KEY TAKEAWAYS
- EVAN phase II Trial (NCT01683175) studied the efficacy and safety of erlotinib in comparison to chemotherapy.
- The study aimed to compare the efficacy and safety of erlotinib vs. vinorelbine/cisplatin as adjuvant chemotherapy.
- The researchers conducted a randomized, open-label trial that split patients evenly. This study compares the DFS, 5-YEAR OS, and safety of erlotinib vs vinorelbine/cisplatin as adjuvant chemotherapy
- Erlotinib showed a 5-year DFS of 48.2% and a 5-year OS of 84.8%. Vinorelbine/cisplatin showed a 5-year DFS of 46.2% and a 5-year OS of 51.1%.
Complete resection (R0) of stage III epidermal growth factor receptor (EGFR) mutation+ non-small-cell lung cancer was the primary endpoint of the randomized, open-label, phase II EVAN study, which compared the efficacy (disease-free survival [DFS] and 5-year overall survival [OS]) and safety of erlotinib versus vinorelbine/cisplatin as adjuvant chemotherapy. Researchers in this study update the findings at the 43-month follow-up stage.
Patients in EVAN were split evenly (n = 51) between erlotinib and vinorelbine/cisplatin. In the erlotinib group, the median follow-up was 54.8 months, while in the chemotherapy group, it was 63.9 months. Kaplan-Meier estimates for erlotinib’s 5-year DFS in the intention-to-treat and per-protocol groups were 48.2% (95% CI, 29.4 to 64.7) and 46.2% (95% CI, 27.6 to 62.9), respectively.
Erlotinib resulted in a median OS of 84.2 months, but chemotherapy only resulted in a median OS of 61.1 months (95% confidence interval [CI], 0.318 to 0.670). The 5-year survival rates for those treated with erlotinib were 84.8%, while those treated with chemotherapy were 51.1%. At baseline, TP53, MUC16, FAM104B, KMT5A, and DNAH9 were among the most frequently co-occurring genes with variants in whole-exome sequencing analysis. A UBXN11 SNP mutation was related to significantly worse DFS when treated with erlotinib (P = .01). According to the researchers, this is the first trial to show that adjuvant erlotinib is superior to chemotherapy for patients with R0-stage III EGFR+ non-small-cell lung cancer, in terms of overall survival.
Source: https://pubmed.ncbi.nlm.nih.gov/36027483/
Clinical trial: https://clinicaltrials.gov/ct2/show/NCT01683175
Citation:Yue, D., Xu, S., Wang, Q., Li, X., Shen, Y., Zhao, H., Chen, C., Mao, W., Liu, W., Liu, J., Zhang, L., Ma, H., Li, Q., Yang, Y., Liu, Y., Chen, H., Zhang, Z., Zhang, B., & Wang, C. (2022). 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. Journal of Clinical Oncology. https://doi.org/10.1200/jco.22.00428
