As reported in the Journal of Clinical Oncology by Yue et al, an updated analysis of the Chinese phase II EVAN study indicated a sizable overall survival advantage with adjuvant erlotinib vs vinorelbine/cisplatin in patients with R0 resected stage IIIA EGFR-mutant non–small cell lung cancer (NSCLC).
In the open-label multicenter trial, 102 patients who underwent R0 resection were randomly assigned to receive erlotinib at 150 mg once daily for 2 years (n = 51) or vinorelbine at 25 mg/m2 on days 1 and 8 and cisplatin at 75 mg/m2 on day 1 of four 21-day cycles. Results are in the intention-to-treat population.
Key Findings
The median follow-up was 54.8 months in the erlotinib group and 63.9 months in the vinorelbine/cisplatin group. On Kaplan-Meier analysis, erlotinib was associated with significantly improved disease-free survival (hazard ratio [HR] = 0.38, 95% confidence interval [CI] = 0.20–0.70, P < .001). Five-year disease-free survival was 48.2% (95% CI = 29.4%–64.7%) in the erlotinib group; since patients in the chemotherapy group either reached the endpoint or were censored at the end of follow-up, 5-year disease-free survival could not be calculated.
Median overall survival was 84.2 months (95% CI = 78.1 months–not evaluable) in the erlotinib group vs 61.1 months (95% CI = 39.6–82.1 months) with chemotherapy (HR = 0.37, 95% CI = 0.19–0.73, P = .003). The 5-year overall survival rates were 84.8% vs 51.1%.
Whole-exome sequencing in 34 patients in the erlotinib group and 31 in the chemotherapy group showed that the most common genes with variants co-occurring at baseline were TP53, MUC16, FAM104B, KMT5A, and DNAH9. In the erlotinib group, the presence of a single-nucleotide polymorphism in UBXN11 was associated with significantly poorer disease-free survival (P = .01).
The investigators concluded, “To our knowledge, this study is the first to demonstrate a clinically meaningful overall survival improvement with adjuvant erlotinib compared with chemotherapy in R0 stage III EGFR-mutant NSCLC.”
Changli Wang, MD, of Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was funded by Shanghai Roche Pharmaceuticals, Inc, and the National Natural Science Foundation of China. For full disclosures of the study authors, visit ascopubs.org.
