The majority of clinical trials investigating the safety and efficacy of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have primarily enrolled patients of Caucasian or Asian ethnicity. African-American patients with non-small cell lung cancer (NSCLC) have been reported to have differences in EGFR mutation frequencies and distribution with several studies showing a lower prevalence of EGFR mutations, and unique mutation subtypes. Given the limited representation of African-American patients in previous clinical trials, it is crucial to specifically assess the safety profile and efficacy outcomes of EGFR-TKIs in this patient population.


In this retrospective study, we utilized the Syapse Learning Health Network database to identify patients with stage IV NSCLC with sensitizing EGFR mutation. Our study cohort (N = 47) comprised of patients who were treated with either erlotinib, gefitinib , afatinib, or osimertinib in any line of therapy between 2000 and 2023. Overall survival and time to next treatment (TTNT) were calculated by utilizing Kaplan-Meier analysis. Safety and efficacy of EGFR-TKIs was assessed, and a subgroup analysis for patients treated with osimertinib was performed.


The median overall survival (mOS) for patients who received EGFR-TKIs in any line was 31 months (95% confidence interval [CI], 23 to 61). The 1-year, 2-year and 5-year OS rates were 88%, 61%, and 31%, respectively. The median TTNT was 28 months (95% CI, 15 to 56). The mOS in the osimertinib group was 36 months (95% CI, 20 to 61) and median TTNT was 30 months (95%CI, 14 to 46). Two out of forty-seven patients (4.3%) discontinued EGFR-TKI due to toxicity/intolerance and five patients (10.6%) discontinued due to either death or were lost to follow up.


This is the first real-world data to assess the efficacy and safety outcomes of EGFR-TKIs in the African-American population.