Busulfan in patients with polycythemia vera or essential thrombocythemia refractory or intolerant to hydroxyurea

Ann Hematol. 2014 Dec;93(12):2037-43. doi: 10.1007/s00277-014-2152-7. Epub 2014 Jul 2.

Abstract

Therapeutic options for patients with polycythemia vera (PV) and essential thrombocythemia (ET) resistant or intolerant to hydroxyurea are limited. Busulfan is effective as first-line therapy, but there is scarce information on this drug as second-line treatment. The efficacy of busulfan in patients with advanced PV or ET refractory or intolerant to hydroxyurea was assessed in 36 patients (PV n = 15, ET n = 21) treated for a median of 256 days. Complete hematological response (CHR) was achieved in 83 % of patients, after a median time of 203 days (range 92-313). The probability of sustained CHR at 1 and 2 years was 87 and 62 %, respectively. Time to CHR was shorter in patients treated with ≥14 mg of busulfan per week than with lower doses (141 versus 336 days, p = 0.01). Partial molecular response was achieved in three out of nine (33 %) patients. Busulfan was stopped in 27 patients (75 %) due to CHR achievement in 18 cases (67 %), hematological toxicity in 8 cases (30 %), and disease transformation in 1 case. With a median follow-up of 721 days, six patients have died, with the probability of survival at 2 years being 85 %. The probability of thrombosis at 2 years was 11 %. Transformation into acute leukemia or myelodysplastic syndrome was observed in three cases, all of them in a JAK2V617F-negative clone carrying additional mutations. Busulfan, at a dose of 2 mg/day, is an effective option for elderly patients with PV or ET who fail to hydroxyurea, but a significant rate of transformation was observed.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alkylating Agents / therapeutic use*
  • Blood Cell Count
  • Busulfan / therapeutic use*
  • Comorbidity
  • Disease Progression
  • Drug Resistance
  • Drug Substitution
  • Female
  • Hematocrit
  • Hemorrhage / etiology
  • Humans
  • Hydroxyurea / adverse effects
  • Hydroxyurea / therapeutic use
  • Janus Kinase 2 / genetics
  • Kaplan-Meier Estimate
  • Leukemia, Myeloid, Acute / epidemiology
  • Leukemia, Myeloid, Acute / etiology
  • Male
  • Middle Aged
  • Polycythemia Vera / complications
  • Polycythemia Vera / drug therapy*
  • Polycythemia Vera / genetics
  • Remission Induction
  • Risk Factors
  • Thrombocythemia, Essential / complications
  • Thrombocythemia, Essential / drug therapy*
  • Thrombocythemia, Essential / genetics
  • Thrombosis / etiology
  • Treatment Outcome

Substances

  • Alkylating Agents
  • JAK2 protein, human
  • Janus Kinase 2
  • Busulfan
  • Hydroxyurea