Population-based pan-Canadian EGFR-mutation testing program.

Abstract

e18017 Background: Gefitinib was licensed in Canada for the first line treatment of advanced non-small cell lung carcinoma (NSCLC) patients with EGFR tyrosine kinase mutation. Methods: A Pan-Canadian EGFR mutation testing program was established to enable the routine testing of patients who might be eligible for first line gefitinib therapy. Five regional clinical diagnostic centres across Canada were selected for this pilot testing network. Initial efforts included the standardization of testing protocols, selection of assay platforms and evaluation/confirmation of individual laboratory’s assay performance. Testing requests were initiated by the treating oncologists for patients with non-squamous NSCLC histology. In a majority of cases, archival samples resided in the primary care hospitals and required submission to their designated regional test centres. Only Exon-19 deletions and the exon-21 L858R mutation were evaluated, and tests were conducted on archival paraffin embedded tumor samples, which could include cytology cell blocks. Results: From March 18 to November 30, 2010, a total of 1869 requests for mutation testing were made. A total of 1716 samples were received by the test centres. Following pre-test histological evaluation of the submitted samples, mutation testing was conducted on 1588 (92.5%) samples. Altogether 279 (17.6%) were found positive for EGFR exon-19 deletion or exon 21 L858R mutation. The median time for the receipt of samples by the test centres was 7 days, and for test centres to complete and report the result was 11 days. Information on the characteristics of test samples in relation to test outcomes will be presented. Conclusions: Canadian population wide EGFR mutation testing in advanced NSCLC patients is feasible and identified 17.6% patients with EGFR sensitizing mutation-positive tumors. The EGFR mutation testing program is supported by AstraZeneca Canada.