Health-related quality of life and its predictors in patients receiving first-line treatment for newly diagnosed glioblastoma multiforme in EU5: A real-world study.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 157-157
Author(s):  
Bryan Bennett ◽  
Roelien Postema ◽  
Jennifer P. Hall ◽  
Abigail Bailey ◽  
Lucy Massey ◽  
...  

157 Background: This study describes health-related quality of life (HRQoL) and its predictors including the role of O6-methylguanine DNA methyltransferase promoter (MGMT) testing in first-line (1L) patients (pts) with newly diagnosed glioblastoma multiforme (GBM). Methods: Real-world data were drawn from the GBM Disease-Specific Programme – a cross-sectional study administered to medical and neuro-oncologists who provided information on demographic/clinical status and treatment (tx) patterns for their next 4 consulting 1L GBM pts from May to July 2016 in EU5 countries. Pts voluntarily completed self-completion forms (PSCs), comprising the EORTC QLQ-C30, BN20, and EQ-5D-3L. Linear regressions were conducted using QLQ-C30 global health status (GHS), EQ-5D-3L utility, and EQ-5D visual analogue scale (VAS) scores as dependent variables. Demographic and clinical factors were included as independent variables. Statistically significant results with P<0.05 are presented. Results: 279 1L GBM pts completed a PSC, with a mean age 58.7 years old, 63% were male. 68% (n=189) were MGMT-tested with known results, of which 58% (n=110) were methylated and 42% (n=79) unmethylated. Mean GHS was 45.6 (SD=19.4), utility was 0.57 (SD=0.35), and VAS was 53.5 (SD=18.3). All functional domain scores of the QLQ-C30 were below reference values for general brain cancer population, with differences larger than published thresholds for clinical importance. Age >75 years and ECOG score of 2+ were associated with decreased HRQoL. Longer 1L tx duration, stable/responding disease, and receiving care in Germany, Italy, Spain, or UK (vs France) were associated with increased HRQoL. Results were similar for the subset of pts that was MGMT-tested; however, a greater Charlson index score and not receiving steroids (or RT) were associated with increased HRQoL. MGMT status did not appear to be an independent predictor of HRQoL. Conclusions: HRQoL in pts with GBM receiving 1L treatment is poor. Functional domain scores indicate clinically meaningful problems for these patients. Important predictors of HRQoL include age, performance status, time since tx initiation, country of care, comorbidities, and steroid use alongside RT. Results suggest there remains an unmet need in the tx management of GBM.

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e044885
Author(s):  
Kristin A Shimano ◽  
Rachael F Grace ◽  
Jenny M Despotovic ◽  
Ellis J Neufeld ◽  
Robert J Klaassen ◽  
...  

IntroductionImmune thrombocytopaenia (ITP) is an acquired disorder of low platelets and risk of bleeding. Although many children can be observed until spontaneous remission, others require treatment due to bleeding or impact on health-related quality of life. Standard first-line therapies for those who need intervention include corticosteroids, intravenous immunoglobulin and anti-D globulin, though response to these agents may be only transient. Eltrombopag is an oral thrombopoietin receptor agonist approved for children with chronic ITP who have had an insufficient response to corticosteroids, intravenous immunoglobulin or splenectomy. This protocol paper describes an ongoing open-label, randomised trial comparing eltrombopag to standard first-line management in children with newly diagnosed ITP.Methods and analysisRandomised treatment assignment is 2:1 for eltrombopag versus standard first-line management and is stratified by age and by prior treatment. The primary endpoint of the study is platelet response, defined as ≥3 of 4 weeks with platelets >50×109/L during weeks 6–12 of therapy. Secondary outcomes include number of rescue therapies needed during the first 12 weeks, proportion of patients who do not need ongoing treatment at 12 weeks and 6 months, proportion of patients with a treatment response at 1 year, and number of second-line therapies used in weeks 13–52, as well as changes in regulatory T cells, iron studies, bleeding, health-related quality of life and fatigue. A planned sample size of up to 162 randomised paediatric patients will be enrolled over 2 years at 20 sites.Ethics and disseminationThe study has been approved by the centralised Baylor University Institutional Review Board. The results are expected to be published in 2023.Trial registration numberNCT03939637.


JAMA Oncology ◽  
2018 ◽  
Vol 4 (4) ◽  
pp. 495 ◽  
Author(s):  
Martin J. B. Taphoorn ◽  
Linda Dirven ◽  
Andrew A. Kanner ◽  
Gitit Lavy-Shahaf ◽  
Uri Weinberg ◽  
...  

2014 ◽  
Vol 16 (suppl 5) ◽  
pp. v182-v182
Author(s):  
K. Peters ◽  
D. Randazzo ◽  
M. Affronti ◽  
E. Lipp ◽  
F. McSherry ◽  
...  

Leukemia ◽  
2019 ◽  
Vol 34 (2) ◽  
pp. 488-498 ◽  
Author(s):  
Fabio Efficace ◽  
Fabio Stagno ◽  
Alessandra Iurlo ◽  
Massimo Breccia ◽  
Francesco Cottone ◽  
...  

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii176-ii176
Author(s):  
Shota Tanaka ◽  
Yoshitaka Narita ◽  
Akitake Mukasa ◽  
Motoo Nagane ◽  
Tomokazu Aoki ◽  
...  

Abstract BACKGROUND In BIOMARK trial, patients with newly diagnosed glioblastoma were treated with standard chemoradiotherapy combined with first-line bevacizumab; a subset of patients continued bevacizumab beyond progression (BBP). Neurocognitive function (NCF), symptom burden, and health-related quality of life (HRQoL) were examined as secondary endpoints. PATIENTS AND METHODS In the primary protocol, newly diagnosed glioblastoma patients aged 20-75 received standard 6-week radiotherapy combined with temozolomide and bevacizumab followed by 4-week cycles of temozolomide plus bevacizumab, and then 2-3-week cycles of bevacizumab monotherapy. Upon recurrence, patients were subjected to the secondary protocol with 2-3-week cycles of bevacizumab monotherapy with or without other chemotherapeutic agents. NCF tests (Hopkins verbal learning test-revised, trail making test, and controlled oral word association), EORTC QLQ-C30/BN20, and MDASI-BT were completed by the patients. Time to deterioration (TTD) was defined as the time from randomization until a pre-specified change from baseline without further improvement or death. The Kaplan-Meier method and the log-rank test were used to assess TTD for each subscale of the above tests. RESULTS Overall, 94 patients were enrolled in the study. Analyses were based on the full analysis set cohort (N=90), excluding non-glioblastoma diagnosis by central review. The median overall survival (OS) and progression-free survival (PFS) were 25.0 and 14.9 months, respectively. Baseline HRQoL and symptom burden subscales (emotional functioning, symptom severity score, affective factor, and focal factor) were significantly associated with PFS. The median TTD was 8.7, 7.5, 8.1 months for global health status/QoL, symptom severity score, interference score, respectively. Among patients who experienced recurrence, disease progression was apparently preceded by deterioration in terms of symptom burden. CONCLUSIONS Detailed analysis of HRQoL and symptom burden may aid care of glioblastoma patients throughout the disease trajectory.


2017 ◽  
Vol 19 (suppl_6) ◽  
pp. vi206-vi206
Author(s):  
Katherine B Peters ◽  
Mary Lou Affronti ◽  
Stevie Threatt ◽  
Patrick Healy ◽  
James E Herndon ◽  
...  

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