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A phase II trial of pegylated interferon alpha-2b therapy for polycythemia vera and essential thrombocythemia: feasibility, clinical and biologic effects, and impact on quality of life.

AbstractBACKGROUND:
Conventional interferon-alpha (IFN) is an effective treatment for patients with myeloproliferative disorders. However, many patients discontinue therapy because of side effects.
METHODS:
In this 24-month, Phase II feasibility study of pegylated interferon alpha-2b (PEG-IFN) treatment, a starting dose of 0.5 microg/kg per week was received by 21 patients with polycythemia vera (PV) and 21 patients with essential thrombocythemia (ET). The treatment objective, a complete platelet response (CR), was a platelet count<400x10(9)/L in symptomatic patients and <600 in asymptomatic patients. Neutrophil polycythemia rubra vera-1 (PRV-1) messenger RNA expression was analyzed prior to and during therapy. Quality of life (QoL) was investigated by using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire.
RESULTS:
At 6 months, 29 of 42 patients (69%) had achieved a CR after a median of 83 days. The CR rate was not related to diagnosis, gender, or previous therapy. Nineteen patients completed the planned 2-year treatment in CR. No thromboembolic or bleeding complications were observed. Phlebotomy requirements were reduced in the majority of patients with PV. Five of 14 patients (36%) who initially were positive for PRV-1 achieved normalized PRV-1 expression under PEG-IFN treatment. Side effects were the cause of therapy failure in 16 of 23 patients. However, only 8 of 19 patients reported any side effects at 2 years. The QLQ-C30 revealed clinically significant impairments in several aspects of QoL at 6 months; however, at 2 years, QoL measurements were not different from baseline.
CONCLUSIONS:
PEG-IFN effectively reduced platelet counts in 29 of 42 patients, but only 19 patients maintained a CR at 2 years. The reversal of PRV-1 positivity noted in a subset of patients suggested that PEG-IFN may have an effect on the malignant clone. PEG-IFN is a valuable therapeutic alternative for patients who tolerate its initial side effects.
AuthorsJan Samuelsson, Hans Hasselbalch, Oystein Bruserud, Snezana Temerinac, Yvonne Brandberg, Mats Merup, Olle Linder, Magnus Bjorkholm, Heike L Pahl, Gunnar Birgegard, Nordic Study Group for Myeloproliferative Disorders
JournalCancer (Cancer) Vol. 106 Issue 11 Pg. 2397-405 (Jun 01 2006) ISSN: 0008-543X [Print] United States
PMID16639737 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright (c) 2006 American Cancer Society.
Chemical References
  • Antiviral Agents
  • CD177 protein, human
  • Drug Carriers
  • GPI-Linked Proteins
  • Interferon alpha-2
  • Interferon-alpha
  • Isoantigens
  • Membrane Glycoproteins
  • RNA, Messenger
  • Receptors, Cell Surface
  • Recombinant Proteins
  • Polyethylene Glycols
  • peginterferon alfa-2b
Topics
  • Adult
  • Aged
  • Antiviral Agents (therapeutic use)
  • Drug Carriers
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • GPI-Linked Proteins
  • Humans
  • Interferon alpha-2
  • Interferon-alpha (therapeutic use)
  • Isoantigens (genetics, metabolism)
  • Male
  • Membrane Glycoproteins (genetics, metabolism)
  • Middle Aged
  • Neutrophils (metabolism)
  • Platelet Count
  • Polycythemia Vera (drug therapy)
  • Polyethylene Glycols
  • Prospective Studies
  • Quality of Life
  • RNA, Messenger (genetics, metabolism)
  • Receptors, Cell Surface (genetics, metabolism)
  • Recombinant Proteins
  • Thrombocytosis (drug therapy)

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