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
| Autor: | 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, Yongyu Liu |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
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 |
| Zdroj: | Journal of Clinical Oncology. 39:713-722 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.20.01820 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|