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

Cancer

Volumn 106, Issue 11, 2006, Pages 2397-2405

  Samuelsson, Jan ^a   Hasselbalch, Hans ^b   Bruserud, Oystein ^c   Temerinac, Snezana ^d   Brandberg, Yvonne ^e   Merup, Mats ^f   Linder, Olle ^g   Bjorkholm, Magnus ^f   Pahl, Heike L ^d   Birgegard, Gunnar ^h   Ghanima, Waleed ⁱ   Gram Hansen, Poul ^j   Johansson, Peter ^k   Malm, Claes ^l   Markevam, Berit ^m   Mourits Andersen, Torben ⁿ   Nillson, Lars ^o  

^a STOCKHOLM SÖDER HOSPITAL   (Sweden)

^b ROSKILDE HOSPITAL   (Denmark)

^c HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^d UNIVERSITY OF FREIBURG   (Germany)

^e KAROLINSKA INSTITUTE   (Sweden)

^f KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^g ÖREBRO UNIVERSITY HOSPITAL   (Sweden)

^h UPPSALA UNIVERSITY HOSPITAL   (Sweden)

ⁱ Department of Medicine   (Norway)

^j ODENSE UNIVERSITY HOSPITAL   (Denmark)

^k SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^l LINKÖPING UNIVERSITY HOSPITAL   (Sweden)

^m UMEÅ UNIVERSITY HOSPITAL   (Sweden)

ⁿ Esbjerg University Hospital   (Denmark)

^o LUND UNIVERSITY HOSPITAL   (Sweden)

more..

Author keywords

interferon; Essential thrombocythemia; Myeloproliferative; Pegylated; Polycythemia rubra vera 1; Polycythemia vera; Quality of life

Indexed keywords

ACETYLSALICYLIC ACID; ALANINE AMINOTRANSFERASE; ANAGRELIDE; BUSULFAN; CREATININE; HYDROXYUREA; MESSENGER RNA; PEGINTERFERON ALPHA2B; PHOSPHORUS; THYROTROPIN;

ADULT; AGED; ALOPECIA; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; DEPRESSION; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FLU LIKE SYNDROME; HEADACHE; HUMAN; INJECTION SITE REACTION; INSOMNIA; MALE; MYALGIA; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PHLEBOTOMY; POLYCYTHEMIA VERA; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; SIDE EFFECT; THROMBOCYTE COUNT; THROMBOCYTHEMIA; UNSPECIFIED SIDE EFFECT; WEIGHT REDUCTION;

ADULT; AGED; ANTIVIRAL AGENTS; DRUG CARRIERS; FEASIBILITY STUDIES; FEMALE; FOLLOW-UP STUDIES; HUMANS; INTERFERON ALFA-2B; ISOANTIGENS; MALE; MEMBRANE GLYCOPROTEINS; MIDDLE AGED; NEUTROPHILS; PLATELET COUNT; POLYCYTHEMIA VERA; PROSPECTIVE STUDIES; QUALITY OF LIFE; RECEPTORS, CELL SURFACE; RNA, MESSENGER; THROMBOCYTOSIS;

EID: 33646470836     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.21900     Document Type: Article

References (40)

1. Gruppo Italiano Studio Polycythemia. Polycythemia vera: the natural history of 1213 patients followed for 20 years. Ann Intern Med. 1995;123:656-664.
2. Marchioli R, Firiazzi G, Landolfi R, et al. Vascular and neoplastic risk in a large cohort of patients with polycythemia vefa. J Clin Oncol. 2005;23:1-9.
3. Cortelazzo S, Viero P, Finazzi G, Demilio A, Rodeghiero F, Barbui T. Incidence and risk factors for thrombotic complications in a historical cohort of 100 patients with essential thrombocythemia. J Clin Oncol. 1990;8:556-5C62.
4. Najean Y, Mugnier P, Dresch C, Rain J.D. Polycythemia vera in young people: an analysis of 58 cases diagnosed before 40 years. Br J Haematol. 1989;67:285-291.
5. Rozman C, Giralt M, Felihu E, et al. Life expectancy of patients with chronic nonleukemic myeloproliferative disorders. Cancer. 1991;63:2658-2663.
6. Cortelazzo S, Finazzi G, Ruggeri M, et al. Hydroxyurea in the treatment of patients with essential thrombocythemia at high risk of thrombosis: a prospective randomized trial. N Engl J Med. 1995;332:1132-1136.
7. Pearson TC, Wetherley-Mein G. Vascular occlusive episodes and venous haematocrit in primary proliferative polycythaemia. Lancet. 1978;2:1219-1222.
8. Harrison CN, Campbell PJ, Buck G, et al. Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med. 2005;353:33-45.
9. Finazzi G, Caruso V, Marchioli R, et al. Acute leukaemia in polycythemia vera: an analysis of 1638 patients enrolled in a prospective observational study. Blood. 2005;105:2664-2670.
10. Finazzi G, Ruggeri M, Rodeghiero F, Barbui T. Second malignancies in patients with essential thrombocythemia treated with busulphan and hydroxyurea: long-term follow-up of a randomized clinical trial. Br J Haematol. 2000;110:577-583.
11. Najean Y, Rain JD. Treatment of polycythemia vera: use of 32P alone or in combination with maintenance therapy using hydroxyurea in 461 patients greater than 65 years of age. Blood. 1997;89:2319-2327.
12. Ludwig H, Linkesch W, Gisslinger H, et al. Interferon-alfa corrects thrombocytosis in patients with myeloproliferative disorders. Cancer Immunol Immunother. 1987;25:266-273.
13. Gisslinger H, Linkesch W, Fritz E, Ludwig H, Chott A, Radaskiewicz T. Long-term Interferon therapy for thrombocytosis in myeloproliferative diseases. Lancet. 1989;2:634-637.
14. Talpaz M, Kurzrock R, Kantarjian H, O'Brien S, Gutterman JU. Recombinant interferon-alpha therapy of Philadelphia chromosome-negative myeloproliferative disorders. Am J Med. 1989;86:554-558.
15. Silver RT. A new treatment for polycythemia vera: recombinant interferon alfa. Blood. 1990;76:664-665.
16. Hino M, Futami E, Okuno S, Miki T, Nishizawa Y, Morii H. Possible selective effect of interferon α-2b on a malignant clone in a case of polycythemia vera. Ann Hematol. 1993;66:161-162.
17. Messora C, Bensi L, Vechi A, et al. Cytogenetic conversion in a case of polycythaemia vera treated with interferon-alpha. Br J Haematol. 1994;86:402-404.
18. Lengfelder E, Berger U, Hehlman R. Interferon-α in the treatment of polycythemia vera. Ann Hematol. 2000;79:103-109.
19. Lengfelder E, Griesshammer M, Hehlmann R. Interferon-alpha in the treatment of essential thrombocythemia. Leuk Lymphoma. 1996;22(Suppl 1):135-142.
20. Talpaz M, O'Brien S, Rose E, et al. Phase I study of polyethylene glycol formulation of interferon-alpha-2B (Schering 54031) in Philadelphia chromosome-positive chronic myelogenous leukemia. Blood. 2001;98:1708-1713.
21. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-376.
22. Michelson H, Bolund C, Nilsson B, Brandberg Y. Health-related quality of life measured by the EORTC QLQ-C30. Acta Oncol. 2000;39:477-484.
23. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychaitr Scand. 1983;67:361-70.
24. Herrman C. International experience with the Hospital Anxiety and Depression Scale-a review of validation data and clinical results. J Psychosom Res. 1997;42:17-41.
25. Klippel S, Strunck E, Temerinac S, et al. Quantification of PRV-1 mRNA distinguishes polycythemia vera from secondary erythrocytosis. Blood. 2003;102:3569-3574.
26. Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health related quality-of-life scores. J Clin Oncol. 1998;16:139-144.
27. Merup M, Aberg W, Lofvenberg E, et al. Symptoms, symptom distress and health-related quality of life in patients with polycythemia vera or essential thrombocythemia during treatment with interferon-alfa. Acta Oncol. 2002;41:50-55.
28. Alvarado Y, Cortes J, Verstovsek S, et al. Pilot study of pegylated interferon-alpha 2b in patients with essential thrombocythemia. Cancer Chemother Pharmacol. 2003;51:81-86.
29. Verstovsek S, Lawhorn K, Giles F, et al. Peg-intron for myeloproliferative diseases: an update of ongoing Phase II study [abstract]. Blood. 2004;104:424a.
30. Gugliotta L, Bulgarelli S, Vianelli N, et al. Peg Intron in essential thrombocythemia. Two years of treatment in 90 patients [abstract]. Blood. 2003;102:919a.
31. Gugliotta L, Bulgarelli S, Tieghi A, et al. PVSG and WHO bone marrow evaluation in 90 essential thrombocythemia patients treated with PEG interferon α-2-b. Preliminary results [abstract]. Haematologica. 2005;90(Suppl 2):264a.
32. Langer C, Lengfelder E, Thiele J, et al. Pegylated interferon for the treatment of high risk essential thrombocythemia: results of a Phase II study. Haematologica. 2005;90:1333-1338.
33. Anagrelide Study Group. Anagrelide, a therapy for thrombocythemic states: experience in 577 patients. Am J Med. 1992;92:69-78.
34. Birgegard G, Bjorkholm M, Kutti J, et al. Adverse effects and benefits of two years of anagrelide treatment for thrombocythemia in chronic myeloproliferative disorders. Haematologica. 2004;89:520-527.
35. Fruchtman SM, Petitt RM, Gilbert HS, Fiddler G, Lyne A. Anagrelide: analysis of long-term efficacy, safety and leukemogenic potential in myeloproliferative disorders. Leuk Res. 2005;29:481-491.
36. Mazzucconi MG, Redi R, Bernasconi S, et al. A long-term study of young patients with essential thrombocythemia treated with anagrelide. Haematologica. 2004;89:1306-1313.
37. Penninga E, Jensen BA, Hansen PB. Anagrelide treatment in 52 patients with chronic myeloproliferative diseases. Clin Lab Hematol. 2004;26:335-340.
38. Liu E, Jelinek J, Pastore YD, Guan Y, Prchal JF, Prchal JT. Discrimination of polycythemias and thrombocytoses by novel, simple, accurate clonality assays and comparison with PRV-1 expression and BFU-e response to erythropoietin. Blood. 2003;101:3294-3301.
39. Fruehauf S, Topaly J, Villalobos M, Veldwijk MR, Laufs S, Ho AD. Quantitative real-time polymerase chain reaction shows that treatment with Interferon reduces the initially upregulated PRV-1 expression in polycytherma vera patients. Haematologica. 2003;88:349-350.
40. Johansson P, Ricksten A, Wasslavik C, Johansson B, Andreasson B. The effects of hydroxyurea on PRV-1 expression in patients with essential thrombocythemia and polycythemia vera. Haematologica. 2004;89:1272-1273.