{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T20:30:28Z","timestamp":1782505828968,"version":"3.54.5"},"reference-count":26,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2014,7,21]],"date-time":"2014-07-21T00:00:00Z","timestamp":1405900800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2014,10]]},"abstract":"<jats:p>Bosutinib, an orally active, Src\/Abl tyrosine kinase inhibitor, has demonstrated clinical activity and acceptable tolerability in chronic phase chronic myeloid leukemia (CP CML). This updated analysis of the BELA trial assessed the safety profile and management of toxicities of bosutinib versus imatinib in adults with newly diagnosed (\u22646 months) CP CML after &gt;30 months from accrual completion. Among patients randomized to bosutinib 500 mg\/d (<jats:italic>n<\/jats:italic>\u2009=\u2009250) or imatinib 400 mg\/d (<jats:italic>n<\/jats:italic>\u2009=\u2009252), 248 and 251, respectively, received \u22651 dose of study treatment. Adverse events (AEs; any grade) with bosutinib versus imatinib were significantly more common for certain gastrointestinal events (diarrhea, 70% vs. 26%;<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001; vomiting, 33% vs. 16%;<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001), alanine aminotransferase (33% vs. 9%;<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001) and aspartate aminotransferase (28% vs. 10%;<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001) elevations, and pyrexia (19% vs. 12%;<jats:italic>P<\/jats:italic>\u2009=\u20090.046). AEs significantly less common with bosutinib included edema (periorbital, 2% vs. 14%;<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001; peripheral, 5% vs. 12%;<jats:italic>P<\/jats:italic>\u2009=\u20090.006), musculoskeletal (myalgia, 5% vs. 12%;<jats:italic>P<\/jats:italic>\u2009=\u20090.010; muscle cramps, 5% vs. 22%;<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001; bone pain, 4% vs. 11%;<jats:italic>P<\/jats:italic>\u2009=\u20090.003), increased creatine phosphokinase (8% vs. 20%;<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001), neutropenia (13% vs. 30%;<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001), and leukopenia (9% vs. 22%;<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001). Between\u2010group differences in the incidence of cardiac and vascular AEs were not significant. Diarrhea was typically transient, mostly Grade 1\/2, occurring early during treatment, and was manageable with antidiarrheal medication. Despite higher rates of aminotransferase elevation with bosutinib, events were managed in most patients with dose modification and\/or concomitant medication. Bosutinib had a manageable safety profile distinct from that of imatinib in patients with newly diagnosed CP CML. Am. J. Hematol. 89:947\u2013953, 2014. \u00a9 2014 The Authors. American Journal of Hematology Published by Wiley Periodicals, Inc.<\/jats:p>","DOI":"10.1002\/ajh.23788","type":"journal-article","created":{"date-parts":[[2014,6,18]],"date-time":"2014-06-18T15:23:29Z","timestamp":1403105009000},"page":"947-953","source":"Crossref","is-referenced-by-count":95,"title":["Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia"],"prefix":"10.1002","volume":"89","author":[{"given":"Carlo","family":"Gambacorti\u2010Passerini","sequence":"first","affiliation":[{"name":"Department of Internal Medicine University of Milano Bicocca Monza Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge E.","family":"Cortes","sequence":"additional","affiliation":[{"name":"Department of Leukemia Division of Cancer Medicine MD Anderson Cancer Center University of Texas Houston Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff H.","family":"Lipton","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Medical Oncology Princess Margaret Hospital Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Dmoszynska","sequence":"additional","affiliation":[{"name":"Hematooncology and Bone Marrow Transplantation Department Medical University of Lublin Lublin Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raymond S.","family":"Wong","sequence":"additional","affiliation":[{"name":"Prince of Wales Hospital The Chinese University of Hong Kong Shatin Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Rossiev","sequence":"additional","affiliation":[{"name":"Hematology Department Samara Regional Clinical Hospital Samara Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitri","family":"Pavlov","sequence":"additional","affiliation":[{"name":"Oncology Clinical Statistics Pfizer Inc New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin","family":"Gogat Marchant","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ladan","family":"Duvilli\u00e9","sequence":"additional","affiliation":[{"name":"Pfizer Global Research and Development Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Navin","family":"Khattry","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Tata Memorial Center Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hagop M.","family":"Kantarjian","sequence":"additional","affiliation":[{"name":"Department of Leukemia Division of Cancer Medicine MD Anderson Cancer Center University of Texas Houston Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim H.","family":"Br\u00fcmmendorf","sequence":"additional","affiliation":[{"name":"Clinic for Oncology Hematology and Stem Cell Transplantation Universit\u00e4tsklinikum Aachen RWTH Aachen Aachen Germany"},{"name":"Oncology Hematology and Stem Cell Transplantation Universit\u00e4tsklinikum Hamburg\u2010Eppendorf Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,7,21]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/315758a0"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.3460176"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.2408149"},{"key":"e_1_2_6_5_1","volume-title":"Full Prescribing Information","author":"Tasigna\u00ae (nilotinib)","year":"2013"},{"key":"e_1_2_6_6_1","volume-title":"Full Prescribing Information","author":"Gleevec\u00ae (imatinib mesylate)","year":"2013"},{"key":"e_1_2_6_7_1","volume-title":"Full Prescribing Information","author":"Sprycel\u00ae (dasatinib)","year":"2013"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2012.672974"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrc3317"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-06-1199"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2008.334"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2007-07-102061"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2010-11-318949"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-08-376087"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1038\/leu.2012.134"},{"key":"e_1_2_6_16_1","volume-title":"Summary of Product Characteristics","author":"Bosulif (bosutinib)","year":"2013"},{"key":"e_1_2_6_17_1","unstructured":"Bosulif: EPAR Product Information. 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