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Observational, retrospective study of the effectiveness of 5-aminolevulinic acid in malignant glioma surgery in Spain (The VISIONA study).

Al's Comment:

 5-aminolevulinic acid (also known as Gliolan) is a simple dye that is given before surgery that makes the tumor visible during surgery. It has been approved for years in Europe but not in the USA yet. This study shows that there is a better chance of removing the entire tumor and patients live longer when using it.  Doesn't make sense that it is not available in the USA.


Posted on: 04/10/2015

  Neurologia. 2014 Apr;29(3):131-8. doi: 10.1016/j.nrl.2013.05.004. Epub 2013 Jul 17.
Observational, retrospective study of the effectiveness of 5-aminolevulinic acid in malignant glioma surgery in Spain (The VISIONA study).
[Article in English, Spanish]
Díez Valle R1, Slof J2, Galván J3, Arza C3, Romariz C3, Vidal C4; VISIONA study researchers.
 
Collaborators: (24)
Valle RD, i Rodriguez PT, Martínez GV, Cabezudo JM, García LM, Sánchez JJ, Rodríguez EF, Ángel M, Sánchez A, Granados GO, Delgado ÁT, Bertrán GC, Martín JJ, Ahicart GP, Díaz AP, Asunción CB, Acin RP, de Pedro Mdel Á, Urzaiz LL, Barcia JA, Brin JR, Campa-Santamarina JM, Sánchez ÁM, Peña JM.
 
Author information:
1Departamento de Neurocirugía, Clínica Universidad de Navarra, Pamplona, España. Electronic address: rdiezvalle@unav.es.
2Universidad Autónoma de Barcelona, Bellaterra, España.there is a much better chance of a complete resection using it.
3Laboratorios Gebro Pharma S.A., Barcelona, España.
4Needs and Aims, Barcelona, España.
 
Abstract
OBJECTIVE:
 
To assess effectiveness of 5-aminolevulinic acid (5-ALA, Gliolan(®)) in patients treated for malignant glioma under typical daily practice conditions in Spain, using complete resection rate (CR) and progression free survival at 6 months (PFS6).
MATERIAL AND METHODS:
 
Retrospective review of data from 18 neurosurgery departments that were categorised as either using or not using 5-ALA. The study included adult patients with suspected malignant gliomas for whom the intended treatment plan included complete resection followed by radiotherapy and chemotherapy with temozolomide. Postoperative MRI and clinical data representing at least 6 months were required for inclusion. Rates of CR and PFS6 were compared between patients with 5-ALA treatment and those without.
RESULTS:
 
The study included 251 evaluable cases. CR and PFS6 rates were significantly higher in the group of patients treated surgically with 5-ALA: CR, 67% versus 45%, p=.000; PFS6 for patients with grade IV tumours, 69% versus 48%; p=.002. The differences retained their significance and magnitude after adjusting for all covariates including age, functional status, and whether gliomas were located in eloquent areas.
CONCLUSIONS:
 
In this retrospective series, use of 5-ALA during habitual surgical procedures in Spain was associated with a higher complete resection rate for malignant glioma and increased PFS6 for grade iv glioma.
 
Copyright © 2013 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

 


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