Phase II propensity-matched controlled trial evaluating metformin as an adjunct to neo-adjuvant, concomitant, and adjuvant temozolomide and hypofractionated-accelerated radiotherapy (M-HART) in glioblastoma patients (NCT02780024)
Abstract
2064
Background:
Phase II, propensity-matched trial, to assess feasibility and toxicity of adding Metformin (MTF) to neo-adjuvant, concomitant and adjuvant Temozolomide (TMZ) and hypofractionated accelerated radiotherapy (M-HART), for patients with Glioblastoma (GBM). We compared median survival time (MST), and progression-free-survival (PFS) of M-HART versus a contemporaneous cohort of propensity-score matched controls (PSMC) who received standard of care (SOC).
Methods:
Eligible patients were ≥ 18 years with newly diagnosed GBM, ECOG score ≤ 2, with known MGMT status, gross total or partial resection, and residual surgical cavity > 15 mm from brainstem, or optic apparatus. Four weeks from surgery, M-HART patients started 2 weeks of neo-adjuvant MTF/TMZ followed by concomitant MTF/TMZ + HART 60 Gy/20 daily fractions, and 6 cycles of adjuvant MTF/TMZ. The PSMC patients received Stupp’s regimen. We used a nearest neighbor matching with a caliper width of 0.2 SD and compared patients’ characteristics using chi-square test (Table). Propensity scores were estimated using logistic regression model, with probability of M-HART treatment as dependent variable.
Results:
From April 2015 to November 2020, 50 patients participated in the M-HART trial and matched with 50 PSMC cohort treated during the same period, with a median follow up of 24.1 (M-HART) vs 17.6 months PSMC, respectively. M-HART patients had significantly longer MST of 24.1 (95% CI, 15.2- 30.3) vs. 17.7 months for PSMC…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 50 participants or records.
Read the paper
Related studies
- The Role of AMPK Activation for Cardioprotection in Doxorubicin-Induced Cardiotoxicity
- Hypoglycemic medicines in the treatment of Alzheimer’s disease: Pathophysiological links between AD and glucose metabolism
- Isorhamnetin Reduces Glucose Level, Inflammation, and Oxidative Stress in High-Fat Diet/Streptozotocin Diabetic Mice Model
- Modulating Sirtuin Biology and Nicotinamide Adenine Diphosphate Metabolism in Cardiovascular Disease—From Bench to Bedside
- Characterization of the SGLT2 Interaction Network and Its Regulation by SGLT2 Inhibitors: A Bioinformatic Analysis
- Early Treatment with Empagliflozin and GABA Improves β-Cell Mass and Glucose Tolerance in Streptozotocin-Treated Mice
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.