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Changes in quality of life and disease‐related symptoms in patients with polycythemia vera receiving ruxolitinib or standard therapy
Author(s) -
Mesa Ruben,
Verstovsek Srdan,
Kiladjian JeanJacques,
Griesshammer Martin,
Masszi Tamas,
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.
Publication year - 2016
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/ejh.12707
Subject(s) - ruxolitinib , medicine , myeloproliferative neoplasm , polycythemia vera , quality of life (healthcare) , myelofibrosis , anemia , clinical endpoint , hematocrit , physical therapy , clinical trial , phlebotomy , bone marrow , nursing
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.