Neuro-oncology practice · 2025
Seizure prophylaxis in glioma surgery (SPRING): A multi-center, unblinded, randomized trial.
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Jenkinson Michael D, Bulbeck Helen, Burns Jackie, Rooney Alasdair G, Dobbie Richard, Carruthers Jade, Lessels Sarah, Watson Rachael, Gribben Ciara, Robinson Tomos, Vale Luke, Thompson Gerard, Erridge Sara C, Watts Colin, Marson Anthony G, Grant Robin, SPRING study Collaborators
Аннотация
BACKGROUND: 50%-80% of glioma patients will have seizures. Guidelines recommend against prophylactic anti-seizure medication, but levetiracetam is frequently prescribed. Our aim was to determine the effectiveness of 12-month prophylactic levetiracetam at reducing seizure risk.
METHODS: Seizure-naïve patients undergoing glioma surgery were randomized (1:1) to 12-month levetiracetam or no prophylaxis and followed until death or a maximum of 18-months. The primary outcome was 1-year risk of first seizure. Patients who died within 12 months of randomization without experiencing a seizure were excluded from the primary outcome analysis. Target accrual was 804 participants. The trial was registered (ISRCTN 49474281 and EudraCT 2018-001312-30).
RESULTS: Between October 10, 2019 and August 30, 2022, 96 patients, from 24 to 79 years of age, were randomized to levetiracetam (n = 49) or no prophylaxis (n = 47). The trial closed early due to slow accrual and the Covid pandemic. In the levetiracetam group, 17 patients had a seizure and 32 did not (19 survived ≥12 months, 13 died within 12 months). In the no-prophylaxis group, 15 patients had a seizure and 30 did not (21 survived ≥12 months, 9 died within 12 months). Seventeen of the 36 evaluable levetiracetam patients (47%) had a seizure, compared with 15 of 36 evaluable no-prophylaxis patients (41%) (OR: 1.25, 95% CI, 0.49-3.21, P = .64). There were no levetiracetam-related serious adverse events.
CONCLUSIONS: The seizure prophylaxis in glioma surgery (SPRING) trial provides no evidence of a difference between levetiracetam and no prophylaxis in the 12-month seizure risk in patients undergoing glioma surgery, but the study was underpowered. The role of prophylactic anti-seizure medication remains undefined.
METHODS: Seizure-naïve patients undergoing glioma surgery were randomized (1:1) to 12-month levetiracetam or no prophylaxis and followed until death or a maximum of 18-months. The primary outcome was 1-year risk of first seizure. Patients who died within 12 months of randomization without experiencing a seizure were excluded from the primary outcome analysis. Target accrual was 804 participants. The trial was registered (ISRCTN 49474281 and EudraCT 2018-001312-30).
RESULTS: Between October 10, 2019 and August 30, 2022, 96 patients, from 24 to 79 years of age, were randomized to levetiracetam (n = 49) or no prophylaxis (n = 47). The trial closed early due to slow accrual and the Covid pandemic. In the levetiracetam group, 17 patients had a seizure and 32 did not (19 survived ≥12 months, 13 died within 12 months). In the no-prophylaxis group, 15 patients had a seizure and 30 did not (21 survived ≥12 months, 9 died within 12 months). Seventeen of the 36 evaluable levetiracetam patients (47%) had a seizure, compared with 15 of 36 evaluable no-prophylaxis patients (41%) (OR: 1.25, 95% CI, 0.49-3.21, P = .64). There were no levetiracetam-related serious adverse events.
CONCLUSIONS: The seizure prophylaxis in glioma surgery (SPRING) trial provides no evidence of a difference between levetiracetam and no prophylaxis in the 12-month seizure risk in patients undergoing glioma surgery, but the study was underpowered. The role of prophylactic anti-seizure medication remains undefined.