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Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial
The Lancet Oncology - Online First, 10/07/09

Chang EL et al. – Patients treated with SRS plus WBRT were at a greater risk of a significant decline in learning and memory function by 4 months compared with the group that received SRS alone. Initial treatment with a combination of SRS and close clinical monitoring is recommended as the preferred treatment strategy to better preserve learning and memory in patients with newly diagnosed brain metastases.

• Patients with 1 to 3 newly diagnosed brain metastases randomly assigned using standard permutated block algorithm with random block sizes to SRS plus WBRT or SRS alone from Jan 2, 2001, to Sept 14, 2007
• Patients stratified by recursive partitioning analysis class, number of brain metastases, and radioresistant histology
• Randomisation sequence masked until assignation, at which point both clinicians and patients were made aware of treatment allocation
• Primary endpoint was neurocognitive function: objectively measured as significant deterioration (5-point drop compared with baseline) in Hopkins Verbal Learning Test—Revised (HVLT-R) total recall at 4 months
• Independent data monitoring committee monitored the trial using Bayesian statistical methods.
• Analysis by intention-to-treat

• After 58 patients recruited , the trial was stopped by data monitoring committee according to early stopping rules on basis that there was high probability (96%) that patients randomly assigned to receive SRS plus WBRT significantly more likely to show decline in learning and memory function (mean posterior probability of decline 52%) at 4 months than patients assigned to receive SRS alone (mean posterior probability of decline 24%)
• At 4 months there were 4 deaths (13%) in group that received SRS alone, and 8 deaths (29%) in group that received SRS plus WBRT
• 73% of patients in SRS plus WBRT group free from CNS recurrence at 1 year, compared with 27% of patients who received SRS alone
• SRS plus WBRT group, 1 case of grade 3 toxicity (seizures, motor neuropathy, depressed level of consciousness) attributed to radiation treatment
• In the group that received SRS, 1 case of grade 3 toxicity (aphasia) attributed to radiation treatment
• 2 cases of grade 4 toxicity in group that received SRS alone diagnosed as radiation necrosis

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