Radiosurgery versus open surgery for mesial temporal lobe epilepsy: The randomized, controlled ROSE trial

Nicholas M Barbaro¹, Mark Quigg², Mariann M Ward³, Edward F Chang³, Donna K Broshek⁴, John T Langfitt⁵, Guofen Yan⁶, Kenneth D Laxer⁷, Andrew J Cole⁸, Penny K Sneed⁹, Christopher P Hess¹⁰, Wei Yu⁶, Manjari Tripathi¹¹, Christianne N Heck¹², John W Miller¹³, Paul A Garcia¹⁴, Andrew McEvoy¹⁵, Nathan B Fountain², Vincenta Salanova¹⁶, Robert C Knowlton¹⁴, Anto Bagić¹⁷, Thomas Henry¹⁸, Siddharth Kapoor¹⁹, Guy McKhann²⁰, Adriana E Palade²¹, Markus Reuber²², Evelyn Tecoma²³

Affiliations

¹ Department of Neurological Surgery, Indiana University, Indianapolis, IN, USA.
² Department of Neurology, University of Virginia, Charlottesville, VA, USA.
³ Department of Neurosurgery, University of California San Francisco, San Francisco, CA, USA.
⁴ Department of Psychiatry, University of Virginia, Charlottesville, VA, USA.
⁵ Department of Neurology, University of Rochester, Rochester, NY, USA.
⁶ Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
⁷ Department of Neurology, California Pacific Medical Center, San Francisco, CA, USA.
⁸ Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.
⁹ Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA.
¹⁰ Department of Radiology, University of California San Francisco, San Francisco, CA, USA.
¹¹ Department of Neurology, All India Institute of Medical Science, New Delhi, India.
¹² Department of Neurology, University of Southern California, Los Angeles, CA, USA.
¹³ Department of Neurology, University of Washington, Seattle, WA, USA.
¹⁴ Department of Neurology, University of California San Francisco, San Francisco, CA, USA.
¹⁵ Department of Clinical and Experimental Epilepsy, University College London, London, UK.
¹⁶ Department of Neurology, Indiana University, Indianapolis, IN, USA.
¹⁷ Department of Neurology, University of Pittsburgh, Pittsburgh, PA, USA.
¹⁸ Department of Neurology, University of Minnesota, Minneapolis, MN, USA.
¹⁹ Department of Neurology, University of Kentucky, Lexington, KY, USA.
²⁰ Department of Neurosurgery, Columbia University, New York, NY, USA.
²¹ Department of Neurology, University of Louisville, Louisville, KY, USA.
²² Department of Neuroscience, University of Sheffield, Sheffield, UK.
²³ Department of Neurology, University of California San Diego, San Diego, CA, USA.

PMID: 29600809
DOI: 10.1111/epi.14045

Randomized Controlled Trial

Radiosurgery versus open surgery for mesial temporal lobe epilepsy: The randomized, controlled ROSE trial

Nicholas M Barbaro et al. Epilepsia. 2018 Jun.

. 2018 Jun;59(6):1198-1207.

doi: 10.1111/epi.14045. Epub 2018 Mar 30.

Authors

Affiliations

¹ Department of Neurological Surgery, Indiana University, Indianapolis, IN, USA.
² Department of Neurology, University of Virginia, Charlottesville, VA, USA.
³ Department of Neurosurgery, University of California San Francisco, San Francisco, CA, USA.
⁴ Department of Psychiatry, University of Virginia, Charlottesville, VA, USA.
⁵ Department of Neurology, University of Rochester, Rochester, NY, USA.
⁶ Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
⁷ Department of Neurology, California Pacific Medical Center, San Francisco, CA, USA.
⁸ Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.
⁹ Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA.
¹⁰ Department of Radiology, University of California San Francisco, San Francisco, CA, USA.
¹¹ Department of Neurology, All India Institute of Medical Science, New Delhi, India.
¹² Department of Neurology, University of Southern California, Los Angeles, CA, USA.
¹³ Department of Neurology, University of Washington, Seattle, WA, USA.
¹⁴ Department of Neurology, University of California San Francisco, San Francisco, CA, USA.
¹⁵ Department of Clinical and Experimental Epilepsy, University College London, London, UK.
¹⁶ Department of Neurology, Indiana University, Indianapolis, IN, USA.
¹⁷ Department of Neurology, University of Pittsburgh, Pittsburgh, PA, USA.
¹⁸ Department of Neurology, University of Minnesota, Minneapolis, MN, USA.
¹⁹ Department of Neurology, University of Kentucky, Lexington, KY, USA.
²⁰ Department of Neurosurgery, Columbia University, New York, NY, USA.
²¹ Department of Neurology, University of Louisville, Louisville, KY, USA.
²² Department of Neuroscience, University of Sheffield, Sheffield, UK.
²³ Department of Neurology, University of California San Diego, San Diego, CA, USA.

PMID: 29600809
DOI: 10.1111/epi.14045

Abstract

Objective: To compare stereotactic radiosurgery (SRS) versus anterior temporal lobectomy (ATL) for patients with pharmacoresistant unilateral mesial temporal lobe epilepsy (MTLE).

Methods: This randomized, single-blinded, controlled trial recruited adults eligible for open surgery among 14 centers in the USA, UK, and India. Treatment was either SRS at 24 Gy to the 50% isodose targeting mesial structures, or standardized ATL. Outcomes were seizure remission (absence of disabling seizures between 25 and 36 months), verbal memory (VM), and quality of life (QOL) at 36-month follow-up.

Results: A total of 58 patients (31 in SRS, 27 in ATL) were treated. Sixteen (52%) SRS and 21 (78%) ATL patients achieved seizure remission (difference between ATL and SRS = 26%, upper 1-sided 95% confidence interval = 46%, P value at the 15% noninferiority margin = .82). Mean VM changes from baseline for 21 English-speaking, dominant-hemisphere patients did not differ between groups; consistent worsening occurred in 36% of SRS and 57% of ATL patients. QOL improved with seizure remission. Adverse events were anticipated cerebral edema and related symptoms for some SRS patients, and cerebritis, subdural hematoma, and others for ATL patients.

Significance: These data suggest that ATL has an advantage over SRS in terms of proportion of seizure remission, and both SRS and ATL appear to have effectiveness and reasonable safety as treatments for MTLE. SRS is an alternative to ATL for patients with contraindications for or with reluctance to undergo open surgery.

Keywords: clinical trial; epilepsy surgery; focal epilepsy; quality of life; radiosurgery.

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Comment in

"Truths and roses have thorns about them" - Henry David Thoreau.
Cook MJ. Cook MJ. Epilepsia. 2018 Jun;59(6):1208-1209. doi: 10.1111/epi.14433. Epilepsia. 2018. PMID: 29873820 No abstract available.
How Can We Guide Patient Choice Between "Minimally Invasive" Radiosurgery Versus Resective Epilepsy Surgery?
Jehi L. Jehi L. Epilepsy Curr. 2018 Nov-Dec;18(6):367-368. doi: 10.5698/1535-7597.18.6.367. Epilepsy Curr. 2018. PMID: 30568549 Free PMC article. No abstract available.
Novel Applications of Stereotactic Radiosurgery Beyond Oncology: Prospective Trials in Functional Radiosurgery.
Trifiletti DM, Redmond KJ, Kim MM, Soltys SG, Milano MT, Hattangadi-Gluth JA. Trifiletti DM, et al. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):4-6. doi: 10.1016/j.ijrobp.2022.06.077. Int J Radiat Oncol Biol Phys. 2023. PMID: 36526398 No abstract available.

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Radiosurgery versus open surgery for mesial temporal lobe epilepsy: The randomized, controlled ROSE trial

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Radiosurgery versus open surgery for mesial temporal lobe epilepsy: The randomized, controlled ROSE trial

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Abstract

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