Evidence map›Paper›PMID 38753093›Full record

ArticleJournal of neuro-oncology2024

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

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

Registry-linked trialAbstract read
In one paragraph

Article in Journal of neuro-oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03048240 (A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03048240 nacompletednot on this map

A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.

TypeinterventionalSponsorUniversity Hospital, LilleRan2017 to 2021Enrolled10ConditionsGlioblastomaArms"perPDT", GLIOLAN
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Iulia Peciu-FlorianuNeurosurgery Department, CHU-Lille, F-59000, Lille, France.
Quentin Vannod-MichelNeuroradiology Department, CHU-Lille, F-59000, Lille, France.
Enora VauleonNeuro-Oncology Department, CHU-Lille, F-59000, Lille, France.
Marie-Edith BonneterreHemerion Therapeutics, Villeneuve D'Ascq, France.
Nicolas ReynsNeurosurgery Department, CHU-Lille, F-59000, Lille, France. nicolas.reyns@chru-lille.fr.ORCID http://orcid.org/0000-0002-1206-9342

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeGlioblastoma 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).

methodsTen 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/cm

resultsAt 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).

conclusionAt 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.

Indexed as

Aminolevulinic AcidBrain NeoplasmsGlioblastomaPhotochemotherapyPhotosensitizing AgentsAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedPilot ProjectsQuality of LifeSurvival RateAminolevulinic AcidPhotosensitizing AgentsFollow-upGlioblastomaIntraoperative photodynamic therapySurvival

Identifiers

PMID38753093
PMCPMC11186870

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.