PMID- 34302324 OWN - NLM STAT- MEDLINE DCOM- 20220922 LR - 20230107 IS - 2095-3941 (Print) IS - 2095-3941 (Linking) VI - 19 IP - 8 DP - 2021 Jul 24 TI - Peripheral blood indices to predict PFS/OS with anlotinib as a subsequent treatment in advanced small-cell lung cancer. PG - 1249-58 LID - j.issn.2095-3941.2020.0727 [pii] LID - 10.20892/j.issn.2095-3941.2020.0727 [doi] AB - OBJECTIVE: In the phase II ALTER-1202 (NCT03059797) trial, anlotinib significantly improved progression-free survival (PFS) and overall survival (OS) in patients with advanced small-cell lung cancer (SCLC) who underwent at least 2 previous chemotherapy cycles, when compared with a placebo group. To identify potential factors for predicting efficacy and prognosis with anlotinib treatment, we analyzed hematological indices at baseline and adverse events (AEs) over the course of anlotinib treatment. METHODS: Data were collected from March 2017 to April 2019 from a randomized, double-blind, placebo-controlled, multicenter, phase II trial of anlotinib. Eligible patients were randomly assigned 2:1 to receive anlotinib or placebo until disease progression, intolerable toxicity, or withdrawal of consent. The patients received anlotinib (12 mg) or an analogue capsule (placebo) orally once daily for 14 days every 3 weeks. The hematological indices at baseline and AEs that occurred in the initial 2 treatment cycles were recorded. The Kaplan-Meier test and Cox regression model were used to assess survival differences. RESULTS: A total of 82 patients (81 patients with complete data) were randomly assigned to receive anlotinib, with 38 receiving a placebo as a control. Multivariate analysis indicated that an elevated neutrophil to lymphocyte ratio > 7.75 and lactate dehydrogenase > 254.65 U/L at baseline were independent risk factors for PFS; basal elevated aspartate aminotransferase > 26.75 U/L, neuron specific enolase > 18.64 ng/mL, and fibrinogen > 4.645 g/L were independent risk factors for OS. During treatment, elevated gamma glutamyltransferase and hypophosphatemia were independent predictors for a poor PFS, and elevated gamma-glutamyl transferase and hypercholesterolemia were independent factors for OS. CONCLUSIONS: Our study preliminarily defined potential factors that affected the PFS and OS at baseline and during anlotinib treatment in patients with advanced SCLC. Our findings provide a basis for screening the dominant population and for dynamic efficacy monitoring with anlotinib therapy. CI - Copyright (c) 2022 Cancer Biology & Medicine. FAU - Zhang, Cuicui AU - Zhang C AD - Department of Thoracic Oncology Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, Tianjin 300060, China. FAU - Wang, Jing AU - Wang J AD - Department of Thoracic Oncology Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, Tianjin 300060, China. FAU - Wang, Xinyue AU - Wang X AD - Department of Thoracic Oncology Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, Tianjin 300060, China. FAU - Meng, Zhaoting AU - Meng Z AD - Department of Thoracic Oncology Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, Tianjin 300060, China. FAU - Cheng, Ying AU - Cheng Y AUID- ORCID: 0000-0001-9908-597X AD - Jilin Cancer Hospital, Changchun 130021, China. FAU - Li, Kai AU - Li K AUID- ORCID: 0000-0002-6895-0024 AD - Department of Thoracic Oncology Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, Tianjin 300060, China. LA - eng SI - ClinicalTrials.gov/NCT03059797 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - China TA - Cancer Biol Med JT - Cancer biology & medicine JID - 101588850 RN - 0 (Indoles) RN - 0 (Quinolines) RN - 0 (anlotinib) RN - 9001-32-5 (Fibrinogen) RN - EC 1.1.- (Lactate Dehydrogenases) RN - EC 2.3.2.2 (gamma-Glutamyltransferase) RN - EC 2.6.1.1 (Aspartate Aminotransferases) RN - EC 4.2.1.11 (Phosphopyruvate Hydratase) SB - IM MH - Aspartate Aminotransferases/therapeutic use MH - *Carcinoma, Non-Small-Cell Lung/drug therapy MH - Fibrinogen/therapeutic use MH - Humans MH - Indoles MH - Lactate Dehydrogenases MH - *Lung Neoplasms/drug therapy MH - Phosphopyruvate Hydratase MH - Progression-Free Survival MH - Quinolines MH - *Small Cell Lung Carcinoma/drug therapy MH - Treatment Outcome MH - gamma-Glutamyltransferase/therapeutic use PMC - PMC9425186 OTO - NOTNLM OT - OS OT - PFS OT - Small-cell lung cancer OT - anlotinib OT - predictive factors COIS- No potential conflicts of interest are disclosed. EDAT- 2021/07/25 06:00 MHDA- 2022/09/23 06:00 PMCR- 2022/08/15 CRDT- 2021/07/24 06:28 PHST- 2021/07/25 06:00 [pubmed] PHST- 2022/09/23 06:00 [medline] PHST- 2021/07/24 06:28 [entrez] PHST- 2022/08/15 00:00 [pmc-release] AID - j.issn.2095-3941.2020.0727 [pii] AID - 10.20892/j.issn.2095-3941.2020.0727 [doi] PST - ppublish SO - Cancer Biol Med. 2021 Jul 24;19(8):1249-58. doi: 10.20892/j.issn.2095-3941.2020.0727.