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| |  Mutation Status Appears to Predict Response to First-Line Gefitinib Treatment for Non-Small-Cell Lung Cancer: Presented at ASCO By Bruce Sylvester ORLANDO, Fla -- June 1, 2009 -- Asian patients with non-small-cell lung cancer (NSCLC) who had epidermal growth factor receptor (EGFR) gene mutations, were nonsmokers or light smokers, and received gefitinib as initial therapy achieved significantly slower cancer progression than similarly matched patients without the gene mutation, researchers reported here at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). These patients also had better results with gefitinib than they did with conventional chemotherapy, although subjects without EGFR mutations achieved greater benefit from standard chemotherapy than gefitinib. These outcomes came from an analysis of biomarker data from the prospective IPASS (Iressa Pan-Asia Study), presented here on May 31. “We found that a molecularly defined population will benefit most from first-line treatment with gefitinib,” stated lead investigator Masahiro Fukuoka, MD, PhD, Kinki University School of Medicine, Osaka, Japan. Dr. Fukuoka and colleagues analysed tissue samples from 683 subjects in IPASS. EGFR mutation status was evaluable in 437 subjects. The primary endpoint of the study was progression-free survival. The secondary endpoint was objective response rate by biomarker status. The investigators evaluated 261 subjects with EGFR mutations who received gefitinib or conventional chemotherapy (carboplatin/paclitaxel) as initial therapy for NSCLC, and compared them to 176 subjects who did not have the mutation. EGFR mutation-positive subjects showed significantly longer progression-free survival (P < .0001) and a higher objective response rate with gefitinib than with carboplatin/paclitaxel. EGFR mutation-negative subjects, on the other hand, demonstrated significantly shorter progression-free survival (P < .0001) and a lower objective response rate with gefitinib than with carboplatin/paclitaxel. Among subjects with EGFR mutations, median progression-free survival was 9.5 months with gefitinib compared with 6.3 months with carboplatin/paclitaxel. For subjects without EGFR mutations, median progression-free survival was 5.5 months with carboplatin/paclitaxel versus 1.5 months with gefitinib. “EGFR [mutation] status was a strong predictive biomarker for the efficacy of gefitinib versus carboplatin/paclitaxel in this clinically selected, first-line setting,” the authors concluded. Funding for this study was provided by AstraZeneca. [Presentation title: Biomarker Analyses From a Phase III, Randomized, Open-Label, First-Line Study of Gefitinib (G) Versus Carboplatin/Paclitaxel (C/P) in Clinically Selected Patients (pts) With Advanced Non-Small Cell Lung Cancer (NSCLC) in Asia (IPASS). Abstract 8006]
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