PMID- 35693282 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240214 IS - 2218-6751 (Print) IS - 2226-4477 (Electronic) IS - 2218-6751 (Linking) VI - 11 IP - 5 DP - 2022 May TI - 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. PG - 832-844 LID - 10.21037/tlcr-22-313 [doi] AB - BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CI - 2022 Translational Lung Cancer Research. All rights reserved. FAU - Liu, Quan AU - Liu Q AD - Department of Medical Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China. FAU - Xu, Juan-Ying AU - Xu JY AD - Department of Oncology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Wuxi, China. FAU - Xu, Ye-Hong AU - Xu YH AD - Department of Respiratory Medicine, Anhui Provincial Cancer Hospital, Hefei, China. FAU - Chen, Meng AU - Chen M AD - Department of Radiation Oncology, Xuzhou Central Hospital, Xuzhou, China. FAU - Deng, Li-Chun AU - Deng LC AD - Department of Oncology, Jiangyin People's Hospital, Wuxi, China. FAU - Wu, Jian-Ping AU - Wu JP AD - Department of Oncology, Changshu No. 1 People's Hospital, Suzhou, China. FAU - Zhou, Tong AU - Zhou T AD - Department of Medical Oncology, Changzhou Tumor Hospital, Changzhou, China. FAU - Zhang, Li-Qin AU - Zhang LQ AD - Department of Respiratory Medicine, Yijishan Hospital of Wannan Medical College, Wuhu, China. FAU - Tan, Jie AU - Tan J AD - Department of Oncology, Suzhou Municipal Hospital, Suzhou, China. FAU - Pu, Xing-Xiang AU - Pu XX AD - Department of Medical Oncology, Hunan Cancer Hospital, Changsha, China. FAU - Shang, Yu-Long AU - Shang YL AD - Department of Respiratory Medicine, Xuzhou Cancer Hospital, Xuzhou, China. FAU - Hua, Jun AU - Hua J AD - Cardio-Thoracic Surgery, The Second People's Hospital of Wuxi, Wuxi, China. FAU - Li, Yuan-Qin AU - Li YQ AD - Department of Respiratory Medicine, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. FAU - Cai, Wei AU - Cai W AD - Department of Oncology, The First People's Hospital of Wujiang, Suzhou, China. FAU - Gu, Yu-Lan AU - Gu YL AD - Department of Oncology, Changshu No. 2 People's Hospital, Suzhou, China. FAU - Peng, Xing-Chen AU - Peng XC AD - Department of Oncology, West China Hospital, Sichuan University, Chengdu, China. FAU - Chan, Po-Chung AU - Chan PC AD - Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong, China. FAU - Jabbour, Salma K AU - Jabbour SK AD - Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, Rutgers University, Piscataway, NJ, USA. FAU - Nam, Hae-Seong AU - Nam HS AD - Division of Pulmonology, Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea. FAU - Hua, Dong AU - Hua D AD - Department of Oncology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Wuxi, China. LA - eng GR - R50 CA275877/CA/NCI NIH HHS/United States PT - Journal Article PL - China TA - Transl Lung Cancer Res JT - Translational lung cancer research JID - 101646875 PMC - PMC9186180 OTO - NOTNLM OT - Second-line therapy OT - anti-angiogenesis OT - apatinib OT - small cell lung cancer (SCLC) COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-22-313/coif). SKJ reports that she receives institutional grant from Merck & Co., Inc. and consulting fees form Merck & Co., Inc., Syntactx and IMX Medical. The other authors have no conflicts of interest to declare. EDAT- 2022/06/14 06:00 MHDA- 2022/06/14 06:01 PMCR- 2022/05/01 CRDT- 2022/06/13 03:13 PHST- 2022/02/24 00:00 [received] PHST- 2022/05/18 00:00 [accepted] PHST- 2022/06/13 03:13 [entrez] PHST- 2022/06/14 06:00 [pubmed] PHST- 2022/06/14 06:01 [medline] PHST- 2022/05/01 00:00 [pmc-release] AID - tlcr-11-05-832 [pii] AID - 10.21037/tlcr-22-313 [doi] PST - ppublish SO - Transl Lung Cancer Res. 2022 May;11(5):832-844. doi: 10.21037/tlcr-22-313.