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

Research output: Contribution to journalArticle

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

Fingerprint

interferon alfa-2b
Myeloproliferative Disorders
Essential Thrombocythemia
Polycythemia Vera
Therapeutics
Primary Myelofibrosis
Interferon-alpha
Hypereosinophilic Syndrome
Musculoskeletal Pain

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Jabbour, E., Kantarjian, H., Cortes, J., Thomas, D., Garcia-Manero, G., Ferrajoli, A., ... 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

PEG-IFN-α-2b therapy in BCR-ABL-negative myeloproliferative disorders : Final result of a phase 2 study. / Jabbour, Elias; Kantarjian, Hagop; Cortes, Jorge; Thomas, Deborah; Garcia-Manero, Guillermo; Ferrajoli, Alessandra; Faderl, Stefan; Richie, Mary Ann; Beran, Miloslav; Giles, Francis; Verstovsek, Srdan.

In: Cancer, Vol. 110, No. 9, 01.11.2007, p. 2012-2018.

Research output: Contribution to journalArticle

Jabbour, E, Kantarjian, H, Cortes, J, Thomas, D, Garcia-Manero, G, Ferrajoli, A, Faderl, S, Richie, MA, 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, vol. 110, no. 9, pp. 2012-2018. https://doi.org/10.1002/cncr.23018
Jabbour E, Kantarjian H, Cortes J, Thomas D, Garcia-Manero G, Ferrajoli A et al. PEG-IFN-α-2b therapy in BCR-ABL-negative myeloproliferative disorders: Final result of a phase 2 study. Cancer. 2007 Nov 1;110(9):2012-2018. https://doi.org/10.1002/cncr.23018
Jabbour, Elias ; Kantarjian, Hagop ; Cortes, Jorge ; Thomas, Deborah ; Garcia-Manero, Guillermo ; Ferrajoli, Alessandra ; Faderl, Stefan ; Richie, Mary Ann ; Beran, Miloslav ; Giles, Francis ; Verstovsek, Srdan. / PEG-IFN-α-2b therapy in BCR-ABL-negative myeloproliferative disorders : Final result of a phase 2 study. In: Cancer. 2007 ; Vol. 110, No. 9. pp. 2012-2018.
@article{e7141e2bafbe422482349d9e7bc23775,
title = "PEG-IFN-α-2b therapy in BCR-ABL-negative myeloproliferative disorders: Final result of a phase 2 study",
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.",
keywords = "BCR-ABL-negative, Essential thrombocythemia, IFN-α, Myeloproliferative disorders, Polycythemia vera, Primary myelofibrosis",
author = "Elias Jabbour and Hagop Kantarjian and Jorge Cortes and Deborah Thomas and Guillermo Garcia-Manero and Alessandra Ferrajoli and Stefan Faderl and Richie, {Mary Ann} and Miloslav Beran and Francis Giles and Srdan Verstovsek",
year = "2007",
month = "11",
day = "1",
doi = "10.1002/cncr.23018",
language = "English (US)",
volume = "110",
pages = "2012--2018",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "9",

}

TY - JOUR

T1 - PEG-IFN-α-2b therapy in BCR-ABL-negative myeloproliferative disorders

T2 - Final result of a phase 2 study

AU - Jabbour, Elias

AU - Kantarjian, Hagop

AU - Cortes, Jorge

AU - Thomas, Deborah

AU - Garcia-Manero, Guillermo

AU - Ferrajoli, Alessandra

AU - Faderl, Stefan

AU - Richie, Mary Ann

AU - Beran, Miloslav

AU - Giles, Francis

AU - Verstovsek, Srdan

PY - 2007/11/1

Y1 - 2007/11/1

N2 - 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.

AB - 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.

KW - BCR-ABL-negative

KW - Essential thrombocythemia

KW - IFN-α

KW - Myeloproliferative disorders

KW - Polycythemia vera

KW - Primary myelofibrosis

UR - http://www.scopus.com/inward/record.url?scp=35648966599&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=35648966599&partnerID=8YFLogxK

U2 - 10.1002/cncr.23018

DO - 10.1002/cncr.23018

M3 - Article

C2 - 17849460

AN - SCOPUS:35648966599

VL - 110

SP - 2012

EP - 2018

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 9

ER -