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A phase II trial of pegylated interferon a-2b therapy for polycythemia vera and essential thrombocythemia: Feasibility, clinical and biologic effects, and impact on quality of life
Department of Medicine, Stockholm South Hospital, Stockholm, Sweden, Department of Medicine, Stockholm South Hospital, Karolinska Institute, S-118 83 Stockholm, Sweden.
Department of Medicine, Roskilde University Hospital, Roskilde, Denmark.
Department of Hematology, Haukeland University Hospital, Bergen, Norway.
Department of Experimental Anesthesiology, University Hospital Freiburg, Freiburg, Germany.
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2006 (English)In: Cancer, ISSN 0008-543X, Vol. 106, no 11, 2397-2405 p.Article in journal (Refereed) Published
Abstract [en]

BACKGROUND. Conventional interferon-a (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 a-2b (PEG-IFN) treatment, a starting dose of 0.5 µg/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 <400 × 109/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 investi-gated 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. © 2006 American Cancer Society.

Place, publisher, year, edition, pages
2006. Vol. 106, no 11, 2397-2405 p.
Keyword [en]
a-interferon, Essential thrombocythemia, Myeloproliferative, Pegylated, Polycythemia rubra vera-1, Polycythemia vera, Quality of life
National Category
Natural Sciences
URN: urn:nbn:se:liu:diva-50216DOI: 10.1002/cncr.21900OAI: diva2:271112
Available from: 2009-10-11 Created: 2009-10-11 Last updated: 2011-01-11

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