung cancer (NSCLC) patients eligible for second-line treatment is scarce. The aim of this study was to assess the prognostic role of a number of routinely collected clinical variables and to provide a summary index to discriminate patients according to probability of survival.
  
  
  METHODS
  Individual data from nine randomised trials of second-line treatment in advanced NSCLC were analysed. Primary end-point was overall survival (OS). Cox model, stratified by trial, was used for multivariate analyses, and a prognostic index was provided and validated according to an internal/external procedure.
  
  
  RESULTS
  Out of 1239 patients, 1197 patients (97%) had complete information. Median OS was 7.4months. At multivariate analysis, prognosis was significantly influenced by gender (worse in males), performance status (PS), tumour histology (worse in squamous and other histology versus adenocarcinoma), stage (worse in IV versus IIIB), type of previous treatment (worse for patients pretreated with platinum) and response to first-line (worse for patients not obtaining objective response). Prognostic score values range from 0 to 14. When three categories were derived, median overall survival values were equal to 11.6, 7.5 and 3.0months for best (<5), intermediate (5-9) and worst (>9) categories, respectively.
  
  
  CONCLUSIONS
  Prognosis of patients eligible for second-line treatment of advanced NSCLC is significantly conditioned by gender, PS, histology, stage, previous use of platinum and response to first-line. A prognostic score was derived that discriminates well subjects with a relatively more favourable prognosis and those with very short life expectancy.
authors.affiliation: Clinical Trials Unit, National Cancer Institute, Napoli, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Maio
authors.forename: Nicola
authors.initials: N
authors.lastname: Lama
authors.forename: Alessandro
authors.initials: A
authors.lastname: Morabito
authors.forename: Egbert F
authors.initials: EF
authors.lastname: Smit
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
authors.forename: Koji
authors.initials: K
authors.lastname: Takeda
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Quoix
authors.forename: Dora
authors.initials: D
authors.lastname: Hatzidaki
authors.forename: Floris M
authors.initials: FM
authors.lastname: Wachters
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
authors.forename: Chun-Ming
authors.initials: CM
authors.lastname: Tsai
authors.forename: Carlos
authors.initials: C
authors.lastname: Camps
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schuette
authors.forename: Paolo
authors.initials: P
authors.lastname: Chiodini
authors.forename: Maria Carmela
authors.initials: MC
authors.lastname: Piccirillo
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
authors.forename: Cesare
authors.initials: C
authors.lastname: Gridelli
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents