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

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.