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Efficacy and safety of gefitinib as third-line treatment in NSCLC patients with activating EGFR mutations treated with first-line gefitinib followed by second-line chemotherapy: A single-arm, prospective, multicenter phase II study (RE-CHALLENGE, CTONG1304)

American Journal of Clinical Oncology May 01, 2019

Song Y, et al. - In this multicenter, open-label, single-arm, phase 2 study, gefitinib was investigated regarding effectiveness and safety as a third-line re-challenge treatment for advanced non–small cell lung cancer (NSCLC) patients with EGFR mutation. Gefitinib 250 mg/d was administered to stage IIIB/IV NSCLC patients with EGFR exon 19del/L858R mutation, who were helped by first-line gefitinib treatment followed by second-line chemotherapy. Outcomes support the effectiveness of re-challenge with gefitinib. For third-line patients, especially for the T790M-negative patients, it could be a choice following the first-line EGFR-tyrosine kinase inhibitor treatment and second-line chemotherapy. Median progression-free survival was 4.4 months and overall survival was 10.3 months.

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