Author:
Yoon Wan-Soo,Chang Jong Hee,Kim Jeong Hoon,Kim Yu Jung,Jung Tae-Young,Yoo Heon,Kim Se-Hyuk,Ko Young-Cho,Nam Do-Hyun,Kim Tae Min,Kim Se Hoon,Park Sung-Hae,Lee Youn Soo,Yim Hyeon Woo,Hong Yong-Kil,Yang Seung Ho
Abstract
AbstractPurposeGlioblastoma (GBM) has a poor prognosis after standard treatment. Recently, metformin has been shown to have an antitumor effect on glioma cells. We performed the first randomized prospective phase II clinical trial to investigate the clinical efficacy and safety of metformin in patients with recurrent or refractory GBM treated with low-dose temozolomide.MethodsIncluded patients were randomly assigned to a control group [placebo plus low-dose temozolomide (50 mg/m2, daily)] or an experimental group [metformin (1000 mg, 1500 mg, and 2000 mg per day during the 1st, 2nd, and 3rd week until disease progression, respectively) plus low-dose temozolomide]. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), disease control rate, overall response rate, health-related quality of life, and safety.ResultsAmong the 92 patients screened, 81 were randomly assigned to the control group (43 patients) or the experimental group (38 patients). Although the control group showed a longer median PFS, the difference between the two groups was not statistically significant (2.66 versus 2.3 months,p = 0.679). The median OS was 17.22 months (95% CI 12.19–21.68 months) in the experimental group and 7.69 months (95% CI 5.16–22.67 months) in the control group, showing no significant difference by the log-rank test (HR: 0.78; 95% CI 0.39–1.58;p = 0.473). The overall response rate and disease control rate were 9.3% and 46.5% in the control group and 5.3% and 47.4% in the experimental group, respectively.ConclusionsAlthough the metformin plus temozolomide regimen was well tolerated, it did not confer a clinical benefit in patients with recurrent or refractory GBM.Trial registrationNCT03243851, registered August 4, 2017.
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Endocrine and Autonomic Systems,Endocrinology,Oncology,Endocrinology, Diabetes and Metabolism
Cited by
8 articles.
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