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Hao-Ran Zheng,1,2,* Ai-Min Jiang,1,* Huan Gao,1 Na Liu,1 Xiao-Qiang Zheng,1 Xiao Fu,1 Rui Zhang,1 Zhi-Ping Ruan,1 Tao Tian,1 Xuan Liang,1 Yu Yao1 1Department of Medical Oncology, The First Affiliated Hospital of Xiâan Jiaotong University, Xiâan, Shaanxi, Peopleâs Republic of China; 2Department of Medical Oncology, Xiâan No.3 Hospital, Xiâan, Shaanxi, Peopleâs Republic of China*These authors contributed equally to this workCorrespondence: Xuan Liang; Yu Yao, Department of Medical Oncology, The First Affiliated Hospital of Xiâan Jiaotong University, No. 277 Yanta West Road, Xiâan, Shaanxi, 710061, Peopleâs Republic of China, Tel +86-29-85324600, Fax +86-29-85324086, Email liangxuan029@163.com; 13572101611@163.comPurpose: 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): 3.9â 5.7], and the median OS was 7.6 months (95% CI 6.5â 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 0.34â 0.70, P < 0.001; OS 9.2 vs 4.8 months, HR = 0.48, 95% CI 0.32â 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, small cell lung cancer, real-world, efficacy, safety |
