安罗替尼联合ICI一线治疗晚期肺鳞状细胞癌的疗效和安全性:37例单中心回顾性队列分析OA

Objective:To explore the efficacy and safety of anlotinib combined with immune checkpoint inhibitors(ICI)as first-line treatment for advanced lung squamous cell carcinoma(LUSC).Methods:In this single-center retrospective cohort study,37 consecutive treatment-naïve advanced LUSC patients treated at Fuzhou Pulmonary Hospital of Fujian between October 2018 and December 2023 were enrolled.All patients received anlotinib(8,10,or 12 mg/d;administered for 2 weeks followed by 1 week off)combined with PD-1/PD-L1 inhibitors.The primary endpoint was progression-free survival(PFS),and the secondary endpoints included objective response rate(ORR),disease control rate(DCR),and treatment-related adverse event(TRAE).Results:With a median follow-up of 15.2 months,the ORR reached 54.1％(20/37),the DCR was 97.3％(36/37),the median PFS was 11.8 months(95％CI:8.3-NA),and the 12-month PFS rate was 48.6％.Exploratory subgroup analyses showed that that patients receiving anlotinib at 12 mg demonstrated significantly longer median PFS(not reached vs 7.5 months;HR=0.09,95％CI:0.01-0.67;P＜0.01)and a higher ORR(100％vs 42.9％,P＜0.01)compared to those receiving 8 or 10 mg.Stage-stratified analysis showed that the ORR of patients in stage ⅢB/ⅢC disease was significantly better than those in stage Ⅳ(84.6％vs 41.7％,P=0.02).In terms of safety,62.2％(23/37)of the patients developed TRAE,mainly grade 1-2 hypertension(29.7％[11/37])and hand-foot syndrome(21.6％[8/37]).Three patients(8.1％)discontinued treatment due to grade 3 TRAE.Conclusion:Anlotinib combined with ICI as a first-line treatment regimen for advanced LUSC demonstrates promising therapeutic efficacy and manageable safety profiles.Notably,in exploratory analyses,the 12 mg dose group exhibited potential signals of superior efficacy,and patients with earlier-stage disease showed a higher ORR.These findings warrant further validation through large-scale prospective studies.