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Erlotinib vs gemcitabine plus cisplatin as neoadjuvant treatment of stage IIIA-N2 EGFR-mutant non–small-cell lung cancer (EMERGING-CTONG 110): A randomized phase 2 study

Journal of Clinical Oncology Sep 05, 2019

Zhong WZ, Chen KN, Chen C, et al. - Researchers conducted a multicenter, open-label, phase 2, randomized controlled trial of erlotinib vs gemcitabine plus cisplatin (GC chemotherapy) as neoadjuvant/adjuvant therapy in patients with stage IIIA-N2 non–small-cell lung cancer with EGFR (epidermal growth factor receptor) mutations in exon 19 or 21 (EMERGING) in order to determine whether EGFR tyrosine kinase inhibitors are beneficial as neoadjuvant/adjuvant therapies in these patients. They screened 386 patients; of these, they randomly assigned 72 to treatment (intention-to-treat population) and included 71 in the safety analysis (one patient withdrew before treatment). For neoadjuvant erlotinib vs GC chemotherapy, they observed an ORR of 54.1% vs 34.3%. A major pathologic response was noted in 3 of 31 patients and none of the 23 patients in the erlotinib and GC chemotherapy arms, respectively. With erlotinib (21.5 months) vs GC chemotherapy, significantly longer median PFS was noted (11.4 months; HR: 0.39).

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