A One-Arm, Open, Single-Center Exploratory Clinical Study on the Safety and Efficacy of Anlotinib in the Treatment of Relapsed High-Grade Gliomas

Abstract

<h3>Purpose/Objective(s)</h3> There is currently no standard treatment for recurrent high-grade gliomas. The study was conducted through a single-arm, open, single-center clinical study to evaluate the safety and efficacy of anlotinib in the treatment of recurrent high-grade gliomas. <h3>Materials/Methods</h3> Patients with recurrent high-grade glioma (WHO class III-IV) from October 2019 to January 2021 in Sichuan Cancer Hospital were given oral anlotinib 8-12 mg/day, and each course of treatment was taken for 2 consecutive weeks with a break of 1 week. Efficacy is assessed according to response assessment in neuro-oncology (RANO) criteria. The main efficacy indicators were progression-free survival (PFS), 6-month progression-free survival (PFS-6), objective response rate (ORR), and disease control rate (DCR). Secondary indicators of efficacy are overall survival (OS) and drug-related adverse effects are observed. <h3>Results</h3> A total of 14 patients (including 10 cases of glioblastoma, 3 cases of anaplastic astrocytoma, and 1 case of anaplastic oligodendrocyte glioma) were analyzed in a co-enrollment group, and the median follow-up time was 8.8 months (6.3-11.7). According to the THE RANO criteria, 8 patients were in partial remission, 5 patients were stable, and 1 patient was assessed as disease progression. The median PFS was 8.0 months (95% CI: 6.0 to 10.3), PFS-6 was 78.6%, the objective response rate was 57.1%, and the disease control rate was 92.9%. Five cases have not yet been studied. According to the Common Terminology Standard for Adverse Events (CTCAE), no adverse reactions ≥-3 were observed. Grade 1-2 hypertension and fatigue are common adverse reactions, with an incidence rate of 28.6%, of which 4 patients with hypertension, 4 cases of fatigue, 2 cases of short-term memory loss, 1 case of hand and foot skin toxicity, 1 case of drowsiness, 1 case of edema, 1 case of joint pain and hoarseness, all adverse reactions can be alleviated and controlled through symptomatic treatment. <h3>Conclusion</h3> The incidence of adverse reactions of anlotinib in the treatment of recurrent high-grade gliomas is low and the safety is good. At the same time, it shows good short-term efficacy, significantly prolongs the patient's progression-free survival, and may become an effective treatment for recurrent high-grade gliomas, laying the foundation for further clinical research.