lung cancer

Gefitinib Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment for Stage II-IIIA (N1-N2) EGFR-Mutant NSCLC: Final Overall Survival Analysis of CTONG1104 Phase III Trial

In the December 17, 2021 edition of Journal of Clinical Oncology, Wen-Zhao Zhong and colleagues report on the results of the CTONG1104 trial.


ADJUVANT-CTONG1104 is a randomized phase III trial, where adjuvant gefitinib significantly improved DFSS versus vinorelbine + cisplatin (VP) in patients with EGFR mutated resected stage II-IIIA (N1-N2) non–small-cell lung cancer (NSCLC). Here, we report the final OS results.


From September 2011 – April 2014, n=222 patients from 27 sites were randomzied assigned in a 1:1 fashion to adjuvant gefitinib (n = 111) or VP (n = 111). Patients with resected stage II-IIIA (N1-N2) disease and EGFR-activating mutation were enrolled, receiving gefitinib for 2 years or VP every 3 weeks for four cycles. The primary end point was DFS ( ITT population). Secondary end points included OS, 3- and 5-year DFS rates, and 5-year OS rate.


The median follow-up was 80.0 months. The median OS in the ITT was 75.5 and 62.8 months with gefitinib and VP, respectively HR, 0.92; 95% CI, 0.62 – 1.36; P = .674); respective 5-year OS rates were 53.2% and 51.2% (P = .784). Subsequent therapy was provided at progression in 68.4% and 73.6% of patients receiving gefitinib and VP, respectively. Subsequent targeted therapy contributed most to OS (HR, 0.23; 95% CI, 0.14 to 0.38) compared with no therapy. Updated 3y DFS rates were 39.6% and 32. 5% with gefitinib and VP (P = .316) and 5y DFS rates were 22. 6% and 23.2% (P = .928), respectively.

The authors concluded “Adjuvant therapy with gefitinib in patients with early-stage NSCLC and EGFR mutation demonstrated improved DFS over standard of care chemotherapy. Although this DFS advantage did not translate to a significant OS difference, OS with adjuvant gefitinib was one of the longest observed in this patient group compared with historic data.”