title: Eligibility of patients with advanced non-small cell lung cancer for phase III chemotherapy trials.
abstract: BACKGROUND
  Evidence that chemotherapy improves survival and quality of life in patients with stage IIIB & IV non small cell lung cancer (NSCLC) is based on large randomized controlled trials. The purpose of this study was to determine eligibility of patients with advanced NSCLC for major chemotherapy trials.
  
  
  METHODS
  Physicians treating stage IIIB/IV NSCLC at Sydney Cancer Centre assessed patient eligibility for the E1594, SWOG9509 and TAX326 trials for patients presenting from October 2001 to December 2002. A review of the centre's registry was used to obtain missing data.
  
  
  RESULTS
  199 patients with advanced NSCLC were registered during the 14-month period. Characteristics of 100 patients were defined prospectively, 85 retrospectively: 77% males, median age 68 (range 32-88), 64% stage IV disease. Only 35% met trial eligibility for E1594 and 28% for SWOG9509 and TAX326. Common reasons for ineligibility were: co-morbidities 75(40%); ECOG Performance Status >or=2 72(39%); symptomatic brain metastasis 15(8%); and previous cancers 21(11%). Many patients were ineligible by more than one criterion.
  
  
  CONCLUSIONS
  The majority of patients with advanced NSCLC were ineligible for the large chemotherapy trials. The applicability of trial results to advanced lung cancer populations may be limited. Future trials should be conducted in a more representative population.
authors.affiliation: Sydney Cancer Centre, Concord Repatriation General Hospital and Royal Prince Alfred Hospital, Sydney, NSW, Australia. jvardy@med.usyd.edu.au
authors.forename: Janette
authors.initials: J
authors.lastname: Vardy
authors.forename: Ryan
authors.initials: R
authors.lastname: Dadasovich
authors.forename: Philip
authors.initials: P
authors.lastname: Beale
authors.forename: Michael
authors.initials: M
authors.lastname: Boyer
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Clarke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic; D004608:Eligibility Determination / Q000592:standards* / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D018579:Patient Selection; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012042:Registries / Q000706:statistics & numerical data; D012189:Retrospective Studies; D011795:Surveys and Questionnaires