Estudio observacional retrospectivo sobre la efectividad del ácido 5-aminolevulínico en la cirugía de los gliomas malignos en España (Estudio VISIONA) / Observational, retrospective study of the effectiveness of 5-aminolevulinic acid in malignant glioma surgery in Spain (The VISIONA study)

Objetivo: Evaluar la efectividad del ácido 5-aminolevulínico (5-ALA, Gliolan(R)) mediante la tasa de resecciones completas (RC) y supervivencia libre de progresión a los 6 meses (SLP6) en pacientes intervenidos quirúrgicamente de glioma maligno, en condiciones de práctica médica habitual en España. Material y métodos: Revisión retrospectiva en 18 servicios de neurocirugía, divididos en centros que usan habitualmente 5-ALA y centros que no. Se incluyó a pacientes adultos con sospecha de glioma maligno, en los que la intención de tratar incluyó resección completa y posterior radioterapia y quimioterapia con temozolomida. Era necesaria la existencia de resonancia magnética posquirúrgica y datos clínicos al menos durante 6 meses. Se comparó la diferencia entre pacientes con o sin 5-ALA en la tasa de RC y en la SLP6. Resultados: Se obtuvieron 251 casos evaluables. La tasa de RC y la tasa de SLP6 fueron significativamente mayores en el grupo de pacientes operados con 5-ALA: RC, 67% frente a 45%, p = 0,000, y SLP6 en el caso de los gliomas de grado IV , 69% frente a 48%; p = 0,002. Estas diferencias se mantuvieron relevantes y significativas tras ajustarlas por todas las covariables estudiadas, que incluyeron edad, estado funcional y localización en área elocuente o no. Conclusiones: En esta serie retrospectiva, el uso de 5-ALA en la cirugía del glioma maligno en la práctica habitual en España se asoció a un incremento en la tasa de resecciones completas y, en el caso de los gliomas de grado IV , a un incremento en la supervivencia libre de progresión a los 6 meses

Objective: To assess effectiveness of 5-aminolevulinic acid (5-ALA, Gliolan(R)) 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). Materials 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

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.