Efficacy and safety of apatinib as second or later-line therapy in extensive-stage small cell lung cancer: a prospective, exploratory, single-arm, multi-center clinical trial.
机构：[1]Department of Medical Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.[2]Department of Oncology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Wuxi, China.[3]Department of Respiratory Medicine, Anhui Provincial Cancer Hospital, Hefei, China.[4]Department of Radiation Oncology, Xuzhou Central Hospital, Xuzhou, China.[5]Department of Oncology, Jiangyin People's Hospital, Wuxi, China.[6]Department of Oncology, Changshu No. 1 People's Hospital, Suzhou, China.[7]Department of Medical Oncology, Changzhou Tumor Hospital, Changzhou, China.[8]Department of Respiratory Medicine, Yijishan Hospital of Wannan Medical College, Wuhu, China.[9]Department of Oncology, Suzhou Municipal Hospital, Suzhou, China.[10]Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China.[11]Department of Respiratory Medicine, Xuzhou Cancer Hospital, Xuzhou, China.[12]Cardio-Thoracic Surgery, The Second People's Hospital of Wuxi, Wuxi, China.[13]Department of Respiratory Medicine, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.[14]Department of Oncology, The First People's Hospital of Wujiang, Suzhou, China.[15]Department of Oncology, Changshu No. 2 People's Hospital, Suzhou, China.[16]Department of Oncology, West China Hospital, Sichuan University, Chengdu, China.四川大学华西医院[17]Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong, China.[18]Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, Rutgers University, Piscataway, NJ, USA.[19]Division of Pulmonology, Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.
A paucity of strategies exist for extensive-stage small cell lung cancer (ES-SCLC) patients who fail the first-line chemotherapy. Apatinib is a tyrosine kinase inhibitor (TKI) that selectively inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), which has been demonstrated to have active anti-tumor activity in ES-SCLC when used only or combined with PD-1 inhibitors or chemotherapy with good tolerance. However, the efficacy and safety of apatinib monotherapy is unclear in second-line or beyond treatment of ES-SCLC.In this prospective, exploratory, single-arm, multi-center study, eligible patients were aged 18 years or older with histologically confirmed ES-SCLC, and had progressed on, or were intolerant to previous systemic treatment. Patients received apatinib 500 mg (orally qd, every 4 weeks a cycle). The efficacy was assessed after 1 cycle and then every 2 cycles based on computed tomography imaging per the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). The primary endpoint was progression-free survival (PFS). The adverse events (AEs) were assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0 (NCI-CTCAE 4.0). This study is registered in the Chinese Clinical Trial Registry, number ChiCTR-OPC-17013964.From 28 July 2017 to 21 June 2019, 62 patients were screened for eligibility, among whom 57 patients were available for efficacy and safety analysis. The objective response rate (ORR) was 14.3% and disease control rate (DCR) was 79.6%. The median PFS was 5.6 months [95% confidence interval (CI): 3.3-8.0 months] and the median overall survival (OS) was 11.2 months (95% CI: 7.5-24.0 months). Among the participants who received apatinib as second-line treatment, the median PFS and OS were 6.1 months (95% CI: 2.6-7.6 months) and 12.0 months (95% CI: 7.9 months to not reached), respectively. The most common AEs of all grades were anemia (36.8%), hypertension (33.3%), fatigue (31.6%), blood bilirubin increased (22.8%), elevated transaminase (19.3%), and hand-foot syndrome (17.54%). Grade 3 AEs included 2 (3.5%) cases of hypertension and 1 (1.8%) case of fatigue. No grade 4/5 AEs were observed.Apatinib showed encouraging anti-tumor activity in pretreated ES-SCLC patients with tolerable toxicities. Further larger scale studies are warranted to demonstrate the efficacy of apatinib.2022 Translational Lung Cancer Research. All rights reserved.
基金：
This study was supported by the Precision
Medicine Project of Wuxi Health Commission (No. jzyx04),
Translational Medicine Research Project of Wuxi Health
Commission (No. ZH202103), and the Clinical Research
Center Fund from Wuxi Science and Technology Bureau
(No. WX18IVJN017).
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2022]版：
大类|3 区医学
小类|3 区呼吸系统4 区肿瘤学
最新[2023]版：
大类|2 区医学
小类|3 区肿瘤学3 区呼吸系统
第一作者：
第一作者机构：[1]Department of Medical Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.
共同第一作者：
通讯作者：
通讯机构：[2]Department of Oncology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Wuxi, China.[*1]Department of Oncology, Wuxi People’s Hospital Affiliated to Nanjing Medical University, No. 299 Qing Yang Road, Wuxi 214023, China
推荐引用方式(GB/T 7714)：
Liu Quan,Xu Juan-Ying,Xu Ye-Hong,et al.Efficacy and safety of apatinib as second or later-line therapy in extensive-stage small cell lung cancer: a prospective, exploratory, single-arm, multi-center clinical trial.[J].Translational lung cancer research.2022,11(5):832-844.doi:10.21037/tlcr-22-313.
APA：
Liu Quan,Xu Juan-Ying,Xu Ye-Hong,Chen Meng,Deng Li-Chun...&Hua Dong.(2022).Efficacy and safety of apatinib as second or later-line therapy in extensive-stage small cell lung cancer: a prospective, exploratory, single-arm, multi-center clinical trial..Translational lung cancer research,11,(5)
MLA：
Liu Quan,et al."Efficacy and safety of apatinib as second or later-line therapy in extensive-stage small cell lung cancer: a prospective, exploratory, single-arm, multi-center clinical trial.".Translational lung cancer research 11..5(2022):832-844
