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

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...

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Detalles Bibliográficos
Autores principales: Zhong, Wen-Zhao, Wang, Qun, Mao, Wei-Min, Xu, Song-Tao, Wu, Lin, Wei, Yu-Cheng, Liu, Yong-Yu, Chen, Chun, Cheng, Ying, Yin, Rong, Yang, Fan, Ren, Sheng-Xiang, Li, Xiao-Fei, Li, Jian, Huang, Cheng, Liu, Zhi-Dong, Xu, Shun, Chen, Ke-Neng, Xu, Shi-Dong, Liu, Lun-Xu, Yu, Ping, Wang, Bu-Hai, Ma, Hai-Tao, Yang, Jin-Ji, Yan, Hong-Hong, Yang, Xue-Ning, Liu, Si-Yang, Zhou, Qing, Wu, Yi-Long
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Clinical Oncology 2021
Materias:
ORIGINAL REPORTS
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8078324/
https://www.ncbi.nlm.nih.gov/pubmed/33332190
http://dx.doi.org/10.1200/JCO.20.01820
Descripción
Sumario: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.

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