Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study
Teixidor, Pilar (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Arráez, Miguel Ángel (Hospital Regional Universitario de Málaga)
Villalba, Glòria (Hospital del Mar (Barcelona, Catalunya))
Garcia, Roser (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Tardáguila, Manel (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
González Sánchez, Juan José (Hospital Clínic i Provincial de Barcelona)
Rimbau, Jordi (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Vidal Guitart, Xavier (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Montané Esteva, Eva (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)

Date:	2016
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.
Note:	Altres ajuts: TRA-085
Note:	Altres ajuts: EC11-040
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Cervell ; Tumors ; 5-Aminolevulinic Acid ; 5-ALA ; Glioma
Published in:	PloS one, Vol. 11 Núm. 2 (February 2016) , ISSN 1932-6203

DOI: 10.1371/journal.pone.0149244
PMID: 26885645

12 p, 450.2 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles