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trial brain-metastases quality-of-life RCT

Early neuropsychological care did not improve three-month quality of life in brain metastases

ATHENA did not improve FACT-Br scores at three months, although an exploratory nine-month analysis favoured neuropsychological integration.

RadOncToday · ·1 min read

KEY POINTS

  • ATHENA was a single-centre phase 2 trial that randomized 110 patients with brain metastases 1:1 to standard care or early neuropsychological integration. Eligible patients were scheduled for intracranial radiotherapy, had an estimated survival of at least six months and had no previous whole-brain radiotherapy or major pre-existing neurological disorder.
  • The intervention included five neuropsychology appointments over approximately three months, beginning before radiotherapy. Patients underwent formal assessments, individualized feedback, review of cognitive compensatory strategies and management recommendations for sleep, fatigue, emotional symptoms, pain, nutrition and medication burden.
  • Patients with 15 or fewer brain metastases received stereotactic radiosurgery, while those with more than 15 received a prespecified whole-brain radiotherapy approach with memantine. Overall, 74% received stereotactic radiosurgery, median age was 63 years and median Karnofsky Performance Status was 90.
  • The primary endpoint was not met. The adjusted intervention-versus-control difference in FACT-Br quality-of-life score at three months was 0.27 (standard error 0.19; p = 0.15), with evaluable data from only 34 control and 32 intervention patients.
  • In an exploratory nine-month analysis, FACT-Br scores favoured neuropsychological integration, with an estimated difference of 0.63 (p = 0.006). However, only 19 control and 15 intervention patients contributed data at that timepoint, and no benefit was observed on FACT-G or EORTC global quality-of-life scores.
  • Neuropsychological integration did not improve Hopkins Verbal Learning Test, Trail Making Test or verbal-fluency outcomes. No individual neurocognitive comparison remained significant after multiplicity correction, and cumulative incidence of neurocognitive decline did not differ between arms.
  • Only 25 of 56 intervention patients (45%) completed all five neuropsychology sessions. Retention for FACT-Br declined to 47%, 31% and 30% at six, nine and 12 months, respectively; no intervention-related adverse events were reported.

CLINICAL TAKEAWAY

Routine five-visit neuropsychological integration cannot be considered proven to preserve quality of life or cognition after brain-metastasis radiotherapy because ATHENA missed its primary endpoint. The later quality-of-life signal is hypothesis-generating, particularly given substantial mortality-related attrition and the small number of evaluable patients at nine months.

SOURCE

International Journal of Radiation Oncology, Biology, Physics