PMID- 34354945 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220425 IS - 2234-943X (Print) IS - 2234-943X (Electronic) IS - 2234-943X (Linking) VI - 11 DP - 2021 TI - Retrospective Study of the Safety and Efficacy of Anlotinib Combined With Dose-Dense Temozolomide in Patients With Recurrent Glioblastoma. PG - 687564 LID - 10.3389/fonc.2021.687564 [doi] LID - 687564 AB - PURPOSE: The purpose of this study was to retrospectively analyze the safety and clinical efficacy of anlotinib combined with dose-dense temozolomide (TMZ) as the first-line therapy in the treatment of recurrent glioblastoma (rGBM). PATIENTS AND METHODS: We collected the clinical data of 20 patients with rGBM. All patients received anlotinib (12 mg daily, orally for 2 weeks, discontinued for 1 week, repeated every 3 weeks) combined with dose-dense TMZ (100 mg/m(2), 7 days on with 7 days off) until the disease progressed (PD) or adverse effects (AEs) above grade 4 appeared. Grade 3 AEs need to be restored to grade 2 before continuing treatment, and the daily dose of anlotinib is reduced to 10 mg. The patients were reexamined by head magnetic resonance imaging (MRI) every 1 to 3 months. The therapeutic effect was evaluated according to Response Assessment in Neuro-Oncology (RANO) criteria. The survival rate was analyzed by Kaplan-Meier survival curve analysis. The baseline of all survival index statistics was the start of anlotinib combined with dose-dense of TMZ. National Cancer Institute-Common Terminology Criteria Adverse Events version 4.0 (NCI-CTCAE 4.0) was used to evaluate AEs. RESULTS: Twenty cases of rGBM were evaluated according to the RANO criteria after treatment with anlotinib and dose-dense TMZ, including five cases of stable disease (SD), thirteen cases of partial response (PR), one case of complete response (CR), and one case of PD. The median follow-up time was 13.4 (95% CI, 10.5-16.3) months. The 1-year overall survival (OS) rate was 47.7%. The 6-month progression-free survival (PFS) rate was 55%. In the IDH wild type group, the median PFS and median OS were 6.1 and 11.9 months, respectively. We observed that AEs associated with treatment were tolerable. One patient stopped taking the drug because of cerebral infarction. There were no treatment-related deaths. CONCLUSION: Anlotinib combined with dose-dense TMZ for the first-line therapy showed good efficacy in OS, PFS, ORR, and DCR in the treatment of rGBM, and the AEs were tolerant. Randomized controlled clinical trials investigating the treatment of rGBM with anlotinib are necessary. CI - Copyright (c) 2021 She, Su, Shen and Liu. FAU - She, Lei AU - She L AD - Department of Oncology, Xiangya Hospital, Central South University, Changsha, China. AD - Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha, China. AD - Institute of Clinical Pharmacology, Central South University, Hunan Key Laboratory of Pharmacogenetics, Changsha, China. FAU - Su, Lin AU - Su L AD - Department of Oncology, Xiangya Hospital, Central South University, Changsha, China. FAU - Shen, Liangfang AU - Shen L AD - Department of Oncology, Xiangya Hospital, Central South University, Changsha, China. FAU - Liu, Chao AU - Liu C AD - Department of Oncology, Xiangya Hospital, Central South University, Changsha, China. LA - eng PT - Journal Article DEP - 20210720 PL - Switzerland TA - Front Oncol JT - Frontiers in oncology JID - 101568867 PMC - PMC8330423 OTO - NOTNLM OT - adverse events OT - anlotinib OT - dose-dense temozolomide OT - efficacy OT - recurrent glioblastoma OT - survival COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2021/08/07 06:00 MHDA- 2021/08/07 06:01 PMCR- 2021/07/20 CRDT- 2021/08/06 06:54 PHST- 2021/03/29 00:00 [received] PHST- 2021/06/30 00:00 [accepted] PHST- 2021/08/06 06:54 [entrez] PHST- 2021/08/07 06:00 [pubmed] PHST- 2021/08/07 06:01 [medline] PHST- 2021/07/20 00:00 [pmc-release] AID - 10.3389/fonc.2021.687564 [doi] PST - epublish SO - Front Oncol. 2021 Jul 20;11:687564. doi: 10.3389/fonc.2021.687564. eCollection 2021.