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Previous Volume 346:645-652 February 28, 2002 Number 9 Next

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ABSTRACT

Background Chronic myelogenous leukemia (CML) is caused by the BCR-ABL tyrosine kinase, the product of the Philadelphia chromosome. Imatinib mesylate, formerly STI571, is a selective inhibitor of this kinase.

Methods A total of 532 patients with late–chronic-phase CML in whom previous therapy with interferon alfa had failed were treated with 400 mg of oral imatinib daily. Patients were evaluated for cytogenetic and hematologic responses. Time to progression, survival, and toxic effects were also evaluated.

Results Imatinib induced major cytogenetic responses in 60 percent of the 454 patients with confirmed chronic-phase CML and complete hematologic responses in 95 percent. After a median follow-up of 18 months, CML had not progressed to the accelerated or blast phases in an estimated 89 percent of patients, and 95 percent of the patients were alive. Grade 3 or 4 nonhematologic toxic effects were infrequent, and hematologic toxic effects were manageable. Only 2 percent of patients discontinued treatment because of drug-related adverse events, and no treatment-related deaths occurred.

Conclusions Imatinib induced high rates of cytogenetic and hematologic responses in patients with chronic-phase CML in whom previous interferon therapy had failed.

Source Information

From the M.D. Anderson Cancer Center, Houston (H.K., M.T.); the University of California at Los Angeles, Los Angeles (C Sawyers); Universitätsklinikum Mannheim der Universität Heidelberg, Mannheim, Germany (A.H.); Centre Hospitalier Universitaire de Poitiers, Poitiers, France (F.G.); Wayne State University, Detroit (C Schiffer); San Gerardo Hospital and National Cancer Institute, Milan, Italy (C.G.-P.); University of Leipzig, Leipzig, Germany (D.N.); Novartis Pharmaceuticals, East Hanover, N.J., and Basel, Switzerland (D.R., R.C., U.Z.); and Oregon Health Sciences University, Portland (B.D.).

Address reprint requests to Dr. Kantarjian at the Department of Leukemia, Box 428, M.D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, or at hkantarj{at}mdanderson.org.

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Imatinib Mesylate and Gray Hair
Etienne G., Cony-Makhoul P., Mahon F.-X.
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N Engl J Med 2002; 347:446, Aug 8, 2002. Correspondence

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• Aloisi, A., Di Gregorio, S., Stagno, F., Guglielmo, P., Mannino, F., Sormani, M. P., Bruzzi, P., Gambacorti-Passerini, C., Saglio, G., Venuta, S., Giustolisi, R., Messina, A., Vigneri, P. (2006). BCR-ABL nuclear entrapment kills human CML cells: ex vivo study on 35 patients with the combination of imatinib mesylate and leptomycin B. Blood 107: 1591-1598 [Abstract] [Full Text]  
• Carter, B. Z., Mak, D. H., Schober, W. D., Cabreira-Hansen, M., Beran, M., McQueen, T., Chen, W., Andreeff, M. (2006). Regulation of survivin expression through Bcr-Abl/MAPK cascade: targeting survivin overcomes imatinib resistance and increases imatinib sensitivity in imatinib-responsive CML cells. Blood 107: 1555-1563 [Abstract] [Full Text]  
• Iacobucci, I., Rosti, G., Amabile, M., Poerio, A., Soverini, S., Cilloni, D., Testoni, N., Abruzzese, E., Montefusco, E., Ottaviani, E., Iuliano, F., Russo, D., Gobbi, M., Alimena, G., Martino, B., Terragna, C., Pane, F., Saglio, G., Baccarani, M., Martinelli, G. (2006). Comparison Between Patients With Philadelphia-Positive Chronic Phase Chronic Myeloid Leukemia Who Obtained a Complete Cytogenetic Response Within 1 Year of Imatinib Therapy and Those Who Achieved Such a Response After 12 Months of Treatment. JCO 24: 454-459 [Abstract] [Full Text]  
• Garton, A. J., Crew, A. P.A., Franklin, M., Cooke, A. R., Wynne, G. M., Castaldo, L., Kahler, J., Winski, S. L., Franks, A., Brown, E. N., Bittner, M. A., Keily, J. F., Briner, P., Hidden, C., Srebernak, M. C., Pirrit, C., O'Connor, M., Chan, A., Vulevic, B., Henninger, D., Hart, K., Sennello, R., Li, A.-H., Zhang, T., Richardson, F., Emerson, D. L., Castelhano, A. L., Arnold, L. D., Gibson, N. W. (2006). OSI-930: A Novel Selective Inhibitor of Kit and Kinase Insert Domain Receptor Tyrosine Kinases with Antitumor Activity in Mouse Xenograft Models. Cancer Res. 66: 1015-1024 [Abstract] [Full Text]  
• Reardon, D. A., Egorin, M. J., Quinn, J. A., Rich, J. N. Sr, Gururangan, I., Vredenburgh, J. J., Desjardins, A., Sathornsumetee, S., Provenzale, J. M., Herndon, J. E. II, Dowell, J. M., Badruddoja, M. A., McLendon, R. E., Lagattuta, T. F., Kicielinski, K. P., Dresemann, G., Sampson, J. H., Friedman, A. H., Salvado, A. J., Friedman, H. S. (2005). Phase II Study of Imatinib Mesylate Plus Hydroxyurea in Adults With Recurrent Glioblastoma Multiforme. JCO 23: 9359-9368 [Abstract] [Full Text]  
• Arora, A., Scholar, E. M. (2005). Role of Tyrosine Kinase Inhibitors in Cancer Therapy. J. Pharmacol. Exp. Ther. 315: 971-979 [Abstract] [Full Text]  
• Stover, E. H., Chen, J., Lee, B. H., Cools, J., McDowell, E., Adelsperger, J., Cullen, D., Coburn, A., Moore, S. A., Okabe, R., Fabbro, D., Manley, P. W., Griffin, J. D., Gilliland, D. G. (2005). The small molecule tyrosine kinase inhibitor AMN107 inhibits TEL-PDGFR{beta} and FIP1L1-PDGFR{alpha} in vitro and in vivo. Blood 106: 3206-3213 [Abstract] [Full Text]  
• Hess, G., Bunjes, D., Siegert, W., Schwerdtfeger, R., Ledderose, G., Wassmann, B., Kobbe, G., Bornhauser, M., Hochhaus, A., Ullmann, A. J., Kindler, T., Haus, U., Gschaidmeier, H., Huber, C., Fischer, T. (2005). Sustained Complete Molecular Remissions After Treatment With Imatinib-Mesylate in Patients With Failure After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia: Results of a Prospective Phase II Open-Label Multicenter Study. JCO 23: 7583-7593 [Abstract] [Full Text]  
• Tussiwand, R., Onai, N., Mazzucchelli, L., Manz, M. G. (2005). Inhibition of Natural Type I IFN-Producing and Dendritic Cell Development by a Small Molecule Receptor Tyrosine Kinase Inhibitor with Flt3 Affinity. J. Immunol. 175: 3674-3680 [Abstract] [Full Text]  
• Willis, S. G., Lange, T., Demehri, S., Otto, S., Crossman, L., Niederwieser, D., Stoffregen, E. P., McWeeney, S., Kovacs, I., Park, B., Druker, B. J., Deininger, M. W. (2005). High-sensitivity detection of BCR-ABL kinase domain mutations in imatinib-naive patients: correlation with clonal cytogenetic evolution but not response to therapy. Blood 106: 2128-2137 [Abstract] [Full Text]  
• Cheson, B. D. (2005). Individualizing Therapy for the Hematologic Malignancies: The Stuff of Genes and Dreams. JCO 23: 6283-6284 [Full Text]  
• Cortes, J., Kantarjian, H. (2005). New Targeted Approaches in Chronic Myeloid Leukemia. JCO 23: 6316-6324 [Abstract] [Full Text]  
• Appel, S., Balabanov, S., Brummendorf, T. H., Brossart, P. (2005). Effects of Imatinib on Normal Hematopoiesis and Immune Activation. Stem Cells 23: 1082-1088 [Abstract] [Full Text]  
• Talpaz, M., Rakhit, A., Rittweger, K., O'Brien, S., Cortes, J., Fettner, S., Hooftman, L., Kantarjian, H. (2005). Phase I Evaluation of a 40-kDa Branched-Chain Long-Acting Pegylated IFN-{alpha}-2a With and Without Cytarabine in Patients with Chronic Myelogenous Leukemia. Clin. Cancer Res. 11: 6247-6255 [Abstract] [Full Text]  
• Haferlach, T., Kohlmann, A., Schnittger, S., Dugas, M., Hiddemann, W., Kern, W., Schoch, C. (2005). Global approach to the diagnosis of leukemia using gene expression profiling. Blood 106: 1189-1198 [Abstract] [Full Text]  
• Thiery, G., Azoulay, E., Darmon, M., Ciroldi, M., De Miranda, S., Levy, V., Fieux, F., Moreau, D., Le Gall, J. R., Schlemmer, B. (2005). Outcome of Cancer Patients Considered for Intensive Care Unit Admission: A Hospital-Wide Prospective Study. JCO 23: 4406-4413 [Abstract] [Full Text]  
• Sorel, N., Chazelas, F., Brizard, A., Chomel, J.-C. (2005). Double-Gradient-Denaturing-Gradient Gel Electrophoresis for Mutation Screening of the BCR-ABL Tyrosine Kinase Domain in Chronic Myeloid Leukemia Patients. Clin. Chem. 51: 1263-1266 [Full Text]  
• Millot, F., Traore, P., Guilhot, J., Nelken, B., Leblanc, T., Leverger, G., Plantaz, D., Bertrand, Y., Bordigoni, P., Guilhot, F. (2005). Clinical and Biological Features at Diagnosis in 40 Children With Chronic Myeloid Leukemia. Pediatrics 116: 140-143 [Abstract] [Full Text]  
• Golemovic, M., Verstovsek, S., Giles, F., Cortes, J., Manshouri, T., Manley, P. W., Mestan, J., Dugan, M., Alland, L., Griffin, J. D., Arlinghaus, R. B., Sun, T., Kantarjian, H., Beran, M. (2005). AMN107, a Novel Aminopyrimidine Inhibitor of Bcr-Abl, Has In vitro Activity against Imatinib-Resistant Chronic Myeloid Leukemia. Clin. Cancer Res. 11: 4941-4947 [Abstract] [Full Text]  
• Soverini, S., Martinelli, G., Rosti, G., Bassi, S., Amabile, M., Poerio, A., Giannini, B., Trabacchi, E., Castagnetti, F., Testoni, N., Luatti, S., de Vivo, A., Cilloni, D., Izzo, B., Fava, M., Abruzzese, E., Alberti, D., Pane, F., Saglio, G., Baccarani, M. (2005). ABL Mutations in Late Chronic Phase Chronic Myeloid Leukemia Patients With Up-Front Cytogenetic Resistance to Imatinib Are Associated With a Greater Likelihood of Progression to Blast Crisis and Shorter Survival: A Study by the GIMEMA Working Party on Chronic Myeloid Leukemia. JCO 23: 4100-4109 [Abstract] [Full Text]  
• Li, Z., Qiao, Y., Liu, B., Laska, E. J., Chakravarthi, P., Kulko, J. M., Bona, R. D., Fang, M., Hegde, U., Moyo, V., Tannenbaum, S. H., Menoret, A., Gaffney, J., Glynn, L., Runowicz, C. D., Srivastava, P. K. (2005). Combination of Imatinib Mesylate with Autologous Leukocyte-Derived Heat Shock Protein and Chronic Myelogenous Leukemia. Clin. Cancer Res. 11: 4460-4468 [Abstract] [Full Text]  
• Schultheis, B., Szydlo, R., Mahon, F. X., Apperley, J. F., Melo, J. V. (2005). Analysis of total phosphotyrosine levels in CD34+ cells from CML patients to predict the response to imatinib mesylate treatment. Blood 105: 4893-4894 [Full Text]  
• Issa, J.-P. J., Gharibyan, V., Cortes, J., Jelinek, J., Morris, G., Verstovsek, S., Talpaz, M., Garcia-Manero, G., Kantarjian, H. M. (2005). Phase II Study of Low-Dose Decitabine in Patients With Chronic Myelogenous Leukemia Resistant to Imatinib Mesylate. JCO 23: 3948-3956 [Abstract] [Full Text]  
• BALABANOV, S., APPEL, S., KANZ, L., BROSSART, P., BRUMMENDORF, T. H. (2005). Effect of Tyrosine Kinase Inhibition Using Imatinib on Normal Lymphohematopoietic Cells. Ann. N. Y. Acad. Sci. 1044: 168-177 [Abstract] [Full Text]  
• Tseng, P.-H., Lin, H.-P., Zhu, J., Chen, K.-F., Hade, E. M., Young, D. C., Byrd, J. C., Grever, M., Johnson, K., Druker, B. J., Chen, C.-S. (2005). Synergistic interactions between imatinib mesylate and the novel phosphoinositide-dependent kinase-1 inhibitor OSU-03012 in overcoming imatinib mesylate resistance. Blood 105: 4021-4027 [Abstract] [Full Text]  
• Cortes, J., Talpaz, M., O'Brien, S., Jones, D., Luthra, R., Shan, J., Giles, F., Faderl, S., Verstovsek, S., Garcia-Manero, G., Rios, M. B., Kantarjian, H. (2005). Molecular Responses in Patients with Chronic Myelogenous Leukemia in Chronic Phase Treated with Imatinib Mesylate. Clin. Cancer Res. 11: 3425-3432 [Abstract] [Full Text]  
• Gu, J. J., Santiago, L., Mitchell, B. S. (2005). Synergy between imatinib and mycophenolic acid in inducing apoptosis in cell lines expressing Bcr-Abl. Blood 105: 3270-3277 [Abstract] [Full Text]  
• Deininger, M., Buchdunger, E., Druker, B. J. (2005). The development of imatinib as a therapeutic agent for chronic myeloid leukemia. Blood 105: 2640-2653 [Abstract] [Full Text]  
• Quintas-Cardama, A., Kantarjian, H., Talpaz, M., O'Brien, S., Garcia-Manero, G., Verstovsek, S., Rios, M. B., Hayes, K., Glassman, A., Bekele, B. N., Zhou, X., Cortes, J. (2005). Imatinib mesylate therapy may overcome the poor prognostic significance of deletions of derivative chromosome 9 in patients with chronic myelogenous leukemia. Blood 105: 2281-2286 [Abstract] [Full Text]  
• Ayirookuzhi, S. J., Ma, L., Ramshesh, P., Mills, G. (2005). Imatinib-Induced Sweet Syndrome in a Patient With Chronic Myeloid Leukemia. Arch Dermatol 141: 368-368 [Abstract] [Full Text]