PEG-IFN-α-2b therapy in BCR-ABL-negative myeloproliferative disorders: Final result of a phase 2 study

Elias Jabbour, Hagop Kantarjian, Jorge Cortes, Deborah Thomas, Guillermo Garcia-Manero, Alessandra Ferrajoli, Stefan Faderl, Mary Ann Richie, Miloslav Beran, Francis Giles, Srdan Verstovsek

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85 Scopus citations

Abstract

BACKGROUND. Interferon-alpha (IFN-α) has shown significant activity in the treatment of BCR-ABL-negative myeloproliferative disorders (MPDs), particularly essential thrombocythemia (ET) and polycythemia vera (PV). PEG-IFN-α-2b is a pegylated IFN-α-2b with a significant advantage over nonpegylated form in that it is administered once a week. METHODS. Thirty-eight patients with BCR-ABL-negative MPDs were treated with PEG-IFN-α-2b, given subcutaneously weekly, at the starting dose of 3 μg/kg/wk for the first 14 patients and then 2 μg/kg/wk for the next 24 patients, with intent to treat patients as long as they benefited from the therapy. RESULTS. Median age was 54 years. Patient diagnoses were: 13 (34%) ET; 11 (29%) primary myelofibrosis (PMF); 5 (13%) BCR-ABL-negative chronic myeloid leukemia (CML); 4 (10.5%) hypereosinophilic syndrome (HES); 4 (10.5%) PV; and 1 (3%) unclassified myeloproliferative disease (uMPD). Recorded grade 3-4 toxicities were related to fatigue, myelosuppression, and musculoskeletal pain. Ten (26%) patients stopped treatment because of toxicity. Thirteen (34%) patients achieved a complete remission, and 4 (11%) achieved a partial response. Only 1 patient with PMF responded. Median time to response was 5 months. Median duration of response was 20 months. Three patients had a sustained response for >24 months. CONCLUSIONS. PEG-IFN-α-2b, with proper dose modifications, is effective in controlling disease in a significant proportion of BCR-ABL-negative MPD patients, particularly ET and PV However, toxicities encountered with PEG-IFN-α-2b therapy are similar to those obtained with conventional IFN-α, thus limiting the duration of therapy.

Original languageEnglish (US)
Pages (from-to)2012-2018
Number of pages7
JournalCancer
Volume110
Issue number9
DOIs
StatePublished - Nov 1 2007
Externally publishedYes

Keywords

  • BCR-ABL-negative
  • Essential thrombocythemia
  • IFN-α
  • Myeloproliferative disorders
  • Polycythemia vera
  • Primary myelofibrosis

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Jabbour, E., Kantarjian, H., Cortes, J., Thomas, D., Garcia-Manero, G., Ferrajoli, A., Faderl, S., Richie, M. A., Beran, M., Giles, F., & Verstovsek, S. (2007). PEG-IFN-α-2b therapy in BCR-ABL-negative myeloproliferative disorders: Final result of a phase 2 study. Cancer, 110(9), 2012-2018. https://doi.org/10.1002/cncr.23018