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

Autor: Vermandel M; Univ. Lille, Inserm, CHU Lille, U1189 - ONCO-THAI -Laser Assisted Therapies and Immunotherapies for Oncology, 59000, Lille, France.; Neurosurgery Department, CHU Lille, 59000, Lille, France., Dupont C; Univ. Lille, Inserm, CHU Lille, U1189 - ONCO-THAI -Laser Assisted Therapies and Immunotherapies for Oncology, 59000, Lille, France., Lecomte F; Univ. Lille, Inserm, CHU Lille, U1189 - ONCO-THAI -Laser Assisted Therapies and Immunotherapies for Oncology, 59000, Lille, France., Leroy HA; Univ. Lille, Inserm, CHU Lille, U1189 - ONCO-THAI -Laser Assisted Therapies and Immunotherapies for Oncology, 59000, Lille, France.; Neurosurgery Department, CHU Lille, 59000, Lille, France., Tuleasca C; Faculty of Biology and Medicine (FBM) and Centre Hospitalier Universitaire Vaudois (CHUV), Clinical Neurosciences Department, Neurosurgery Service and Gamma Knife Center, University of Lausanne (Unil), Lausanne, Switzerland.; Signal Processing Laboratory (LTS 5), Ecole Polytechnique Fédérale de Lausanne (EPFL), Lausanne, Switzerland., Mordon S; Univ. Lille, Inserm, CHU Lille, U1189 - ONCO-THAI -Laser Assisted Therapies and Immunotherapies for Oncology, 59000, Lille, France., Hadjipanayis CG; Department of Neurosurgery, Icahn School of Medicine At Mount Sinai, Mount Sinai Health System, New York, NY, USA.; Department of Neurosurgery, Mount Sinai Beth Israel, New York, NY, USA., Reyns N; Univ. Lille, Inserm, CHU Lille, U1189 - ONCO-THAI -Laser Assisted Therapies and Immunotherapies for Oncology, 59000, Lille, France. nicolas.reyns@chru-lille.fr.; Neurosurgery Department, CHU Lille, 59000, Lille, France. nicolas.reyns@chru-lille.fr.
Jazyk: angličtina
Zdroj: Journal of neuro-oncology [J Neurooncol] 2021 May; Vol. 152 (3), pp. 501-514. Date of Electronic Publication: 2021 Mar 20.
DOI: 10.1007/s11060-021-03718-6
Abstrakt: Purpose: 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.
Methods: 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.
Results: 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).
Conclusions: 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.
Databáze: MEDLINE
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