Imatinib mesylate therapy improves survival in patients with newly diagnosed Philadelphia chromosome‐positive chronic myelogenous leukemia in the chronic phase

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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. Cancer 2003;98:2636–42. © 2003 American Cancer Society.

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