scholarly journals Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study

2021 ◽  
Vol 14 ◽  
pp. 175628642199399 ◽  
Author(s):  
Annette Wundes ◽  
Sibyl Wray ◽  
Ralf Gold ◽  
Barry A. Singer ◽  
Elzbieta Jasinska ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Medication Use ◽  
Dimethyl Fumarate ◽  
Daily Activities ◽  
Phase Iii ◽  
Symptomatic Medication ◽  
Gi Symptoms ◽  
Symptom Intensity ◽  
The Impact

Background: Diroximel fumarate (DRF) is a novel oral fumarate approved for relapsing forms of multiple sclerosis (MS). DRF demonstrated significantly improved gastrointestinal (GI) tolerability versus dimethyl fumarate (DMF) with fewer days of Individual Gastrointestinal Symptom and Impact Scale (IGISIS) scores ⩾2, GI adverse events (AEs), and treatment discontinuations due to GI AEs. Our aim was to evaluate the impact of GI tolerability events on quality of life (QoL) for patients with relapsing–remitting MS who received DRF or DMF in EVOLVE-MS-2. Methods: A post hoc analysis was conducted in patients who were enrolled in the randomized, blinded, 5-week, EVOLVE-MS-2 [ClinicalTrials.gov identifier: NCT03093324] study of DRF versus DMF. Patients completed daily IGISIS and Global GISIS (GGISIS) eDiary questionnaires to assess GI symptom intensity and interference with daily activities and work. Results: In total, 504 patients (DRF, n = 253; DMF, n = 251) received study drug and 502 (DRF, n = 253; DMF, n = 249) completed at least one post-baseline questionnaire. With DRF, GI symptoms were less likely to interfere ‘quite a bit’ or ‘extremely’ with regular daily activities [IGISIS: DRF, 9.5% (24/253) versus DMF, 28.9% (72/249)] or work productivity [GGISIS: DRF, 6.1% (10/165) versus DMF, 11.3% (18/159)]. DRF-treated patients had fewer days with ⩾1 h of missed work (DRF, 43 days, n = 20 versus DMF, 88 days, n = 26). DMF-treated patients reported highest GI symptom severity and missed work at week 2–3 shortly after completing the titration period, which coincided with the majority of GI-related treatment discontinuations [58.3% (7/12)]. GI tolerability AEs [DRF, 34.8% (88/253); DMF, 48.2% (121/251)], concomitant symptomatic medication use [DRF, 19.3% (17/88) versus DMF, 30.6% (37/121)], and GI-related discontinuations (DRF, 0.8% versus DMF, 4.8%) were lower with DRF versus DMF. Conclusions: The improved GI tolerability with DRF translated into clinically meaningful benefits to QoL, as patients experienced less impact on daily life and work and required less concomitant symptomatic medication use. Trial registration: [ClinicalTrials.gov identifier: NCT03093324]

Health-related quality of life/patient-reported outcomes in relapsed ovarian cancer: Results from a randomized phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5526-5526
Author(s):  
C. N. Krasner ◽  
A. Poveda ◽  
T. Herzog ◽  
J. Vermorken ◽  
B. Monk ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ovarian Cancer ◽  
Health Status ◽  
Patient Reported Outcomes ◽  
Phase Iii ◽  
Gi Symptoms ◽  
Patient Reported ◽  
Phase Iii Study ◽  
The Impact

5526 Background: In an open-label, multicenter, randomized phase III study comparing the combination of trabectedin and PLD to PLD alone in patients with relapsed ovarian cancer, the combination demonstrated significantly improved progression free survival and response rates, manageable non-cumulative toxicity, and fewer PLD-associated adverse events. We studied the impact of the combination of trabectedin with PLD on the quality of life (QoL)/patient-reported outcomes (PRO) evaluated as part of the trial. Methods: QoL/PRO questionnaires, EORTC-QLQ C30, OV28, and EQ-5D were completed by patients at screening and on Day 1 of every other treatment cycle starting with Cycle 1, and at the end-of-treatment visit. Global health status/QoL, fatigue, rain subscales from QLQ C30, and abdominal pain/GI symptoms scale from OV28 were chosen a priori for primary analyses. Other scales of the three questionnaires were analyzed on a supportive basis. Results: A total of 672 patients were randomized. 663 (98%) completed at least the baseline questionnaires. Median cycles of treatment was 6 (131 days) for the combination arm and 5 (143 days) for the monotherapy arm. Mixed effects models (using a covariance structure of AR[1]) predicting the score at baseline and follow-up scores as a function of treatment, days after baseline, and interaction between treatment and days after baseline showed no significant differences between the treatment arms for any of the prespecified scales. Similar analyses of other scales, including EQ-5D Health Index scores and Health State on the Visual Analog Scale, support the findings. Conclusions: The addition of trabectedin to PLD results in superior efficacy in patients with relapsed ovarian cancer, with no added decrement to overall health status as assessed by PRO. [Table: see text]

Effects of BG-12 (dimethyl fumarate) on health-related quality of life in patients with relapsing–remitting multiple sclerosis: findings from the CONFIRM study

2013 ◽  
Vol 20 (2) ◽  
pp. 253-257 ◽  
Author(s):  
Mariko Kita ◽  
Robert J Fox ◽  
J Theodore Phillips ◽  
Michael Hutchinson ◽  
Eva Havrdova ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Short Form ◽  
Dimethyl Fumarate ◽  
Phase Iii ◽  
Health Related Quality ◽  
Relapsing Remitting ◽  
Related Quality ◽  
Health Related

Multiple sclerosis (MS) has a significant impact on health-related quality of life (HRQoL) with symptoms adversely affecting many aspects of everyday living. BG-12 (dimethyl fumarate) demonstrated significant efficacy in the phase III studies DEFINE and CONFIRM in patients with relapsing–remitting MS. In CONFIRM, HRQoL was worse in patients with greater disability at baseline, and who relapsed during the study, and improved with BG-12 treatment. Mean Short Form-36 Physical Component Summary scores for BG-12 increased over 2 years and scores for placebo decreased. Coupled with clinical and neuroradiological benefits, these HRQoL results further support BG-12 as an effective oral treatment for relapsing MS.

scholarly journals Positive impact of cladribine on quality of life in people with relapsing multiple sclerosis

2017 ◽  
Vol 24 (11) ◽  
pp. 1461-1468 ◽  
Author(s):  
Dayo Afolabi ◽  
Christo Albor ◽  
Lukasz Zalewski ◽  
Dan R Altmann ◽  
David Baker ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Positive Impact ◽  
Rank Correlation ◽  
Phase Iii ◽  
European Medicines Agency ◽  
Total N ◽  
The Impact ◽  
Relapsing Multiple Sclerosis

Background: A number of elements of the pivotal ‘cladribine tablets treating multiple sclerosis orally’ (CLARITY) trial have remained unpublished. Objective: To report the impact of cladribine on health-related quality of life (QoL) in people with relapsing multiple sclerosis (pwRMS). Methods: QoL data from the phase III trial of two different doses (3.5 and 5.25 mg/kg) of oral cladribine in pwRMS were acquired from the European Medicines Agency through Freedom of Information. Spearman’s rank correlation was used to analyse the relationship between baseline QoL scores and baseline Expanded Disability Status Scale (EDSS) scores. Responses of the Euro Quality of Life 5 Dimensions (EQ-5D) and Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaires were compared between treatment and control groups using univariate analyses of covariance. Results: In total, n = 5148 EQ-5D responses and n = 894 MSQOL-54 physical, mental health and dimension scores were extracted. Baseline EQ-5D indices correlated with EDSS scores. After 2 years, pwRMS taking 3.5 ( p = .001) and 5.25 mg/kg ( p = .022) reported significantly improved EQ-5D index scores compared with placebo. Positive, yet non-significant, differences were detected in MSQOL-54 scores between cladribine and placebo. Conclusion: Analysis of the CLARITY dataset suggests that, over and above its established clinical efficacy, cladribine leads to improved QoL over 96 weeks. ClinicalTrials.gov identifier: NCT00213135.

scholarly journals Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial

2018 ◽  
Vol 36 (25) ◽  
pp. 2578-2584 ◽  
Author(s):  
Jonathan Strosberg ◽  
Edward Wolin ◽  
Beth Chasen ◽  
Matthew Kulke ◽  
David Bushnell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Phase Iii ◽  
High Dose ◽  
Health Related Qol ◽  
Health Related ◽  
Phase Iii Study ◽  
The Impact

Purpose Neuroendocrine tumor (NET) progression is associated with deterioration in quality of life (QoL). We assessed the impact of 177Lu-Dotatate treatment on time to deterioration in health-related QoL. Methods The NETTER-1 trial is an international phase III study in patients with midgut NETs. Patients were randomly assigned to treatment with 177Lu-Dotatate versus high-dose octreotide. European Organisation for Research and Treatment of Cancer quality-of-life questionnaires QLQ C-30 and G.I.NET-21 were assessed during the trial to determine the impact of treatment on health-related QoL. Patients completed the questionnaires at baseline and every 12 weeks until tumor progression. QoL scores were converted to a 100-point scale according to European Organisation for Research and Treatment of Cancer instructions, and individual changes from baseline scores were assessed. Time to QoL deterioration (TTD) was defined as the time from random assignment to the first QoL deterioration ≥ 10 points for each patient in the corresponding domain scale. All analyses were conducted on the intention-to-treat population. Patients with no deterioration were censored at the last QoL assessment date. Results TTD was significantly longer in the 177Lu-Dotatate arm (n = 117) versus the control arm (n = 114) for the following domains: global health status (hazard ratio [HR], 0.406), physical functioning (HR, 0.518), role functioning (HR, 0.580), fatigue (HR, 0.621), pain (HR, 0.566), diarrhea (HR, 0.473), disease-related worries (HR, 0.572), and body image (HR, 0.425). Differences in median TTD were clinically significant in several domains: 28.8 months versus 6.1 months for global health status, and 25.2 months versus 11.5 months for physical functioning. Conclusion This analysis from the NETTER-1 phase III study demonstrates that, in addition to improving progression-free survival, 177Lu-Dotatate provides a significant QoL benefit for patients with progressive midgut NETs compared with high-dose octreotide.

scholarly journals Relationship between dental fluorosis and quality of life: a population based study

2005 ◽  
Vol 19 (2) ◽  
pp. 150-155 ◽  
Author(s):  
Edgard Michel-Crosato ◽  
Maria Gabriela Haye Biazevic ◽  
Edgard Crosato
Keyword(s):  
Quality Of Life ◽  
Water Supply ◽  
Dental Fluorosis ◽  
Female Gender ◽  
Population Based ◽  
Daily Activities ◽  
Cross Sectional ◽  
Significance Level ◽  
The Impact

The aim of this study was to verify the prevalence of dental fluorosis in schoolchildren aged 6 to 15 and its possible association with the impacts on their daily activities. This study is observational, cross-sectional and analytical. A total of 513 schoolchildren from the city of Pinheiro Preto, SC, took part in this study. The children were examined by three calibrated dentists, after obtaining a kappa > 0.80. To assess the prevalence of fluorosis, clinical examinations were performed according to the methodology set forth by the 4th edition of the WHO. To assess the impact of fluorosis on their daily activities, a modified OIDP (Oral Impacts on Daily Performance) was adopted. The statistical analysis used was the Chi-squared test with a 5% significance level. Of the total number of children examined, 262 (51.1%) were of the female gender and 251 (48.9%) were of the male gender. In regard to the prevalence of fluorosis, 94 (18.3%) of the children presented this condition, while 419 children (81.7%) presented a normal condition. In regard to the severity of fluorosis, few children presented severe alterations. No association was found between dental fluorosis and gender (p = 0.646), between fluorosis and socioeconomic status (p = 0.848) or between fluorosis and access to public water supply system (p = 0.198). The activities that most affected children's daily performance were: oral hygiene (40.9%) and food intake or enjoying food (40.4%). None of the daily activities could be associated with the occurrence of dental fluorosis. The prevalence of dental fluorosis was consonant with the standards found for locations with optimum fluoride content in the water supply. The questionable and very slight levels of fluorosis were the most frequently found, without influence in the quality of life of the schoolchildren participating in the study.

Gastrointestinal symptoms of pelvic radiation disease (part 1): literature review

2020 ◽  
Vol 18 (2) ◽  
pp. 40-45 ◽  
Author(s):  
Helen Ludlow ◽  
John Green
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Literature Review ◽  
Patient Experience ◽  
Gastrointestinal Symptoms ◽  
Pelvic Radiation ◽  
Gi Symptoms ◽  
Pelvic Cancer ◽  
The Impact

Radiotherapy used to treat cancers in the pelvic region can have lasting side effects, and the persistence of these symptoms for 3 months or more is described as pelvic radiation disease (PRD). The growing number of pelvic cancer patients being diagnosed and successfully treated is increasing the incidence of PRD. This review examines the literature on the gastrointestinal symptoms of PRD. This includes how PRD is defined, how it is identified and how it relates specifically to the three pelvic cancers in which it most commonly manifests (prostate, gynaecological and colorectal). It pays particular attention to the impact of PRD on patient experience and quality of life. This review is the first part in a series on the GI symptoms of PRD.

Quality of life in patients with locally advanced head and neck cancer undergoing chemoradiation with once-a-week versus once-every-three-weeks cisplatin.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12092-12092
Author(s):  
Nandini Sharrel Menon ◽  
Vanita Noronha ◽  
Amit Joshi ◽  
Vijay Maruti Patil ◽  
Atanu Bhattacharjee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Locally Advanced ◽  
Phase Iii ◽  
Locoregional Control ◽  
Advanced Head ◽  
Significant Difference ◽  
Eortc Qlq ◽  
The Impact

12092 Background: This trial was conducted to compare the efficacy of low dose once-a-week cisplatin with once-every-3-weeks cisplatin with radiation in locally advanced head and neck squamous cell carcinoma (LAHNSCC). The current analysis focuses on the quality of life (QoL) of patients in this trial. Methods: In this phase III randomized trial, patients with stage III or IV non-metastatic LAHNSCC were randomized to receive cisplatin 30 mg/m2 once a week or cisplatin 100 mg/m2 once every 3 weeks concurrently with curative intent radiotherapy. The primary endpoint was locoregional control. QoL was a key secondary endpoint. QoL was assessed using the EORTC QLQ-C30 (v.3) and EORTC QLQ-H&N35 (v.1). QoL data were assessed at baseline and days 22 and 43 during treatment; at the end of chemoradiation and at each follow-up. The linear mixed effects model was used for longitudinal analysis of QoL domains to determine the impact of treatment (arm) and time on QoL scores. Results: Three hundred patients were enrolled, 150 in each arm. QoL data from 283 patients with at least one assessable questionnaire were analyzed. The pretreatment QoL scores were similar in both the arms in all domains. There was no significant difference in the global health status/QoL with respect to the treatment arm ( P =0.608) or time ( P=0.0544 ). There was no significant difference in the longitudinal QoL scores between the two treatment arms in all domains except the physical function ( P= .0074), constipation ( P= .0326), trouble with social contact ( P= .0321) and sexuality ( P= .0004). There was a decline in the QoL scores in all domains in both arms during treatment. After completion of treatment, the QoL scores started improving steadily up to 1 year and plateaued thereafter in both arms. Conclusions: The use of once-every-three weeks cisplatin significantly improved the locoregional control without adversely impacting the quality of life as compared to once-a-week cisplatin in combination with radical radiotherapy in locally advanced HNSCC. Clinical trial information: CTRI/2012/10/ 003062. .

PROSPER: A phase III randomized study comparing perioperative nivolumab (nivo) versus observation in patients with localized renal cell carcinoma (RCC) undergoing nephrectomy (ECOG-ACRIN 8143).

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. TPS684-TPS684 ◽  
Author(s):  
Lauren Christine Harshman ◽  
Maneka Puligandla ◽  
Naomi B. Haas ◽  
Mohamad Allaf ◽  
Charles G. Drake ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Immune System ◽  
Clinical Outcomes ◽  
Clinical Stage ◽  
Randomized Study ◽  
Phase Iii ◽  
The Impact ◽  
Metastatic Rcc

TPS684 Background: The anti-PD-1 antibody nivo improves overall survival in metastatic RCC and is well tolerated. There is no standard adjuvant systemic therapy that increases overall survival (OS) over surgery alone for non-metastatic RCC. Priming the immune system prior to surgery with anti-PD-1 has shown an OS benefit compared to a pure adjuvant approach in mouse solid tumor models. The PROSPER RCC trial aims to improve clinical outcomes by priming the immune system prior to nephrectomy with neoadjuvant nivo and continued engagement with adjuvant blockade in patients with high risk M0 RCC compared to surgery alone. Methods: This global, unblinded, phase 3 National Clinical Trials Network study is currently accruing patients with clinical stage ≥T2 or node positive M0 RCC of any histology. Tumor biopsy prior to randomization is mandatory to ensure RCC and permits in depth correlative science. The investigational arm will receive two doses of nivo 240mg prior to surgery followed by adjuvant nivo for 9 months (q2 wks x 3 mo followed by 480mg q4 wks x 6 mo). The control arm will undergo standard nephrectomy followed by observation. Randomized patients are stratified by clinical T stage, node positivity, and histology. To enhance accrual and patient quality of life, key upcoming amendments are being instituted. These include biopsy only in the nivo arm, allowance of oligometastatic disease and bilateral renal masses that can be fully resected/ablated, and change of nivo dosing to q4 wks (1 neoadj; 9 adj). With accrual of 766 patients, there is 84.2% power to detect a 14.4% absolute benefit in recurrence-free survival (RFS) at 5 years assuming the ASSURE historical control of ~56% to 70% (HR = 0.70). The study is also powered to evaluate a significant increase in overall survival (HR 0.67). Safety, feasibility, and quality of life endpoints critical to adjuvant therapy considerations are incorporated. PROSPER RCC embeds a wealth of translational work aimed at investigating the impact of the baseline immune milieu, the changes induced by neoadjuvant anti-PD-1 priming, and how both correlate with clinical outcomes. Clinical trial information: NCT03055013.

Su2085 The Impact of Fear of GI Symptoms on Quality of Life Impairment Due to Irritable Bowel Syndrome

2014 ◽  
Vol 146 (5) ◽  
pp. S-542
Author(s):  
Jeffrey M. Lackner ◽  
Gregory D. Gudleski ◽  
Changxing Ma ◽  
Akriti Dewanwala ◽  
Bruce D. Naliboff
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Gi Symptoms ◽  
Irritable Bowel ◽  
The Impact

scholarly journals Pulmonary rehabilitation and tuberculosis: a new approach for an old disease

Pneumologia ◽  
2019 ◽  
Vol 68 (3) ◽  
pp. 107-113
Author(s):  
Beatrice Mahler ◽  
Alina Croitoru
Keyword(s):  
Quality Of Life ◽  
Muscle Weakness ◽  
Pulmonary Rehabilitation ◽  
Functional Independence ◽  
Daily Activities ◽  
New Approach ◽  
Antituberculous Treatment ◽  
Long Time ◽  
The Impact

Abstract Tuberculosis (TB) is still a leading cause of morbidity and mortality worldwide. The impact on patient’s life is significant, leading to physical, mental and social deconditioning, not only in active TB but also in post TB sequela. Although with specific antituberculous treatment sputum negativity can be achieved, TB extrapulmonary symptoms such as cachexia, muscle weakness and depression may persist for a long time. The pulmonary rehabilitation (PR) may be a useful tool in this patient’s therapy in active and also in sequela phase. The benefits of PR are: reducing symptomatology, improving the degree of functional independence and quality of life, and increasing the ability to perform daily activities. This article discusses the components of a PR programme in active TB and TB sequela, and the results obtained by studies so far.

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