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Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data

BACKGROUND: Carfilzomib and daratumumab are licensed in relapsed/refractory multiple myeloma (RRMM), but no head-to-head trials have been conducted. METHODS: We used data from dossiers prepared for the German Federal Joint Committee based on two phase III randomized trials of carfilzomib-based thera...

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Autores principales: Weisel, Katja, Ludwig, Heinz, Rieth, Achim, Lebioda, Andrea, Goldschmidt, Hartmut
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6962286/
https://www.ncbi.nlm.nih.gov/pubmed/31552577
http://dx.doi.org/10.1007/s11136-019-02307-5
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author Weisel, Katja
Ludwig, Heinz
Rieth, Achim
Lebioda, Andrea
Goldschmidt, Hartmut
author_facet Weisel, Katja
Ludwig, Heinz
Rieth, Achim
Lebioda, Andrea
Goldschmidt, Hartmut
author_sort Weisel, Katja
collection PubMed
description BACKGROUND: Carfilzomib and daratumumab are licensed in relapsed/refractory multiple myeloma (RRMM), but no head-to-head trials have been conducted. METHODS: We used data from dossiers prepared for the German Federal Joint Committee based on two phase III randomized trials of carfilzomib-based therapies (ASPIRE, ENDEAVOR) and two of daratumumab-based therapies (POLLUX, CASTOR) to conduct a descriptive assessment of health-related quality of life (HRQoL). HRQoL was assessed using the European Organisation for Research and Treatment of Cancer 30-item HRQoL Questionnaire, with hazard ratios calculated for carfilzomib- and daratumumab-based therapy versus comparators for time to HRQoL deterioration of ≥ 10 points. Analyses were also conducted on data from the EORTC 20-item myeloma-specific questionnaire, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale, and the visual analog scale of the EuroQoL 5-dimension, 5-level questionnaire, where results for these instruments were available. As the designs and patient population of the four trials were similar but not identical, the analysis included only indirect, descriptive comparisons. RESULTS: Compared with lenalidomide/dexamethasone, median time to deterioration in global health status/QoL was longer for carfilzomib-based therapy versus control, but similar for daratumumab-based therapy and control. Compared with bortezomib/dexamethasone, time to deterioration was significantly longer for carfilzomib-based therapy versus control for global health status/QoL and numerous functional and symptom subscales. HRQoL measurement is feasible in large RRMM populations. CONCLUSION: Descriptive assessment of HRQoL data suggests potential benefits for carfilzomib-based over daratumumab-based therapy. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11136-019-02307-5) contains supplementary material, which is available to authorized users.
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spelling pubmed-69622862020-01-30 Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data Weisel, Katja Ludwig, Heinz Rieth, Achim Lebioda, Andrea Goldschmidt, Hartmut Qual Life Res Article BACKGROUND: Carfilzomib and daratumumab are licensed in relapsed/refractory multiple myeloma (RRMM), but no head-to-head trials have been conducted. METHODS: We used data from dossiers prepared for the German Federal Joint Committee based on two phase III randomized trials of carfilzomib-based therapies (ASPIRE, ENDEAVOR) and two of daratumumab-based therapies (POLLUX, CASTOR) to conduct a descriptive assessment of health-related quality of life (HRQoL). HRQoL was assessed using the European Organisation for Research and Treatment of Cancer 30-item HRQoL Questionnaire, with hazard ratios calculated for carfilzomib- and daratumumab-based therapy versus comparators for time to HRQoL deterioration of ≥ 10 points. Analyses were also conducted on data from the EORTC 20-item myeloma-specific questionnaire, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale, and the visual analog scale of the EuroQoL 5-dimension, 5-level questionnaire, where results for these instruments were available. As the designs and patient population of the four trials were similar but not identical, the analysis included only indirect, descriptive comparisons. RESULTS: Compared with lenalidomide/dexamethasone, median time to deterioration in global health status/QoL was longer for carfilzomib-based therapy versus control, but similar for daratumumab-based therapy and control. Compared with bortezomib/dexamethasone, time to deterioration was significantly longer for carfilzomib-based therapy versus control for global health status/QoL and numerous functional and symptom subscales. HRQoL measurement is feasible in large RRMM populations. CONCLUSION: Descriptive assessment of HRQoL data suggests potential benefits for carfilzomib-based over daratumumab-based therapy. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11136-019-02307-5) contains supplementary material, which is available to authorized users. Springer International Publishing 2019-09-24 2020 /pmc/articles/PMC6962286/ /pubmed/31552577 http://dx.doi.org/10.1007/s11136-019-02307-5 Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Article
Weisel, Katja
Ludwig, Heinz
Rieth, Achim
Lebioda, Andrea
Goldschmidt, Hartmut
Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data
title Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data
title_full Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data
title_fullStr Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data
title_full_unstemmed Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data
title_short Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on German benefit assessment data
title_sort health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on german benefit assessment data
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6962286/
https://www.ncbi.nlm.nih.gov/pubmed/31552577
http://dx.doi.org/10.1007/s11136-019-02307-5
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