| 1. |
- Heggebo, L. C., et al.
(author)
-
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
-
In: Bmj Open. - : BMJ. - 2044-6055. ; 13:3
-
Journal article (peer-reviewed)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).
|
|
| 2. |
|
|
| 3. |
|
|
| 4. |
|
|
| 5. |
|
|
| 6. |
|
|
| 7. |
- Rosenlund, Lena, et al.
(author)
-
Moving from clinician-defined to patient-reported outcome measures for survivors of high-grade glioma
- 2019
-
In: Patient-Related Outcome Measures. - 1179-271X. ; 10, s. 267-276
-
Journal article (peer-reviewed)abstract
- Background: Persons with high-grade glioma face both neurological and cancer-related symptoms from the tumor itself and its treatment affecting their daily lives. Survival alone is not an adequate outcome, the quality of the survivorship experience needs to be regarded with equal importance. Patient-reported outcome (PRO) measures can be used to evaluate treatment effects and symptom management interventions. Purpose: The aim of this review was to identify the use, challenges, and potential of PRO measures in survivors of high-grade glioma. Methods: A narrative expert opinion review was performed on the subject. In addition to our own experiences we searched PubMed, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, and PsycINFO for brain tumor-specific PRO measures used in the population of adult patients with high-grade glioma, both original articles and reviews were included. Results: There are several PRO measures that have been validated for patients with primary brain tumors including high-grade glioma. PRO measures are used both in clinical trials to evaluate the effect of treatment on health-related quality of life, and in daily clinical practice for holistic needs assessment and symptom management. Common PRO measures used for patients with high-grade glioma are European Organization for Research and Treatment of Cancer general instrument for patients with cancer together with brain tumor module, Functional Assessment of Cancer Therapy-Brain, and MD Anderson Symptom Inventory for Brain Tumor. Neurologic and cognitive disorders often occur in patients with high-grade glioma, which affects patients' ability to self-report over time, making it more challenging in this population. PRO as a primary outcome seems underutilized. Conclusion: For clinical research, PRO measures need to be used together with other clinical outcome measures rather than replacing traditional outcome measures. Moving to more use of PRO measures in survivorship care has potential to improve patient-caregiver-healthcare team communication, symptom management, and quality of care. Implementing PROs in survivorship care should also involve caregivers and a response based on the results.
|
|
