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First line gefitinib in EGFR mutation positive NSCLC in an Israeli cohort: unmet expectations

First line gefitinib in EGFR mutation positive NSCLC in an Israeli cohort: unmet expectations. Epidermal growth factor receptor (EGFR) mutations occur in approximately 10-25% of metastatic non-small cell lung carcinoma (NSCLC)

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First line gefitinib in EGFR mutation positive NSCLC in an Israeli cohort: unmet expectations

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  1. First line gefitinib in EGFR mutation positive NSCLC in an Israeli cohort: unmet expectations Epidermal growth factor receptor (EGFR) mutations occur in approximately 10-25% of metastatic non-small cell lung carcinoma (NSCLC) EGFR mutations are more common in patients of Asian descent, adenocarcinoma, never-smokers and females Response rates to EGFR tyrosine kinase inhibitors, specifically gefitinib, in patients harboring EGFR mutations are reported as high as 55-85% Gefitinib was included in the Israeli Health Scheme since February 2010 for first line treatment of metastatic NSCLC harboring EGFR mutations Our study retrospectively evaluated the efficacy of gefitinib in the first line treatment of EGFR-mutated advanced NSCLC patients in two Israeli tertiary hospitals INTRODUCTION METHOD 38 patients (20% of patients evaluated) were identified as harboring EGFR mutations RESULTS Of the 38 patients, 24 were treated with first line gefitinib 19 patients have been evaluated for treatment response 89% had an ECOG performance status of 0-2 Adverse events were generally mild and similar to published results • Grade 1-2 rash – 9 patients (47%) • Grade 1-2 diarrhea – 6 patients (32%) • Grade 3 hypomagnesaemia – 1 patient (5%) RESULTS CONCLUSION Israeli metastatic NSCLC patients harboring EGFR mutations treated with first line gefitinib had an overall response rate of only 10.5% Albeit the very small number of patients in this current retrospective study, the low rate of radiological response suggests that in our tested population, the actual response rate is significantly lower than reported in the literature Epidemiologic, pharmacogenetic and/or molecular mechanisms of resistance need to be explored to explain these differences CORRESPONDENCE Dr. Damien Urban MBBS BMedSci Department of Medical Oncology Sheba Medical Center Email: damien.urban@sheba.health.gov.il The clinical data of patients tested positive for EGFR mutations from the Sheba Medical Center and the Meir Hospital since the beginning of 2010 were included in the current retrospective analysis. Analyses were based on demographic, clinical and molecular data. 4/19 (21%) patients had died within 4 months of starting gefitinib The null-hypothesis of a minimal 50% response rate (the minimum response rate seen for other western populations) is rejected with a P value of 0.02 using a two-tailed chi-square test Best response rate defined by RECIST • Partial response (PR) – 2 patients (10.5%) • Stable disease (SD) – 12 patients (63%) • Progressive disease (PD) – 5 patients (26.5%) DEMOGRAPHICS AND TYPE OF EGFR MUTATION 1 - Department of Oncology, Sheba Medical Center, Tel Hashomer 2 - Department of Oncology, Meir Hospital, Kfar Saba Damien Urban1, Natalie Maimon,2 Raya Leibowitz-Amit1, Haim Biran1, Moshe Mishaeli2, Amir Onn1 and Maya Gottfried2

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