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Seizure Risk in Patients With Brain Metastases: Interim Analysis From a Prospective Observational Study. Is it Time
J de Boisanger1, J Konadu2, A Tran2
1The Royal Marsden Hospital, Fulham Road, London, SW3 6JJ, UK; The Institute of Cancer Research, 123 Old Brompton Road, London, SW7 3RP, UK.
Aim:
Seizures are a common complication of brain metastases (BMs) and, in the UK, their diagnosis results in a driving ban enforced for 1-2 years with significant lifestyle implications. This driving ban is based on an estimated seizure risk ≥20%. However, the studies to support this figure are retrospective, heterogenous, and outdated. We present the interim analysis of the SAFER study, which reports for the first time the seizure rate in patients with BMs after stereotactic radiosurgery (SRS) from a prospective study.
Materials And Methods:
The first 75 patients to be recruited to the SAFER study were included in this pre-planned interim analysis. The primary endpoint was the demonstration of a post-SRS seizure rate <20%, using an exact two-sided binomial test with an alpha of 0.05.
Results:
Post-SRS seizure incidence was 10.7% (95% CI 4.7-19.9%). The cumulative incidence function, accounting for the competing risk of death, was also 10.7% (95% CI 5.0-18.8%). The new-onset seizure rate was 9.2% (95% CI 3.5-19.0%). Of those seizure-free at 6 months, the risk of experiencing a seizure by 12 months was 5.8% (3/52), and in those who were seizure-free by 9 months, no new seizures were observed by 12 months.
Conclusion:
This study is the first to prospectively evaluate seizures as a primary endpoint in patients undergoing SRS for BMs. Our results indicate a seizure rate that is considerably below 20% and reduces over time. These findings may change patient and clinician perceptions of post-SRS BM seizure risk and could have implications for UK driving regulations.
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