A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations.

摘要: Retrospective analysis has shown that activating mutations in exons 18–21 of the epidermal growth factor receptor (EGFR) gene are a predictor response to gefitinib. We conducted phase II trial evaluate efficacy and safety gefitinib as first-line therapy for advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Patients stage IIIB or IV chemotherapy-naive NSCLC mutation were treated 250 mg daily. For mutational analysis, DNA was extracted from paraffin-embedded tissues analysed by direct sequence PCR products. Twenty (24%) 82 patients had (deletions near E746-A750, n=16; L858R, n=4). Sixteen enrolled Twelve objective rate 75% (95% CI, 48–93%). After median follow-up 12.7 months (range, 3.1–16.8 months), 10 demonstrated disease progression, progression-free survival 8.9 6.7–11.1 months). The overall time not yet been reached. Most toxicities mild. This study showed is very active well tolerated