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Blood, 1 February 2008, Vol. 111, No. 3, pp. 1039-1043.
Prepublished online as a Blood First Edition Paper on October 11, 2007; DOI 10.1182/blood-2007-07-103523.
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Submitted July 27, 2007
Accepted August 31, 2007
Favorable long-term follow-up results over six years for response, survival and safety with imatinib mesylate therapy in chronic phase chronic myeloid leukemia post failure of interferon-alpha treatment
Andreas Hochhaus, Brian Druker, Charles Sawyers, Francois Guilhot, Charles A. Schiffer, Jorge Cortes, Dietger W Niederwieser, Carlo Gambacorti, Richard M. Stone, John Goldman, Thomas Fischer, Stephen G. O'Brien, Jose J Reiffers, Manisha Mone, Tillmann Krahnke, Moshe Talpaz, and Hagop M Kantarjian*
Medizinische Fakultaet Mannheim, University of Heidelberg, Mannheim, Germany
HHMI, Oregon Health & Science University Cancer Institute, Portland, OR, United States
Hematology, Memorial Sloan Kettering Cancer Center, New York, NY, United States
Hematology, CHU La La Miletri, Poitiers, France
Karmanos Cancer Institute, Detroit, MI, United States
Department of Leukemia, University of Texas M.D. Anderson Cancer Center, Houston, TX, United States
Hematology, University of Leipzig, Leipzig, Germany
Hematology, Instituto Nationale Tumori, Milan, Italy
Hematology, Dana-Farber Cancer Institute, Boston, MA, United States
Hematology, Imperial College, London, United Kingdom
University of Mainz, Maintz, Germany
Hematology, University of Newcastle, Newcastle, United Kingdom
Laboratoire de Greffe de Moelle, Universite Victor Segalen, Bordeaux, France
Hematology, Novartis Pharmaceuticals Corp., East Hanover, NJ, United States
Cancer Center and Geriatrics Center, University of Michigan, Ann Arbor, MI, United States
* Corresponding author; email: hkantarj{at}mdanderson.org.
Imatinib mesylate (Gleevec®/Glivec®), a targeted inhibitor of BCR-ABL tyrosine-kinase, is the standard of care for chronic myeloid leukemia (CML). A phase II trial of imatinib in late chronic-phase (CP) CML post interferon alpha (IFN) failure enrolled 532 patients, 454 with a confirmed diagnosis of CP CML. Median time from diagnosis was 34 months; median duration of imatinib treatment was 65 months. Cumulative best rates of major cytogenetic response (MCyR) and complete cytogenetic response (CCyR) were 67% and, 57%, respectively. At the 5-year landmark 184 of the 454 patients (41%) are in CCyR. At >6 years, 199 (44%) of the 454 patients remain on imatinib. Most responses occurred within 12 months of starting imatinib; however, some patients achieved initial MCyR and CCyR more than five years after imatinib initiation. Estimated rates of freedom from progression to accelerated phase (AP) and blastic phase (BP) or overall survival at six years were 61% and 76%, respectively. Both freedom from progression to AP/BC and OS were associated with cytogenetic response level at 12 months. No increase in rates of serious adverse events was observed with continuous use of imatinib for up to 6.5 years, compared with earlier timepoints. Imatinib continues to be an effective and safe therapy for patients with CP CML after failure of IFN.
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