Adjuvant icotinib of 12 months or 6 months versus observation following adjuvant chemotherapy for resected EGFR-mutated stage II–IIIA non-small cell lung cancer (ICTAN, GASTO1002): a randomized phase 3 trial

Author:

Wang Si-Yu1ORCID,Li Ning2ORCID,Ou Wei1,Cheng Chao3ORCID,You Jian4ORCID,Yang Lin5,Chen Fengxia6,Liang Yi7,Yang Zhixiong8,Wang Bao-Xiao9,Chang Zeng-Hao2,Lin Yao-Bin2,Yang Weixiong3,Xu Feng4,Ding Guanggui10,Chen Xian-Shan6,Hu Ronggui7,Li Shujun11,Jiang Hao2,Hu Xin-Xin2,Long Hao2

Affiliation:

1. Sun-Yat Sen University Cancer Center

2. Sun Yat-sen University Cancer Center

3. The First Affiliated Hospital of Sun Yat-Sen University

4. Tianjin Medical University Cancer Institute & Hospital

5. Shenzhen People's Hospital, 2nd Clinical Medical College of Jinan University

6. Hainan General Hospital

7. Zhongshan City People's Hospital

8. Affiliated Hospital of Guangdong Medical University

9. Sun Yat-sen Memorial Hospital

10. Shenzhen People’s Hospital

11. Affiliated Hospital of Guangdong Medical Universityl

Abstract

Abstract

The efficacy, safety and ideal treatment duration of an adjuvant epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) for patients with completely resected EGFR-mutated non-small cell lung cancer (NSCLC) after adjuvant chemotherapy were not known until 2014, when this study was initiated. In this phase 3 ICTAN trial, patients with completely resected, EGFR-mutated, stage II-IIIA NSCLC after platinum-based adjuvant chemotherapy were assigned in a 1:1:1 ratio to receive icotinib (125 mg, three times daily) for 12 months, to receive icotinib for 6 months or to undergo observation. The primary endpoint was DFS according to investigator assessment. This trial was terminated early. A total of 251 patients were randomized. Baseline characteristics were balanced among the groups. After a median follow-up of 61.4 months, 6 months of icotinib significantly improved DFS (hazard ratio (HR): 0.41, 95% confidence interval (CI), 0.27–0.62; P < 0.001) and overall survival (OS, HR: 0.56, 95% CI, 0.32–0.98; P = 0.041) compared with observation. Adjuvant icotinib of 12 months also significantly improved DFS (HR: 0.40, 95% CI, 0.27–0.61; P < 0.001) and OS (HR: 0.55, 95% CI, 0.32–0.96; P = 0.035) compared with observation. Adjuvant icotinib for 12 months did not improve DFS (HR: 0.97; P = 0.89) or OS (HR: 1.00; P = 0.99) compared with 6 months of this drug. Rates of adverse events of grade 3 or higher were 8.3%, 5.9% and 2.4% for the 12-month icotinib, 6-month icotinib and observation groups, respectively. The safety profile remained similar to that reported previously for icotinib. Adjuvant icotinib for 12 months and 6 months following adjuvant chemotherapy provided a significant DFS and OS benefit compared with observation in patients with completely resected EGFR-mutated stage II-IIIA NSCLC with a manageable safety profile. Nevertheless, 12 months of icotinib had no additional benefit compared with 6 months.

Publisher

Springer Science and Business Media LLC

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