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Previous Volume 348:994-1004 March 13, 2003 Number 11 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Peggs, K. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Imatinib, a selective inhibitor of the BCR-ABL tyrosine kinase, produces high response rates in patients with chronic-phase chronic myeloid leukemia (CML) who have had no response to interferon alfa. We compared the efficacy of imatinib with that of interferon alfa combined with low-dose cytarabine in newly diagnosed chronic-phase CML.

Methods We randomly assigned 1106 patients to receive imatinib (553 patients) or interferon alfa plus low-dose cytarabine (553 patients). Crossover to the alternative group was allowed if stringent criteria defining treatment failure or intolerance were met. Patients were evaluated for hematologic and cytogenetic responses, toxic effects, and rates of progression.

Results After a median follow-up of 19 months, the estimated rate of a major cytogenetic response (0 to 35 percent of cells in metaphase positive for the Philadelphia chromosome) at 18 months was 87.1 percent (95 percent confidence interval, 84.1 to 90.0) in the imatinib group and 34.7 percent (95 percent confidence interval, 29.3 to 40.0) in the group given interferon alfa plus cytarabine (P<0.001). The estimated rates of complete cytogenetic response were 76.2 percent (95 percent confidence interval, 72.5 to 79.9) and 14.5 percent (95 percent confidence interval, 10.5 to 18.5), respectively (P<0.001). At 18 months, the estimated rate of freedom from progression to accelerated-phase or blast-crisis CML was 96.7 percent in the imatinib group and 91.5 percent in the combination-therapy group (P<0.001). Imatinib was better tolerated than combination therapy.

Conclusions In terms of hematologic and cytogenetic responses, tolerability, and the likelihood of progression to accelerated-phase or blast-crisis CML, imatinib was superior to interferon alfa plus low-dose cytarabine as first-line therapy in newly diagnosed chronic-phase CML.

Source Information

From the University of Newcastle, Newcastle, United Kingdom (S.G.O.); Centre Hospitalier Universitaire de Poitiers, Poitiers, France (F.G.); University of Chicago, Chicago (R.A.L.); Novartis, Basel, Switzerland (I.G., A.E.B., R.C.); Policlinico S. Orsola–Malpighi, Bologna, Italy (M.B.); Hospital Clinic I Provincial, Barcelona, Spain (F.C.); Erasmus Medical Center, Daniel Den Hoed Cancer Center, Rotterdam, the Netherlands (J.J.C.); Johannes-Gutenberg-Universität, Mainz, Germany (T.F.); Klinikum Mannheim, Universität Heidelberg, Mannheim, Germany (A.H.); Royal Adelaide Hospital, Adelaide, Australia (T.H.); Universitäts Klinik für Innere Medizin I, Vienna, Austria (K.L.); Aarhus Amtssygehus, Aarhus, Denmark (J.L.N.); Hôpital Saint Louis, Paris (P.R.); Centre Hospitalier Universitaire de Bordeaux, Pessac, France (J.R.); Azienda Ospedaliera S. Luigi Gonzaga, Orbassano, Italy (G.S.); Vancouver Hospital, Vancouver, Canada (J.S.); Akademiska Sjukhuset, Uppsala, Sweden (B.S.); Kantonsspital Basel, Switzerland (A.G.); Hammersmith Hospital, London (J.M.G.); M.D. Anderson Cancer Center, Houston (H.K.); Mater Misericordiae Public Hospital, Brisbane, Australia (K.T.); University Hospital Gasthuisberg, Leuven, Belgium (G.V.); and Oregon Health and Science University Cancer Institute, Portland (B.J.D.).

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