Updated Overall Survival and Exploratory Analysis From Randomized, Phase II EVAN Study of Erlotinib Versus Vinorelbine Plus Cisplatin Adjuvant Therapy in Stage IIIA Epidermal Growth Factor Receptor+ Non–Small-Cell Lung Cancer
The randomized, open-label, phase II EVAN study investigated the efficacy (disease-free survival [DFS] and 5-year overall survival [OS]) and safety of erlotinib versus vinorelbine/cisplatin as adjuvant chemotherapy after complete resection (R0) for stage III epidermal growth factor receptor (EGFR) mutation+ non–small-cell lung cancer. We describe the updated results at the 43-month follow-up. In EVAN, patients were randomly assigned (1:1) to erlotinib (n = 51) or vinorelbine/cisplatin (n = 51). The median follow-up was 54.8 and 63.9 months in the erlotinib and chemotherapy arms, respectively. With erlotinib, the respective 5-year DFS by Kaplan-Meier analysis was 48.2% (95% CI, 29.4 to 64.7) and 46.2% (95% CI, 27.6 to 62.9) in the intention-to-treat and per-protocol populations. The median OS was 84.2 months with erlotinib versus 61.1 months with chemotherapy (hazard ratio, 0.318; 95% CI, 0.151 to 0.670). The 5-year survival rates were 84.8% and 51.1% with erlotinib and chemotherapy, respectively. In whole-exome sequencing analysis, frequent genes with variants co-occurring at baseline were TP53, MUC16, FAM104B, KMT5A, and DNAH9. With erlotinib, a single-nucleotide polymorphism mutation in UBXN11 was associated with significantly worse DFS (P = .01). To our knowledge, this study is the first to demonstrate clinically meaningful OS improvement with adjuvant erlotinib compared with chemotherapy in R0 stage III EGFR+ non–small-cell lung cancer.
Author Affiliations1Tianjin Medical University Cancer Institute and Hospital, Tianjin, China 2Harbin Medical University Cancer Hospital, Harbin, China 3Zhongshan Hospital, Fudan University, Shanghai, China 4Tangdu Hospital, Fourth Military Medical University, Xi’an, China 5The Affiliated Hospital of Qingdao University, Qingdao, China 6Shanghai Jiao Tong University Affiliated Chest Hospital, Shanghai, China 7Fujian Medical University Union Hospital, Fuzhou, China 8Zhejiang Cancer Hospital, Hangzhou, China 9Jilin University First Hospital, Changchun, China 10Hebei Cancer Institute, Shijiazhuang, China 11Sun Yat-sen University Cancer Center, Guangzhou, China 12First Affiliated Hospital of Soochow University, Suzhou, China 13Sichuan Cancer Hospital and Institute, Chengdu, China 14Peking University Cancer Hospital, Beijing, China 15Liaoning Cancer Institute and Hospital, Shenyang, China 16Fudan University, Shanghai Cancer Center, Shanghai, China
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