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

Year: 2019
Type: article
Study design: Clinical Trial
Abstract: 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: , 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.
Language: English
Subfield: Genetics
Field: Medicine
Open Access status: gold
Estimated APC paid: $2,836
OpenAlex ID: W2990419607
FWCI: 1.74
Cites: 34
Cited by: 29
Related to: 10