Evidence map›Paper›PMID 37196069›Full record

Trial reportThe oncologist2023

Hypofractionated Stereotactic Re-irradiation and 
Anti-PDL1 Durvalumab Combination in Recurrent Glioblastoma: STERIMGLI Phase I Results.

Damien Pouessel, Soléakhéna Ken, Valérie Gouaze-Andersson, Lucie Piram, Augustin Mervoyer, Delphine Larrieu-Ciron, Bastien Cabarrou, Amélie Lusque, Marie Robert, Jean-Sebastien Frenel and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02866747 (A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 5% of its field
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.

NCT02866747 phase1 / phase2completednot on this map

A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1 (PD-L1) Durvalumab (Medi4736) for Patients With Recurrent Glioblastoma (STERIMGLI)

TypeinterventionalSponsorInstitut Claudius RegaudRan2017 to 2024Enrolled108ConditionsGlioblastomaArmsHypofractionated stereotactic radiation therapy, Durvalumab
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

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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

18 authors at 8 institutions in 2 countries.

Damien PouesselDepartment of Medical Oncology, Institut Universitaire du Cancer Toulouse Oncopole, Institut Claudius Re-gaud, Toulouse, France.
Soléakhéna KenDepartment of Engineering and Medical Physics, Institut Universitaire du Cancer Toulouse Oncopole, Institut Claudius Regaud, Toulouse, France.
Valérie Gouaze-AnderssonINSERM UMR1037, Centre de Recherche en Cancérologie de Toulouse (CRCT), Team Radiation Optimization "RADOPT", Toulouse, France.
Lucie PiramINSERM UMR1037, Centre de Recherche en Cancérologie de Toulouse (CRCT), Team Radiation Optimization "RADOPT", Toulouse, France.
Augustin MervoyerDepartment of Radiation Oncology, Institut de Cancérologie de l'Ouest, Nantes, France.
Delphine Larrieu-CironDepartment of Medical Oncology, Institut Universitaire du Cancer Toulouse Oncopole, Institut Claudius Re-gaud, Toulouse, France.
Bastien CabarrouDepartment of Biostatistics, Institut Universitaire du Cancer Toulouse Oncopole, Institut Claudius Regaud, Toulouse, France.
Amélie LusqueDepartment of Biostatistics, Institut Universitaire du Cancer Toulouse Oncopole, Institut Claudius Regaud, Toulouse, France.
Marie RobertDepartment of Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France.
Jean-Sebastien FrenelDepartment of Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France.
Emmanuelle Uro-CosteINSERM UMR1037, Centre de Recherche en Cancérologie de Toulouse (CRCT), Team Radiation Optimization "RADOPT", Toulouse, France.
Pascale OlivierDepartment of Medical and Clinical Pharmacology, Center of Pharmacovigilance and Pharmacoepidemiology, Toulouse University Hospital, Toulouse, France.
Muriel MounierClinical Research Unit, Institut Universitaire du Cancer Toulouse Oncopole, Institut Claudius Regaud, Toulouse, France.
Umberto SabatiniInstitute of Neuroradiology, University Magna Graecia, Catanzaro, Italy.
Eduardo Hugo SanchezInstitut de Recherche Technologique Saint Exupéry, Toulouse, France.
Mehdi ZouitineInstitut de Recherche Technologique Saint Exupéry, Toulouse, France.
Ahmad BerjaouiINSERM UMR1037, Centre de Recherche en Cancérologie de Toulouse (CRCT), Team Radiation Optimization "RADOPT", Toulouse, France.
Elizabeth Cohen-Jonathan MoyalINSERM UMR1037, Centre de Recherche en Cancérologie de Toulouse (CRCT), Team Radiation Optimization "RADOPT", Toulouse, France.
Institut Claudius Regaud · FRInserm · FRInstitut de Cancérologie de l'Ouest · FRIRT Saint ExupéryCentre de Recherche en Cancérologie de Toulouse · FRIRT M2P · FRMagna Graecia University · ITUniversité Fédérale de Toulouse Midi-Pyrénées · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHypofractionated stereotactic radiotherapy (hFSRT) is a salvage option for recurrent glioblastoma (GB) which may synergize anti-PDL1 treatment. This phase I study evaluated the safety and the recommended phase II dose of anti-PDL1 durvalumab combined with hFSRT in patients with recurrent GB.

methodsPatients were treated with 24 Gy, 8 Gy per fraction on days 1, 3, and 5 combined with the first 1500 mg Durvalumab dose on day 5, followed by infusions q4weeks until progression or for a maximum of 12 months. A standard 3 + 3 Durvalumab dose de-escalation design was used. Longitudinal lymphocytes count, cytokines analyses on plasma samples, and magnetic resonance imaging (MRI) were collected.

resultsSix patients were included. One dose limiting toxicity, an immune-related grade 3 vestibular neuritis related to Durvalumab, was reported. Median progression-free interval (PFI) and overall survival (OS) were 2.3 and 16.7 months, respectively. Multi-modal deep 
learning-based analysis including MRI, cytokines, and lymphocytes/neutrophil ratio isolated the patients presenting pseudoprogression, the longest PFI and those with the longest OS, but statistical significance cannot be established considering phase I data only.

conclusionCombination of hFSRT and Durvalumab in recurrent GB was well tolerated in this phase I study. These encouraging results led to an ongoing randomized phase II. (ClinicalTrials.gov Identifier: NCT02866747).

Indexed as

Brain NeoplasmsGlioblastomaRadiosurgeryRe-IrradiationAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCytokinesHumansNeoplasm Recurrence, LocalTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedatezolizumabCytokinesdurvalumabdeep learningDurvalumabhypofractionated stereotactic re-irradiationphase I clinical trialrecurrent glioblastoma

Identifiers

PMID37196069
PMCPMC10485381
OpenAlexW4376959782

What OpenQuestion holds

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LicenceCC BY-NC
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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.