title: Outcome and economic implications of proteomic test-guided second- or third-line treatment for advanced non-small cell lung cancer: extended analysis of the PROSE trial.
abstract: OBJECTIVE
  Lung cancer accounts for a significant number of new cancer cases and deaths, with the majority of patients presenting with non-small cell lung cancer (NSCLC). Although epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitors are recommended as an alternative to chemotherapy for certain patients, challenges exist for clinical utilization. The objective of this analysis was to assess the outcome and economic implications of a clinically validated serum-based proteomic test to guide treatment decisions in patients with advanced NSCLC, who are EGFR-negative or status unknown, and have progressed following at least one chemotherapy regimen.
  
  
  METHODS
  This analysis was conducted from a US payer perspective. Clinical outcomes were evaluated over the lifetime of a patient, based on data from randomized trials and clinical studies. The clinical endpoints included treatment utilization, adverse events, survival, and a composite measure of length and quality of life, referred to as the quality-adjusted life year (QALY). Costs for testing, treatment, surveillance, and management of adverse events were analyzed based on publicly available costs of the related procedures. The economic endpoints were cumulative lifetime direct medical costs and cost per QALY gained.
  
  
  RESULTS
  In the base case, treatment recommendation for 27.3% of the patient population changed from erlotinib to chemotherapy after using the proteomic test. Overall survival increased by 0.091 year and QALYs increased by 0.050 year. The total lifetime direct medical cost per patient decreased by $135 with test-guided treatment. The findings were robust over a wide range of variation in the input parameters.
  
  
  CONCLUSIONS
  The serum-based proteomic test informed treatment selection for patients with advanced NSCLC who failed previous chemotherapy regimen(s), improving QALYs and saving costs.
authors: Department of Internal Medicine, Stanford University School of Medicine, 291 Campus Dr., Stanford, CA 94305, USA; Cedar Associates LLC, 3715 Haven Avenue, Suite 100, Menlo Park, CA 94025, USA. Electronic address: ujch@stanford.edu.
authors: John
authors: J
authors: Hornberger
authors: Departments of Medicine and Pathology, Colorado University of Colorado Cancer Center, 1665 Aurora Ct, Aurora, CO 80045, USA. Electronic address: fred.hirsch@ucdenver.edu.
authors: Fred R
authors: FR
authors: Hirsch
authors: Cedar Associates LLC, 3715 Haven Avenue, Suite 100, Menlo Park, CA 94025, USA. Electronic address: qli@cedarecon.com.
authors: Qianyi
authors: Q
authors: Li
authors: The Center for Cancer and Blood Disorders, 800W Magnolia Avenue, Fort Worth, TX 76104, USA. Electronic address: rpage@txcc.com.
authors: Ray D
authors: RD
authors: Page
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000191:economics* / Q000378:metabolism; D000068456:Clinical Studies as Topic; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D066246:ErbB Receptors / Q000235:genetics; D000069347:Erlotinib Hydrochloride / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000191:economics* / Q000378:metabolism; D040901:Proteomics / Q000379:methods; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors
keywords: Chemotherapy; Cost-effectiveness; Economics; Erlotinib; Non-small cell lung cancer; Proteomic test