Changes in quality of life and disease-related symptoms in patients with polycythemia vera receiving ruxolitinib or standard therapy

Ruben Mesa, Srdan Verstovsek, Jean Jacques Kiladjian, Martin Griesshammer, T. Masszi, Simon Durrant, Francesco Passamonti, Claire N. Harrison, Fabrizio Pane, Pierre Zachee, Huiling Zhen, Mark M. Jones, Shreekant Parasuraman, Jingjin Li, Isabelle Côté, Dany Habr, Alessandro M. Vannucchi

Research output: Article

21 Citations (Scopus)

Abstract

Objectives: Polycythemia vera (PV)-related symptoms may not be adequately controlled with conventional therapy. This current analysis of the RESPONSE trial evaluated the effects of ruxolitinib compared with standard therapy on quality of life (QoL) and symptoms in patients with PV who were hydroxyurea resistant/intolerant. Methods: In the previously reported primary analysis, ruxolitinib achieved the primary composite endpoint of hematocrit control and ≥35% reduction in spleen volume at Week 32. The current analysis evaluated patient-reported outcomes using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF), the Pruritus Symptom Impact Scale (PSIS), and the Patient Global Impression of Change (PGIC). Results: Compared with standard therapy, ruxolitinib was associated with greater improvements in global health status/QoL, functional subscales, and individual symptom scores of the EORTC QLQ-C30. At Week 32, more patients in the ruxolitinib arm (44%) achieved a ≥10-point improvement in global health status/QoL vs. standard therapy (9%). Improvements in MPN-SAF symptom scores were consistent with improvements in EORTC QLQ-C30, PSIS, and PGIC scores. Conclusions: Ruxolitinib provides clinically relevant improvements in QoL and ameliorates symptom burden in patients with PV who are hydroxyurea resistant/intolerant.

Original languageEnglish
Pages (from-to)192-200
Number of pages9
JournalEuropean Journal of Haematology
Volume97
Issue number2
DOIs
Publication statusPublished - aug. 1 2016

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Polycythemia Vera
Quality of Life
Symptom Assessment
Hydroxyurea
Pruritus
Therapeutics
Health Status
Neoplasms
Organizations
INCB018424
Hematocrit
Research
Spleen

ASJC Scopus subject areas

  • Hematology

Cite this

Changes in quality of life and disease-related symptoms in patients with polycythemia vera receiving ruxolitinib or standard therapy. / Mesa, Ruben; Verstovsek, Srdan; Kiladjian, Jean Jacques; Griesshammer, Martin; Masszi, T.; Durrant, Simon; Passamonti, Francesco; Harrison, Claire N.; Pane, Fabrizio; Zachee, Pierre; Zhen, Huiling; Jones, Mark M.; Parasuraman, Shreekant; Li, Jingjin; Côté, Isabelle; Habr, Dany; Vannucchi, Alessandro M.

In: European Journal of Haematology, Vol. 97, No. 2, 01.08.2016, p. 192-200.

Research output: Article

Mesa, R, Verstovsek, S, Kiladjian, JJ, Griesshammer, M, Masszi, T, Durrant, S, Passamonti, F, Harrison, CN, Pane, F, Zachee, P, Zhen, H, Jones, MM, Parasuraman, S, Li, J, Côté, I, Habr, D & Vannucchi, AM 2016, 'Changes in quality of life and disease-related symptoms in patients with polycythemia vera receiving ruxolitinib or standard therapy', European Journal of Haematology, vol. 97, no. 2, pp. 192-200. https://doi.org/10.1111/ejh.12707
Mesa, Ruben ; Verstovsek, Srdan ; Kiladjian, Jean Jacques ; Griesshammer, Martin ; Masszi, T. ; Durrant, Simon ; Passamonti, Francesco ; Harrison, Claire N. ; Pane, Fabrizio ; Zachee, Pierre ; Zhen, Huiling ; Jones, Mark M. ; Parasuraman, Shreekant ; Li, Jingjin ; Côté, Isabelle ; Habr, Dany ; Vannucchi, Alessandro M. / Changes in quality of life and disease-related symptoms in patients with polycythemia vera receiving ruxolitinib or standard therapy. In: European Journal of Haematology. 2016 ; Vol. 97, No. 2. pp. 192-200.
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abstract = "Objectives: Polycythemia vera (PV)-related symptoms may not be adequately controlled with conventional therapy. This current analysis of the RESPONSE trial evaluated the effects of ruxolitinib compared with standard therapy on quality of life (QoL) and symptoms in patients with PV who were hydroxyurea resistant/intolerant. Methods: In the previously reported primary analysis, ruxolitinib achieved the primary composite endpoint of hematocrit control and ≥35{\%} reduction in spleen volume at Week 32. The current analysis evaluated patient-reported outcomes using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF), the Pruritus Symptom Impact Scale (PSIS), and the Patient Global Impression of Change (PGIC). Results: Compared with standard therapy, ruxolitinib was associated with greater improvements in global health status/QoL, functional subscales, and individual symptom scores of the EORTC QLQ-C30. At Week 32, more patients in the ruxolitinib arm (44{\%}) achieved a ≥10-point improvement in global health status/QoL vs. standard therapy (9{\%}). Improvements in MPN-SAF symptom scores were consistent with improvements in EORTC QLQ-C30, PSIS, and PGIC scores. Conclusions: Ruxolitinib provides clinically relevant improvements in QoL and ameliorates symptom burden in patients with PV who are hydroxyurea resistant/intolerant.",
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AU - Mesa, Ruben

AU - Verstovsek, Srdan

AU - Kiladjian, Jean Jacques

AU - Griesshammer, Martin

AU - Masszi, T.

AU - Durrant, Simon

AU - Passamonti, Francesco

AU - Harrison, Claire N.

AU - Pane, Fabrizio

AU - Zachee, Pierre

AU - Zhen, Huiling

AU - Jones, Mark M.

AU - Parasuraman, Shreekant

AU - Li, Jingjin

AU - Côté, Isabelle

AU - Habr, Dany

AU - Vannucchi, Alessandro M.

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N2 - Objectives: Polycythemia vera (PV)-related symptoms may not be adequately controlled with conventional therapy. This current analysis of the RESPONSE trial evaluated the effects of ruxolitinib compared with standard therapy on quality of life (QoL) and symptoms in patients with PV who were hydroxyurea resistant/intolerant. Methods: In the previously reported primary analysis, ruxolitinib achieved the primary composite endpoint of hematocrit control and ≥35% reduction in spleen volume at Week 32. The current analysis evaluated patient-reported outcomes using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF), the Pruritus Symptom Impact Scale (PSIS), and the Patient Global Impression of Change (PGIC). Results: Compared with standard therapy, ruxolitinib was associated with greater improvements in global health status/QoL, functional subscales, and individual symptom scores of the EORTC QLQ-C30. At Week 32, more patients in the ruxolitinib arm (44%) achieved a ≥10-point improvement in global health status/QoL vs. standard therapy (9%). Improvements in MPN-SAF symptom scores were consistent with improvements in EORTC QLQ-C30, PSIS, and PGIC scores. Conclusions: Ruxolitinib provides clinically relevant improvements in QoL and ameliorates symptom burden in patients with PV who are hydroxyurea resistant/intolerant.

AB - Objectives: Polycythemia vera (PV)-related symptoms may not be adequately controlled with conventional therapy. This current analysis of the RESPONSE trial evaluated the effects of ruxolitinib compared with standard therapy on quality of life (QoL) and symptoms in patients with PV who were hydroxyurea resistant/intolerant. Methods: In the previously reported primary analysis, ruxolitinib achieved the primary composite endpoint of hematocrit control and ≥35% reduction in spleen volume at Week 32. The current analysis evaluated patient-reported outcomes using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF), the Pruritus Symptom Impact Scale (PSIS), and the Patient Global Impression of Change (PGIC). Results: Compared with standard therapy, ruxolitinib was associated with greater improvements in global health status/QoL, functional subscales, and individual symptom scores of the EORTC QLQ-C30. At Week 32, more patients in the ruxolitinib arm (44%) achieved a ≥10-point improvement in global health status/QoL vs. standard therapy (9%). Improvements in MPN-SAF symptom scores were consistent with improvements in EORTC QLQ-C30, PSIS, and PGIC scores. Conclusions: Ruxolitinib provides clinically relevant improvements in QoL and ameliorates symptom burden in patients with PV who are hydroxyurea resistant/intolerant.

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