Neurocognitive function and quality of life results from a phase 2 study of temozolomide-based CRT regimen for high-risk low-grade gliomas

The multicenter phase 2 NRG/RTOG 0424 study evaluated radiation and concurrent and adjuvant temozolomide (RT-TMZ) in patients with high-risk low-grade glioma (HR-LGG). Neurocognitive function (NCF) and quality of life (QOL) results from the study have now-been published. Standardized NCF tests were performed at baseline, 6, and 12 months. Rates of changes in NCF were examined using the reliable change index (RCI) on Hopkins Verbal Learning Test (HVLT), Trail Making Test (TMT), and Controlled Oral Word Association (COWA). QOL was assessed using FACT-Brain subscale. From January 2005 to August 2009, a total of 129 evaluable patients were accrued, and 93 completed at least the baseline and one post-treatment NCF/QOL measurement. RCI-determined decline occurred in 50% at 6 months and 40% at 12 months, and was most-frequent on HVLT (21%, 20%), TMTA (29%, 20%), and TMTB (22%, 14%). QOL decline on the FACT-Br occurred in about 25% at 6 and 12 months. Several tumor and clinical characteristics were associated with worse NCF including tumor crossing the midline, the number of high-risk factors, and EORTC OS risk group. The authors conclude that many patients with HR-LGG experience NCF decline in the first year after treatment with RT-TMZ., while QOL remained stable or improved.