Lacosamide in monotherapy in BTRE (brain tumor-related epilepsy): results from an Italian multicenter retrospective study

Purpose Lacosamide (LCM) is a third-generation anti-seizure medication (ASM) approved for focal onset epilepsy in patients aged ≥ 4.378 Previous studies have reported an efficacy of LCM as add-on treatment in brain tumor-related epilepsy (BTRE). To date, there are no studies in the literature focusi...

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Veröffentlicht in:Journal of neuro-oncology 2022-05, Vol.157 (3), p.551-559
Hauptverfasser: Mo, F., Meletti, S., Belcastro, V., Quadri, S., Napolitano, M., Bello, L., Dainese, F., Scarpelli, M., Florindo, I., Mascia, A., Pauletto, G., Bruno, F., Pellerino, A., Giovannini, G., Polosa, M., Sessa, M., Conti Nibali, M., Di Gennaro, G., Gigli, G. L., Pisanello, A., Cavallieri, F., Rudà, R.
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container_end_page 559
container_issue 3
container_start_page 551
container_title Journal of neuro-oncology
container_volume 157
creator Mo, F.
Meletti, S.
Belcastro, V.
Quadri, S.
Napolitano, M.
Bello, L.
Dainese, F.
Scarpelli, M.
Florindo, I.
Mascia, A.
Pauletto, G.
Bruno, F.
Pellerino, A.
Giovannini, G.
Polosa, M.
Sessa, M.
Conti Nibali, M.
Di Gennaro, G.
Gigli, G. L.
Pisanello, A.
Cavallieri, F.
Rudà, R.
description Purpose Lacosamide (LCM) is a third-generation anti-seizure medication (ASM) approved for focal onset epilepsy in patients aged ≥ 4.378 Previous studies have reported an efficacy of LCM as add-on treatment in brain tumor-related epilepsy (BTRE). To date, there are no studies in the literature focusing on lacosamide used in monotherapy to treat BTRE. In our retrospective study we investigated efficacy and tolerability of LCM in monotherapy in a multicenter national cohort of primary brain tumor patients. Methods We collected from 12 Italian Centers 132 patients with primary brain tumors who were treated with LCM in monotherapy. For each patient we evaluated seizure freedom at 3 and 6 months (primary endpoints), side effects and drop-out rate (secondary endpoints). Results Overall, LCM led to seizure freedom in 64.4% of patients at 3 months and 55% at 6 months. Patients who used two or more ASMs before LCM had a worse seizure control than patients in monotherapy with LCM as first choice. In 14 patients, we observed seizure control despite tumor progression on magnetic resonance (MRI). Multivariate analysis showed that gross-total resection at diagnosis was significantly associated with higher seizure freedom rate at 6 months. Side effects were mainly mild (grade 1–2 according to CTCAE classification) and drop-out rate was low (1.5%). Main side effects were dizziness and somnolence. Conclusions This is the first study showing a good efficacy and tolerability of LCM when used in monotherapy in BTRE. Further prospective studies are needed to confirm these preliminary data, investigating also quality of life and neurocognitive functions.
doi_str_mv 10.1007/s11060-022-03998-6
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L. ; Pisanello, A. ; Cavallieri, F. ; Rudà, R.</creator><creatorcontrib>Mo, F. ; Meletti, S. ; Belcastro, V. ; Quadri, S. ; Napolitano, M. ; Bello, L. ; Dainese, F. ; Scarpelli, M. ; Florindo, I. ; Mascia, A. ; Pauletto, G. ; Bruno, F. ; Pellerino, A. ; Giovannini, G. ; Polosa, M. ; Sessa, M. ; Conti Nibali, M. ; Di Gennaro, G. ; Gigli, G. L. ; Pisanello, A. ; Cavallieri, F. ; Rudà, R.</creatorcontrib><description>Purpose Lacosamide (LCM) is a third-generation anti-seizure medication (ASM) approved for focal onset epilepsy in patients aged ≥ 4.378 Previous studies have reported an efficacy of LCM as add-on treatment in brain tumor-related epilepsy (BTRE). To date, there are no studies in the literature focusing on lacosamide used in monotherapy to treat BTRE. In our retrospective study we investigated efficacy and tolerability of LCM in monotherapy in a multicenter national cohort of primary brain tumor patients. Methods We collected from 12 Italian Centers 132 patients with primary brain tumors who were treated with LCM in monotherapy. For each patient we evaluated seizure freedom at 3 and 6 months (primary endpoints), side effects and drop-out rate (secondary endpoints). Results Overall, LCM led to seizure freedom in 64.4% of patients at 3 months and 55% at 6 months. Patients who used two or more ASMs before LCM had a worse seizure control than patients in monotherapy with LCM as first choice. In 14 patients, we observed seizure control despite tumor progression on magnetic resonance (MRI). Multivariate analysis showed that gross-total resection at diagnosis was significantly associated with higher seizure freedom rate at 6 months. Side effects were mainly mild (grade 1–2 according to CTCAE classification) and drop-out rate was low (1.5%). Main side effects were dizziness and somnolence. Conclusions This is the first study showing a good efficacy and tolerability of LCM when used in monotherapy in BTRE. Further prospective studies are needed to confirm these preliminary data, investigating also quality of life and neurocognitive functions.</description><identifier>ISSN: 0167-594X</identifier><identifier>EISSN: 1573-7373</identifier><identifier>DOI: 10.1007/s11060-022-03998-6</identifier><identifier>PMID: 35397759</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Acetamides ; Anticonvulsants - therapeutic use ; Brain cancer ; Brain Neoplasms - complications ; Brain Neoplasms - drug therapy ; Brain tumors ; Clinical Study ; Cognition ; Convulsions &amp; seizures ; Drug-Related Side Effects and Adverse Reactions ; Epilepsies, Partial - complications ; Epilepsies, Partial - drug therapy ; Epilepsy ; Epilepsy - complications ; Epilepsy - etiology ; Humans ; Lacosamide - therapeutic use ; Magnetic resonance imaging ; Medicine ; Medicine &amp; Public Health ; Multivariate analysis ; Neurology ; Oncology ; Patients ; Quality of Life ; Retrospective Studies ; Seizures ; Seizures - drug therapy ; Side effects ; Treatment Outcome</subject><ispartof>Journal of neuro-oncology, 2022-05, Vol.157 (3), p.551-559</ispartof><rights>The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022</rights><rights>2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.</rights><rights>The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c490t-4433d3c06aa6b9239f39335e7b1022e7b343002aec8ee24657e4a5a5e4fd29fe3</citedby><cites>FETCH-LOGICAL-c490t-4433d3c06aa6b9239f39335e7b1022e7b343002aec8ee24657e4a5a5e4fd29fe3</cites><orcidid>0000-0002-8469-7567</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11060-022-03998-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11060-022-03998-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35397759$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mo, F.</creatorcontrib><creatorcontrib>Meletti, S.</creatorcontrib><creatorcontrib>Belcastro, V.</creatorcontrib><creatorcontrib>Quadri, S.</creatorcontrib><creatorcontrib>Napolitano, M.</creatorcontrib><creatorcontrib>Bello, L.</creatorcontrib><creatorcontrib>Dainese, F.</creatorcontrib><creatorcontrib>Scarpelli, M.</creatorcontrib><creatorcontrib>Florindo, I.</creatorcontrib><creatorcontrib>Mascia, A.</creatorcontrib><creatorcontrib>Pauletto, G.</creatorcontrib><creatorcontrib>Bruno, F.</creatorcontrib><creatorcontrib>Pellerino, A.</creatorcontrib><creatorcontrib>Giovannini, G.</creatorcontrib><creatorcontrib>Polosa, M.</creatorcontrib><creatorcontrib>Sessa, M.</creatorcontrib><creatorcontrib>Conti Nibali, M.</creatorcontrib><creatorcontrib>Di Gennaro, G.</creatorcontrib><creatorcontrib>Gigli, G. L.</creatorcontrib><creatorcontrib>Pisanello, A.</creatorcontrib><creatorcontrib>Cavallieri, F.</creatorcontrib><creatorcontrib>Rudà, R.</creatorcontrib><title>Lacosamide in monotherapy in BTRE (brain tumor-related epilepsy): results from an Italian multicenter retrospective study</title><title>Journal of neuro-oncology</title><addtitle>J Neurooncol</addtitle><addtitle>J Neurooncol</addtitle><description>Purpose Lacosamide (LCM) is a third-generation anti-seizure medication (ASM) approved for focal onset epilepsy in patients aged ≥ 4.378 Previous studies have reported an efficacy of LCM as add-on treatment in brain tumor-related epilepsy (BTRE). To date, there are no studies in the literature focusing on lacosamide used in monotherapy to treat BTRE. In our retrospective study we investigated efficacy and tolerability of LCM in monotherapy in a multicenter national cohort of primary brain tumor patients. Methods We collected from 12 Italian Centers 132 patients with primary brain tumors who were treated with LCM in monotherapy. For each patient we evaluated seizure freedom at 3 and 6 months (primary endpoints), side effects and drop-out rate (secondary endpoints). Results Overall, LCM led to seizure freedom in 64.4% of patients at 3 months and 55% at 6 months. Patients who used two or more ASMs before LCM had a worse seizure control than patients in monotherapy with LCM as first choice. In 14 patients, we observed seizure control despite tumor progression on magnetic resonance (MRI). Multivariate analysis showed that gross-total resection at diagnosis was significantly associated with higher seizure freedom rate at 6 months. Side effects were mainly mild (grade 1–2 according to CTCAE classification) and drop-out rate was low (1.5%). Main side effects were dizziness and somnolence. 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L.</au><au>Pisanello, A.</au><au>Cavallieri, F.</au><au>Rudà, R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Lacosamide in monotherapy in BTRE (brain tumor-related epilepsy): results from an Italian multicenter retrospective study</atitle><jtitle>Journal of neuro-oncology</jtitle><stitle>J Neurooncol</stitle><addtitle>J Neurooncol</addtitle><date>2022-05-01</date><risdate>2022</risdate><volume>157</volume><issue>3</issue><spage>551</spage><epage>559</epage><pages>551-559</pages><issn>0167-594X</issn><eissn>1573-7373</eissn><abstract>Purpose Lacosamide (LCM) is a third-generation anti-seizure medication (ASM) approved for focal onset epilepsy in patients aged ≥ 4.378 Previous studies have reported an efficacy of LCM as add-on treatment in brain tumor-related epilepsy (BTRE). To date, there are no studies in the literature focusing on lacosamide used in monotherapy to treat BTRE. In our retrospective study we investigated efficacy and tolerability of LCM in monotherapy in a multicenter national cohort of primary brain tumor patients. Methods We collected from 12 Italian Centers 132 patients with primary brain tumors who were treated with LCM in monotherapy. For each patient we evaluated seizure freedom at 3 and 6 months (primary endpoints), side effects and drop-out rate (secondary endpoints). Results Overall, LCM led to seizure freedom in 64.4% of patients at 3 months and 55% at 6 months. Patients who used two or more ASMs before LCM had a worse seizure control than patients in monotherapy with LCM as first choice. In 14 patients, we observed seizure control despite tumor progression on magnetic resonance (MRI). Multivariate analysis showed that gross-total resection at diagnosis was significantly associated with higher seizure freedom rate at 6 months. Side effects were mainly mild (grade 1–2 according to CTCAE classification) and drop-out rate was low (1.5%). Main side effects were dizziness and somnolence. Conclusions This is the first study showing a good efficacy and tolerability of LCM when used in monotherapy in BTRE. Further prospective studies are needed to confirm these preliminary data, investigating also quality of life and neurocognitive functions.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>35397759</pmid><doi>10.1007/s11060-022-03998-6</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-8469-7567</orcidid></addata></record>
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subjects Acetamides
Anticonvulsants - therapeutic use
Brain cancer
Brain Neoplasms - complications
Brain Neoplasms - drug therapy
Brain tumors
Clinical Study
Cognition
Convulsions & seizures
Drug-Related Side Effects and Adverse Reactions
Epilepsies, Partial - complications
Epilepsies, Partial - drug therapy
Epilepsy
Epilepsy - complications
Epilepsy - etiology
Humans
Lacosamide - therapeutic use
Magnetic resonance imaging
Medicine
Medicine & Public Health
Multivariate analysis
Neurology
Oncology
Patients
Quality of Life
Retrospective Studies
Seizures
Seizures - drug therapy
Side effects
Treatment Outcome
title Lacosamide in monotherapy in BTRE (brain tumor-related epilepsy): results from an Italian multicenter retrospective study
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