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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.

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机构： [1]Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China. [2]Fudan University Affiliated Zhongshan Hospital, Shanghai, China. [3]Zhejiang Cancer Hospital, Hangzhou, China. [4]Hunan Cancer Hospital, Changsha, China. [5]The Affiliated Hospital of Medical College Qingdao University, Qingdao, China. [6]Shenyang Chest Hospital, Shenyang, China. [7]Fujian Medical University Union Hospital, Fuzhou, China. [8]Jilin Provincial Tumor Hospital, Changchun, China. [9]Jiangsu Cancer Hospital, Nanjing, China. [10]The People's Hospital of Peking University, Beijing, China. [11]Shanghai Pulmonary Hospital, Shanghai, China. [12]Tangdu Hospital, Xi'an, China. [13]Peking University First Hospital, Beijing, China. [14]Fujian Cancer Hospital, Fuzhou, China. [15]Beijing Chest Hospital, Beijing, China. [16]The First Hospital of China Medical University, Shenyang, China. [17]Beijing Cancer Hospital, Beijing, China. [18]Harbin Medical University Cancer Hospital, Harbin, China. [19]West China Hospital of Sichuan University, Chengdu, China. [20]Sichuan Cancer Hospital, Chengdu, China. [21]The Northern Jiangsu People's Hospital, Yangzhou, China. [22]The First Affiliated Hospital of Suzhou University, Suzhou, China.

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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. 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. 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. 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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大类 | 1 区

医学

小类 | 1 区肿瘤学

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大类 | 1 区

医学

小类 | 1 区肿瘤学

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Q1 ONCOLOGY

最新[2023]版：

Q1 ONCOLOGY

影响因子： 42.1 最新[2023版] 37.4 最新五年平均 50.739 出版当年[2021版] 38.79 出版当年五年平均 44.544 出版前一年[2020版] 45.4 出版后一年[2022版]

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第一作者机构： [1]Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.

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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. $(function () { $("[data-toggle='tooltip']").tooltip(); });

文献详情

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.