1. 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
- Author
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Shengxiang Ren, Lunxu Liu, Shun Xu, Ke-Neng Chen, Weimin Mao, Xiaofei Li, Wen-Zhao Zhong, Rong Yin, Bu-Hai Wang, Jian Li, Qun Wang, Shidong Xu, Cheng Huang, Yi-Long Wu, Haitao Ma, Ping Yu, Songtao Xu, Hong-Hong Yan, Jin-Ji Yang, Qing Zhou, Chun Chen, Si-Yang Liu, Ying Cheng, Fan Yang, Lin Wu, Zhidong Liu, Xue-Ning Yang, Yucheng Wei, and Yongyu Liu
- Subjects
Adult ,Male ,0301 basic medicine ,Oncology ,China ,Cancer Research ,medicine.medical_specialty ,Lung Neoplasms ,Time Factors ,medicine.medical_treatment ,Vinorelbine ,Disease-Free Survival ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Gefitinib ,Randomized controlled trial ,law ,Carcinoma, Non-Small-Cell Lung ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Carcinoma ,medicine ,Humans ,Aged ,Neoplasm Staging ,Cisplatin ,Chemotherapy ,business.industry ,Middle Aged ,medicine.disease ,ErbB Receptors ,Clinical trial ,030104 developmental biology ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Mutation ,Female ,business ,Adjuvant ,medicine.drug - Abstract
PURPOSE ADJUVANT-CTONG1104 (ClinicalTrials.gov identifier: NCT01405079 ), a randomized phase III trial, showed that adjuvant gefitinib treatment significantly improved disease-free survival (DFS) versus vinorelbine plus cisplatin (VP) in patients with epidermal growth factor receptor ( EGFR) mutation-positive resected stage II-IIIA (N1-N2) non–small-cell lung cancer (NSCLC). Here, we report the final overall survival (OS) results. METHODS From September 2011 to April 2014, 222 patients from 27 sites were randomly assigned 1:1 to adjuvant gefitinib (n = 111) or VP (n = 111). Patients with resected stage II-IIIA (N1-N2) NSCLC and EGFR-activating mutation were enrolled, receiving gefitinib for 24 months or VP every 3 weeks for four cycles. The primary end point was DFS (intention-to-treat [ITT] population). Secondary end points included OS, 3-, 5-year (y) DFS rates, and 5-year OS rate. Post hoc analysis was conducted for subsequent therapy data. RESULTS Median follow-up was 80.0 months. Median OS (ITT) was 75.5 and 62.8 months with gefitinib and VP, respectively (hazard ratio [HR], 0.92; 95% CI, 0.62 to 1.36; P = .674); respective 5-year OS rates were 53.2% and 51.2% ( P = .784). Subsequent therapy was administered upon 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 subsequent 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. CONCLUSION 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.
- Published
- 2021