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...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer
2023-11-01
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| Series: | HemaSphere |
| Online Access: | http://journals.lww.com/10.1097/HS9.0000000000000966 |
| _version_ | 1797449534238883840 |
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| author | Ruben A. Mesa Claire Harrison Jeanne M. Palmer Vikas Gupta Donal P. McLornan Mary Frances McMullin Jean-Jacques Kiladjian Lynda Foltz Uwe Platzbecker Maria Laura Fox Adam J. Mead David M. Ross Stephen T. Oh Andrew Charles Perkins Michael F. Leahy Jun Kawashima Sunhee Ro Rafe Donahue Boris Gorsh Samineh Deheshi Srdan Verstovsek |
| author_facet | Ruben A. Mesa Claire Harrison Jeanne M. Palmer Vikas Gupta Donal P. McLornan Mary Frances McMullin Jean-Jacques Kiladjian Lynda Foltz Uwe Platzbecker Maria Laura Fox Adam J. Mead David M. Ross Stephen T. Oh Andrew Charles Perkins Michael F. Leahy Jun Kawashima Sunhee Ro Rafe Donahue Boris Gorsh Samineh Deheshi Srdan Verstovsek |
| author_sort | Ruben A. Mesa |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-09T14:26:21Z |
| format | Article |
| id | doaj.art-f9632edb1b7c4fa09e09d3f5fe8a8134 |
| institution | Directory Open Access Journal |
| issn | 2572-9241 |
| language | English |
| last_indexed | 2024-03-09T14:26:21Z |
| publishDate | 2023-11-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | HemaSphere |
| spelling | doaj.art-f9632edb1b7c4fa09e09d3f5fe8a81342023-11-28T07:10:29ZengWolters KluwerHemaSphere2572-92412023-11-01711e96610.1097/HS9.0000000000000966202311000-00003Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM StudyRuben A. Mesa0Claire Harrison1Jeanne M. Palmer2Vikas Gupta3Donal P. McLornan4Mary Frances McMullin5Jean-Jacques Kiladjian6Lynda Foltz7Uwe Platzbecker8Maria Laura Fox9Adam J. Mead10David M. Ross11Stephen T. Oh12Andrew Charles Perkins13Michael F. Leahy14Jun Kawashima15Sunhee Ro16Rafe Donahue17Boris Gorsh18Samineh Deheshi19Srdan Verstovsek201 Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA4 Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom5 Mayo Clinic, Phoenix, AZ, USA6 Princess Margaret Cancer Centre, University of Toronto, ON, Canada4 Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom8 Queen’s University, Belfast, United Kingdom9 Université de Paris, AP-HP, Hôpital Saint-Louis, Centre d’Investigations Cliniques, Paris, France10 University of British Columbia, Vancouver, BC, Canada11 University Hospital Leipzig, Germany12 Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain13 Oxford University Hospitals NHS Foundation Trust, United Kingdom14 Flinders Medical Centre and SA Pathology, Adelaide, SA, Australia15 Washington University School of Medicine, St Louis, MO, USA16 The Alfred Hospital and Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia17 Royal Perth Hospital, PathWest Laboratory Medicine; University of Western Australia, Perth, WA, Australia18 Sierra Oncology, Inc., a GSK company, San Mateo, CA, USA18 Sierra Oncology, Inc., a GSK company, San Mateo, CA, USA18 Sierra Oncology, Inc., a GSK company, San Mateo, CA, USA19 GSK, Philadelphia, PA, USA18 Sierra Oncology, Inc., a GSK company, San Mateo, CA, USA20 The University of Texas MD Anderson Cancer Center, Houston, TX, USAMyelofibrosis (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.http://journals.lww.com/10.1097/HS9.0000000000000966 |
| spellingShingle | Ruben A. Mesa Claire Harrison Jeanne M. Palmer Vikas Gupta Donal P. McLornan Mary Frances McMullin Jean-Jacques Kiladjian Lynda Foltz Uwe Platzbecker Maria Laura Fox Adam J. Mead David M. Ross Stephen T. Oh Andrew Charles Perkins Michael F. Leahy Jun Kawashima Sunhee Ro Rafe Donahue Boris Gorsh Samineh Deheshi Srdan Verstovsek Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis: Results From the MOMENTUM Study HemaSphere |
| 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 |
| url | http://journals.lww.com/10.1097/HS9.0000000000000966 |
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