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Imatinib mesylate therapy improves survival in patients with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukemia in the chronic phase: comparison with historic data.

AbstractBACKGROUND:
The International Randomized study of Interferon-alpha plus cytarabine (IFN-alpha 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-alpha 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-alpha 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-alpha 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-alpha, the previous standard of care, in patients with early chronic-phase CML.
AuthorsHagop 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
JournalCancer (Cancer) Vol. 98 Issue 12 Pg. 2636-42 (Dec 15 2003) ISSN: 0008-543X [Print] United States
PMID14669283 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright 2003 American Cancer Society.
Chemical References
  • Antineoplastic Agents
  • Benzamides
  • Interferon-alpha
  • Piperazines
  • Pyrimidines
  • Imatinib Mesylate
  • Protein-Tyrosine Kinases
Topics
  • Administration, Oral
  • Antineoplastic Agents (administration & dosage, therapeutic use)
  • Benzamides
  • Drug Administration Schedule
  • Follow-Up Studies
  • Humans
  • Imatinib Mesylate
  • Interferon-alpha (administration & dosage, therapeutic use)
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy, mortality)
  • Leukemia, Myeloid, Chronic-Phase (drug therapy, mortality)
  • Middle Aged
  • Philadelphia Chromosome
  • Piperazines (administration & dosage, therapeutic use)
  • Prognosis
  • Protein-Tyrosine Kinases (antagonists & inhibitors)
  • Pyrimidines (administration & dosage, therapeutic use)
  • Risk Factors
  • Survival Rate
  • Treatment Outcome

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