PMID- 37837490 OWN - NLM STAT- MEDLINE DCOM- 20231122 LR - 20231124 IS - 1573-0646 (Electronic) IS - 0167-6997 (Print) IS - 0167-6997 (Linking) VI - 41 IP - 6 DP - 2023 Dec TI - Therapeutic effectiveness of anlotinib combined with etoposide in extensive-stage small-cell lung cancer: a single-arm, phase II trial. PG - 825-833 LID - 10.1007/s10637-023-01398-9 [doi] AB - BACKGROUND: Anlotinib plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) achieves good efficacy, but there is still room for improvement. This clinical study examined the effectiveness of anlotinib plus etoposide for maintenance therapy in ES-SCLC. METHODS: The current single-arm, prospective phase II study was performed at Jiangsu Cancer Hospital (March 2019 to March 2022). After successful primary etoposide-based therapy, anlotinib was administered at 12 mg/day on days 1 to 14 of 21-day cycles until disease progression or consent withdrawal. All patients also received etoposide at 50 mg/day on days 1 to 14 of 21-day cycles for a maximum of six cycles. Progression-free survival (PFS) constituted the primary study endpoint. Secondary endpoints were overall survival (OS), objective remission rate (ORR), disease control rate (DCR), and safety. In addition, adverse events (AEs) were assessed. RESULTS: Twenty-eight patients were treated. Median PFS and OS were 8.02 (95%CI 5.36-10.67) and 11.04 (95%CI 10.37-11.68) months, respectively. Totally 9 and 18 participants showed a partial response and stable disease, respectively; ORR and DCR were 32.14% and 96.43%, respectively. The commonest all-grade AEs were fatigue (n = 11, 39.28%), hypertension (n = 11, 39.28%), loss of appetite (n = 9, 32.14%), oral mucositis (n = 7, 25.00%) and proteinuria (n = 6, 21.40%). Grade 3-4 AEs included fatigue (n = 4, 14.28%), hypertension (n = 2, 7.14%), hand and foot syndrome (n = 2, 7.14%), oral mucositis (n = 1, 3.57%), hemoptysis (n = 1, 3.57%), proteinuria (n = 1, 3.57%), gingival bleeding (n = 1, 3.57%), and serum creatinine elevation (n = 1, 3.57%). CONCLUSION: Maintenance anlotinib plus etoposide achieves promising PFS and OS in clinical ES-SCLC. REGISTRATION NUMBER: ChiCTR1800019421. CI - (c) 2023. The Author(s). FAU - Wu, Yuan AU - Wu Y AD - Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, China. FAU - Zhou, Xuefeng AU - Zhou X AD - Department of Oncology, Dongtai People's Hospital, Dongtai, 224200, China. FAU - Zhao, Weiqing AU - Zhao W AD - Department of Oncology, The Third Affiliated Hospital of Soochow University, Suzhou, 213003, China. FAU - Wang, Qiong AU - Wang Q AD - Department of Oncology, The Jiangyin Clinical College of Xuzhou Medical University, Jiangyin, 214400, China. FAU - Han, Zhengxiang AU - Han Z AD - Department of Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, 221004, China. FAU - Wang, Lifeng AU - Wang L AD - The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Nanjing Drum Tower Hospital, Nanjing, 210008, China. FAU - Zhou, Wenjie AU - Zhou W AD - Department of Oncology, The Third Affiliated Hospital of Soochow University, Suzhou, 213003, China. FAU - Zhou, Tong AU - Zhou T AD - Department of Medical Oncology, Changzhou Cancer Hospital, Changzhou, 213001, China. FAU - Song, Haizhu AU - Song H AD - Department of Medical Oncology, Jinling Hospital, Nanjing, 210016, China. FAU - Chen, Yong AU - Chen Y AD - Department of Medical Oncology, Affiliated Hospital of Yangzhou University, Yangzhou, 225001, China. FAU - Yang, Kaihua AU - Yang K AD - Department of Radiotherapy and Oncology, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China. FAU - Shi, Lin AU - Shi L AD - Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, China. FAU - Pan, Banzhou AU - Pan B AD - Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, China. FAU - Guo, Renhong AU - Guo R AD - Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, China. FAU - Zhou, Guoren AU - Zhou G AD - Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, China. FAU - Jiang, Feng AU - Jiang F AD - Department of Thoracic Surgery, The Affiliated Cancer Hospital of Nanjing Medical University & Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, Nanjing, 210009, China. FAU - Feng, Jifeng AU - Feng J AD - Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, China. FAU - Shen, Bo AU - Shen B AD - Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, 210009, China. shenbo987@126.com. AD - Department of Oncology, Dongtai People's Hospital, Dongtai, 224200, China. shenbo987@126.com. AD - , 42 Baiziting, Xuanwu District, Nanjing, Jiangsu Province, China. shenbo987@126.com. LA - eng GR - Z-2014-06-2103/the China International Medical Foundation Project/ GR - ZJ202110/the Project of Jiangsu Cancer Hospital/ GR - 82272863/the National Natural Science Foundation of China/ GR - YWJKJJHKYJJ-F2030E/Beijing Medical and Health Foundation Project/ GR - HL-HS-2020102/the Huilan Public Interest Project/ PT - Clinical Trial, Phase II PT - Journal Article DEP - 20231014 PL - United States TA - Invest New Drugs JT - Investigational new drugs JID - 8309330 RN - 6PLQ3CP4P3 (Etoposide) RN - 0 (anlotinib) SB - IM MH - Humans MH - Etoposide/adverse effects MH - *Lung Neoplasms/drug therapy MH - Prospective Studies MH - *Small Cell Lung Carcinoma/drug therapy MH - *Hypertension/chemically induced MH - Proteinuria/chemically induced MH - *Stomatitis/chemically induced PMC - PMC10663256 OTO - NOTNLM OT - Anlotinib OT - Etoposide OT - Maintenance therapy OT - Prognosis OT - Small-cell lung cancer OT - Survival COIS- The authors declare no competing interests. EDAT- 2023/10/15 05:41 MHDA- 2023/11/22 06:42 PMCR- 2023/10/14 CRDT- 2023/10/14 11:07 PHST- 2023/08/22 00:00 [received] PHST- 2023/09/26 00:00 [accepted] PHST- 2023/11/22 06:42 [medline] PHST- 2023/10/15 05:41 [pubmed] PHST- 2023/10/14 11:07 [entrez] PHST- 2023/10/14 00:00 [pmc-release] AID - 10.1007/s10637-023-01398-9 [pii] AID - 1398 [pii] AID - 10.1007/s10637-023-01398-9 [doi] PST - ppublish SO - Invest New Drugs. 2023 Dec;41(6):825-833. doi: 10.1007/s10637-023-01398-9. Epub 2023 Oct 14.