NEW YORK (Reuters Health) – When antiepileptic drug therapy fails to control disabling temporal lobe epilepsy adequately, patients have a much better chance of becoming seizure free with early resective surgery than with continued medical management.
That finding, from the Early Randomized Surgical Epilepsy Trial (ERSET), is reported in the Journal of the American Medical Association for March 7. However, the trial was stopped after 38 participants were enrolled rather than 200 as planned, because of slow recruitment.
“Given the premature termination of the trial, the results should be interpreted with appropriate caution,” advise Dr. Jerome Engel Jr., at the David Geffen School of Medicine at UCLA in Los Angeles, California, and colleagues.
In their paper, they note that surgery for patients with drug-resistant seizures is often deferred, typically for 20 years, until it is “too late to avoid significant disability and premature death.”
In ERSET, patients with mesial temporal lobe epilepsy (MTLE) and disabling seizures for no more than 2 years after adequate treatment with two antiepileptic drugs (AEDs) were randomized to anteromesial temporal resection (AMTR) and AED treatment (n=15) or continued AED therapy only (n=23).
The primary outcome, freedom from seizures during 2 years of follow-up, was achieved by 11 patients in the surgery group but by none of those in the medical management group (p<0.001), the authors report.
On intention-to-treat basis, the secondary outcome of epilepsy-related quality of life was better in the surgery group than the medical group (T scores 12.6 vs 4.0), although the difference was not statistically significant (p=0.08), the report indicates.
Numbers were too small to reach definitive conclusions about differences in cognitive outcomes between groups. However, 80% of the surgery group were driving an automobile at month 24 compared with 22% of those in the medical arm. The number of days socializing increased by a median of 6.5 days per month in the AMTR group but decreased by 1 day in the AED group, the authors found.
One patient in the surgery group had a postoperative stroke, and there were three cases of status epilepticus in the medical group, Dr. Engel and colleagues report.
Summing up, they write, “Surgery was superior to pharmacotherapy for MTLE with respect to seizure outcome, and the data strongly suggested that surgery also improved QOL and ability and access to driving and socialization, despite the small number of participants.”
They add, “The results of this study support the conclusions of the American Academy of Neurology practice parameter, namely that all patients with epilepsy should be referred to an epilepsy center as soon as trials of 2 AEDs fail, and surgery should be performed if patients meet criteria for an AMTR.”
The authors of an editorial point out that, despite the clear benefit of early surgery, freedom from seizures did not predict return to work. “Patients with MTLE need ongoing counseling and access to work-related training whether they receive surgery or not,” they comment.
SOURCE:
JAMA 2012; 307:922-930,966-967.
