Sustained Preservation of Cognition and Prevention of Patient-Reported Symptoms with Hippocampal Avoidance during Whole-Brain Radiotherapy for Brain Metastases: Final Results of NRG Oncology CC001
Abstract
PURPOSE: Initial report of NRG Oncology CC001, a phase III trial of whole-brain radiotherapy plus memantine (WBRT+memantine) with or without hippocampal avoidance (HA), demonstrated neuroprotective effects of HA with median follow-up less than 8 months. Herein, we report the final results with complete cognition and patient-reported outcomes and longer-term follow-up exceeding one year. METHODS: Adult patients with brain metastases were randomized to HA-WBRT+memantine or WBRT+memantine. The primary endpoint was time to cognitive function failure, defined as decline using the reliable change index on the Hopkins Verbal Learning Test-Revised (HVLT-R), Controlled Oral Word Association (COWA), and/or the Trail Making Tests (TMT) A and B. Patient-reported symptom burden was assessed using the M.D. Anderson Symptom Inventory with Brain Tumor Module and EQ-5D-5L. RESULTS: Between July 2015 and March 2018, 518 patients were randomized. Median follow-up for alive patients was 12.1 months. The addition of HA to WBRT+memantine prevented cognitive failure (adjusted hazard ratio, 0.74, p=0.016), and was associated with less deterioration in TMT-B at 4 months (p=0.012) and HVLT-R Recognition at 4 (p=0.055) and 6 months (p=0.011). Longitudinal modeling of imputed data showed better preservation of all HVLT-R domains (p<0.005). Patients who received HA-WBRT+Memantine reported less symptom burden at 6 (p<0.001 using imputed data) and 12 months (p=0.026 using complete-case data; p<0.001 using…
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