Abstract:Objective To explore the clinical efficacy of osimertinib in first-line treatment of epidermal growth factor receptor (EGFR) mutation-sensitive non-small cell lung cancer (NSCLC) patients with brain metastases.Methods A total of 82 patients with brain metastases from NSCLC with EGFR mutation and first-line treatment with osimertinib were enrolled in Xiangya Hospital of Central South University between January 2018 and August 2021. The intracranial objective response rate (iORR) and intracranial disease control rate (iDCR) of all patients were observed after 3 months of treatment, and the differences of iORR and iDCR of patients with different clinical characteristics were compared. The incidence of adverse reactions during treatment was calculated. All patients were followed up for disease progression and death after treatment. And COX regression model was used to analyze the prognostic factors after first-line treatment with osimertinib.Results A total of 82 patients with NSCLC brain metastasis were enrolled in this study, the iORR and iDCR were 69.5% and 96.3% after 3 months of osimertinib treatment. There were no significant differences in iORR and iDCR among the patients with different age, sex, smoking status, PS scores, EGFR mutation types, brain metastasis sites, metastasis of other sites, and central nervous symptoms (P>0.05). The incidence of adverse reactions during treatment was 50.0%. The overall survival rate of the patients was 73.2%, and the disease progression-free survival rate was 78.0%. COX regression results showed that the patients with EFGR mutation type L858R had a 2.793-fold increased risk of death as compared with those who had 19del mutation (95% CI: 0.134~0.956, P=0.040), and the patients > 60 years old had a 4.385-fold increased risk of death as compared with those ≤60 years old (95% CI: 1.267~15.175, P=0.020).Conclusion Osimertinib can achieve good iORR and iDCR in first-line treatment of EGFR-mutated NSCLC patients with brain metastasis, with good safety. EGFR mutation type L858R and age >60 years were risk factors for prognosis of NSCLC patients with brain metastasis after first-line treatment with osimertinib.