Imatinib Mesylate Therapy Improves Survival in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia in the Chronic Phase: Comparison with Historic Data

Hagop M. Kantarjian, Susan O'Brien, Jorge Cortes, Francis J. Giles, Mary Beth Rios, Jianqin Shan, Stefan Faderl, Guillermo Garcia-Manero, Alessandra Ferrajoli, Srdan Verstovsek, William Wierda, Michael Keating, Moshe Talpaz

Research output: Contribution to journalArticle

Abstract

BACKGROUND. The International Randomized study of Interferon-alpha plus cytarabine (IFN-α plus ara-C) versus STI571 (imatinib mesylate) [IRIS trial] in patients with newly diagnosed Philadelphia chromosome (Ph)-positive, chronic-phase chronic myelogenous leukemia (CML) has not shown (to date) a survival advantage for imatinib. This was most likely because approximately 90% of patients receiving IFN-α plus ara-C changed to imatinib therapy after a median of 8 months into therapy. METHODS. The authors analyzed the results with imatinib therapy in patients with newly diagnosed Ph-positive CML in chronic phase and compared their outcome with patients who received IFN-α regimens. A total of 187 patients with Ph-positive CML in early chronic phase treated with imatinib were compared with a historic group of 650 similar patients treated with IFN-α regimens from 1982 until 1997, RESULTS. Patients who received imatinib were significantly older and had significantly more bone marrow basophilia and less leukocytosis. The complete cytogenetic response (Ph 0%) rates were better with imatinib (81% vs. 32%; P < 0.001), as were the survival rates (30-month estimated survival rates 98% vs, 88%; P = 0.01). A multivariate analysis of the total study group of 837 patients identified imatinib therapy to be a significant independent favorable prognostic factor for survival (P = 0.01). CONCLUSIONS. The current study is the first to indicate the survival advantage of imatinib compared with IFN-α, the previous standard of care, in patients with early chronic-phase CML.

Original languageEnglish (US)
Pages (from-to)2636-2642
Number of pages7
JournalCancer
Volume98
Issue number12
DOIs
StatePublished - Dec 15 2003
Externally publishedYes

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Leukemia, Myeloid, Chronic Phase
Philadelphia Chromosome
Survival
Cytarabine
Therapeutics
Survival Rate
Imatinib Mesylate
Leukocytosis
Standard of Care
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Interferon-alpha
Cytogenetics
Multivariate Analysis
Bone Marrow

Keywords

  • Chronic myelogenous leukemia (CML)
  • Imtinib mesylate therapy
  • Interferon-alpha
  • Philadelphia chromosome (Ph)

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Imatinib Mesylate Therapy Improves Survival in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia in the Chronic Phase : Comparison with Historic Data. / Kantarjian, Hagop M.; O'Brien, Susan; Cortes, Jorge; Giles, Francis J.; Rios, Mary Beth; Shan, Jianqin; Faderl, Stefan; Garcia-Manero, Guillermo; Ferrajoli, Alessandra; Verstovsek, Srdan; Wierda, William; Keating, Michael; Talpaz, Moshe.

In: Cancer, Vol. 98, No. 12, 15.12.2003, p. 2636-2642.

Research output: Contribution to journalArticle

Kantarjian, HM, O'Brien, S, Cortes, J, Giles, FJ, Rios, MB, Shan, J, Faderl, S, Garcia-Manero, G, Ferrajoli, A, Verstovsek, S, Wierda, W, Keating, M & Talpaz, M 2003, 'Imatinib Mesylate Therapy Improves Survival in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia in the Chronic Phase: Comparison with Historic Data', Cancer, vol. 98, no. 12, pp. 2636-2642. https://doi.org/10.1002/cncr.11831
Kantarjian, Hagop M. ; O'Brien, Susan ; Cortes, Jorge ; Giles, Francis J. ; Rios, Mary Beth ; Shan, Jianqin ; Faderl, Stefan ; Garcia-Manero, Guillermo ; Ferrajoli, Alessandra ; Verstovsek, Srdan ; Wierda, William ; Keating, Michael ; Talpaz, Moshe. / Imatinib Mesylate Therapy Improves Survival in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia in the Chronic Phase : Comparison with Historic Data. In: Cancer. 2003 ; Vol. 98, No. 12. pp. 2636-2642.
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title = "Imatinib Mesylate Therapy Improves Survival in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia in the Chronic Phase: Comparison with Historic Data",
abstract = "BACKGROUND. The International Randomized study of Interferon-alpha plus cytarabine (IFN-α plus ara-C) versus STI571 (imatinib mesylate) [IRIS trial] in patients with newly diagnosed Philadelphia chromosome (Ph)-positive, chronic-phase chronic myelogenous leukemia (CML) has not shown (to date) a survival advantage for imatinib. This was most likely because approximately 90{\%} of patients receiving IFN-α plus ara-C changed to imatinib therapy after a median of 8 months into therapy. METHODS. The authors analyzed the results with imatinib therapy in patients with newly diagnosed Ph-positive CML in chronic phase and compared their outcome with patients who received IFN-α regimens. A total of 187 patients with Ph-positive CML in early chronic phase treated with imatinib were compared with a historic group of 650 similar patients treated with IFN-α regimens from 1982 until 1997, RESULTS. Patients who received imatinib were significantly older and had significantly more bone marrow basophilia and less leukocytosis. The complete cytogenetic response (Ph 0{\%}) rates were better with imatinib (81{\%} vs. 32{\%}; P < 0.001), as were the survival rates (30-month estimated survival rates 98{\%} vs, 88{\%}; P = 0.01). A multivariate analysis of the total study group of 837 patients identified imatinib therapy to be a significant independent favorable prognostic factor for survival (P = 0.01). CONCLUSIONS. The current study is the first to indicate the survival advantage of imatinib compared with IFN-α, the previous standard of care, in patients with early chronic-phase CML.",
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T1 - Imatinib Mesylate Therapy Improves Survival in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia in the Chronic Phase

T2 - Comparison with Historic Data

AU - Kantarjian, Hagop M.

AU - O'Brien, Susan

AU - Cortes, Jorge

AU - Giles, Francis J.

AU - Rios, Mary Beth

AU - Shan, Jianqin

AU - Faderl, Stefan

AU - Garcia-Manero, Guillermo

AU - Ferrajoli, Alessandra

AU - Verstovsek, Srdan

AU - Wierda, William

AU - Keating, Michael

AU - Talpaz, Moshe

PY - 2003/12/15

Y1 - 2003/12/15

N2 - BACKGROUND. The International Randomized study of Interferon-alpha plus cytarabine (IFN-α plus ara-C) versus STI571 (imatinib mesylate) [IRIS trial] in patients with newly diagnosed Philadelphia chromosome (Ph)-positive, chronic-phase chronic myelogenous leukemia (CML) has not shown (to date) a survival advantage for imatinib. This was most likely because approximately 90% of patients receiving IFN-α plus ara-C changed to imatinib therapy after a median of 8 months into therapy. METHODS. The authors analyzed the results with imatinib therapy in patients with newly diagnosed Ph-positive CML in chronic phase and compared their outcome with patients who received IFN-α regimens. A total of 187 patients with Ph-positive CML in early chronic phase treated with imatinib were compared with a historic group of 650 similar patients treated with IFN-α regimens from 1982 until 1997, RESULTS. Patients who received imatinib were significantly older and had significantly more bone marrow basophilia and less leukocytosis. The complete cytogenetic response (Ph 0%) rates were better with imatinib (81% vs. 32%; P < 0.001), as were the survival rates (30-month estimated survival rates 98% vs, 88%; P = 0.01). A multivariate analysis of the total study group of 837 patients identified imatinib therapy to be a significant independent favorable prognostic factor for survival (P = 0.01). CONCLUSIONS. The current study is the first to indicate the survival advantage of imatinib compared with IFN-α, the previous standard of care, in patients with early chronic-phase CML.

AB - BACKGROUND. The International Randomized study of Interferon-alpha plus cytarabine (IFN-α plus ara-C) versus STI571 (imatinib mesylate) [IRIS trial] in patients with newly diagnosed Philadelphia chromosome (Ph)-positive, chronic-phase chronic myelogenous leukemia (CML) has not shown (to date) a survival advantage for imatinib. This was most likely because approximately 90% of patients receiving IFN-α plus ara-C changed to imatinib therapy after a median of 8 months into therapy. METHODS. The authors analyzed the results with imatinib therapy in patients with newly diagnosed Ph-positive CML in chronic phase and compared their outcome with patients who received IFN-α regimens. A total of 187 patients with Ph-positive CML in early chronic phase treated with imatinib were compared with a historic group of 650 similar patients treated with IFN-α regimens from 1982 until 1997, RESULTS. Patients who received imatinib were significantly older and had significantly more bone marrow basophilia and less leukocytosis. The complete cytogenetic response (Ph 0%) rates were better with imatinib (81% vs. 32%; P < 0.001), as were the survival rates (30-month estimated survival rates 98% vs, 88%; P = 0.01). A multivariate analysis of the total study group of 837 patients identified imatinib therapy to be a significant independent favorable prognostic factor for survival (P = 0.01). CONCLUSIONS. The current study is the first to indicate the survival advantage of imatinib compared with IFN-α, the previous standard of care, in patients with early chronic-phase CML.

KW - Chronic myelogenous leukemia (CML)

KW - Imtinib mesylate therapy

KW - Interferon-alpha

KW - Philadelphia chromosome (Ph)

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