Clinical Cancer Research
Clinical Cancer Research
5 years ago

Fluorescein-guided surgery for resection of high-grade gliomas: A multicentric prospective phase II study (FLUOGLIO).

Schiariti, Anghileri, Boffano, Cavallo, Broggi, Ferroli, Eoli, De Laurentis, La Corte, Servida, Bosio, Brawanski, Montomoli, Visintini, Pollo, Broggi, Schebesch, Höhne, Acerbi
Purpose Sodium Fluorescein is a dye that, intravenously injected, selectively accumulates in high-grade glioma (HGG) tissue through a damaged blood-brain barrier. In this paper, the final results of a multicentric prospective phase II trial (FLUOGLIO) on fluorescein-guided HGG resection through a dedicated filter on the surgical microscope were reported. Methods Patients with suspected HGG considered suitable for removal were eligible to participate in this trial. Fluorescein was intravenously injected at a dose of 5-10 mg/Kg. Primary endpoint was the percentage of patients with histologically-confirmed HGG, without contrast-enhancing tumor at the immediate post-operative MRI. Secondary endpoints were progression free survival (PFS), residual tumor on postoperative MRI, overall survival, neurological deficits and fluorescein-related toxicity. The sensitivity and specificity of fluorescein in identifying tumor tissue were estimated by fluorescent and non-fluorescent biopsies at the tumor margin. The study was registered on the European Regulatory Authorities website (EudraCT 2011-002527-18). Results Fifty-seven patients aged 45-75 years were screened for participation and 46 were considered for primary and secondary endpoints. Mean pre-operative tumor volume was 28.75 cm3 (range 1.3-87.8 cm3). Thirty-eight patients (82.6%) underwent a complete tumor removal. Median follow-up was 11 months. PFS-6 and PFS-12 were 56,6% and 15.2%. Median survival was 12 months. No adverse reaction related to SF administration was recorded. The sensitivity and specifity of fluorescein in identifying tumor tissue were respectively 80.8% and 79.1%. Conclusion Fluorescein-guided technique with a dedicated filter on the surgical microscope is safe and enables a high percentage of contrast-enhancing tumor in patients with HGG.

Publisher URL: http://doi.org/10.1158/1078-0432.CCR-17-1184

DOI: 10.1158/1078-0432.CCR-17-1184

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