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- Title
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.
- Authors
Samuelsson, Jan; Hasselbalch, Hans; Bruserud, Oystein; Temerinac, Snezana; Brandberg, Yvonne; Merup, Mats; Linder, Olle; Bjorkholm, Magnus; Pahl, Heike L; Birgegard, Gunnar; Nordic Study Group for Myeloproliferative Disorders
- Abstract
<bold>Background: </bold>Conventional interferon-alpha (IFN) is an effective treatment for patients with myeloproliferative disorders. However, many patients discontinue therapy because of side effects.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
THERAPEUTIC use of proteins; RNA metabolism; ANTIVIRAL agents; BONE marrow diseases; CELL receptors; CLINICAL trials; COMPARATIVE studies; DRUG delivery systems; GLYCOPROTEINS; ISOANTIGENS; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; NEUTROPHILS; POLYETHYLENE glycol; QUALITY of life; QUESTIONNAIRES; RECOMBINANT proteins; RESEARCH; RESEARCH funding; RNA; THROMBOCYTOSIS; PILOT projects; EVALUATION research; MEMBRANE glycoproteins; PLATELET count
- Publication
Cancer (0008543X), 2006, Vol 106, Issue 11, p2397
- ISSN
0008-543X
- Publication type
journal article