title: The eligibility of advanced non-small-cell lung cancer patients for targeted therapy clinical trials.
abstract: BACKGROUND
  The selection criteria for phase III trials are often stringent. We aimed to determine how many advanced non-small-cell lung cancer (NSCLC) patients would have been eligible for phase III targeted therapy trials and the proportion receiving anticancer treatment.
  
  
  METHODS
  From March 2007 to May 2008, all advanced NSCLC patients presented at our lung cancer multidisciplinary team meeting were included to assess eligibility for the targeted therapy trials: ECOG-4599, AVAiL, FLEX, TALENT, INTACT-1, INTACT-2, ESCAPE, NEXUS and MONET1. Medical records were examined to determine treatment utilisation and overall survival.
  
  
  RESULTS
  A total of 62 patients were registered: 63% male; median age 71 years; 61% stage IIIB disease. Percentages that met criteria were: ECOG-4599 31%, AVAiL 24%, FLEX 69%, TALENT 27%, INTACT-1 50%, INTACT-2 42%, ESCAPE 39%, NEXUS 63% and MONET1 34%. Common reasons for ineligibility were insufficient life expectancy, poor performance status, abnormal bloods, proteinuria and associated cancer problems. Systemic therapies were received by 66% of patients and median survival was 10.3 months.
  
  
  CONCLUSIONS
  Only 24%-69% were eligible for targeted therapy trials but 66% received anticancer treatment. Clinical trials in patients with advanced NSCLC need to be more representative of the majority of patients.
authors: Faculty of Medicine, University of Sydney, Sydney.
authors: J
authors: J
authors: Clarey
authors: Faculty of Medicine, University of Sydney, Sydney; Department of Medical Oncology, Concord Repatriation General Hospital, Sydney.
authors: S C
authors: SC
authors: Kao
authors: Faculty of Medicine, University of Sydney, Sydney; Department of Medical Oncology, Royal North Shore Hospital, Sydney, Australia.
authors: S J
authors: SJ
authors: Clarke
authors: Faculty of Medicine, University of Sydney, Sydney; Department of Medical Oncology, Concord Repatriation General Hospital, Sydney. Electronic address: janette.vardy@sydney.edu.au.
authors: J
authors: J
authors: Vardy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000453:epidemiology / Q000473:pathology / Q000628:therapy*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods* / Q000706:statistics & numerical data; D018450:Disease Progression; D004608:Eligibility Determination; D005260:Female; D006801:Humans; D033183:Interdisciplinary Communication; D008017:Life Expectancy; D008175:Lung Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008495:Medical Oncology / Q000379:methods / Q000458:organization & administration / Q000706:statistics & numerical data; D008875:Middle Aged; D058990:Molecular Targeted Therapy / Q000706:statistics & numerical data*; D010348:Patient Care Team / Q000458:organization & administration / Q000706:statistics & numerical data; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data