title: Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study.
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.
  
  
  METHODS
  authorized conditions of use of 5-ALA.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Neurosurgery, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Teixidor
authors.affiliation: Department of Neurosurgery, Hospital Carlos Haya, Málaga, Spain.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Arráez
authors.affiliation: Department of Neurosurgery, Hospital del Mar, Barcelona, Spain.
authors.forename: Glòria
authors.initials: G
authors.lastname: Villalba
authors.affiliation: Department of Neurosurgery, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.
authors.forename: Roser
authors.initials: R
authors.lastname: Garcia
authors.affiliation: Department of Neurosurgery, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.
authors.forename: Manel
authors.initials: M
authors.lastname: Tardáguila
authors.affiliation: Department of Neurosurgery, Hospital Clínic I Provincial de Barcelona, Barcelona, Spain.
authors.forename: Juan José
authors.initials: JJ
authors.lastname: González
authors.affiliation: Department of Neurosurgery, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Rimbau
authors.affiliation: Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.|Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Vidal
authors.affiliation: Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain.|Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.
authors.forename: Eva
authors.initials: E
authors.lastname: Montané
mesh_terms: D000328:Adult; D000368:Aged; D000622:Aminolevulinic Acid / Q000009:adverse effects* / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D015331:Cohort Studies; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005910:Glioma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010818:Practice Patterns, Physicians'; D011336:Probability; D016016:Proportional Hazards Models; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000622:Aminolevulinic Acid