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Early Integrated Neuropsychological Care for Patients With Brain Metastases: A Randomized Controlled Trial (ATHENA
Haley K Perlow1, Erica L Dawson2, Yilun Sun3
1Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio.
Purpose:
Decline of quality of life (QOL) and cognitive function is common for patients with brain metastases receiving radiation therapy, but there is currently no standard of care for addressing those symptoms. This phase 2 randomized controlled trial examined the efficacy of early neuropsychological evaluation and integration to preserve QOL and cognition for patients treated with radiation for brain metastases.
Methods And Materials:
Patients with brain metastases seen in a radiation oncology department were eligible for inclusion and randomized 1:1 to neuropsychology integration versus standard of care. The neuropsychology integration involved 5 appointments over a 3-month period beginning prior to radiation therapy treatment initiation. QOL was measured with Functional Assessment of Cancer Therapy - Brain (FACT-Br) and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire assessments. Cognition was measured by the Hopkins Verbal Learning Test-Revised, Controlled Oral Word Association Test, and Trail Making Test A/B. Depression (Patient Health Questionnaire-9) and anxiety (General Anxiety Disorder-7) assessments were also collected. The primary endpoint was change in QOL 3 months after completion of radiation therapy, measured by FACT-Br. Longitudinal outcomes were analyzed using linear mixed-effects models adjusting for baseline score and radiation type.
Results:
From August 2022 to June 2024, 110 patients were enrolled. The median age and Karnofsky Performance Status were 62.5 (IQR, 54-70) and 90 (IQR, 80-90), respectively. A plurality of patients (43%) had primary lung cancer, and most patients (74%) had ≤15 brain metastases. With a median follow-up of 21.1 months (95% CI, 16.2-25.5), the primary endpoint was not met (estimated difference 0.27, SE = 0.19, P = .15). In exploratory analyses at 9 months, FACT-Br scores were higher in the integration arm (0.63, P = .006). There were no differences in neurocognitive function between arms.
Conclusions:
In this phase 2 randomized trial, the primary endpoint of improved FACT-Br QOL at 3 months after radiation therapy was not met. Exploratory findings at later timepoints suggest potential benefits in QOL.