Neurocognitive function and quality of life results from a phase II study (NRG/RTOG 0424) of temozolomide-based chemoradiotherapy regimen for high-risk low-grade gliomas.

PURPOSE: This analysis of NRG/RTOG 0424 describes post-treatment changes in neurocognitive function (NCF) and quality of life (QOL) in patients with high-risk low-grade glioma (HR-LGG). METHODS: Patients with HR-LGG were treated with radiation and concurrent and adjuvant temozolomide (RT-TMZ). Standardized NCF tests were performed at baseline, 6, and 12 months. Rates of change 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). Relationships between NCF and subjective cognitive concerns (MOS-CF) were evaluated. QOL was assessed using Functional Assessment of Cancer Therapy - Brain (FACT-Br). Longitudinal modeling evaluated predictors of change in NCF and QOL. Cox models assessed the association of baseline NCF with overall survival (OS). RESULTS: From January 2005 to August 2009, 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% and 40% at 6 and 12 months, respectively and was most frequent on HVLT (21%, 20%), TMTA (29%, 20%), and TMTB (22%, 14%). MID-determined QOL decline on the FACT-Brain Subscale 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. CONCLUSIONS: Many patients with HR-LGG experience NCF decline in the first year after treatment with temozolomide-based concurrent chemoradiation. QOL remained stable or improved. Ongoing studies with integrated NCF monitoring using these tests will aid clinicians and patients in treatment decisions that seek to consider oncologic and functional outcomes.