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To evaluate the efficacy, toxicity, overall survival and response of Gefitinib in previously untreated patients of metastatic NSCLC with EGFR mutation.
60 patients with metastatic, non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy were randomly assigned to receive Gefitinib 250 mg orally daily or carboplatin -paclitaxel. The primary end point was progression-free survival; secondary end points included overall survival, response rate, and toxic effects.
The progression free survival was significanly longer in Gefitinb group than in standard chemotherapy group. The Gefitinib group had significantly longer median progression free survival (10 months versus 5 months) as well as higher response rates (70% versus 30%). The median overall survival was 30 months in Gefitinib group and 24 months in chemotherapy group. The most common adverse events in Gefitinib group were rash and elevated aminotransferase levels.
First-line Gefitinib for patients with advanced non-small-cell lung cancer who were selected on the basis of EGFR mutations improved progression-free survival, with acceptable toxicity, as compared with standard chemotherapy.