期刊
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
卷 307, 期 9, 页码 922-930出版社
AMER MEDICAL ASSOC
DOI: 10.1001/jama.2012.220
关键词
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资金
- National Institutes of Health (NIH)
- National Institute of Neurological Disorders and Stroke (NINDS)
- Medtronics
- Valeant
- Acorda
- US Food and Drug Administration
- Esai
- Johnson Johnson
- Novartis
- Lippincott [WO2009/123734A1, WO2009/123735A1]
- UCB Pharmaceuticals
- Teva Pharmaceutical Industries
- Smith and Nephew
- Synosia
- Impax Pharmaceuticals
- Medivation
- NeuroSearch Sweden AB
- Boehringer-Ingelheim
- Pfizer
- Canadian Institutes of Health Research
- International League Against Epilepsy
- UCSF/Elekta
- Northern Illinois University
- University of Cincinnatti
- NIH CSR (Center for Scientific Review)
- NINDS
- Agency for Healthcare Research and Quality
- UCB
- Vertex
- Sunovion
- Eisai
- Neuropace
- SK Life Sciences
- Neuronex
- Epilepsia
- National Institutes of Health [R21 NS37897, U01 NS42372]
Context Despite reported success, surgery for pharmacoresistant seizures is often seen as a last resort. Patients are typically referred for surgery after 20 years of seizures, often too late to avoid significant disability and premature death. Objective We sought to determine whether surgery soon after failure of 2 antiepileptic drug (AED) trials is superior to continued medical management in controlling seizures and improving quality of life (QOL). Design, Setting, and Participants The Early Randomized Surgical Epilepsy Trial (ERSET) is a multicenter, controlled, parallel-group clinical trial performed at 16 US epilepsy surgery centers. The 38 participants (18 men and 20 women; aged >= 12 years) had mesial temporal lobe epilepsy (MTLE) and disabling seizues for no more than 2 consecutive years following adequate trials of 2 brand-name AEDs. Eligibility for anteromesial temporal resection (AMTR) was based on a standardized presurgical evaluation protocol. Participants were randomized to continued AED treatment or AMTR 2003-2007, and observed for 2 years. Planned enrollment was 200, but the trial was halted prematurely due to slow accrual. Intervention Receipt of continued AED treatment (n=23) or a standardized AMTR plus AED treatment (n=15). In the medical group, 7 participants underwent AMTR prior to the end of follow-up and 1 participant in the surgical group never received surgery. Main Outcome Measures The primary outcome variable was freedom from disabling seizures during year 2 of follow-up. Secondary outcome variables were health-related QOL (measured primarily by the 2-year change in the Quality of Life in Epilepsy 89 [QOLIE-89] overall T-score), cognitive function, and social adaptation. Results Zero of 23 participants in the medical group and 11 of 15 in the surgical group were seizure free during year 2 of follow-up (odds ratio=infinity; 95% CI, 11.8 to infinity; P<.001). In an intention-to-treat analysis, the mean improvement in QOLIE-89 overall T-score was higher in the surgical group than in the medical group but this difference was not statistically significant (12.6 vs 4.0 points; treatment effect=8.5; 95% CI, -1.0 to 18.1; P=.08). When data obtained after surgery from participants in the medical group were excluded, the effect of surgery on QOL was significant (12.8 vs 2.8 points; treatment effect=9.9; 95% CI, 2.2 to 17.7; P=.01). Memory decline (assessed using the Rey Auditory Verbal Learning Test) occurred in 4 participants (36%) after surgery, consistent with rates seen in the literature; but the sample was too small to permit definitive conclusions about treatment group differences in cognitive outcomes. Adverse events included a transient neurologic deficit attributed to a magnetic resonance imaging-identified postoperative stroke in a participant who had surgery and 3 cases of status epilepticus in the medical group. Conclusions Among patients with newly intractable disabling MTLE, resective surgery plus AED treatment resulted in a lower probability of seizures during year 2 of follow-up than continued AED treatment alone. Given the premature termination of the trial, the results should be interpreted with appropriate caution.
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