Present study investigated correlation of EGFR (epidermal growth factor receptor) mutation status with gefitinib response rate used as second-line therapy in patient with metastatic non-small-cell lung cancer. 20 Patients with non-small cell lung cancer with stage IV on Gefitinib as second line therapy for more than 3 months were enrolled from Vedanta Institute of Medical Sciences, Ahmedabad, Gujarat. EGFR mutations in exons 18 to 21 were analyzed by DNA sequencing of paraffin embedded tumor tissues. EGFR mutational status of tumors and clinical data were collected. 14 (70%) out of 20 tumors had EGFR domain mutations. 9 (64%) out of 14 cases with mutated type showed sensitivity to Gefitinib, while 3 of 6 cases without EGFR mutation showed sensitivity to Gefitinib. The median progression free survival for patients with EGFR mutation (8.08 ± 2.67) was significantly longer than patients without EGFR mutations (5.25 ± 0.707). Patients with adenocarcinoma (76 %) are more EGFR positive than non-adenocarcinoma (57%). However, there was no significant difference in smoking status, pathological features, responders and non-responders between patients with EGFR mutation and those without mutation were observed. Overall response rate (complete or partial response) was 60 % and overall disease control rate (complete or partial response + stable disease) was 75%. Gefitinib demonstrated significant antitumor activity with a favorable toxicity profile for pretreated Indian patients with advanced NSCLC. The active mutation of EGFR domain was not strongly associated with response to Gefitinib but significantly prolonged progression free survival of the patients.
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