The Efficacy and Safety of Anlotinib in Extensive-Stage Small Cell Lung Cancer: A Multicenter Real-World Study

Hao-Ran Zheng; Ai-Min Jiang; Huan Gao; Na Liu; Xiao-Qiang Zheng; Xiao Fu; Rui Zhang; Zhi-Ping Ruan; Tao Tian; Xuan Liang; Yu Yao

doi:10.2147/CMAR.S364125

The Efficacy and Safety of Anlotinib in Extensive-Stage Small Cell Lung Cancer: A Multicenter Real-World Study

Cancer Manag Res. 2022 Aug 2:14:2273-2287. doi: 10.2147/CMAR.S364125. eCollection 2022.

Authors

Hao-Ran Zheng^#^{1

2}, Ai-Min Jiang^#¹, Huan Gao¹, Na Liu¹, Xiao-Qiang Zheng¹, Xiao Fu¹, Rui Zhang¹, Zhi-Ping Ruan¹, Tao Tian¹, Xuan Liang¹, Yu Yao¹

Affiliations

¹ Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, People's Republic of China.
² Department of Medical Oncology, Xi'an No.3 Hospital, Xi'an, Shaanxi, People's Republic of China.

^# Contributed equally.

Abstract

Purpose: Anlotinib, an antiangiogenic multi-target tyrosine kinase inhibitor (TKI), has shown favorable anticancer efficacy and acceptable safety in treating extensive-stage small cell lung cancer (ES-SCLC) in some clinical studies. This research aimed to explore the real-world efficacy and safety of anlotinib in ES-SCLC.

Methods: Pathologically confirmed ES-SCLC patients receiving anlotinib were enrolled for this retrospective study. The primary endpoint of this study was progression-free survival (PFS), and secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse reactions.

Results: In total, 202 patients were included in this study. The median PFS of all patients was 4.8 months [95% confidence interval (CI): 3.9-5.7], and the median OS was 7.6 months (95% CI 6.5-8.7). Respectively, the overall ORR and DCR were 30.2% and 87.1%. The univariate and multivariate Cox regression analyses revealed that patients with Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1, plus chemotherapy or immunotherapy, plus radiotherapy, and post-medication hypertension might have longer PFS and OS. The PFS and OS were significantly prolonged in combination group than that in monotherapy group [PFS 6.0 vs 3.6 months, hazards ratio (HR)=0.49, 95% CI 0.34-0.70, P < 0.001; OS 9.2 vs 4.8 months, HR = 0.48, 95% CI 0.32-0.72, P < 0.001]. The main treatment-related adverse reactions were generally tolerated. The incidence of adverse reactions in combination group was higher than that in monotherapy group (75.0% vs 52.6%, P = 0.001). The most common adverse reaction was hypertension, followed by hand-foot syndrome and fatigue, regardless of monotherapy or combination group.

Conclusion: Anlotinib is effective and well tolerated in patients with ES-SCLC in the real-world. The clinical efficacy of anlotinib combined with chemotherapy or immunotherapy is better than that of monotherapy. Further investigations are needed for prospective studies with larger sample size.

Keywords: anlotinib; efficacy; real-world; safety; small cell lung cancer.

Grants and funding

This study was funded by the International Cooperation Project in Science and Technology of Shaanxi Province (No. 2019KW-074), Nation Natural Science Funding of China (No. 82002437), and Shaanxi Province Technology Innovation Team (No. 2021TD-44).