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- Heggebo, L. C., et al.
(författare)
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Investigating survival, quality of life and cognition in PROton versus photon therapy for IDH-mutated diffuse grade 2 and 3 GLIOmas (PRO-GLIO): a randomised controlled trial in Norway and Sweden
- 2023
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Ingår i: Bmj Open. - : BMJ. - 2044-6055. ; 13:3
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionThe use of proton therapy increases globally despite a lack of randomised controlled trials demonstrating its efficacy and safety. Proton therapy enables sparing of non-neoplastic tissue from radiation. This is principally beneficial and holds promise of reduced long-term side effects. However, the sparing of seemingly non-cancerous tissue is not necessarily positive for isocitrate dehydrogenase (IDH)-mutated diffuse gliomas grade 2-3, which have a diffuse growth pattern. With their relatively good prognosis, yet incurable nature, therapy needs to be delicately balanced to achieve a maximal survival benefit combined with an optimised quality of life.Methods and analysisPRO-GLIO (PROton versus photon therapy in IDH-mutated diffuse grade 2 and 3 GLIOmas) is an open-label, multicentre, randomised phase III non-inferiority study. 224 patients aged 18-65 years with IDH-mutated diffuse gliomas grade 2-3 from Norway and Sweden will be randomised 1:1 to radiotherapy delivered with protons (experimental arm) or photons (standard arm). First intervention-free survival at 2 years is the primary endpoint. Key secondary endpoints are fatigue and cognitive impairment, both at 2 years. Additional secondary outcomes include several survival measures, health-related quality of life parameters and health economy endpoints.Ethics and disseminationTo implement proton therapy as part of standard of care for patients with IDH-mutated diffuse gliomas grade 2-3, it should be deemed safe. With its randomised controlled design testing proton versus photon therapy, PRO-GLIO will provide important information for this patient population concerning safety, cognition, fatigue and other quality of life parameters. As proton therapy is considerably more costly than its photon counterpart, cost-effectiveness will also be evaluated. PRO-GLIO is approved by ethical committees in Norway (Regional Committee for Medical & Health Research Ethics) and Sweden (The Swedish Ethical Review Authority) and patient inclusion has commenced. Trial results will be published in international peer-reviewed journals, relevant conferences, national and international meetings and expert forums.Trial registration numberClinicalTrials.gov Registry (NCT05190172).
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| 2. |
- Olsson, C. E., et al.
(författare)
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Feasibility of Mastication-Structure-Sparing Radiotherapy for Head and Neck Cancer
- 2021
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Ingår i: International journal of radiation oncology, biology, physics. - : Elsevier BV. - 1879-355X .- 0360-3016. ; 111:3
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE/OBJECTIVE(S): Although radiation-induced side-effects affecting mastication functionality have been studied in head and neck cancer (HNC) radiotherapy (RT), dose constraints for the associated structures are rarely included during treatment plan optimization. Previous research has identified several radiation dose relationships with mean dose thresholds around 30-40 Gy for masseter muscles, 40-50 Gy for pterygoid muscles, and 15-60 Gy for temporomandibular joint (TMJ) relating to a 10% trismus risk post RT. The purpose of this work was to use a multi-criteria optimization (MCO) approach to investigate to what extent doses to these structures can be lowered without violating existing clinical treatment goals in inverse planning of HNC RT. MATERIALS/METHODS: This exploratory treatment planning study used data from 22 HNC patients treated to 68 Gy without mastication-structure-sparing intent in 2017-2019 at one institute in Sweden. Original volumetric-modulated arc therapy (VMAT) plans were re-activated in the treatment planning system and masseter muscles, pterygoid muscles (medial and lateral), and TMJ were consistently delineated according to a previously reported delineation manual4. Re-planning was done using the MCO function of the treatment planning system with the resulting dose distribution normalized to match the clinical target volume (CTV T) mean dose of the clinical treatment plan. Dose differences between MCO and clinical plans were not allowed to exceed 2 Gy for any original clinical treatment goal unless tolerance doses had been substantially exceeded in the clinical treatment plan. To what extent dose to mastication structures could be lowered without violating existing clinical treatment goals were quantified by group and by patient. RESULTS: Altogether, there were 334 clinical treatment goals in the clinical treatment plans (median=15, range: 7-24 per patient, depending on tumor location), which easily could be met in the corresponding MCO plans. Mean doses to the mastication structures were in most cases below proposed tolerance doses in the clinical plan but could on average be further reduced between 3-5 Gy in the MCO plans (Table). Of the 25/88 patient reductions below 5 Gy (28%), 18/25 (72%) were for the masseter (n=8) and medial pterygoid (n=10) muscles. CONCLUSION: With modern RT, it seems possible to reduce the dose to mastication structures below proposed trismus dose tolerance thresholds for most HNC patients without violating clinical treatment goals. Focusing on masseter and medial pterygoid muscle doses may prove to give the largest benefit in individual cases. Copyright © 2021. Published by Elsevier Inc.
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