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

Nicholas M. Barbaro; Mark Quigg; Mariann M. Ward; Edward F. Chang; Donna K. Broshek; John T. Langfitt; Guofen Yan; Kenneth D. Laxer; Andrew J. Cole; Penny K. Sneed; Christopher P. Hess; Wei Yu; Manjari Tripathi; Christianne N. Heck; John W. Miller; Paul A. Garcia; Andrew McEvoy; Nathan B. Fountain; Vincenta Salanova; Robert C. Knowlton; Anto Bagić; Thomas Henry; Siddharth Kapoor; Guy McKhann; Adriana E. Palade; Markus Reuber; Evelyn Tecoma

doi:10.1111/epi.14045

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

Nicholas M. Barbaro, Mark Quigg, Mariann M. Ward, Edward F. Chang, Donna K. Broshek, John T. Langfitt, Guofen Yan, Kenneth D. Laxer, Andrew J. Cole, Penny K. Sneed, Christopher P. Hess, Wei Yu, Manjari Tripathi, Christianne N. Heck, John W. Miller, Paul A. Garcia, Andrew McEvoy, Nathan B. Fountain, Vincenta Salanova, Robert C. KnowltonAnto Bagić, Thomas Henry, Siddharth Kapoor, Guy McKhann, Adriana E. Palade, Markus Reuber, Evelyn Tecoma

Neurology

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74 Scopus citations

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.

Original language	English (US)
Pages (from-to)	1198-1207
Number of pages	10
Journal	Epilepsia
Volume	59
Issue number	6
DOIs	https://doi.org/10.1111/epi.14045
State	Published - Jun 2018

Bibliographical note

Publisher Copyright:
Wiley Periodicals, Inc. © 2018 International League Against Epilepsy

Keywords

clinical trial
epilepsy surgery
focal epilepsy
quality of life
radiosurgery

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Barbaro, N. M., Quigg, M., Ward, M. M., Chang, E. F., Broshek, D. K., Langfitt, J. T., Yan, G., Laxer, K. D., Cole, A. J., Sneed, P. K., Hess, C. P., Yu, W., Tripathi, M., Heck, C. N., Miller, J. W., Garcia, P. A., McEvoy, A., Fountain, N. B., Salanova, V., ... Tecoma, E. (2018). Radiosurgery versus open surgery for mesial temporal lobe epilepsy: The randomized, controlled ROSE trial. Epilepsia, 59(6), 1198-1207. https://doi.org/10.1111/epi.14045

Barbaro, NM, Quigg, M, Ward, MM, Chang, EF, Broshek, DK, Langfitt, JT, Yan, G, Laxer, KD, Cole, AJ, Sneed, PK, Hess, CP, Yu, W, Tripathi, M, Heck, CN, Miller, JW, Garcia, PA, McEvoy, A, Fountain, NB, Salanova, V, Knowlton, RC, Bagić, A, Henry, T, Kapoor, S, McKhann, G, Palade, AE, Reuber, M & Tecoma, E 2018, 'Radiosurgery versus open surgery for mesial temporal lobe epilepsy: The randomized, controlled ROSE trial', Epilepsia, vol. 59, no. 6, pp. 1198-1207. https://doi.org/10.1111/epi.14045

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

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",

author = "Barbaro, {Nicholas M.} and Mark Quigg and Ward, {Mariann M.} and Chang, {Edward F.} and Broshek, {Donna K.} and Langfitt, {John T.} and Guofen Yan and Laxer, {Kenneth D.} and Cole, {Andrew J.} and Sneed, {Penny K.} and Hess, {Christopher P.} and Wei Yu and Manjari Tripathi and Heck, {Christianne N.} and Miller, {John W.} and Garcia, {Paul A.} and Andrew McEvoy and Fountain, {Nathan B.} and Vincenta Salanova and Knowlton, {Robert C.} and Anto Bagi{\'c} and Thomas Henry and Siddharth Kapoor and Guy McKhann and Palade, {Adriana E.} and Markus Reuber and Evelyn Tecoma",

note = "Publisher Copyright: Wiley Periodicals, Inc. {\textcopyright} 2018 International League Against Epilepsy",

year = "2018",

month = jun,

doi = "10.1111/epi.14045",

language = "English (US)",

volume = "59",

pages = "1198--1207",

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T1 - Radiosurgery versus open surgery for mesial temporal lobe epilepsy

T2 - The randomized, controlled ROSE trial

AU - Barbaro, Nicholas M.

AU - Quigg, Mark

AU - Ward, Mariann M.

AU - Chang, Edward F.

AU - Broshek, Donna K.

AU - Langfitt, John T.

AU - Yan, Guofen

AU - Laxer, Kenneth D.

AU - Cole, Andrew J.

AU - Sneed, Penny K.

AU - Hess, Christopher P.

AU - Yu, Wei

AU - Tripathi, Manjari

AU - Heck, Christianne N.

AU - Miller, John W.

AU - Garcia, Paul A.

AU - McEvoy, Andrew

AU - Fountain, Nathan B.

AU - Salanova, Vincenta

AU - Knowlton, Robert C.

AU - Bagić, Anto

AU - Henry, Thomas

AU - Kapoor, Siddharth

AU - McKhann, Guy

AU - Palade, Adriana E.

AU - Reuber, Markus

AU - Tecoma, Evelyn

PY - 2018/6

Y1 - 2018/6

N2 - 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.

AB - 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.

KW - clinical trial

KW - epilepsy surgery

KW - focal epilepsy

KW - quality of life

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

Abstract

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Keywords

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