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Gefitinib Has Efficacy Only in Patients With NSCLC With EGFR Mutation: Presented at ECCO-ESMO By Chris Berrie BERLIN -- September 23, 2009 -- Gefitinib produces a significantly higher objective response rate (ORR) in patients with advanced non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) gene mutations (M+), compared with patients with no gene mutations (M-). Jean-Yves Douillard, MD, Clinical and Translational Research, Rene Gauducheau Cancer Centre, Nantes, France, presented a retrospective analysis of 4 randomised, double-blind, placebo-controlled, phase 3 trials, and a literature review here on September 21 at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO). “Among previous studies, the data have identified a few clinical factors that could predict response to gefitinib, including Asian ethnicity, never-smokers, adenocarcinoma histology, and female predominantly,” said Dr. Douillard. Similarly, mutations in the EGFR gene (exon 19 deletion, exon 21 point mutation) can constitutively activate the EGFR kinase, with higher prevalence of these mutations coinciding with patient subgroups that show higher responses to gefitinib. This analysis included data from 4 trials comparing oral gefitinib 250 mg daily versus placebo or another agent in patients with advanced NSCLC (n = 4,864). Of these, the EGFR gene mutation status was known for 1,006 patients (21%), who were included in the present analysis. The trials analysed were the Iressa Survival Evaluation in Lung Cancer (ISEL) study, the Iressa Non-Small-Cell Lung Cancer Trial Evaluating Response and Survival Against Taxotere (INTEREST), a phase 3 study of Gefitinib Versus Docetaxel in Previously Treated Japanese Patients With Non-Small-Cell Lung Cancer (V-15-32), and the Iressa Pan-Asia Study (IPASS). Across the 4 trials (respectively), for EGFR M+ patients the ORRs for gefitinib treatment were 37.5%, 42.1%, 66.7%, and 71.2%, with the EGFR M- patients showing 2.6%, 6.6%, 0.0%, and 1.1%. Data for progression-free survival were 10.8, 7.0, 7.5, and 9.5 months versus 2.0, 1.7, 2.3, and 1.5 months. The pooled data for ORR rate with gefitinib in EGFR M+ patients was 65%. In EGFR M- patients it was 3%. For active comparators, ORRs in EGFR M+ patients were 30% for docetaxel alone and 47% for carboplatin/paclitaxel. For M- patients, ORRs were 9% with docetaxel alone and 24% with carboplatin/paclitaxel. “This reflects the point that the EGFR mutation is a predictive factor for gefitinib, and also a prognostic factor overall,” said Dr. Douillard. Across the ethnicity data, with exon 19 deletion there was no difference between its distribution between Asian patients (54%, 42%) and non-Asian patients (51%). However, a higher incidence of exon 21 point mutations was seen in Asians (44%, 52%) than non-Asian (27%). Dr. Douillard noted greater benefit associated with exon 19 deletion (hazard ratio [HR], 0.337; P < .0001) compared with the exon 21 substitution (HR, 0.553; P = .0101). These data were also backed-up with additional cases from a literature search, providing 5,241 patients from 91 reports. “There is a constant benefit across the lines [of therapy] in terms of response rate for patients with the mutation, with a mean value of response of 69%,” said Dr. Douillard. The greater benefits with gefitinib treatment of patients with Asian ethnicity were also indicated in these data. “Taken together, these analyses indicate that gefitinib has efficacy only in the EGFR-mutated patients, and it is consistent across lines of therapy and ethnicity, Asian or non-Asian.” Funding for this study was provided by GlaxoSmithKline. [Presentation title: Response and Progression-Free Survival in 1006 Patients With Known EGFR Mutation Status in Phase 3 Randomized Trials of Gefitinib in Individuals With Non-Small-Cell Lung Cancer. Abstract 9003] E-mail this page to a friend or colleague! To print, use this version