{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T05:34:48Z","timestamp":1791178488677,"version":"4.1.0"},"reference-count":39,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2011,4,20]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> Treatment of chronic-phase (CP) chronic myeloid leukemia (CML) with imatinib 400 mg\/d can be unsatisfactory. Optimization of treatment is warranted. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> In all, 1,014 newly diagnosed CP-CML patients were randomly assigned to imatinib 800 mg\/d (n = 338), imatinib 400 mg\/d (n = 325), or imatinib 400 mg\/d plus interferon alfa (IFN-\u03b1; n = 351). Dose adaptation to avoid higher-grade toxicity was recommended. First primary end point was major molecular remission (MMR) at 12 months. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> A higher rate of MMR at 12 months occurred with tolerability-adapted imatinib 800 mg\/d than with imatinib 400 mg\/d (59% [95% CI, 53% to 65%] v 44% [95% CI, 37% to 50%]; P &lt; .001) or imatinib 400 mg\/d plus IFN-\u03b1 (59% v 46% [95% CI, 40% to 52%]; P = .002). Median dose in the 800-mg\/d arm was 628 mg\/d with a maximum dose of 737 mg\/d during months 4 to 6 and a maintenance dose of 600 mg\/d. All three treatment approaches were well tolerated with similar grade 3 and 4 adverse events. Independent of treatment approach, MMR at 12 months showed better progression-free survival (99% v 94%; P = .0023) and overall survival (99% v 93%; P = .0011) at 3 years when compared with &gt; 1% on the international scale or no MMR but showed no difference in 0.1% to &lt; 1% on the international scale, which closely correlates with complete cytogenetic remission. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Treatment of early-phase CML with imatinib can be optimized. Early high-dose therapy followed by rapid adaptation to good tolerability increases the rate of MMR at 12 months. Achievement of MMR by month 12 is directly associated with improved survival. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2010.32.0598","type":"journal-article","created":{"date-parts":[[2011,3,22]],"date-time":"2011-03-22T05:45:42Z","timestamp":1300772742000},"page":"1634-1642","source":"Crossref","is-referenced-by-count":278,"title":["Tolerability-Adapted Imatinib 800 mg\/d Versus 400 mg\/d Versus 400 mg\/d Plus Interferon-\u03b1 in Newly Diagnosed Chronic Myeloid Leukemia"],"prefix":"10.1200","volume":"29","author":[{"given":"R\u00fcdiger","family":"Hehlmann","sequence":"first","affiliation":[{"name":"Medizinische Fakult\u00e4t Mannheim, Universit\u00e4t Heidelberg, Mannheim; Institut f\u00fcr Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universit\u00e4t; M\u00fcnchner Leuk\u00e4mielabor; St\u00e4dtisches Klinikum Schwabing, M\u00fcnchen; Medizinische Hochschule, Hannover; Evangelisches Krankenhaus, Hamm; Klinikum, Chemnitz; Universit\u00e4t, Erlangen; Universit\u00e4t Giessen, Giessen; Universit\u00e4tsklinikum Eppendorf, Hamburg; Universit\u00e4tsklinikum Jena, Jena, Germany; and Universit\u00e4tsspital Basel, Basel,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Lauseker","sequence":"additional","affiliation":[{"name":"Medizinische Fakult\u00e4t Mannheim, Universit\u00e4t Heidelberg, Mannheim; Institut f\u00fcr Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universit\u00e4t; M\u00fcnchner Leuk\u00e4mielabor; St\u00e4dtisches Klinikum Schwabing, M\u00fcnchen; Medizinische Hochschule, Hannover; Evangelisches Krankenhaus, Hamm; Klinikum, Chemnitz; Universit\u00e4t, Erlangen; Universit\u00e4t Giessen, Giessen; Universit\u00e4tsklinikum Eppendorf, Hamburg; Universit\u00e4tsklinikum Jena, Jena, Germany; and Universit\u00e4tsspital Basel, 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