Table 1

Outcomes for individual patient data meta-analysis

OutcomeDefinition
Primary outcome
ic-PFS at 12 monthsKaplan-Meier estimate at 12 months. Time from randomisation to intracranial disease progression, as defined according to RANO-BM
Secondary outcomes
ic-PFSTime from randomisation to intracranial disease progression, as defined according to RANO-BM
ec-PFSTime from randomisation to extracranial disease progression, as defined according to response evaluation criteria in solid tumours
PFSTime from randomisation to any disease progression
Overall survivalTime from randomisation to death
Time to salvage whole-brain radiotherapyTime from randomisation to salvage whole-brain radiotherapy
Time to salvage stereotactic radiosurgeryTime from randomisation to salvage stereotactic radiotherapy
Time to local brain failureTime from randomisation to local brain failure
Time to distant progressionTime from randomisation to distant disease progression
Quality of lifeEORTC QLQ for cancer (QLQ-C30). This is the core module of the QLQ suite.
EORTC QLQ for brain neoplasm (QLQ-BN20). This is the brain tumour module.
Adverse events of special interestRates of the following adverse events (e.g.): radiation necrosis, neurocognitive impairment, oedema cerebral, muscle weakness right side, muscle weakness left side, fatigue, gait disturbance, headache, seizures, tremors, lethargy, dizziness, syncope, stroke and intracranial haemorrhage.
  • ec-PFS, etracranial progression-free survival; EORTC, European Organization for Research and Treatment of Cancer; ic-PFS, intracranial progression-free survival; QLQ, Quality of Life Questionnaire ; RANO, response assessment in neuro-oncology.