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:

Zhong Wen-Zhao1ORCID,Wang Qun2,Mao Wei-Min3,Xu Song-Tao2,Wu Lin4ORCID,Wei Yu-Cheng5,Liu Yong-Yu6,Chen Chun7,Cheng Ying8ORCID,Yin Rong9,Yang Fan10,Ren Sheng-Xiang11,Li Xiao-Fei12,Li Jian13,Huang Cheng14,Liu Zhi-Dong15,Xu Shun16,Chen Ke-Neng17,Xu Shi-Dong18,Liu Lun-Xu19ORCID,Yu Ping20,Wang Bu-Hai21,Ma Hai-Tao22,Yang Jin-Ji1ORCID,Yan Hong-Hong1ORCID,Yang Xue-Ning1ORCID,Liu Si-Yang1,Zhou Qing1,Wu Yi-Long1ORCID

Affiliation:

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

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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