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Blood, 15 May 2002, Vol. 99, No. 10, pp. 3530-3539

CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

Imatinib induces hematologic and cytogenetic responses in patients with chronic myelogenous leukemia in myeloid blast crisis: results of a phase II study

Charles L. Sawyers, Andreas Hochhaus, Eric Feldman, John M. Goldman, Carole B. Miller, Oliver G. Ottmann, Charles A. Schiffer, Moshe Talpaz, Francois Guilhot, Michael W. N. Deininger, Thomas Fischer, Steve G. O'Brien, Richard M. Stone, Carlo B. Gambacorti-Passerini, Nigel H. Russell, Jose J. Reiffers, Thomas C. Shea, Bernard Chapuis, Steven Coutre, Sante Tura, Enrica Morra, Richard A. Larson, Alan Saven, Christian Peschel, Alois Gratwohl, Franco Mandelli, Monique Ben-Am, Insa Gathmann, Renaud Capdeville, Ronald L. Paquette, and Brian J. Druker

From the Department of Medicine and Molecular Biology Institute, University of California, Los Angeles, CA; III. Medizinische Universitätsklinik Mannheim der Universität Heidelberg, Mannheim, Germany; New York Presbyterian Hospital-Weill Medical College of Cornell University, New York, NY; Department of Haematology, Hammersmith Hospital/ICSM, London, United Kingdom ; Johns Hopkins Oncology Center, Baltimore, MD; Medizinische Klinik III, Johann Wolfgang Goethe-Universität, Frankfurt, Germany; Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI; MD Anderson Cancer Center, Houston, TX; Department of Oncology, Hematology and Cell Therapy, CHU de Poitiers, Poitiers, France; Abteilung Haematologie/Onkologie, Universität Leipzig, Germany; Universitätsklinikum, 3. Medizinische Klinik und Poliklinik, Mainz, Germany; Department of Haematology, Royal Victoria Infirmary, University of Newcastle upon Tyne, United Kingdom; Dana Farber Cancer Institute, Boston, MA; Hematology Section, San Gerardo Hospital, Monza, and Department of Experimental Oncology, National Cancer Institute, Milano, Italy; Department of Haematology, City Hospital, Nottingham, United Kingdom; Laboratoire de Greffe de Moelle, Universite Victor Segalen, Bordeaux, France; Division of Hematology/Oncology, University of North Carolina, Chapel Hill; Division d'hématologie, Hopitâl cantonal universitaire, Geneva, Switzerland; Division of Hematology, Stanford University School of Medicine, Stanford, CA; Instituto di Ematologia, Ospedale Policlinicl Sant'Orsola-Malpighi, Bologna, Italy; Divisione di Ematologia, Azienda Ospedaliera Niguarda Ca'Granda, Milan, Italy; University of Chicago Medical Center, IL; Ida and Cecil Green Cancer Center, Scripps Clinic, La Jolla, CA; III. Medizinische Klinik und Poliklinik der TU, Haematologie/Onkologie, Munich, Germany; Division of Hematology, Universitätsklinik, Kantonspital, Basel, Switzerland; Dipartimento di Biotechologie Cedulari ed Ematologia, Azienda Policlinico Umberto 1, Universita La Sapienza, Rome, Italy; Novartis Pharmaceuticals, Basel, Switzerland; School of Medicine, University of California, Los Angeles, CA; and Division of Hematology, Oregon Health Sciences University, Portland, OR.

Blast crisis is the most advanced stage of chronic myelogenous leukemia (CML) and is highly refractory to therapy. CML is caused by expression of the chimeric BCR-ABL tyrosine kinase oncogene, the product of the t(9;22) Philadelphia translocation. Imatinib (Glivec, formerly STI571) is a rationally developed, orally administered inhibitor of the Bcr-Abl tyrosine kinase. A total of 260 patients with CML were enrolled in a phase II trial, of whom 229 had a confirmed diagnosis of CML in blast crisis. Patients were treated with imatinib in daily oral doses of 400 mg or 600 mg. Imatinib induced hematologic responses in 52% of patients and sustained hematologic responses lasting at least 4 weeks in 31% of patients, including complete hematologic responses in 8%. For patients with a sustained response, the estimated median response duration was 10 months. Imatinib induced major cytogenetic responses in 16% of patients, with 7% of the responses being complete. Median survival time was 6.9 months. Nonhematologic adverse reactions were frequent but generally mild or moderate. Episodes of severe cytopenia were also frequent and were attributable to the underlying condition and treatment with imatinib. Drug-related adverse events led to discontinuation of therapy in 5% of patients, most often because of cytopenia, skin disorders, or gastrointestinal reactions. These results demonstrate that imatinib has substantial activity and a favorable safety profile when used as a single agent in patients with CML in blast crisis. Additional clinical studies are warranted to explore the efficacy and feasibility of imatinib used in combination with other antileukemic drugs.

© 2002 by The American Society of Hematology.
 

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Myeloproliferative disorders
ASH Self-Assessment Program, January 1, 2007; 2007(1): 172 - 227.
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ANN INTERN MEDHome page
H. M. Kantarjian, M. Talpaz, F. Giles, S. O'Brien, and J. Cortes
New Insights into the Pathophysiology of Chronic Myeloid Leukemia and Imatinib Resistance
Ann Intern Med, December 19, 2006; 145(12): 913 - 923.
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Clin. Cancer Res.Home page
S. Soverini, S. Colarossi, A. Gnani, G. Rosti, F. Castagnetti, A. Poerio, I. Iacobucci, M. Amabile, E. Abruzzese, E. Orlandi, et al.
Contribution of ABL Kinase Domain Mutations to Imatinib Resistance in Different Subsets of Philadelphia-Positive Patients: By the GIMEMA Working Party on Chronic Myeloid Leukemia
Clin. Cancer Res., December 15, 2006; 12(24): 7374 - 7379.
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NEJMHome page
B. J. Druker, F. Guilhot, S. G. O'Brien, I. Gathmann, H. Kantarjian, N. Gattermann, M. W.N. Deininger, R. T. Silver, J. M. Goldman, R. M. Stone, et al.
Five-Year Follow-up of Patients Receiving Imatinib for Chronic Myeloid Leukemia
N. Engl. J. Med., December 7, 2006; 355(23): 2408 - 2417.
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Clin. Cancer Res.Home page
F. R. Luo, Z. Yang, A. Camuso, R. Smykla, K. McGlinchey, K. Fager, C. Flefleh, S. Castaneda, I. Inigo, D. Kan, et al.
Dasatinib (BMS-354825) Pharmacokinetics and Pharmacodynamic Biomarkers in Animal Models Predict Optimal Clinical Exposure
Clin. Cancer Res., December 1, 2006; 12(23): 7180 - 7186.
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Cancer Res.Home page
M. Puttini, A. M. L. Coluccia, F. Boschelli, L. Cleris, E. Marchesi, A. Donella-Deana, S. Ahmed, S. Redaelli, R. Piazza, V. Magistroni, et al.
In vitro and In vivo Activity of SKI-606, a Novel Src-Abl Inhibitor, against Imatinib-Resistant Bcr-Abl+ Neoplastic Cells
Cancer Res., December 1, 2006; 66(23): 11314 - 11322.
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BloodHome page
D. J. DeAngelo, R. M. Stone, M. L. Heaney, S. D. Nimer, R. L. Paquette, R. B. Klisovic, M. A. Caligiuri, M. R. Cooper, J.-M. Lecerf, M. D. Karol, et al.
Phase 1 clinical results with tandutinib (MLN518), a novel FLT3 antagonist, in patients with acute myelogenous leukemia or high-risk myelodysplastic syndrome: safety, pharmacokinetics, and pharmacodynamics
Blood, December 1, 2006; 108(12): 3674 - 3681.
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Clin. Cancer Res.Home page
P. La Rosee, T. Jia, S. Demehri, N. Hartel, P. de Vries, L. Bonham, D. Hollenback, J. W. Singer, J. V. Melo, B. J. Druker, et al.
Antileukemic Activity of Lysophosphatidic Acid Acyltransferase-{beta} Inhibitor CT32228 in Chronic Myelogenous Leukemia Sensitive and Resistant to Imatinib.
Clin. Cancer Res., November 1, 2006; 12(21): 6540 - 6546.
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JCOHome page
M. Agulnik, A. M. Oza, G. R. Pond, and L. L. Siu
Impact and Perceptions of Mandatory Tumor Biopsies for Correlative Studies in Clinical Trials of Novel Anticancer Agents
J. Clin. Oncol., October 20, 2006; 24(30): 4801 - 4807.
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BloodHome page
H. A. Bradeen, C. A. Eide, T. O'Hare, K. J. Johnson, S. G. Willis, F. Y. Lee, B. J. Druker, and M. W. Deininger
Comparison of imatinib mesylate, dasatinib (BMS-354825), and nilotinib (AMN107) in an N-ethyl-N-nitrosourea (ENU)-based mutagenesis screen: high efficacy of drug combinations
Blood, October 1, 2006; 108(7): 2332 - 2338.
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BloodHome page
M. Baccarani, G. Saglio, J. Goldman, A. Hochhaus, B. Simonsson, F. Appelbaum, J. Apperley, F. Cervantes, J. Cortes, M. Deininger, et al.
Evolving concepts in the management of chronic myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet
Blood, September 15, 2006; 108(6): 1809 - 1820.
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Hum Mol GenetHome page
F.-C. Yang, S. Chen, T. Clegg, X. Li, T. Morgan, S. A. Estwick, J. Yuan, W. Khalaf, S. Burgin, J. Travers, et al.
Nf1+/- mast cells induce neurofibroma like phenotypes through secreted TGF-{beta} signaling
Hum. Mol. Genet., August 15, 2006; 15(16): 2421 - 2437.
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BloodHome page
N. von Bubnoff, P. W. Manley, J. Mestan, J. Sanger, C. Peschel, and J. Duyster
Bcr-Abl resistance screening predicts a limited spectrum of point mutations to be associated with clinical resistance to the Abl kinase inhibitor nilotinib (AMN107)
Blood, August 15, 2006; 108(4): 1328 - 1333.
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BloodHome page
V. L. Goss, K. A. Lee, A. Moritz, J. Nardone, E. J. Spek, J. MacNeill, J. Rush, M. J. Comb, and R. D. Polakiewicz
A common phosphotyrosine signature for the Bcr-Abl kinase
Blood, June 15, 2006; 107(12): 4888 - 4897.
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BloodHome page
D. Ye, N. Wolff, L. Li, S. Zhang, and R. L. Ilaria Jr
STAT5 signaling is required for the efficient induction and maintenance of CML in mice
Blood, June 15, 2006; 107(12): 4917 - 4925.
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Proc. Natl. Acad. Sci. USAHome page
M. Azam, V. Nardi, W. C. Shakespeare, C. A. Metcalf III, R. S. Bohacek, Y. Wang, R. Sundaramoorthi, P. Sliz, D. R. Veach, W. G. Bornmann, et al.
Activity of dual SRC-ABL inhibitors highlights the role of BCR/ABL kinase dynamics in drug resistance
PNAS, June 13, 2006; 103(24): 9244 - 9249.
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Clin. Cancer Res.Home page
N. Koyama, S. Koschmieder, S. Tyagi, I. Portero-Robles, J. Chromic, S. Myloch, H. Nurnberger, T. Rossmanith, W.-K. Hofmann, D. Hoelzer, et al.
Inhibition of phosphotyrosine phosphatase 1B causes resistance in BCR-ABL-positive leukemia cells to the ABL kinase inhibitor STI571.
Clin. Cancer Res., April 1, 2006; 12(7 Pt 1): 2025 - 2031.
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JCOHome page
P. Ault, H. Kantarjian, S. O'Brien, S. Faderl, M. Beran, M. B. Rios, C. Koller, F. Giles, M. Keating, M. Talpaz, et al.
Pregnancy Among Patients With Chronic Myeloid Leukemia Treated With Imatinib
J. Clin. Oncol., March 1, 2006; 24(7): 1204 - 1208.
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Ann OncolHome page
G. Martinelli, I. Iacobucci, G. Rosti, F. Pane, M. Amabile, F. Castagnetti, D. Cilloni, S. Soverini, N. Testoni, G. Specchia, et al.
Prediction of response to imatinib by prospective quantitation of BCR-ABL transcript in late chronic phase chronic myeloid leukemia patients
Ann. Onc., March 1, 2006; 17(3): 495 - 502.
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Mayo Clin Proc.Home page
M. J. Mauro and R. T. Maziarz
Stem Cell Transplantation in Patients With Chronic Myelogenous Leukemia: When Should It Be Used?
Mayo Clin. Proc., March 1, 2006; 81(3): 404 - 416.
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BloodHome page
A. Aloisi, S. Di Gregorio, F. Stagno, P. Guglielmo, F. Mannino, M. P. Sormani, P. Bruzzi, C. Gambacorti-Passerini, G. Saglio, S. Venuta, et al.
BCR-ABL nuclear entrapment kills human CML cells: ex vivo study on 35 patients with the combination of imatinib mesylate and leptomycin B
Blood, February 15, 2006; 107(4): 1591 - 1598.
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BloodHome page
Y. Du, K. Wang, H. Fang, J. Li, D. Xiao, P. Zheng, Y. Chen, H. Fan, X. Pan, C. Zhao, et al.
Coordination of intrinsic, extrinsic, and endoplasmic reticulum-mediated apoptosis by imatinib mesylate combined with arsenic trioxide in chronic myeloid leukemia
Blood, February 15, 2006; 107(4): 1582 - 1590.
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JCOHome page
D. A. Reardon, M. J. Egorin, J. A. Quinn, J. N. Rich Sr, I. Gururangan, J. J. Vredenburgh, A. Desjardins, S. Sathornsumetee, J. M. Provenzale, J. E. Herndon II, et al.
Phase II Study of Imatinib Mesylate Plus Hydroxyurea in Adults With Recurrent Glioblastoma Multiforme
J. Clin. Oncol., December 20, 2005; 23(36): 9359 - 9368.
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JCOHome page
H. I. Scher and C. L. Sawyers
Biology of Progressive, Castration-Resistant Prostate Cancer: Directed Therapies Targeting the Androgen-Receptor Signaling Axis
J. Clin. Oncol., November 10, 2005; 23(32): 8253 - 8261.
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BloodHome page
E. H. Stover, J. Chen, B. H. Lee, J. Cools, E. McDowell, J. Adelsperger, D. Cullen, A. Coburn, S. A. Moore, R. Okabe, et al.
The small molecule tyrosine kinase inhibitor AMN107 inhibits TEL-PDGFR{beta} and FIP1L1-PDGFR{alpha} in vitro and in vivo
Blood, November 1, 2005; 106(9): 3206 - 3213.
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JCOHome page
G. Hess, D. Bunjes, W. Siegert, R. Schwerdtfeger, G. Ledderose, B. Wassmann, G. Kobbe, M. Bornhauser, A. Hochhaus, A. J. Ullmann, et al.
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
J. Clin. Oncol., October 20, 2005; 23(30): 7583 - 7593.
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Cancer Res.Home page
D. J. Barnes, D. Palaiologou, E. Panousopoulou, B. Schultheis, A. S.M. Yong, A. Wong, L. Pattacini, J. M. Goldman, and J. V. Melo
Bcr-Abl Expression Levels Determine the Rate of Development of Resistance to Imatinib Mesylate in Chronic Myeloid Leukemia
Cancer Res., October 1, 2005; 65(19): 8912 - 8919.
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Toxicol SciHome page
I. N. Rich and K. M. Hall
Validation and Development of a Predictive Paradigm for Hemotoxicology Using a Multifunctional Bioluminescence Colony-Forming Proliferation Assay
Toxicol. Sci., October 1, 2005; 87(2): 427 - 441.
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Ann OncolHome page
G. Dresemann
Imatinib and hydroxyurea in pretreated progressive glioblastoma multiforme: a patient series
Ann. Onc., October 1, 2005; 16(10): 1702 - 1708.
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BloodHome page
S. G. Willis, T. Lange, S. Demehri, S. Otto, L. Crossman, D. Niederwieser, E. P. Stoffregen, S. McWeeney, I. Kovacs, B. Park, et al.
High-sensitivity detection of BCR-ABL kinase domain mutations in imatinib-naive patients: correlation with clonal cytogenetic evolution but not response to therapy
Blood, September 15, 2005; 106(6): 2128 - 2137.
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Clin. Chem.Home page
N. Sorel, F. Chazelas, A. Brizard, and J.-C. Chomel
Double-Gradient-Denaturing-Gradient Gel Electrophoresis for Mutation Screening of the BCR-ABL Tyrosine Kinase Domain in Chronic Myeloid Leukemia Patients
Clin. Chem., July 1, 2005; 51(7): 1263 - 1266.
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Clin. Cancer Res.Home page
M. Golemovic, S. Verstovsek, F. Giles, J. Cortes, T. Manshouri, P. W. Manley, J. Mestan, M. Dugan, L. Alland, J. D. Griffin, et al.
AMN107, a Novel Aminopyrimidine Inhibitor of Bcr-Abl, Has In vitro Activity against Imatinib-Resistant Chronic Myeloid Leukemia
Clin. Cancer Res., July 1, 2005; 11(13): 4941 - 4947.
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JCOHome page
J.-P. J. Issa, V. Gharibyan, J. Cortes, J. Jelinek, G. Morris, S. Verstovsek, M. Talpaz, G. Garcia-Manero, and H. M. Kantarjian
Phase II Study of Low-Dose Decitabine in Patients With Chronic Myelogenous Leukemia Resistant to Imatinib Mesylate
J. Clin. Oncol., June 10, 2005; 23(17): 3948 - 3956.
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BloodHome page
N. C. Wolff, D. R. Veach, W. P. Tong, W. G. Bornmann, B. Clarkson, and R. L. Ilaria Jr
PD166326, a novel tyrosine kinase inhibitor, has greater antileukemic activity than imatinib mesylate in a murine model of chronic myeloid leukemia
Blood, May 15, 2005; 105(10): 3995 - 4003.
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BloodHome page
P.-H. Tseng, H.-P. Lin, J. Zhu, K.-F. Chen, E. M. Hade, D. C. Young, J. C. Byrd, M. Grever, K. Johnson, B. J. Druker, et al.
Synergistic interactions between imatinib mesylate and the novel phosphoinositide-dependent kinase-1 inhibitor OSU-03012 in overcoming imatinib mesylate resistance
Blood, May 15, 2005; 105(10): 4021 - 4027.
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BloodHome page
A. L. Dewar, A. C. Cambareri, A. C. W. Zannettino, B. L. Miller, K. V. Doherty, T. P. Hughes, and A. B. Lyons
Macrophage colony-stimulating factor receptor c-fms is a novel target of imatinib
Blood, April 15, 2005; 105(8): 3127 - 3132.
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Cancer Res.Home page
C. Cebo, I. A. Voutsadakis, S. Da Rocha, J.-H. Bourhis, A. Jalil, B. Azzarone, A. G. Turhan, M. Chelbi-Alix, S. Chouaib, and A. Caignard
Altered IFN{gamma} Signaling and Preserved Susceptibility to Activated Natural Killer Cell-Mediated Lysis of BCR/ABL Targets
Cancer Res., April 1, 2005; 65(7): 2914 - 2920.
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BloodHome page
M. Deininger, E. Buchdunger, and B. J. Druker
The development of imatinib as a therapeutic agent for chronic myeloid leukemia
Blood, April 1, 2005; 105(7): 2640 - 2653.
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BloodHome page
A. Quintas-Cardama, H. Kantarjian, M. Talpaz, S. O'Brien, G. Garcia-Manero, S. Verstovsek, M. B. Rios, K. Hayes, A. Glassman, B. N. Bekele, et al.
Imatinib mesylate therapy may overcome the poor prognostic significance of deletions of derivative chromosome 9 in patients with chronic myelogenous leukemia
Blood, March 15, 2005; 105(6): 2281 - 2286.
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