Abstract | BACKGROUND: 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.
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Authors | Jan 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 |
Journal | Cancer
(Cancer)
Vol. 106
Issue 11
Pg. 2397-405
(Jun 01 2006)
ISSN: 0008-543X [Print] United States |
PMID | 16639737
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright (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
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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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