title: Cost-effectiveness of first-line erlotinib in patients with advanced non-small-cell lung cancer unsuitable for chemotherapy.
abstract: OBJECTIVE
  To assess the cost-effectiveness of erlotinib versus supportive care (placebo) overall and within a predefined rash subgroup in elderly patients with advanced non-small-cell lung cancer who are unfit for chemotherapy and receive only active supportive care due to their poor performance status or presence of comorbidities.
  
  
  METHODS
  Between 2005 and 2009, a total of 670 patients with non-small cell lung cancer (NSCLC) were randomised across 78 hospital sites (centres) in the UK.
  
  
  METHODS
  670 patients with pathologically confirmed stage IIIb-IV NSCLC, unfit for chemotherapy, predominantly poor performance status (>2 on Eastern Cooperative Oncology Group, ECOG) and estimated life expectancy of at least 8 weeks. Patients were followed until disease progression or death, including a subgroup of patients who developed first cycle rash.
  
  
  METHODS
  Patients were randomised (1:1) to receive best supportive care plus oral placebo or erlotinib (150 mg/day) until disease progression, toxicity or death.
  
  
  METHODS
  Overall survival (OS).
  
  
  RESULTS
  Progression-free survival (PFS), tumour response and quality adjusted life years (QALY), including within prespecified subgroups.
  
  
  RESULTS
  The mean incremental cost per QALY in all patients was £202,571/QALY. The probability of cost-effectiveness of erlotinib in all patients was <10% at thresholds up to £100,000. However, within the rash subgroup, the incremental cost/QALY was £56,770/QALY with a probability of cost-effectiveness of about 80% for cost-effectiveness thresholds between £50,000 to £60,000.
  
  
  CONCLUSIONS
  Erlotinib has about 80% chance of being cost-effective at thresholds between £50,000-£60,000 in a subset of elderly poor performance patients with NSCLC unfit for chemotherapy who develop first cycle (28 days) rash. Erlotinib is potentially cost-effective for this population, for which few treatment options apart from best supportive care are available.
  
  
  BACKGROUND
  (ISCRTN): 77383050.
authors.affiliation: CRUK & UCL Cancer Trial Centre, University College London, London, UK Department of Applied Health Research, University College London, London, UK.
authors.forename: Iftekhar
authors.initials: I
authors.lastname: Khan
authors.affiliation: Department of Applied Health Research, University College London, London, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Morris
authors.affiliation: CRUK & UCL Cancer Trial Centre, University College London, London, UK.
authors.forename: Allan
authors.initials: A
authors.lastname: Hackshaw
authors.affiliation: University College London Hospital/UCL Cancer Institute, London, UK.
authors.forename: Siow-Ming
authors.initials: SM
authors.lastname: Lee
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000191:economics*; D003362:Cost-Benefit Analysis / Q000379:methods*; D018572:Disease-Free Survival; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage* / Q000009:adverse effects; D005076:Exanthema; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000191:economics*; D008297:Male; D008875:Middle Aged; D019057:Quality-Adjusted Life Years
chemical_list: D000970:Antineoplastic Agents; D000069347:Erlotinib Hydrochloride
keywords: EPIDEMIOLOGY; HEALTH ECONOMICS; STATISTICS & RESEARCH METHODS