Abstract BACKGROUND Glioblastoma (GBM) is the most common and aggressive primary brain tumor in adults, with particularly poor survival outcome in elderly patients (≥65 years) with unmethylated MGMT promoter (MGMTp). Standard treatment for this population consists of hypofractionated radiotherapy with concurrent Temozolomide (TMZ), followed by adjuvant TMZ. However, elderly patients with unmethylated MGMTp have limited benefit from this adjuvant regimen. Daily (metronomic) TMZ may overcome MGMT-related resistance by depleting MGMT activity and could have antiangiogenic effects. We hypothesize this alternative dosing strategy could improve outcomes. METHODS TEMPO will be phase II, single-arm, open-label trial designed to evaluate the efficacy and safety of daily TMZ in patients ≥65 years with newly diagnosed GBM and unmethylated MGMTp. Patients will be enrolled after completing hypofractionated radiotherapy (40 Gy in 15 fractions) with concurrent TMZ. Adjuvant daily TMZ (50 mg/m2) will be given continuously for up to 6 cycles (28-day cycles) or until disease progression or unacceptable toxicity. The primary endpoint is overall survival (OS), compared to historical data from the CE.6 trial (median OS 10.0 months). Secondary endpoints include progression-free survival (PFS) and toxicity (CTCAE v5.0). A total of 118 patients will be enrolled to detect a 3-month improvement in median OS (80% power, one-sided α of 0.05).
Godoy-Santín et al. (Fri,) studied this question.
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