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Apatinib Plus Temozolomide for Recurrent Glioblastoma: An Uncontrolled, Open-Label Study

Authors Wang Y, Meng X, Zhou S, Zhu Y, Xu J, Tao R

Received 11 August 2019

Accepted for publication 23 November 2019

Published 3 December 2019 Volume 2019:12 Pages 10579—10585

DOI https://doi.org/10.2147/OTT.S226804

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Ms Sandhya Gopi

Peer reviewer comments 2

Editor who approved publication: Dr Teng


Yong Wang, Xiangji Meng, Shizhen Zhou, Yufang Zhu, Jun Xu, Rongjie Tao

Department of Neurosurgery, Shandong Cancer Hospital Affiliated to Shandong University; Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People’s Republic of China

Correspondence: Rongjie Tao; Jun Xu
Department of Neurosurgery, Shandong Cancer Hospital Affiliated to Shandong University, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, No.440. Jiyan Road, Jinan 250117, People’s Republic of China
Email rongjietao@163.com; sdszlyy03@163.com

Objective: This study aimed to determine the efficacy and tolerability of apatinib plus dose-dense temozolomide (TMZ) as first-line treatment for recurrent glioblastoma (rGBM).
Methods: Patients with rGBM were enrolled in this study. Patients were subjected to concurrent treatment of apatinib (500 mg qd) and dose-dense TMZ (100 mg/m2, 7 days on with 7 days off) until disease progression or intolerable toxicity. Efficacy was evaluated using Response Assessment in Neuro-Oncology criteria for high-grade glioma. Safety was assessed using NCI-CTCAE 4.0. Survival was estimated with Kaplan–Meier curve and log rank test.
Results: From March 2016 to January 2018, 20 eligible patients who had relapsed from the standard chemoradiotherapy regimen (TMZ and radiotherapy) were enrolled in this study. The median follow-up time was 12 months. All patients were eligible for efficacy analysis. The objective response rate (ORR) was 45%. The disease control rate (DCR) was 90%. The median progress-free survival time was 6 months (95% CI, 5.3 to 7.8 months). The 6-month progression-free survival rate was 50%. The median overall survival was 9 months (95% CI, 8.2 to 12.2 months). The most common treatment-related adverse events were hypertension (21%), hand–foot syndrome (16%), leukopenia (14%), and thrombocytopenia (12%).
Conclusion: Apatinib combined with dose-dense TMZ was effective in terms of PFS, ORR, and DCR and was well tolerated after appropriate dose reduction in the Chinese population tested. Further randomized controlled clinical studies are needed to confirm the efficacy of apatinib combined with TMZ for treatment of rGBM.

Keywords: central nervous system, recurrence, glioblastoma, apatinib, temozolomide, vascular endothelial growth factor receptor
 

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