Health-related quality-of-life (HRQoL) results from the FAST study, a phase 2 trial of epirubicin, oxaliplatin and capecitabine with or without IMAB362 in patients with advanced CLDN18.2+ gastric (GA) and gastroesophageal junction (GEJ) adenocarcinoma.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e16005-e16005
Author(s):  
Robert Morlock ◽  
James Turnbul ◽  
Steven Blahut ◽  
Michelle R Krukas-Hampel ◽  
Emily Hawryluk ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gastroesophageal Junction ◽  
Phase 2 ◽  
Health Related Quality ◽  
Phase 2 Trial ◽  
Related Quality ◽  
Health Related

scholarly journals Health-related Quality of Life in Patients With Recurrent Pericarditis: Results From a Phase 2 Study of Rilonacept

2021 ◽  
Author(s):  
David Lin ◽  
Allan Klein ◽  
David Cella ◽  
Anna Beutler ◽  
Fang Fang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Qualitative Interviews ◽  
Phase 2 ◽  
Health Related Quality ◽  
Recurrent Pericarditis ◽  
Phase 2 Trial ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Abstract Background: Impact of recurrent pericarditis (RP) on patient health-related quality of life (HRQoL) was evaluated through qualitative patient interviews and as an exploratory endpoint in a Phase 2 trial evaluating the efficacy and safety of rilonacept (IL-1α/IL-1β blocker) to treat RP.Methods: Qualitative interviews were conducted with ten adults with RP to understand symptoms and HRQoL impacts, and the 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS Global) v1.2 was evaluated to determine questionnaire coverage of patient experience. The Phase 2 trial enrolled participants with active symptomatic RP (A-RP, n=16) and corticosteroid-dependent participants with no active recurrence at baseline (CSD-RP, n=9). All participants received rilonacept weekly for 6 weeks during a base treatment period (TP) plus an optional 18-week extension period (EP). Concomitant medications, including corticosteroids (CS), were tapered, if possible, during EP. HRQoL was assessed using the PROMIS Global, and patient-reported pain and blood levels of c-reactive protein (CRP) were also collected at Baseline and follow-up periods. Results: Information from qualitative interviews demonstrated that PROMIS GH concepts are relevant to adults with RP. From the Phase 2 trial, both participant groups showed impacted HRQoL at Baseline [mean PROMIS Global Physical Health (GPH) and Global Mental Health (GMH), were lower than population norm average]. In A-RP, GPH/MPH improved by end of base TP and were sustained through EP (similar trends were observed for pain and CRP). Similarly, in CSD-RP, GPH/MPH improved by end of TP and further improved at EP, during CS tapering or discontinuation, without disease recurrence (low pain scores and CRP levels continued during the TP and EP). Conclusion: This is the first study demonstrating impaired HRQoL in RP. Rilonacept treatment was associated with HRQoL improvements using PROMIS GH scores. Maintained/improved HRQoL during tapering/withdrawal of CS without recurrence suggests that rilonacept may provide an alternative to corticosteroids. Trial Registration: ClinicalTrials.Gov; NCT03980522; 5 June 2019, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03980522

Health-related quality of life outcomes from CABARET: a randomized phase 2 trial of carboplatin and bevacizumab in recurrent glioblastoma

2017 ◽  
Vol 133 (3) ◽  
pp. 623-631 ◽  
Author(s):  
Kathryn M. Field ◽  
Madeleine T. King ◽  
John Simes ◽  
David Espinoza ◽  
Elizabeth H. Barnes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Recurrent Glioblastoma ◽  
Phase 2 ◽  
Health Related Quality ◽  
Life Outcomes ◽  
Phase 2 Trial ◽  
Related Quality ◽  
Health Related ◽  
Randomized Phase 2

scholarly journals Health-related quality of life in patients with recurrent pericarditis: results from a phase 2 study of rilonacept

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Lin ◽  
Allan Klein ◽  
David Cella ◽  
Anna Beutler ◽  
Fang Fang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Qualitative Interviews ◽  
Phase 2 ◽  
Health Related Quality ◽  
Recurrent Pericarditis ◽  
Phase 2 Trial ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

Abstract Background Impact of recurrent pericarditis (RP) on patient health-related quality of life (HRQoL) was evaluated through qualitative patient interviews and as an exploratory endpoint in a Phase 2 trial evaluating the efficacy and safety of rilonacept (IL-1α/IL-1β cytokine trap) to treat RP. Methods Qualitative interviews were conducted with ten adults with RP to understand symptoms and HRQoL impacts, and the 10-item Patient-Reported Outcomes Measurement Information System Global Health (PROMIS GH) v1.2 was evaluated to determine questionnaire coverage of patient experience. The Phase 2 trial enrolled participants with active symptomatic RP (A-RP, n = 16) and corticosteroid-dependent participants with no active recurrence at baseline (CSD-RP, n = 9). All participants received rilonacept weekly during a 6-week base treatment period (TP) plus an optional 18-week extension period (EP). Tapering of concomitant medications, including corticosteroids (CS), was permitted during EP. HRQoL was assessed using the PROMIS GH, and patient-reported pain and blood levels of c-reactive protein (CRP) were collected at Baseline and follow-up periods. A secondary, descriptive analysis of the Phase 2 trial efficacy results was completed using HRQoL measures to characterize both the impact of RP and the treatment effect of rilonacept. Results Information from qualitative interviews demonstrated that PROMIS GH concepts are relevant to adults with RP. From the Phase 2 trial, both participant groups showed impacted HRQoL at Baseline (mean PROMIS Global Physical Health [GPH] and Global Mental Health [GMH], were lower than population norm average). In A-RP, GPH/MPH improved by end of base TP and were sustained through EP (similar trends were observed for pain and CRP). Similarly, in CSD-RP, GPH/MPH improved by end of TP and further improved during EP, during CS tapering or discontinuation, without disease recurrence (low pain scores and CRP levels continued during the TP and EP). Conclusion This is the first study demonstrating impaired HRQoL in RP. Rilonacept treatment was associated with HRQoL improvements using PROMIS GH scores. Maintained/improved HRQoL during tapering/withdrawal of CS without recurrence suggests that rilonacept may provide an alternative to CS. Trial registration: ClinicalTrials.Gov; NCT03980522; 5 June 2019, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03980522.

Tu1887 IMPACT OF MIRIKIZUMAB TREATMENT ON HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH ULCERATIVE COLITIS: A PHASE 2 STUDY ANALYSIS USING THE SF-36 V2 STANDARD

2020 ◽  
Vol 158 (6) ◽  
pp. S-1204-S-1205
Author(s):  
Gary R. Lichtenstein ◽  
Brian G. Feagan ◽  
Jay Tuttle ◽  
Nathan Morris ◽  
Yan Dong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Phase 2 ◽  
Health Related Quality ◽  
Study Analysis ◽  
Sf 36 ◽  
Phase 2 Study ◽  
Related Quality ◽  
Health Related

Abstract 241: Health-related Quality of Life in Patients With Recurrent Pericarditis: Results From a Phase 2 Study of Rilonacept

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
David Lin ◽  
Allan L Klein ◽  
David Cella ◽  
Anna Beutler ◽  
Fang Fang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Period ◽  
Phase 2 ◽  
Health Related Quality ◽  
Recurrent Pericarditis ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
The Impact

Background: Recurrent pericarditis (RP) episodes and conventional treatments result in morbidity, but the impact on patient health-related quality of life (HRQoL) has not been quantified. The Phase 2 trial NCT03980522 of rilonacept (IL-1α/IL-1β inhibitor) evaluated HRQoL. Methods: Patients with active RP who were symptomatic at Baseline (A-RP, n=16) and RP patients who were not currently experiencing a recurrence but were corticosteroid-dependent at Baseline (CSD-RP, n=9) were enrolled. All received rilonacept weekly for 6 weeks to end of base treatment period (TP) plus an optional 18-week extension treatment period (EP). Corticosteroid tapering occurred in the EP. Physical and mental HRQoL (PROMIS Global Health v1.2 Physical and Mental Component Scores [PCS/MCS]) were assessed at baseline and follow-up. Results: Figure 1 presents the PROMIS PCS/MCS and pain scale scores (both patient-reported) as well as C-reactive protein levels over time. Mean PCS/MCS scores at baseline were 39.9/44.5 and 43.3/46.5 for A-RP and CSD-RP groups respectively (versus the norm mean of 50). In A-RP, PCS/MCS scores improved by 11.4/5.6 points by end of base TP, and this improvement was sustained throughout the EP (increase of 11.4/6.0 points from baseline at end of EP). In CSD-RP, PCS/MCS scores increased by 1.8/1.4 points by end of TP and improved by 3.5/4.2 points at end of study, after tapering or discontinuation of corticosteroid without disease recurrence. Conclusion: Impaired baseline HRQoL suggests negative impact of RP. For A-RP, rilonacept rapidly improved pericarditis signs and symptoms which was associated with HRQoL improvements. For CSD-RP, rilonacept supported tapering/withdrawal of corticosteroids without recurrence, with maintained/improved HRQoL. These results suggest rilonacept can improve RP patient HRQoL while providing an alternative to corticosteroids.

The Health Related Quality of Life Is Maintained Following Treatment of Indolent Non-Hodgkin's Lymphoma Patients with the Novel Effective Antibody Radionuclide Conjugate 177lu-Satetraxetan-Lilotomab

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5339-5339
Author(s):  
Arne Kolstad ◽  
Matthew Beasley ◽  
Michael Bayne ◽  
Ingemar Lagerlöf ◽  
Noelle O'Rourke ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Research Funding ◽  
Median Score ◽  
Phase 2 ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Equity Ownership ◽  
Grade 3

Abstract Betalutin (177Lu-satetraxetan-lilotomab) is an antibody radionuclide conjugate (ARC) in development for the treatment of Non-Hodgkin's lymphoma (NHL). The FACT-Lym is a validated health related quality of life instrument specifically designed to assess lymphoma patients. This questionnaire has been used previously to demonstrate significant reductions in the quality of life of patients undergoing treatment, likely as a result of treatment related toxicities (Hlubocky FJ, et al, Lymphoma 2013). Methods Patients with relapsed incurable NHL of follicular grade I-IIIA, marginal zone, mantle cell, lymphoplasmacytic and small lymphocytic subtypes who had received at least one prior treatment regimen were eligible for enrolment. All patients received a single dose of 15 MBq/kg of 177Lu-satetraxetan-lilotomab. The FACT-Lym instrument used in the study has 42 questions grouped into 5 subscales (physical, social/family, emotional and functional well-being and additional concerns). Questionnaires were completed by all subjects in the phase 2 stage of the study during screening, at month 3 and month 12. Responses were categorised on a 5-point Likert scale from "0- not at all" to "4-very much" with a higher score indicating a better quality of life. The analysis is conducted as part of a protocol specified interim analysis of efficacy, safety and quality of life. Results A total of 36 patients have been enrolled into this phase 1/2 study of which 15 patients who have undergone treatment in the phase 2 part are included in the current analysis. The median age of the patients was 68 years and the median number of prior regimens was 2 (range: 1-9). All 15 subjects have completed the screening assessment and 7 patients have completed the 3 month assessment, data from all subjects at both screening and the month 3 assessment will be presented at the annual meeting. To date 907 responses to questions have been collected including 622 questions at screening and 285 responses at 3 months post-treatment. At enrolment patients overall had a good health-related quality of life with a median baseline score of 121 and this was similar at 3 months post-treatment (median score: 132, p-value: 0.558). This maintenance of the patients quality of life was achieved while 5/7 patients (71%) showed a complete or partial response to treatment. Of the 7 patients who have so far completed the month 3 assessment, 3 had grade 3 thrombocytopenia or neutropenia (none had grade 4), the quality of life assessment of these patients (median score: 158) was similar to or higher than the 4 patients who did not have grade 3 thrombocytopenia/neutropenia (median score: 110). This indicates no negative impact on the health related quality of life when patients experienced haematological side effects associated with 177Lu-satetraxetan-lilotomab. When the 3-month assessment has been completed by all patients a subscale analysis and a correlation with ECOG performance status will be performed. Conclusion The health related quality of life as measured by the validated FACT-Lym questionnaire was maintained following treatment with Betalutin, while also achieving a durable tumour response in a significant proportion of the patients assessed. The treatment related hematological side effects experienced by patients were modest and appeared not to have a negative effect on the quality of life. Further analysis is required to confirm these findings when the 3 month assessment has been completed by all patients. Disclosures Kolstad: Nordic Nanovector: Other: Membership of Scientific Advisory Board. Dahle:Nordic Nanovector ASA: Employment, Equity Ownership. Baylor Curtis:Nordic Nanovector: Employment. Østengen:Nordic Nanovector: Employment. Turner:Nordic Nanovector: Employment. Hartvig Larsen:Nordic nanovector: Equity Ownership. Holte:Amgen: Research Funding; Mundipharma: Research Funding.

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