Five-Year Follow-up of Patients Receiving Imatinib for Chronic Myeloid Leukemia
Brian J. Druker, M.D., François Guilhot, M.D., Stephen G. O'Brien, M.D., Ph.D., Insa Gathmann, M.Sc., Hagop Kantarjian, M.D., Norbert Gattermann, M.D., Michael W.N. Deininger, M.D., Ph.D., Richard T. Silver, M.D., John M. Goldman, D.M., Richard M. Stone, M.D., Francisco Cervantes, M.D., Andreas Hochhaus, M.D., Bayard L. Powell, M.D., Janice L. Gabrilove, M.D., Philippe Rousselot, M.D., Josy Reiffers, M.D., Jan J. Cornelissen, M.D., Ph.D., Timothy Hughes, M.D., Hermine Agis, M.D., Thomas Fischer, M.D., Gregor Verhoef, M.D., John Shepherd, M.D., Giuseppe Saglio, M.D., Alois Gratwohl, M.D., Johan L. Nielsen, M.D., Jerald P. Radich, M.D., Bengt Simonsson, M.D., Kerry Taylor, M.D., Michele Baccarani, M.D., Charlene So, Pharm.D., Laurie Letvak, M.D., Richard A. Larson, M.D., for the IRIS Investigators
Background The cause of chronic myeloid leukemia (CML) is aconstitutively active BCR-ABL tyrosine kinase. Imatinib inhibitsthis kinase, and in a short-term study was superior to interferonalfa plus cytarabine for newly diagnosed CML in the chronicphase. For 5 years, we followed patients with CML who receivedimatinib as initial therapy.
Methods We randomly assigned 553 patients to receive imatiniband 553 to receive interferon alfa plus cytarabine and thenevaluated them for overall and event-free survival; progressionto accelerated-phase CML or blast crisis; hematologic, cytogenetic,and molecular responses; and adverse events.
Results The median follow-up was 60 months. Kaplan–Meierestimates of cumulative best rates of complete cytogenetic responseamong patients receiving imatinib were 69% by 12 months and87% by 60 months. An estimated 7% of patients progressed toaccelerated-phase CML or blast crisis, and the estimated overallsurvival of patients who received imatinib as initial therapywas 89% at 60 months. Patients who had a complete cytogeneticresponse or in whom levels of BCR-ABL transcripts had fallenby at least 3 log had a significantly lower risk of diseaseprogression than did patients without a complete cytogeneticresponse (P<0.001). Grade 3 or 4 adverse events diminishedover time, and there was no clinically significant change inthe profile of adverse events.
Conclusions After 5 years of follow-up, continuous treatmentof chronic-phase CML with imatinib as initial therapy was foundto 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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