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.
Conclusion: 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.