PMID- 38089404 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231213 IS - 2770-9183 (Electronic) IS - 2770-9191 (Print) IS - 2770-9183 (Linking) VI - 2 IP - 3 DP - 2023 Jun TI - Third-line or above anlotinib in relapsed and refractory small cell lung cancer patients with brain metastases: A post hoc analysis of ALTER1202, a randomized, double-blind phase 2 study. PG - 181-190 LID - 10.1002/cai2.43 [doi] AB - BACKGROUND: The prognosis of patients with small cell lung cancer (SCLC) and brain metastases (BM) was poor. This study aimed to explore the efficacy and safety of anlotinib as third-line or above treatment in SCLC with BM. METHODS: This was a subgroup analysis of the ALTER1202 trial, which was a randomized, placebo-controlled trial aimed to evaluate the role of anlotinib as third-line treatment or above in patients with SCLC. This study included patients with BM at baseline. The efficacy and safety outcomes included progression-free survival (PFS), overall survival (OS), central nervous system (CNS), objective response rate (ORR), CNS disease control rate (DCR), time to CNS progression, and adverse events (AEs). RESULTS: Twenty-one and nine patients with BM were included in the anlotinib and placebo groups, respectively. The median PFS and OS were 3.8 months (95% confidence interval [CI]: 1.8-6.1) and 6.1 months (95% CI: 4.1-8.0) in the anlotinib group. Anlotinib was associated with a significant improvement in PFS (hazard ratio [HR] = 0.15, 95% CI: 0.04-0.51, p = 0.0005) and OS (HR = 0.26, 95% CI: 0.09-0.73, p = 0.0061) than placebo. Anlotinib significantly prolonged the time to CNS progression (p < 0.0001). The anlotinib group had a higher CNS DCR than placebo (95.2% vs. 22.2%, p = 0.0001). The most common grade 3 or higher AEs were increased lipase (19.0%), hypertension (14.3%), and hyponatremia (14.3%) in the anlotinib group. CONCLUSIONS: Anlotinib proved to have potential CNS activity and a manageable toxicity profile in patients with SCLC and BM, significantly delaying CNS progression. CI - (c) 2023 The Authors. Cancer Innovation published by John Wiley & Sons Ltd. on behalf of Tsinghua University Press. FAU - Cheng, Ying AU - Cheng Y AUID- ORCID: 0000-0001-9908-597X AD - Department of Thoracic Medical Oncology Jilin Cancer Hospital Changchun China. FAU - Wang, Qiming AU - Wang Q AD - Department of Internal Medicine Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital Zhengzhou China. FAU - Li, Kai AU - Li K AD - Department of Pulmonary Oncology Tianjin Medical University Cancer Hospital Tianjin China. FAU - Shi, Jianhua AU - Shi J AD - Department of Medical Oncology Linyi Cancer Hospital Linyi China. FAU - Han, Baohui AU - Han B AD - Department of Respiratory Medicine, Shanghai Chest Hospital Shanghai Jiaotong University Shanghai China. FAU - Wu, Lin AU - Wu L AD - Department of Thoracic Medical Oncology Hunan Cancer Hospital Changsha China. FAU - Chen, Gongyan AU - Chen G AD - Department of Respiratory Medicine Harbin Medical University Cancer Hospital Harbin China. FAU - He, Jianxing AU - He J AD - Department of Thoracic Surgery The First Affiliated Hospital of Guangzhou Medical University Guangzhou China. FAU - Wang, Jie AU - Wang J AD - Department of Thoracic Medical Oncology Cancer Hospital Chinese Academy of Medical Sciences Beijing China. FAU - Qin, Haifeng AU - Qin H AD - Department of Pulmonary Oncology The Fifth Medical Centre of Chinese PLA General Hospital Beijing China. FAU - Li, Xiaoling AU - Li X AD - Department of Medical Oncology Liaoning Cancer Hospital and Institute Shenyang China. LA - eng PT - Journal Article DEP - 20230117 PL - England TA - Cancer Innov JT - Cancer innovation JID - 9918713888606676 PMC - PMC10686170 OTO - NOTNLM OT - advanced small cell lung cancer OT - angiogenesis inhibitors OT - anlotinib OT - brain metastasis OT - safety COIS- The authors declare no conflict of interest. EDAT- 2023/12/13 18:42 MHDA- 2023/12/13 18:43 PMCR- 2023/01/17 CRDT- 2023/12/13 12:50 PHST- 2022/10/21 00:00 [received] PHST- 2022/11/17 00:00 [revised] PHST- 2022/11/24 00:00 [accepted] PHST- 2023/12/13 18:43 [medline] PHST- 2023/12/13 18:42 [pubmed] PHST- 2023/12/13 12:50 [entrez] PHST- 2023/01/17 00:00 [pmc-release] AID - CAI243 [pii] AID - 10.1002/cai2.43 [doi] PST - epublish SO - Cancer Innov. 2023 Jan 17;2(3):181-190. doi: 10.1002/cai2.43. eCollection 2023 Jun.