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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CLINICAL TRIALS AND OBSERVATIONS
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- treatment
Andreas Hochhaus1,
Brian Druker2,
Charles Sawyers3,
Francois Guilhot4,
Charles A. Schiffer5,
Jorge Cortes6,
Dietger W. Niederwieser7,
Carlo Gambacorti8,
Richard M. Stone9,
John Goldman10,
Thomas Fischer11,
Stephen G. O'Brien12,
Jose J. Reiffers13,
Manisha Mone14,
Tillmann Krahnke14,
Moshe Talpaz15, and
Hagop M. Kantarjian6
1 Medizinische Fakultaet Mannheim, University of Heidelberg, Mannheim, Germany;
2 Oregon Health and Science University Cancer Institute, Portland;
3 Memorial Sloan Kettering Cancer Center, New York, NY;
4 Centre Hospitalier Universitaire (CHU) La La Milétri, Poitiers, France;
5 Karmanos Cancer Institute, Detroit, MI;
6 Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston;
7 University of Leipzig, Leipzig, Germany;
8 Instituto Nationale Tumori, Milan, Italy;
9 Dana-Farber Cancer Institute, Boston, MA;
10 Imperial College London, London, United Kingdom;
11 University of Mainz, Mainz, Germany;
12 University of Newcastle, Newcastle, United Kingdom;
13 Laboratoire de Greffe de Moelle, Université Victor Segalen, Bordeaux, France;
14 Novartis Pharmaceuticals, East Hanover, NJ; and
15 University of Michigan, Ann Arbor
Imatinib mesylate, a targeted inhibitor of BCR-ABL tyrosine kinase, is the standard of care for chronic myeloid leukemia (CML). A phase 2 trial of imatinib in late chronic-phase (CP) CML after interferon- (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 (41%) of the 454 patients are in CCyR. At more than 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 5 years after imatinib initiation. Estimated rates of freedom from progression to accelerated phase (AP) and blastic phase (BP) and overall survival at 6 years were 61% and 76%, respectively. Both freedom from progression to AP/BP and overall survival (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 time points. Imatinib continues to be an effective and safe therapy for patients with CP CML after failure of IFN.
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