Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia
- PMID: 12637609
- DOI: 10.1056/NEJMoa022457
Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia
Abstract
Background: Imatinib, a selective inhibitor of the BCR-ABL tyrosine kinase, produces high response rates in patients with chronic-phase chronic myeloid leukemia (CML) who have had no response to interferon alfa. We compared the efficacy of imatinib with that of interferon alfa combined with low-dose cytarabine in newly diagnosed chronic-phase CML.
Methods: We randomly assigned 1106 patients to receive imatinib (553 patients) or interferon alfa plus low-dose cytarabine (553 patients). Crossover to the alternative group was allowed if stringent criteria defining treatment failure or intolerance were met. Patients were evaluated for hematologic and cytogenetic responses, toxic effects, and rates of progression.
Results: After a median follow-up of 19 months, the estimated rate of a major cytogenetic response (0 to 35 percent of cells in metaphase positive for the Philadelphia chromosome) at 18 months was 87.1 percent (95 percent confidence interval, 84.1 to 90.0) in the imatinib group and 34.7 percent (95 percent confidence interval, 29.3 to 40.0) in the group given interferon alfa plus cytarabine (P<0.001). The estimated rates of complete cytogenetic response were 76.2 percent (95 percent confidence interval, 72.5 to 79.9) and 14.5 percent (95 percent confidence interval, 10.5 to 18.5), respectively (P<0.001). At 18 months, the estimated rate of freedom from progression to accelerated-phase or blast-crisis CML was 96.7 percent in the imatinib group and 91.5 percent in the combination-therapy group (P<0.001). Imatinib was better tolerated than combination therapy.
Conclusions: In terms of hematologic and cytogenetic responses, tolerability, and the likelihood of progression to accelerated-phase or blast-crisis CML, imatinib was superior to interferon alfa plus low-dose cytarabine as first-line therapy in newly diagnosed chronic-phase CML.
Copyright 2003 Massachusetts Medical Society
Comment in
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Imatinib mesylate--the new gold standard for treatment of chronic myeloid leukemia.N Engl J Med. 2003 Mar 13;348(11):1048-50. doi: 10.1056/NEJMe030009. N Engl J Med. 2003. PMID: 12637616 No abstract available.
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A new standard treatment for chronic myelogenous leukemia.Curr Hematol Rep. 2004 Jan;3(1):37-8. Curr Hematol Rep. 2004. PMID: 14695847 No abstract available.
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Clinical usefulness of transcription-mediated amplification and hybridization protection assay in imatinib-treated chronic myelogenous leukemia patients.Clin Lab Haematol. 2005 Dec;27(6):416-7. doi: 10.1111/j.1365-2257.2005.00723.x. Clin Lab Haematol. 2005. PMID: 16307547 No abstract available.
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