PMID- 36116169 OWN - NLM STAT- MEDLINE DCOM- 20221020 LR - 20221109 IS - 1872-8332 (Electronic) IS - 0169-5002 (Linking) VI - 173 DP - 2022 Nov TI - Safety and efficacy of anlotinib in combination with standard chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A multi-center, prospective study (ACTION-2). PG - 43-48 LID - S0169-5002(22)00617-1 [pii] LID - 10.1016/j.lungcan.2022.09.003 [doi] AB - INTRODUCTION: Extensive stage small cell lung cancer (ES-SCLC) is associated with poor prognosis. Recently, anlotinib has demonstrated significant clinical activity as a third-line or further on treatment. This study aimed to evaluate the safety and efficacy of a combination of anlotinib and platinum-etoposide as first-line treatment in patients with ES-SCLC. METHODS: The present multi-center, single-arm, prospective study (NCT04684017) was conducted at three Chinese sites, and included patients with asymptomatic metastasis in the central nervous system. Patients were treated with up to six cycles of chemotherapy comprising etoposide with either carboplatin or cisplatin on day 1 of each cycle. Anlotinib was administered orally once daily on days 1-14 per cycle. The primary end points of the study were safety and investigator assessed objective response rate (ORR). RESULTS: A total of 101 patients were screened from August 2018 to September 2021, of which 86 who had received at least one dose of the treatment were included in the formal analysis. The median follow-up duration was 27.9 months. Complete response and partial response were observed in 2 and 73 patients, respectively, with an ORR of 87.2 % and a disease control rate of 97.7 %. Progression-free survival (PFS) and overall survival (OS) events occurred in 78 and 47 patients, respectively. The median PFS and OS were 9.0 (95 % confidence interval [CI]: 7.5-10.5) and 19 (95 % CI: 16.7-21.3) months, respectively. The incidence of grade 3 or higher adverse events (AEs) was 58.1 % and 24 patients (27.9 %) experienced serious treatment-related AEs. No fatalities consequent to AEs were recorded. CONCLUSION: Given its promising efficacy, safety profile and durability, anlotinib combined with chemotherapy deserves further investigation as first-line anticancer therapy in ES-SCLC (NCT: 04684017). CI - Copyright (c) 2022 Elsevier B.V. All rights reserved. FAU - Zhang, Wei AU - Zhang W AD - Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 Huaihai West Road, Shanghai 200030, China. FAU - Deng, Pengbo AU - Deng P AD - Respiratory and Critical Care Department, Xiang Ya Hospital Central South University, No. 87 Xiangya Road, Changsha, Hunan Province 410008, China. FAU - Kong, Tiandong AU - Kong T AD - Department of Medical Oncology, The Third People's Hospital of Zhengzhou, No. 136 Nanshuncheng Street, Zhengzhou, Henan Province 450001, China. FAU - Zhang, Bo AU - Zhang B AD - Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 Huaihai West Road, Shanghai 200030, China. FAU - Qian, Fangfei AU - Qian F AD - Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 Huaihai West Road, Shanghai 200030, China. FAU - Dong, Yu AU - Dong Y AD - Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 Huaihai West Road, Shanghai 200030, China. FAU - Chen, Ya AU - Chen Y AD - Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 Huaihai West Road, Shanghai 200030, China. FAU - Chen, Lu AU - Chen L AD - Department of Medical Oncology, The Third People's Hospital of Zhengzhou, No. 136 Nanshuncheng Street, Zhengzhou, Henan Province 450001, China. FAU - Liu, Danna AU - Liu D AD - Department of Medical Oncology, The Third People's Hospital of Zhengzhou, No. 136 Nanshuncheng Street, Zhengzhou, Henan Province 450001, China. FAU - Zhang, Yanwei AU - Zhang Y AD - Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 Huaihai West Road, Shanghai 200030, China. Electronic address: zhangywshxkyy@163.com. FAU - Yang, Huaping AU - Yang H AD - Respiratory and Critical Care Department, Xiang Ya Hospital Central South University, No. 87 Xiangya Road, Changsha, Hunan Province 410008, China. Electronic address: yhp9956@csu.edu.cn. FAU - Han, Baohui AU - Han B AD - Department of Respiratory Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 Huaihai West Road, Shanghai 200030, China. Electronic address: 18930858216@163.com. LA - eng SI - ClinicalTrials.gov/NCT04684017 PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20220908 PL - Ireland TA - Lung Cancer JT - Lung cancer (Amsterdam, Netherlands) JID - 8800805 RN - BG3F62OND5 (Carboplatin) RN - 0 (anlotinib) RN - 6PLQ3CP4P3 (Etoposide) RN - Q20Q21Q62J (Cisplatin) RN - 49DFR088MY (Platinum) SB - IM MH - Humans MH - *Small Cell Lung Carcinoma/pathology MH - Carboplatin MH - Etoposide MH - Prospective Studies MH - Cisplatin/therapeutic use MH - Platinum/therapeutic use MH - *Lung Neoplasms/pathology MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Treatment Outcome OTO - NOTNLM OT - Anlotinib OT - Chemotherapy OT - Extensive stage small cell lung cancer OT - First-line treatment COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2022/09/19 06:00 MHDA- 2022/10/21 06:00 CRDT- 2022/09/18 18:07 PHST- 2022/06/17 00:00 [received] PHST- 2022/09/02 00:00 [revised] PHST- 2022/09/05 00:00 [accepted] PHST- 2022/09/19 06:00 [pubmed] PHST- 2022/10/21 06:00 [medline] PHST- 2022/09/18 18:07 [entrez] AID - S0169-5002(22)00617-1 [pii] AID - 10.1016/j.lungcan.2022.09.003 [doi] PST - ppublish SO - Lung Cancer. 2022 Nov;173:43-48. doi: 10.1016/j.lungcan.2022.09.003. Epub 2022 Sep 8.