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N Engl J Med. 2017 Mar 9;376(10):917-927. doi: 10.1056/NEJMoa1609324.

Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia.

Collaborators (180)

Durrant S, Schwarer A, Joske D, Seymour J, Grigg A, Ma D, Arthur C, Bradstock K, Joshua D, Louwagie A, Martiat P, Straetmans N, Bosly A, Shustik C, Lipton J, Forrest D, Walker I, Roy D-C, Rubinger M, Bence-Bruckler I, Stewart D, Kovacs M, Turner AR, Birgens H, Bjerrum O, Facon T, Harousseau J-L, Tulliez M, Guerci A, Blaise D, Maloisel F, Michallet M, Hossfeld D, Mertelsmann R, Andreesen R, Nerl C, Freund M, Gattermann N, Hoeffken K, Ehninger G, Ottmann O, Peschel C, Frühauf S, Neubauer A, Le Coutre P, Aulitzky W, Fanin R, Rosti G, Mandelli F, Morra E, Carella A, Lazzarino M, Petrini M, Rossi Ferrini P, Nobile F, Liso V, Ferrara F, Rizzoli V, Fioritoni G, Martinelli G, Ossenkoppele G, Browett P, Gedde-Dahl T, Tangen J-M, Dahl I, Odriozola J, Hernández Boluda JC, Steegmann JL, Cañizo C, Sureda A, Diaz J, Granena A, Fernández MN, Stenke L, Paul C, Bjoreman M, Malm C, Wadenvik H, Nilsson P-G, Turesson I, Hess U, Solenthaler M, Goldman JM, Russel N, Mufti G, Cavenagh J, Clark RE, Green AR, Holyoake TL, Lucas GS, Smith G, Milligan DW, Rule SJ, Burnett AK, Moroose R, Wetzler M, Bearden J, Brown R, Lobell M, Cataland S, Rabinowitz I, Meisenberg B, Gabrilove J, Thompson K, Graziano S, Emanuel P, Gross H, Cobb P, Bhatia R, Dakhil S, Irwin D, Issell B, Pavletic S, Kuebler P, Layhe E, Butera P, Glass J, Moore J, Grant B, Niell H, Herzig R, Burris H, Peterson B, Powell B, Kalaycio M, Stirewalt D, Samlowski W, Berman E, Limentani S, Seay T, Shea T, Akard L, Smith G, Becker P, DeVine S, Hart R, Veith R, Wade J, Brunvand M, Silver R, Kalman L, Strickland D, Shurafa M, Bashey A, Shadduck R, Cooper S, Safah H, Rubenstein M, Collins R, Keller A, Stone R, Tallman M, Stevens D, Pecora A, Agha M, Holmes H, Druker BJ, Guilhot F, Larson RA, O’Brien SG, Rowe J, Schiffer CA, Buyse M, Baccarani M, Cervantes F, Cornelissen J, Fischer T, Hochhaus A, Hughes T, Kantarjian H, Lechner K, Nielsen JL, Reiffers J, Rousselot P, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Taylor K, Verhoef G.

Author information

From Abteilung Hämatologie-Onkologie, Universitätsklinikum Jena, Jena, Germany (A.H.); the Department of Medicine, University of Chicago, Chicago (R.A.L.); INSERM Centre d'Investigation Clinique 1402, Centre Hospitalier Universitaire de Poitiers, Poitiers, France (F.G.); Fred Hutchinson Cancer Research Center, Seattle (J.P.R.); Centre for Cancer Biology, SA Pathology, University of South Australia and University of Adelaide (S.B.), and the South Australian Health and Medical Research Institute and University of Adelaide (T.P.H.), Adelaide, SA, Australia; University of Bologna, Bologna, Italy (M.B.); the University of Utah Huntsman Cancer Institute, Salt Lake City (M.W.D.); the Hematology Department, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona (F.C.); Novartis, Basel, Switzerland (S.F., C.-E.O., H.D.M.); M.D. Anderson Cancer Center, Houston (H.K.); the University of Newcastle, Newcastle, United Kingdom (S.G.O.); and Knight Cancer Institute, Oregon Health and Science University and Howard Hughes Medical Institute, Portland (B.J.D.).



Imatinib, a selective BCR-ABL1 kinase inhibitor, improved the prognosis for patients with chronic myeloid leukemia (CML). We conducted efficacy and safety analyses on the basis of more than 10 years of follow-up in patients with CML who were treated with imatinib as initial therapy.


In this open-label, multicenter trial with crossover design, we randomly assigned patients with newly diagnosed CML in the chronic phase to receive either imatinib or interferon alfa plus cytarabine. Long-term analyses included overall survival, response to treatment, and serious adverse events.


The median follow-up was 10.9 years. Given the high rate of crossover among patients who had been randomly assigned to receive interferon alfa plus cytarabine (65.6%) and the short duration of therapy before crossover in these patients (median, 0.8 years), the current analyses focused on patients who had been randomly assigned to receive imatinib. Among the patients in the imatinib group, the estimated overall survival rate at 10 years was 83.3%. Approximately half the patients (48.3%) who had been randomly assigned to imatinib completed study treatment with imatinib, and 82.8% had a complete cytogenetic response. Serious adverse events that were considered by the investigators to be related to imatinib were uncommon and most frequently occurred during the first year of treatment.


Almost 11 years of follow-up showed that the efficacy of imatinib persisted over time and that long-term administration of imatinib was not associated with unacceptable cumulative or late toxic effects. (Funded by Novartis Pharmaceuticals; IRIS numbers, NCT00006343 and NCT00333840 .).

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