Gefitinib (G) versus vinorelbine+cisplatin (VP) as adjuvant treatment in stage II-IIIA (N1-N2) non-small-cell lung cancer (NSCLC) with EGFR-activating mutation (ADJUVANT): A randomized, Phase III trial (CTONG 1104).

• DOI: 10.1200/jco.2017.35.15_suppl.8500
• Publication Date: 2018-09-06T15:50:53Z
• Authors: Yi-Long Wu; Wenzhao Zhong; Qun Wang; Song-Tao Xu; Wei-Min Mao; Lin Wu; Yi Shen; Yong-Yu Liu; Chun Chen; Ying Cheng; Lin Xu; Jun Wang; Ke Fei; Xiao-Fei Li; Jian Li; Cheng Huang; Zhi-Dong Liu; Ke-Neng Chen; Hong-Hong Yan; Xue-Ning Yang
• Keywords: Vinorelbine; Clinical endpoint

8500 Background: Cisplatin-based adjuvant chemotherapy is standard of care for patients (pts) with stage II-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors have shown no benefits in the setting pts unselected resected NSCLC BR19 and RADIANT trials. ADJUVANT (NCT01405079) first randomized trial to compare gefitinib (G) vinorelbine+cisplatin (VP) completely pathological (N1-N2) EGFR-activating mutation. Methods: Completely mutation were 1:1 receive G (250 mg once daily) 24 months or vinorelbine (25 mg/m 2 Day 1 8) plus cisplatin (75 1) every 3 weeks 4 cycles. Stratification factors lymph node status (pN1/N2) EGFRmutation status. The primary endpoint was disease-free survival (DFS) intent-to-treat population. Results: A total 222 randomly assigned (Sep 19 2011 Apr 2014). Baseline characteristics balanced. At time data cutoff, median duration treatment 21.9 arm, cycles VP arm. follow-up period 36.5 (range 0.1 62.8). had significantly longer DFS (28.7 months, 95% confidence interval [CI] 24.9 32.5) than (18.0 CI 13.6 22.3; hazard ratio 0.60; 0.42 0.87; p= 0.005). 3-year better (34.0% vs 27.0%; 0.013). number overall events 76 (34.2%). In subgroup analysis treated G, demonstrated significant correlation ( p< 0.05). Grade higher adverse less common (12.3% 48.3%; 0.001). No interstitial disease observed G. Conclusions: Adjuvant prolonged compared should be considered as an important option EGFR Clinical information: NCT01405079.