Efficacy and safety of ruxolitinib and hydroxyurea combination in patients with hyperproliferative myelofibrosis
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Ruxolitinib is the only commercially available JAK1/2 inhibitor approved for the treatment of myelofibrosis-related splenomegaly and symptoms. During treatment, as rare conditions, leukocytosis and/or thrombocytosis could develop and the management of these situations is not well established. We report here 53 myelofibrosis patients that received a combination of hydroxyurea and ruxolitinib because of uncontrolled myeloproliferation. Both drugs were administered outside clinical trials. At 48 weeks, a significant reduction in leucocyte and platelet counts was observed (p = 0.02 and p = 0.04, respectively). Additionally, the spleen volume decreased from a median value of 10 cm below the left costal margin (range, 0–10) to 6 cm (range, 0–15). The rate of spleen response increased from 14% at the start of the combination to 45% after 48 weeks. The safety profile of the combination was consistent with that observed with ruxolitinib single agent. These data require further confirmation in large cohorts of patients prospectively assessed.
KeywordsMyelofibrosis Ruxolitinib Hydroxyurea Efficacy
MB designed the study, wrote and revised the manuscript; LL, NP, ER, MT, ES, MB, BM, RL, GB, GC, GB, VM, MC, FP, and VDS followed patients; FP and RF critically revised the paper and approved the final version.
Compliance with ethical standards
Conflict of interest
MB received honoraria by Novartis, Pfizer, Incyte, and Celgene. All other authors declare no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained for all patients included.
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