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PURPOSE: To report the long-term outcomes and MGMT analysis of temozolomide (TMZ) and radiotherapy (RT) in a high-risk low-grade gliomas (LGG) population. PATIENTS/ METHODS For this single-arm phase II study,… Click to show full abstract
PURPOSE: To report the long-term outcomes and MGMT analysis of temozolomide (TMZ) and radiotherapy (RT) in a high-risk low-grade gliomas (LGG) population. PATIENTS/ METHODS For this single-arm phase II study, LGG patients with ≥3 risk factors (age ≥40, astrocytoma, bi-hemispheric tumor, size ≥6 cm or preoperative neurologic function status >1) received RT (54 Gy/30 fractions) with TMZ and up to 12 cycles of post-RT TMZ. The primary endpoint was overall survival (OS) at 3 years after registration. A one-sided Z-test was used to test the hazard rate based on the observed 3-year OS rate versus a prespecified historical control from the EORTC high-risk LGG population. Secondary endpoints included progression-free survival (PFS), and the association of survival outcomes with MGMT methylation status, for which the MGMT-STP27 prediction model was used based on 450k data. The initial report of this study was published in 2015, when the results of the MGMT analysis were unavailable.