| Background and objective : Leptomeningeal metastasis(LM)is a fatal complication of advanced non-small-cell lung cancer(NSCLC),LM is prone to occur in patients with epidermal growth factor receptor(EGFR)positive driver gene than negative.This study aims to evaluate the efficacy of osimertinib combined with bevacizumab versus osimertinib as a single agent in the treatment of EGFR mutationpositive NSCLC with LM.Methods: This study retrospectively analyzed of the efficacy and safety of osimertinib combined with bevacizumab or osimertinib for EGFR mutation-positive NSCLC patients diagnosed with LM by cytology and/or imaging in the Department of Oncology,Second Affiliated Hospital of Nanchang University from October 2017 to September 2020.The primary endpoint is LM overall survival(LM overall survival,OS);the secondary research endpoint is LM progression-free survival(PFS),LM disease control Rate(DCR)and safety,LM objective response rate(ORR).Results: Among the 44 patients,19 were males(43.2%)and 25 were females(56.8%),The male to female ratio was 1:1.32.The average age of 57.7 years old.The overall median OS of 44 patients was 9.3 months(95%CI: 6.136-12.524 months).Among them,the osimertinib group compared to the osimertinib combined with bevacizumab group was 7.2 VS 12.6 months,HR =0.502(95%CI: 0.249-1.010),p=0.031,the difference is statistically significant.The total median PFS of 44 patients was 9.1 months(95%CI: 5.603-12.537),Among them,the osimertinib group compared to the osimertinib combined with bevacizumab group was 6.0 vs 9.2 months,HR=1.496(95%CI 0.773-2.896),p=0.216,the difference was not statistically significant.The total DCR of 44 patients was 79.5%(35/44),and the ORR was 40.9%(18/44).Among them,the DCR of the osimertinib group was 68.2%(15/22)and the ORR was 40.9%(9/22);the DCR of the osimertinib combined with bevacizumab group was 90.9%(20/22),and the ORR was 40.9%(9/22).There were no grade 4-5 adverse events in the osimertinib combined with bevacizumab group or osimertinib group.Conclusion: Osimertinib combined with bevacizumab is longer than osimertinib monotherapy for EGFR mutation-positive NSCLC patients with LM OS.The side effects of osimertinib and bevacizumab are acceptable,and the combination of osimertinib and bevacizumab for LM is safe.Osimertinib combined with bevacizumab for EGFR mutation-positive NSCLC with LM is a potential treatment option,and large sample multi-center randomized controlled studies are necessary for further verification in the future. |
