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Previous Volume 355:2408-2417 December 7, 2006 Number 23 Next

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ABSTRACT

Background The cause of chronic myeloid leukemia (CML) is a constitutively active BCR-ABL tyrosine kinase. Imatinib inhibits this kinase, and in a short-term study was superior to interferon alfa plus cytarabine for newly diagnosed CML in the chronic phase. For 5 years, we followed patients with CML who received imatinib as initial therapy.

Methods We randomly assigned 553 patients to receive imatinib and 553 to receive interferon alfa plus cytarabine and then evaluated them for overall and event-free survival; progression to accelerated-phase CML or blast crisis; hematologic, cytogenetic, and molecular responses; and adverse events.

Results The median follow-up was 60 months. Kaplan–Meier estimates of cumulative best rates of complete cytogenetic response among patients receiving imatinib were 69% by 12 months and 87% by 60 months. An estimated 7% of patients progressed to accelerated-phase CML or blast crisis, and the estimated overall survival of patients who received imatinib as initial therapy was 89% at 60 months. Patients who had a complete cytogenetic response or in whom levels of BCR-ABL transcripts had fallen by at least 3 log had a significantly lower risk of disease progression than did patients without a complete cytogenetic response (P<0.001). Grade 3 or 4 adverse events diminished over time, and there was no clinically significant change in the profile of adverse events.

Conclusions After 5 years of follow-up, continuous treatment of chronic-phase CML with imatinib as initial therapy was found to induce durable responses in a high proportion of patients. (ClinicalTrials.gov number, NCT00006343 [ClinicalTrials.gov] .)

Source Information

Address reprint requests to Dr. Druker at the Oregon Health and Science University Cancer Institute, L592, 3181 SW Sam Jackson Park Rd., Portland, OR 97239, or at drukerb{at}ohsu.edu.

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Imatinib in Chronic Myeloid Leukemia
Krause S. W., Holler E., Druker B., Gathmann I.
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N Engl J Med 2007; 356:1780, Apr 26, 2007. Correspondence

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• Palandri, F., Iacobucci, I., Castagnetti, F., Testoni, N., Poerio, A., Amabile, M., Breccia, M., Intermesoli, T., Iuliano, F., Rege-Cambrin, G., Tiribelli, M., Miglino, M., Pane, F., Saglio, G., Martinelli, G., Rosti, G., Baccarani, M., on behalf of the GIMEMA Working Party on CML, (2008). Front-line treatment of Philadelphia positive chronic myeloid leukemia with imatinib and interferon-{alpha}: 5-year outcome. haematol 93: 770-774 [Abstract] [Full Text]  
• Larson, R. A., Druker, B. J., Guilhot, F., O'Brien, S. G., Riviere, G. J., Krahnke, T., Gathmann, I., Wang, Y., for the IRIS (International Randomized Interferon, (2008). Imatinib pharmacokinetics and its correlation with response and safety in chronic-phase chronic myeloid leukemia: a subanalysis of the IRIS study. Blood 111: 4022-4028 [Abstract] [Full Text]  
• O'Hare, T., Eide, C. A., Tyner, J. W., Corbin, A. S., Wong, M. J., Buchanan, S., Holme, K., Jessen, K. A., Tang, C., Lewis, H. A., Romero, R. D., Burley, S. K., Deininger, M. W. (2008). SGX393 inhibits the CML mutant Bcr-AblT315I and preempts in vitro resistance when combined with nilotinib or dasatinib. Proc. Natl. Acad. Sci. USA 105: 5507-5512 [Abstract] [Full Text]  
• Holland, J. F. (2008). Breaking the Cure Barrier 25 Years Later. JCO 26: 1575-1575 [Full Text]  
• Kenealy, L. K., Christenson, C. B., Williams, C. B. (2008). Current Therapies for Chronic Myeloid Leukemia. Journal of Pharmacy Practice 21: 116-125 [Abstract]  
• Ramirez, P., DiPersio, J. F. (2008). Therapy Options in Imatinib Failures. The Oncologist 13: 424-434 [Abstract] [Full Text]  
• Harb, J. G., Chyla, B. I., Huettner, C. S. (2008). Loss of Bcl-x in Ph+ B-ALL increases cellular proliferation and does not inhibit leukemogenesis. Blood 111: 3760-3769 [Abstract] [Full Text]  
• Wu, J., Meng, F., Lu, H., Kong, L., Bornmann, W., Peng, Z., Talpaz, M., Donato, N. J. (2008). Lyn regulates BCR-ABL and Gab2 tyrosine phosphorylation and c-Cbl protein stability in imatinib-resistant chronic myelogenous leukemia cells. Blood 111: 3821-3829 [Abstract] [Full Text]  
• Laudadio, J., Deininger, M. W.N., Mauro, M. J., Druker, B. J., Press, R. D. (2008). An Intron-Derived Insertion/Truncation Mutation in the BCR-ABL Kinase Domain in Chronic Myeloid Leukemia Patients Undergoing Kinase Inhibitor Therapy. J. Mol. Diagn. 10: 177-180 [Abstract] [Full Text]  
• Deenik, W., van der Holt, B., Verhoef, G. E. G., Smit, W. M., Kersten, M. J., Kluin-Nelemans, H. C., Verdonck, L. F., Ferrant, A., Schattenberg, A. V. M. B., Janssen, J. J. W. M., Sonneveld, P., van Marwijk Kooy, M., Wittebol, S., Willemze, R., Wijermans, P. W., Westveer, P. H. M., Beverloo, H. B., Valk, P., Lowenberg, B., Ossenkoppele, G. J., Cornelissen, J. J. (2008). Dose-finding study of imatinib in combination with intravenous cytarabine: feasibility in newly diagnosed patients with chronic myeloid leukemia. Blood 111: 2581-2588 [Abstract] [Full Text]  
• Tyner, J. W., Walters, D. K., Willis, S. G., Luttropp, M., Oost, J., Loriaux, M., Erickson, H., Corbin, A. S., O'Hare, T., Heinrich, M. C., Deininger, M. W., Druker, B. J. (2008). RNAi screening of the tyrosine kinome identifies therapeutic targets in acute myeloid leukemia. Blood 111: 2238-2245 [Abstract] [Full Text]  
• le Coutre, P., Ottmann, O. G., Giles, F., Kim, D.-W., Cortes, J., Gattermann, N., Apperley, J. F., Larson, R. A., Abruzzese, E., O'Brien, S. G., Kuliczkowski, K., Hochhaus, A., Mahon, F.-X., Saglio, G., Gobbi, M., Kwong, Y.-L., Baccarani, M., Hughes, T., Martinelli, G., Radich, J. P., Zheng, M., Shou, Y., Kantarjian, H. (2008). Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia. Blood 111: 1834-1839 [Abstract] [Full Text]  
• Kantarjian, H., Schiffer, C., Jones, D., Cortes, J. (2008). Monitoring the response and course of chronic myeloid leukemia in the modern era of BCR-ABL tyrosine kinase inhibitors: practical advice on the use and interpretation of monitoring methods. Blood 111: 1774-1780 [Full Text]  
• Konig, H., Holyoake, T. L., Bhatia, R. (2008). Effective and selective inhibition of chronic myeloid leukemia primitive hematopoietic progenitors by the dual Src/Abl kinase inhibitor SKI-606. Blood 111: 2329-2338 [Abstract] [Full Text]  
• Takeuchi, E. E., Alison, D. L. (2008). What's new in oncology: targeted therapy. Contin Educ Anaesth Crit Care Pain 8: 36-38 [Full Text]  
• Baccarani, M., Pane, F., Saglio, G. (2008). Monitoring treatment of chronic myeloid leukemia. haematol 93: 161-169 [Full Text]  
• Lundan, T., Juvonen, V., Mueller, M. C., Mustjoki, S., Lakkala, T., Kairisto, V., Hochhaus, A., Knuutila, S., Porkka, K. (2008). Comparison of bone marrow high mitotic index metaphase fluorescence in situ hybridization to peripheral blood and bone marrow real time quantitative polymerase chain reaction on the International Scale for detecting residual disease in chronic myeloid leukemia. haematol 93: 178-185 [Abstract] [Full Text]  
• Marshall, H. M, Hammond, J. M (2008). Treatment Options in Imatinib-Resistant Chronic Myelogenous Leukemia. The Annals of Pharmacotherapy 42: 259-264 [Abstract] [Full Text]  
• Mesa, R. A. (2008). Not too late for imatinib. Blood 111: 973-974 [Full Text]  
• Hochhaus, A., Druker, B., Sawyers, C., Guilhot, F., Schiffer, C. A., Cortes, J., Niederwieser, D. W., Gambacorti-Passerini, C., Stone, R. M., Goldman, J., Fischer, T., O'Brien, S. G., Reiffers, J. J., Mone, M., Krahnke, T., Talpaz, M., Kantarjian, H. M. (2008). Favorable long-term follow-up results over 6 years for response, survival, and safety with imatinib mesylate therapy in chronic-phase chronic myeloid leukemia after failure of interferon-{alpha} treatment. Blood 111: 1039-1043 [Abstract] [Full Text]  
• Palandri, F., Iacobucci, I., Martinelli, G., Amabile, M., Poerio, A., Testoni, N., Soverini, S., Castagnetti, F., De Vivo, A., Breccia, M., Specchia, G., Abruzzese, E., Martino, B., Cilloni, D., Saglio, G., Pane, F., Liberati, A. M., Rosti, G., Baccarani, M. (2008). Long-Term Outcome of Complete Cytogenetic Responders After Imatinib 400 mg in Late Chronic Phase, Philadelphia-Positive Chronic Myeloid Leukemia: The GIMEMA Working Party on CML. JCO 26: 106-111 [Abstract] [Full Text]  
• Jamieson, C. H. (2008). Chronic Myeloid Leukemia Stem Cells. ASH Education Book 2008: 436-442 [Abstract] [Full Text]