Abstract:

Objective This study aimed to investigate the efficacy and safety of anlotinib plus PD ⁃ 1 blockades in patients with advanced non⁃small cell lung cancer（NSCLC）previously treated with immunotherapy. Methods A total of 52 patients with advanced NSCLC previously treated with immunotherapy who had received anlotinib plus PD⁃1 blockades were included in this study. Anlotinib was administered with the conventional usage and dosage，and PD⁃1 blockades were available in China，including sintilimab，camrelizumab and pembrolizumab. The data on the efficacy and safety were retrospectively collected during treatment with anlotinib plus PD⁃1 block⁃ ades and all the patients were followed up regularly to assess the long⁃term survival. Results The best overall response suggested that 12 of the advanced NSCLC patients with previous immunotherapy who received anlotinib plus PD⁃1 blockades achieved partial response，32 were stable，and 8 were progressive，revealing an objective response rate of 23.1%（95%CI：12.5% ~ 36.8%）and a disease control rate of 84.6%（95%CI：71.9% ~ 93.1%）. The median progress⁃free survival（PFS）was 6.3 months（95%CI：2.64 ~ 9.96），the median overall survival（OS） was 16.6 months（95%CI：8.08 ~ 25.12）. 10 patients intolerant to the previous immune⁃related regimens obtained a relatively better prognosis when they received this regimen（median OS：23.4 months vs. 11.5 months，P = 0.034）. Safety profile suggested that the overall adverse reactions related to anlotinib combined with PD⁃ 1 blockades were safe and controllable. Conclusions Anlotinib plus PD ⁃1 blockades demonstrated potential efficacy and tolerabletoxicity among the advanced NSCLC patients previously treated with immunotherapy. Those intolerant to the previ⁃ ous immune⁃related regimens might benefit from this regimen. The finding of this paper need to be further verified via large sample studies. 

Key words:

previously treated with immunotherapy, NSCLC, anlotinib, PD ?1 blockades, efficacy, safety