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Objective: To evaluate the effect of gefitinib as a first-line therapy in patients with advanced non-small cell lung cancer (NSCLC) who were positive for epidermal growth factor receptor (EGFR) mutations. Subject and method: This prospective analysis included 120 patients with advanced NSCLC with EGFR mutations who were administered gefitinib as the first-line therapy. Patient follow-up and evaluation were performed every three months or when there were symptoms of progressive disease. The main criteria for the analysis of response were progression-free survival (PFS) and overall response rate (ORR). The secondary criteria were overall survival (OS) and disease control rate (DCR). Additionally, the relationship of OS with sex, smoking history, and performance status (PS), as well as gefitinib toxicity were analyzed. Result: The ORR and DCR were 59.2% and 95.8%, respectively. The median PFS was 14.5 months and the median OS was 33 months. The longer OS was statistically significant in women and non-smokers, and the patients had a good PS. Adverse events occurred in 59.2% patients, but most of them were grade 1 and 2 events. Conclusion: This study conducted in Vietnam suggests the effectiveness of gefitinib as a first-line treatment option in patients with advanced NSCLC and positive EGFR mutations regardless of whether the patients have a good PS or not. In particular, targeted therapy with gefitinib improved the OS in women and non-smokers.
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