Originally published as JCO Early Release 10.1200/JCO.2007.15.8154 on June 2 2008

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Imatinib for Newly Diagnosed Patients With Chronic Myeloid Leukemia: Incidence of Sustained Responses in an Intention-to-Treat Analysis

Hugues de Lavallade, Jane F. Apperley, Jamshid S. Khorashad, Dragana Milojkovic, Alistair G. Reid, Marco Bua, Richard Szydlo, Eduardo Olavarria, Jaspal Kaeda, John M. Goldman, David Marin

From the Department of Haematology, Hammersmith Hospitals Trust, Imperial College London, London, United Kingdom

Corresponding author: David Marin, MD, Department of Haematology, Imperial College London, Du Cane Rd, London W12 0NN, United Kingdom; e-mail: d.marin{at}imperial.ac.uk

Purpose Imatinib is remarkably effective in treating newly diagnosed patients with chronic myeloid leukemia (CML) in chronic phase (CP). To date, most of the available data come from a single multicenter study in which some of the patients were censored for diverse reasons. Here, we report our experience in treating patients at a single institution in a setting where all events were recorded.

Patients and Methods A total of 204 consecutive adult patients with newly diagnosed CML in CP received imatinib from June 2000 until August 2006. Response (hematologic, cytogenetic, and molecular), progression-free survival (PFS) and survival were evaluated.

Results At 5 years, cumulative incidences of complete cytogenetic response (CCyR) and major molecular response (MMR) were 82.7% and 50.1%, respectively. Estimated overall survival and PFS were 83.2% and 82.7%, respectively. By 5 years, 25% of patients had discontinued imatinib treatment because of an unsatisfactory response and/or toxicity. The 5-year probability of remaining in major cytogenetic response while still receiving imatinib was 62.7%. Patients achieving a CCyR at 1 year had a better PFS and overall survival than those failing to reach CCyR, but achieving a MMR conferred no further advantage. The identification of a kinase domain mutation was the only factor predicting for loss of CCyR.

Conclusion Imatinib is highly effective in most patients with CML-CP; patients who respond are likely to live substantially longer than those treated with earlier therapies. Achieving CCyR correlated with PFS and overall survival, but achieving MMR had no further predictive value. However, approximately one third of patients still need better therapy.

published online ahead of print at www.jco.org on June 2, 2008.

Supported by the National Institute for Health Research Biomedical Research Centre Funding Scheme and a grant from the "Fondation de France" (H. de L.).

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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