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Gefitinib vs vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC: Final overall survival analysis of CTONG1104 phase III trial

Journal of Clinical Oncology Dec 23, 2020

Zhong WZ, Wang Q, Mao WM, et al. - In patients suffering from epidermal growth factor receptor (EGFR) mutation-positive resected stage II-IIIA (N1-N2) non–small-cell lung cancer (NSCLC), significantly improved disease-free survival (DFS) was reported to be achieved with adjuvant gefitinib treatment vs vinorelbine plus cisplatin (VP) in the randomized phase 3 ADJUVANT-CTONG1104 trial, so researchers now present the final overall survival (OS) outcomes. Overall 222 patients from 27 sites were randomized 1:1 to adjuvant gefitinib (n = 111) or VP (n = 111). Enrolled patients were those with resected stage II-IIIA (N1-N2) NSCLC and EGFR-activating mutation, taking gefitinib for 24 months or VP every 3 weeks for four cycles. Findings showed improved DFS was conferred by adjuvant therapy with gefitinib vs standard of care chemotherapy in patients with early-stage NSCLC and EGFR mutation. With gefitinib and VP, median OS (ITT) was 75.5 and 62.8 months respectively; 53.2% and 51.2% were the respective 5-year OS rates. Upon progression, subsequent therapy was administered in 68.4% and 73.6% of patients receiving gefitinib and VP, respectively, and it was that subsequent targeted therapy that contributed most to OS. This DFS benefit failed to translate to a significant OS difference, but OS with adjuvant gefitinib was one of the longest noted in this patient group vs historic data.

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