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Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm that typically manifests with debilitating symptoms that progressively worsen, negatively impacting patients’ quality of life. Fatigue is a multifactorial and burdensome MF-related symptom due to its severity, persistence, and prevalence, w...

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Autores principales: Mesa, Ruben A., Harrison, Claire, Palmer, Jeanne M., Gupta, Vikas, McLornan, Donal P., McMullin, Mary Frances, Kiladjian, Jean-Jacques, Foltz, Lynda, Platzbecker, Uwe, Fox, Maria Laura, Mead, Adam J., Ross, David M., Oh, Stephen T., Perkins, Andrew Charles, Leahy, Michael F., Kawashima, Jun, Ro, Sunhee, Donahue, Rafe, Gorsh, Boris, Deheshi, Samineh, Verstovsek, Srdan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10599984/
https://www.ncbi.nlm.nih.gov/pubmed/37901848
http://dx.doi.org/10.1097/HS9.0000000000000966
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author Mesa, Ruben A.
Harrison, Claire
Palmer, Jeanne M.
Gupta, Vikas
McLornan, Donal P.
McMullin, Mary Frances
Kiladjian, Jean-Jacques
Foltz, Lynda
Platzbecker, Uwe
Fox, Maria Laura
Mead, Adam J.
Ross, David M.
Oh, Stephen T.
Perkins, Andrew Charles
Leahy, Michael F.
Kawashima, Jun
Ro, Sunhee
Donahue, Rafe
Gorsh, Boris
Deheshi, Samineh
Verstovsek, Srdan
author_facet Mesa, Ruben A.
Harrison, Claire
Palmer, Jeanne M.
Gupta, Vikas
McLornan, Donal P.
McMullin, Mary Frances
Kiladjian, Jean-Jacques
Foltz, Lynda
Platzbecker, Uwe
Fox, Maria Laura
Mead, Adam J.
Ross, David M.
Oh, Stephen T.
Perkins, Andrew Charles
Leahy, Michael F.
Kawashima, Jun
Ro, Sunhee
Donahue, Rafe
Gorsh, Boris
Deheshi, Samineh
Verstovsek, Srdan
author_sort Mesa, Ruben A.
collection PubMed
description Myelofibrosis (MF) is a chronic myeloproliferative neoplasm that typically manifests with debilitating symptoms that progressively worsen, negatively impacting patients’ quality of life. Fatigue is a multifactorial and burdensome MF-related symptom due to its severity, persistence, and prevalence, with anemia a contributing factor and major unmet need. Clinical trials of the Janus kinase (JAK)1/JAK2/activin A receptor type 1 inhibitor momelotinib have shown consistent anemia benefits, in addition to improvements in MF-related symptoms. The phase 3 MOMENTUM trial in symptomatic and anemic patients met its primary end point, with a greater proportion having a Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score (TSS) reduction ≥50% at week 24 with momelotinib versus danazol. To support the positive primary end point result, we conducted longitudinal, responder, and time-to-event analyses of patient-reported outcomes from MOMENTUM, as measured by the MFSAF, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Patient-Reported Outcomes Measurement Information System (PROMIS) assessments. These analyses demonstrated rapid and durable response benefits with momelotinib, with achievement of first TSS response by day 29 and continued improvement over time. Improvements favored momelotinib versus danazol for each MFSAF individual item, and greater improvements were observed for disease- and cancer-related fatigue and physical functioning at week 24, with significant results for multiple items/domains across the 3 assessments. These findings are consistent in demonstrating that momelotinib provides substantial symptom benefit.
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spelling pubmed-105999842023-10-27 Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study Mesa, Ruben A. Harrison, Claire Palmer, Jeanne M. Gupta, Vikas McLornan, Donal P. McMullin, Mary Frances Kiladjian, Jean-Jacques Foltz, Lynda Platzbecker, Uwe Fox, Maria Laura Mead, Adam J. Ross, David M. Oh, Stephen T. Perkins, Andrew Charles Leahy, Michael F. Kawashima, Jun Ro, Sunhee Donahue, Rafe Gorsh, Boris Deheshi, Samineh Verstovsek, Srdan Hemasphere Article Myelofibrosis (MF) is a chronic myeloproliferative neoplasm that typically manifests with debilitating symptoms that progressively worsen, negatively impacting patients’ quality of life. Fatigue is a multifactorial and burdensome MF-related symptom due to its severity, persistence, and prevalence, with anemia a contributing factor and major unmet need. Clinical trials of the Janus kinase (JAK)1/JAK2/activin A receptor type 1 inhibitor momelotinib have shown consistent anemia benefits, in addition to improvements in MF-related symptoms. The phase 3 MOMENTUM trial in symptomatic and anemic patients met its primary end point, with a greater proportion having a Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score (TSS) reduction ≥50% at week 24 with momelotinib versus danazol. To support the positive primary end point result, we conducted longitudinal, responder, and time-to-event analyses of patient-reported outcomes from MOMENTUM, as measured by the MFSAF, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Patient-Reported Outcomes Measurement Information System (PROMIS) assessments. These analyses demonstrated rapid and durable response benefits with momelotinib, with achievement of first TSS response by day 29 and continued improvement over time. Improvements favored momelotinib versus danazol for each MFSAF individual item, and greater improvements were observed for disease- and cancer-related fatigue and physical functioning at week 24, with significant results for multiple items/domains across the 3 assessments. These findings are consistent in demonstrating that momelotinib provides substantial symptom benefit. Lippincott Williams & Wilkins 2023-10-24 /pmc/articles/PMC10599984/ /pubmed/37901848 http://dx.doi.org/10.1097/HS9.0000000000000966 Text en Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Article
Mesa, Ruben A.
Harrison, Claire
Palmer, Jeanne M.
Gupta, Vikas
McLornan, Donal P.
McMullin, Mary Frances
Kiladjian, Jean-Jacques
Foltz, Lynda
Platzbecker, Uwe
Fox, Maria Laura
Mead, Adam J.
Ross, David M.
Oh, Stephen T.
Perkins, Andrew Charles
Leahy, Michael F.
Kawashima, Jun
Ro, Sunhee
Donahue, Rafe
Gorsh, Boris
Deheshi, Samineh
Verstovsek, Srdan
Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study
title Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study
title_full Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study
title_fullStr Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study
title_full_unstemmed Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study
title_short Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study
title_sort patient-reported outcomes and quality of life in anemic and symptomatic patients with myelofibrosis: results from the momentum study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10599984/
https://www.ncbi.nlm.nih.gov/pubmed/37901848
http://dx.doi.org/10.1097/HS9.0000000000000966
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