RT Journal Article
T1 Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study.
A1 Teixidor, Pilar
A1 Arráez, Miguel Ángel
A1 Villalba, Glòria
A1 Garcia, Roser
A1 Tardáguila, Manel
A1 González, Juan José
A1 Rimbau, Jordi
A1 Vidal, Xavier
A1 Montané, Eva
K1 Anciano
K1 Adulto
K1 Ácido aminolevulínico
K1 Neoplasias cerebrales
K1 Estudios de cohortes
K1 Progresión de la enfermedad
K1 Supervivencia sin enfermedad
K1 Femenino
K1 Glioma
K1 Humanos
K1 Masculino
K1 Mediana edad
K1 Patrones de la práctica médica
K1 Análisis multifactorial
K1 Probabilidad
K1 Modelos de riesgos proporcionales
K1 Resultado del tratamiento
K1 Adulto joven
AB BACKGROUNDDuring 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.METHODSNational, multicenter and prospective observational study.INCLUSION CRITERIAauthorized conditions of use of 5-ALA.EXCLUSION CRITERIAcontraindication 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.RESULTSBetween 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.CONCLUSIONIn 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.
PB Public Libray of Science
YR 2016
FD 2016-02-17
LK http://hdl.handle.net/10668/2393
UL http://hdl.handle.net/10668/2393
LA en
NO 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; 11(2):e0149244
NO Journal Article; Research Support, Non-U.S. Gov't;
DS RISalud
RD Apr 7, 2025