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 48weeks, 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 10cm below the left costal margin (range, 0-10) to 6cm (range, 0-15). The rate of spleen response increased from 14% at the start of the combination to 45% after 48weeks. 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.

Efficacy and safety of ruxolitinib and hydroxyurea combination in patients with hyperproliferative myelofibrosis

Bonifacio, Massimiliano;
2019-01-01

Abstract

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 48weeks, 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 10cm below the left costal margin (range, 0-10) to 6cm (range, 0-15). The rate of spleen response increased from 14% at the start of the combination to 45% after 48weeks. 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.
2019
Efficacy; Hydroxyurea; Myelofibrosis; Ruxolitinib; Aged; Aged, 80 and over; Blood Platelets; Cell Count; Cell Proliferation; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Hydroxyurea; Leukocytes; Male; Middle Aged; Patient Safety; Primary Myelofibrosis; Pyrazoles; Retrospective Studies; Splenomegaly; Survival Analysis; Treatment Outcome
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/1015859
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