Efficacy of anlotinib combined with tislelizumab in the treatment of patients with extensive-stage small cell lung cancer
MENG Chunpeng
SUN Shuai
LI Jianhua
LAN Binbin
MENG Qinghai
ZHENG Zhifeng
Abstract：Objective To investigate the clinical efficacy and safety of anlotinib combined with tislelizumab in the treatment of extensive-stage small cell lung cancer(ES-SCLC).Methods A randomized controlled trial was conducted.A total of 148 patients with ES-SCLC who had progressed/relapsed after first-line treatment from June 2021 to June 2023 in Linfen Peo-ple's Hospital were selected and randomly divided into the combination group(74 cases,receiving anlotinib combined with tisleli-zumab)and the control group(74 cases,receiving anlotinib monotherapy)using a random number table method.The short-term efficacy and long-term survival outcomes(including objective response rate,disease control rate,progression-free survival,and overall survival),changes in tumor marker levels,and the incidence of adverse reactions were compared between the two groups.Results The combination group demonstrated significantly higher objective response rate(59.46％(44/74))and disease control rate(91.89％(68/74))compared to the control group(41.89％(31/74)and 77.03％(57/74))(x2=4.568,6.299,both P＜0.05).As of December 31,2024,the median follow-up time was 22.3 months.Kaplan-Meier survival analysis showed that the combination group had both a longer median progression-free survival of 8.00 months(95％CI:6.073-9.927)and a longer median overall survival of 10.00 months(95％CI:4.815-15.185)compared to the control group(6.00 months(95％CI:5.252-6.748)and 8.00 months(95％CI:7.263-8.737),respectively)(Log-rankx2=4.066,5.467,both P＜0.05).After 4 cycles of treatment,the levels of neuron-specific enolase and cytokeratin 19 fragment in both groups decreased compared to before treatment,and the above indicators in the combination group((12.53±3.18)μg/L,(4.08±0.92)ng/mL)were lower than those in the control group((16.36±4.25)μg/L,(5.25±1.08)ng/mL)(t=6.207,7.094,both P＜0.05).The incidence of hypertension in the combination group was 35.14％(26/74),higher than that in the control group(18.92％(14/74))(x2=4.933,P＜0.05).Conclusion In patients with ES-SCLC after first-line treatment failure,the combination therapy of anlotinib and tislelizumab significantly improves short-term efficacy and long-term survival compared to anlotinib monotherapy,with overall manageable adverse reactions.
Keywords：extensive-stage small cell lung canceranlotinibtislelizumabefficacyadverse reaction
Publication Date：2026-01-25
Online Publishing Date：2026-03-03(First online date of this platform, not the publication date of the document)
Pages：5( 22-26 )