102 - Effect of Early Integrated Neuropsychological Care in Patients with Brain Metastases: A Phase 2 Randomized Controlled Trial (ATHENA Trial)
Presenter(s)
H. K. Perlow1, E. Dawson2, K. Dibs3, A. Ritter4, Y. Sun5, D. Boulter6, A. Nalin7, R. Singh3, S. Beyer3, E. M. Thomas3, S. Zhu3, D. M. Blakaj3, J. C. Grecula3, R. Raval3, S. Vazquez2, S. Whitman2, C. Presley8, C. Pillainayagam9, P. Giglio10, and J. D. Palmer3; 1Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, 2Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, 3Department of Radiation Oncology, The Ohio State University Wexner Medical Center, Columbus, OH, 4The Ohio State University, Columbus, OH, 5Department of Population and Quantitative Health Sciences, School of Medicine, Cleveland, OH, 6Department of Radiology, The Ohio State University Wexner Medical Center, Columbus, OH, 7Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 8Department of Medical Oncology, The Ohio State University James Cancer Center, Columbus, OH, 9Department of Solid Tumor Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, 10Division of Neuro-Oncology, Ohio State University, Columbus, OH
Purpose/Objective(s):
Advancements in radiotherapy delivery through both hippocampal avoidance whole brain radiotherapy (HA-WBRT) and stereotactic radiosurgery (SRS) can better preserve quality-of-life (QOL) and mitigate the risk of cognitive decline. However, even patients treated with advanced brain radiotherapy (RT) techniques experience reductions in their QOL and cognitive abilities due to radiation, systemic therapy, or progression of disease. This Phase 2 Randomized Controlled Trial aimed to evaluate the impact of a neuropsychological evaluation and intervention with a certified neuropsychologist on QOL and cognitive function for brain metastases patients treated with RT.Materials/Methods:
Patients with brain metastases were randomized 1:1 to either neuropsychology evaluation and intervention plus brain RT or brain RT alone. The intervention arm included five appointments with the neuropsychology team for testing, evaluation, and counseling over a three-month period starting before initiation of RT. Patients with any number of brain metastases and an estimated survival of = 6 months were included. Exclusion criteria included prior WBRT and pre-existing mental disability. Stratification factors for randomization were Karnofsky performance status (KPS, > 70 vs. = 70) and radiation cohort (>15 brain metastases received WBRT, =15 received SRS). All patients receiving WBRT were prescribed memantine. The primary endpoint was deterioration of QOL at 3 months as measured by Functional Assessment of Cancer Therapy-Brain (FACT-Br). Repeated measures analysis of variance was used to measure QOL. Cognition was measured by Hopkins Verbal Learning Test-Revised, Controlled Oral Word Association Test, and Trail Making Test A/B, with cognitive decline defined as decline on at least one assessment using reliable change index.Results:
Between August 2022 and June 2024, 110 patients were randomized. Baseline characteristics were balanced between arms and included a median KPS of 90 (IQR 80, 90), median age of 62.5 years (IQR 54, 70), 53% female patients, and 43% of patients with a primary lung cancer. Most patients (74%) had =15 brain metastases. The median overall survival or time to last follow-up was 8.5 months. Deterioration of QOL at 3 months was not different between the control and intervention arms (p = 0.93). Cognitive decline incidence between the control and intervention arms was not significant at 3 months (24.1% vs. 27.3%) or 6 months (50.0% vs. 43.8%, p = 0.46). Additionally, there were no differences at 3 or 6 months with verbal fluency, executive function, immediate recall, delayed recall, or delayed recognition between arms.Conclusion:
This study did not meet its primary endpoint, better preserved QOL at 3 months, for patients receiving early integrated neuropsychological care. Further evaluation of the delayed impact (> 6 months) of neuropsychology intervention on QOL and cognitive function will be reported when data are available. (NCT05503251)