Re-irradiation for recurrent high grade glioma (HGG) patients: Results of a single arm prospective phase 2 study.


Journal

Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
ISSN: 1879-0887
Titre abrégé: Radiother Oncol
Pays: Ireland
ID NLM: 8407192

Informations de publication

Date de publication:
02 2022
Historique:
received: 16 09 2021
revised: 08 11 2021
accepted: 14 12 2021
pubmed: 25 12 2021
medline: 20 4 2022
entrez: 24 12 2021
Statut: ppublish

Résumé

Standard of care for recurrent high grade glioma (HGG) is missing. Several treatment options have been investigated including re-irradiation (re-RT). Results are promising but provided by retrospective studies. We designed a single arm prospective phase II study aiming to evaluate efficacy, and toxicity of re-irradiation. Adults patients with good performance status, HGG diagnosis reclassified according to the new 2021 fifth edition WHO CNS classification, an interval time (IT) from previous RT ≥ 6 months were included. Outcome was evaluated by MRI imaging at 1 month, and every 3 months thereafter. Toxicities were evaluated in terms of radionecrosis occurrence, and neurocognitive status. Ninety recurrent HGG patients were treated, 11 oligodendroglioma grade 3, 18 astrocytoma grade 3 and 4, and 61 glioblastoma grade 4. The median age was 54 years, and majority had KPS 90-100. The median IT between first-RT and re-RT was 24 months. Re-surgery has been performed in 56.6%, and chemotherapy in 53.3%. The median follow up time was 64 months; median overall survival (OS) time,1,2,3-year OS rates were 17 months (95%CI 14-19), 66.7%±4.9, 32.6%±5.0, and 22.2 ± 4.7. Prognostic factors impacting on survival were age (p = 0.0154), IT between first RT and re-RT (p = 0.0051), glioma grade (p = 0.0090), and IDH status (p = 0.0001). Radionecrosis grade 2-3 occurred in 9 (10%) patients; neurocognitive functions remained stable until disease progression. Re-RT proved to be a safe and feasible treatment option with low toxicity. Younger patients with grade 3 IDH mutated gliomas, and a longer IT had the better outcome. NCT02567539.

Sections du résumé

BACKGROUND AND PURPOSE
Standard of care for recurrent high grade glioma (HGG) is missing. Several treatment options have been investigated including re-irradiation (re-RT). Results are promising but provided by retrospective studies. We designed a single arm prospective phase II study aiming to evaluate efficacy, and toxicity of re-irradiation.
MATERIALS AND METHODS
Adults patients with good performance status, HGG diagnosis reclassified according to the new 2021 fifth edition WHO CNS classification, an interval time (IT) from previous RT ≥ 6 months were included. Outcome was evaluated by MRI imaging at 1 month, and every 3 months thereafter. Toxicities were evaluated in terms of radionecrosis occurrence, and neurocognitive status.
RESULTS
Ninety recurrent HGG patients were treated, 11 oligodendroglioma grade 3, 18 astrocytoma grade 3 and 4, and 61 glioblastoma grade 4. The median age was 54 years, and majority had KPS 90-100. The median IT between first-RT and re-RT was 24 months. Re-surgery has been performed in 56.6%, and chemotherapy in 53.3%. The median follow up time was 64 months; median overall survival (OS) time,1,2,3-year OS rates were 17 months (95%CI 14-19), 66.7%±4.9, 32.6%±5.0, and 22.2 ± 4.7. Prognostic factors impacting on survival were age (p = 0.0154), IT between first RT and re-RT (p = 0.0051), glioma grade (p = 0.0090), and IDH status (p = 0.0001). Radionecrosis grade 2-3 occurred in 9 (10%) patients; neurocognitive functions remained stable until disease progression.
CONCLUSION
Re-RT proved to be a safe and feasible treatment option with low toxicity. Younger patients with grade 3 IDH mutated gliomas, and a longer IT had the better outcome.
TRIAL REGISTRATION NUMBER
NCT02567539.

Identifiants

pubmed: 34952000
pii: S0167-8140(21)09067-8
doi: 10.1016/j.radonc.2021.12.019
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT02567539']

Types de publication

Clinical Trial, Phase II Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

89-96

Informations de copyright

Published by Elsevier B.V.

Auteurs

Pierina Navarria (P)

Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy. Electronic address: pierina.navarria@humanitas.it.

Federico Pessina (F)

Neurosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Elena Clerici (E)

Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy.

Luisa Bellu (L)

Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy.

Ciro Franzese (C)

Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Andrea Franzini (A)

Neurosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy.

Matteo Simonelli (M)

Oncology and Hematology Department, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Lorenzo Bello (L)

Oncology and Hematology Department, Università degli studi di Milano, Italy.

Armando Santoro (A)

Oncology and Hematology Department, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Letterio Salvatore Politi (LS)

Neuroradiology Department, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Giuseppe Roberto D'agostino (GR)

Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy.

Alessandra Casarotti (A)

Neurosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy.

Bethania Fernandes (B)

Pathology Department, IRCCS Humanitas Research Hospital, Milan, Italy.

Valter Torri (V)

Oncology Department, IRCCS Istituto Mario Negri, Milan, Italy.

Marta Scorsetti (M)

Radiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Milan, Italy.

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