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dc.contributor.authorTalpaz, M.
dc.contributor.authorErickson-Viitanen, S.
dc.contributor.authorHou, K.
dc.date.accessioned2019-05-17T12:53:03Z
dc.date.available2019-05-17T12:53:03Z
dc.date.issued2018
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85051194971&doi=10.1186%2fs13045-018-0642-0&partnerID=40&md5=8322c5c23ccb04b652fa288166c876b8
dc.identifier.urihttp://hdl.handle.net/10713/9066
dc.description.abstractBackground: Ruxolitinib improves splenomegaly and symptoms in patients with intermediate-2 or high-risk myelofibrosis; however, nearly half develop grade 3/4 anemia and/or thrombocytopenia, necessitating dose reductions and/or transfusions. We report findings from an open-label phase 2 study exploring a dose-escalation strategy aimed at preserving clinical benefit while reducing hematological adverse events early in ruxolitinib treatment. Methods: Patients with myelofibrosis received ruxolitinib 10 mg twice daily (BID), with incremental increases of 5 mg BID at weeks 12 and 18 for lack of efficacy (maximum, 20 mg BID). Symptom severity was measured using the Myelofibrosis Symptom Assessment Form Total Symptom Score (MFSAF TSS). Results: Forty-five patients were enrolled, 68.9% of whom had a Dynamic International Prognostic Scoring System score of 1 to 2 (i.e., intermediate-1 disease risk). Median percentage change in spleen volume from baseline to week 24 was − 17.3% (≥ 10% reduction achieved by 26 patients [57.8%]), with a clear dose response. Median percentage change in MFSAF TSS from baseline at week 24 was − 45.6%, also with a dose response. The most frequent treatment-emergent adverse events were anemia (26.7%), fatigue (22.2%), and arthralgias (20.0%). Grade 3/4 anemia (20.0%) and dose decreases due to anemia (11.1%) or thrombocytopenia (6.7%) were infrequent. Conclusions: A dose-escalation approach may mitigate worsening anemia during early ruxolitinib therapy in some patients with myelofibrosis. Trial registration: ClinicalTrials.gov identifier, NCT01445769 . Registered September 23, 2011. Copyright 2018 The Author(s).en_US
dc.description.sponsorshipWe gratefully acknowledge the assistance of Ramon Tiu, MD, as the coordinating principal investigator for this study. Medical writing assistance was provided by Tania R. Iqbal, PhD, of Complete Healthcare Communications, LLC (West Chester, PA), a CHC Group company, and was funded by Incyte Corporation (Wilmington, DE).en_US
dc.description.urihttps://dx.doi.org/10.1186/s13045-018-0642-0en_US
dc.language.isoen_USen_US
dc.publisherBioMed Central Ltd.en_US
dc.relation.ispartofJournal of Hematology and Oncology
dc.subjectAnemiaen_US
dc.subjectJanus kinaseen_US
dc.subjectMyelofibrosisen_US
dc.subjectRuxolitiniben_US
dc.subjectThrombocytopeniaen_US
dc.subjectTransfusionen_US
dc.titleEvaluation of an alternative ruxolitinib dosing regimen in patients with myelofibrosis: an open-label phase 2 studyen_US
dc.typeArticleen_US
dc.identifier.doi10.1186/s13045-018-0642-0


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