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

Elena Rossi, Valerio De Stefano, Massimo Breccia, Luigiana Luciano, Novella Pugliese, Mario Tiribelli, Emilia Scalzulli, Massimiliano Bonifacio, Bruno Martino, Roberto Latagliata, Giulia Benevolo, Giovanni Caocci, Gianni Binotto, Vincenzo Martinelli, Michele Cavo, Fabrizio Pane, Robin Foà, Francesca Palandri

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2 Citations (Scopus)


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.
Original languageEnglish
Pages (from-to)1933-1936
Number of pages4
JournalAnnals of Hematology
Publication statusPublished - 2019


  • Efficacy
  • Hydroxyurea
  • Myelofibrosis
  • Ruxolitinib


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