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Open Access 16-05-2024 | Photodynamic Therapy | Research

Long term follow-up of patients with newly diagnosed glioblastoma treated by intraoperative photodynamic therapy: an update from the INDYGO trial (NCT03048240)

Authors: Iulia Peciu-Florianu, Quentin Vannod-Michel, Enora Vauleon, Marie-Edith Bonneterre, Nicolas Reyns

Published in: Journal of Neuro-Oncology | Issue 3/2024

Abstract

Purpose

Glioblastoma remains incurable despite optimal multimodal management. The interim analysis of open label, single arm INDYGO pilot trial showed actuarial 12-months progression-free survival (PFS) of 60% (median 17.1 months), actuarial 12-months overall survival (OS) of 80% (median 23.1 months). We report updated, exploratory analyses of OS, PFS, and health-related quality of life (HRQOL) for patients receiving intraoperative photodynamic therapy (PDT) with 5-aminolevulinic acid hydrochloride (5-ALA HCl).

Methods

Ten patients were included (May 2017 – April 2021) for standardized therapeutic approach including 5-ALA HCl fluorescence-guided surgery (FGS), followed by intraoperative PDT with a single 200 J/cm² dose of light. Postoperatively, patients received adjuvant therapy (Stupp protocol) then followed every 3 months (clinical and cerebral MRI) and until disease progression and/or death. Procedure safety and toxicity occurring during the first four weeks after PDT were assessed. Data concerning relapse, HRQOL and survival were prospectively collected and analyzed.

Results

At the cut-off date (i.e., November 1st 2023), median follow-up was 23 months (9,7–71,4). No unacceptable or unexpected toxicities and no treatment-related deaths occurred during the study. Kaplan–Meier estimated 23.4 months median OS, actuarial 12-month PFS rate 60%, actuarial 12-month, 24-month, and 5-year OS rates 80%, 50% and 40%, respectively. Four patients were still alive (1 patient free of recurrence).

Conclusion

At 5 years-follow-up, intraoperative PDT with surgical maximal excision as initial therapy and standard adjuvant treatment suggests an increase of time to recurrence and overall survival in a high proportion of patients. Quality of life was maintained without any severe side effects.

Trial registration NCT number

NCT03048240. EudraCT number: 2016–002706-39.

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Title: Long term follow-up of patients with newly diagnosed glioblastoma treated by intraoperative photodynamic therapy: an update from the INDYGO trial (NCT03048240)
Authors: Iulia Peciu-Florianu
Quentin Vannod-Michel
Enora Vauleon
Marie-Edith Bonneterre
Nicolas Reyns
Publication date: 16-05-2024
Publisher: Springer US
Keywords: Photodynamic Therapy
Glioblastoma
Glioblastoma
Glioblastoma
Published in: Journal of Neuro-Oncology / Issue 3/2024
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI: https://doi.org/10.1007/s11060-024-04693-4

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Long term follow-up of patients with newly diagnosed glioblastoma treated by intraoperative photodynamic therapy: an update from the INDYGO trial (NCT03048240)

Abstract

Purpose

Methods

Results

Conclusion

Trial registration NCT number

Advances in Alzheimer's

EASD 2024

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Trial registration NCT number

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