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Safety and efficacy of 5-aminolevulinic acid for high grade glioma inusual clinical practice: a prospective cohort study.

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dc.contributor.author Teixidor, Pilar
dc.contributor.author Arráez, Miguel Ángel
dc.contributor.author Villalba Martínez, Gloria
dc.contributor.author Garcia, Roser
dc.contributor.author Tardáguila, Manel
dc.contributor.author González, Juan José
dc.contributor.author Rimbau, Jordi
dc.contributor.author Vidal, Xavier
dc.contributor.author Montané, Eva
dc.date.accessioned 2016-04-11T11:13:55Z
dc.date.available 2016-04-11T11:13:55Z
dc.date.issued 2016
dc.identifier.citation Teixidor P, Arráez MÁ, Villalba G, Garcia R, Tardáguila M, González JJ. et al. Safety and efficacy of 5-aminolevulinic acid for high grade glioma in usual clinical practice: a prospective cohort study. PLoS One. 2016 Feb 17;11(2):e0149244. doi: 10.1371/journal.pone.0149244.
dc.identifier.issn 1932-6203
dc.identifier.uri http://hdl.handle.net/10230/26067
dc.description.abstract BACKGROUND: During the last decade, the use of 5-aminolevulinic acid (5-ALA) has been steadily increasing in neurosurgery. The study's main objectives were to prospectively evaluate the effectiveness and safety of 5-ALA when used in clinical practice setting on high-grade gliomas' patients. METHODS: National, multicenter and prospective observational study. INCLUSION CRITERIA: authorized conditions of use of 5-ALA. EXCLUSION CRITERIA: contraindication to 5-ALA, inoperable or partial resected tumors, pregnancy and children. Epidemiological, clinical, laboratory, radiological, and safety data were collected. Effectiveness was assessed using complete resection of the tumor, and progression-free and overall survival probabilities. RESULTS: Between May 2010 and September 2014, 85 patients treated with 5-ALA were included, and 77 were suitable for the effectiveness analysis. Complete resection was achieved in 41 patients (54%). Surgeons considered suboptimal the fluorescence of 5-ALA in 40% of the patients assessed. The median duration of follow-up was 12.3 months. The progression-free survival probability at 6 months was 58%. The median duration overall survival was 14.2 months. Progression tumor risk factors were grade of glioma, age and resection degree; and death risk factors were grade of glioma and gender. No severe adverse effects were reported. At one month after surgery, new or increased neurological morbidity was 6.5%. Hepatic enzymes were frequently increased within the first month after surgery; however, they subsequently normalized, and this was found to have no clinical significance. CONCLUSION: In clinical practice, the 5-ALA showed a good safety profile, but the benefits related to 5-ALA have not been yet clearly shown. The improved differentiation expected by fluorescence between normal and tumor cerebral tissue was suboptimal in a relevant number of patients; in addition, the expected higher degree of resection was lower than in clinical trials as well as incomplete resection was not identified as a prognostic factor risk for death. Because optimal fluorescence was correlated to higher complete resection rate, further research is needed to identify patients (or tumors) with more surgery benefits when using the 5-ALA.
dc.description.sponsorship Funding for this work was provided by the Spanish Ministry of Health (through two research projects which codes were: TRA-085 [convocatoria de ayudas para el fomento de la traslación de la aplicación de terapéutica de medicamentos de uso humano, huérfanos y terapias avanzadas de la Orden Ministerial SAS 2481/2009] and EC11-040 [convocatoria de ayudas para la investigación clínica independiente de la Orden Ministerial SPI 2885/ 2011]).
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher Public Library of Science 
dc.rights © 2016 Teixidor et al. This is an open access article distributed under the terms of the http://creativecommons.org/licenses/by/4.0/, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source arecredited.
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.subject.other Sistema nerviós--Cirurgia
dc.subject.other Tumors -- Tractament
dc.title Safety and efficacy of 5-aminolevulinic acid for high grade glioma inusual clinical practice: a prospective cohort study.
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0149244
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion

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