title: Challenges to implementation of an epidermal growth factor receptor testing strategy for non-small-cell lung cancer in a publicly funded health care system.
abstract: BACKGROUND
  Data from seven recent randomized clinical trials have demonstrated that epidermal growth factor (EGFR) mutation status is predictive of improved progression-free survival and quality of life from first-line EGFR tyrosine kinase inhibitor therapy compared with platinum-based chemotherapy. We examined barriers to the initial implementation of a national EGFR testing policy in Canada.
  
  
  METHODS
  Five laboratories across Canada underwent a validation and quality-control exercise for EGFR mutation testing using reverse transcriptase-polymerase chain reaction with financial support from the pharmaceutical industry for the initial 12 months. Oncologists registered patients with nonquamous histology for EGFR mutation testing using a Web-based platform. Basic demographics were collected including age, histology, sex, smoking status, and ethnicity. The decision to prescribe gefitinib was subsequently registered on the system.
  
  
  RESULTS
  Between March and December 2010, 2104 requests were received for EGFR mutation testing. Demographic details are as follows: adenocarcinoma (91.6%); Asian ethnicity (13.9%); female (58%); light/never smoker (41.3%); stage IV disease (87.1%). The number of tests requested each month ranged from 200 to 250. Mutation testing was conducted in 1771 of 2104 requests (84%). The median turnaround time for EGFR testing was 18 days (standard deviation 9.7). Gefitinib was prescribed in 302 patients (17.1%). The number of test requests dropped to 50 to 100 per month at the end of the initial 12 months.
  
  
  CONCLUSIONS
  There was rapid uptake of EGFR mutation testing into routine clinical practice in Canada. Uptake of EGFR mutation testing dropped substantially once funding from pharmaceutical industry was discontinued. There is a need for a national strategy to ensure resources are in place to implement molecular testing for new molecularly targeted agents.
authors.affiliation: Department of Oncology, McMaster University, Juravinski Cancer Centre, Hamilton, Ontario, Canada. peter.ellis@jcc.hhsc.ca
authors.forename: Peter M
authors.initials: PM
authors.lastname: Ellis
authors.forename: Sunil
authors.initials: S
authors.lastname: Verma
authors.forename: Sandeep
authors.initials: S
authors.lastname: Sehdev
authors.forename: Jawaid
authors.initials: J
authors.lastname: Younus
authors.forename: Natasha B
authors.initials: NB
authors.lastname: Leighl
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000235:genetics / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D002170:Canada; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000235:genetics* / Q000473:pathology; D066246:ErbB Receptors / Q000235:genetics*; D005260:Female; D005380:Financing, Government; D005500:Follow-Up Studies; D000077156:Gefitinib; D006284:Health Plan Implementation; D006296:Health Services / Q000639:trends*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000235:genetics / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009154:Mutation / Q000235:genetics*; D009367:Neoplasm Staging; D017410:Practice Guidelines as Topic / Q000592:standards*; D011379:Prognosis; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011799:Quinazolines / Q000627:therapeutic use; D015996:Survival Rate
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; C512478:EGFR protein, human; D066246:ErbB Receptors; D000077156:Gefitinib