Standardized intraoperative 5-ALA photodynamic therapy for newly diagnosed glioblastoma patients: a preliminary analysis of the INDYGO clinical trial.

Details

Serval ID
serval:BIB_832AB9614A49
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Standardized intraoperative 5-ALA photodynamic therapy for newly diagnosed glioblastoma patients: a preliminary analysis of the INDYGO clinical trial.
Journal
Journal of neuro-oncology
Author(s)
Vermandel M., Dupont C., Lecomte F., Leroy H.A., Tuleasca C., Mordon S., Hadjipanayis C.G., Reyns N.
ISSN
1573-7373 (Electronic)
ISSN-L
0167-594X
Publication state
Published
Issued date
05/2021
Peer-reviewed
Oui
Volume
152
Number
3
Pages
501-514
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
Glioblastoma (GBM) is the most aggressive malignant primary brain tumor. The unfavorable prognosis despite maximal therapy relates to high propensity for recurrence. Thus, overall survival (OS) is quite limited and local failure remains the fundamental problem. Here, we present a safety and feasibility trial after treating GBM intraoperatively by photodynamic therapy (PDT) after 5-aminolevulinic acid (5-ALA) administration and maximal resection.
Ten patients with newly diagnosed GBM were enrolled and treated between May 2017 and June 2018. The standardized therapeutic approach included maximal resection (near total or gross total tumor resection (GTR)) guided by 5-ALA fluorescence-guided surgery (FGS), followed by intraoperative PDT. Postoperatively, patients underwent adjuvant therapy (Stupp protocol). Follow-up included clinical examinations and brain MR imaging was performed every 3 months until tumor progression and/or death.
There were no unacceptable or unexpected toxicities or serious adverse effects. At the time of the interim analysis, the actuarial 12-months progression-free survival (PFS) rate was 60% (median 17.1 months), and the actuarial 12-months OS rate was 80% (median 23.1 months).
This trial assessed the feasibility and the safety of intraoperative 5-ALA PDT as a novel approach for treating GBM after maximal tumor resection. The current standard of care remains microsurgical resection whenever feasible, followed by adjuvant therapy (Stupp protocol). We postulate that PDT delivered immediately after resection as an add-on therapy of this primary brain cancer is safe and may help to decrease the recurrence risk by targeting residual tumor cells in the resection cavity. Trial registration NCT number: NCT03048240. EudraCT number: 2016-002706-39.
Keywords
5-ALA, Clinical trial, Glioblastoma, Intraoperative MRI, Photodynamic therapy
Pubmed
Web of science
Create date
30/03/2021 12:06
Last modification date
22/05/2021 6:34
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