{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T23:47:30Z","timestamp":1777420050596,"version":"3.51.4"},"reference-count":29,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2013,12,1]],"date-time":"2013-12-01T00:00:00Z","timestamp":1385856000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2013,12]]},"abstract":"<jats:p>Objective: To review clinical trials and main characteristics of bosutinib, a second-generation tyrosine kinase inhibitor (TKI) for treatment of chronic myelogenous leukemia (CML). Data Sources: Pertinent data were identified through a search of PubMed (January 1990-April 2013) using the primary search terms SKI-606, bosutinib, and CML. Additionally, preliminary reports published in abstract form by the American Society of Clinical Oncology and American Society of Hematology (January 1990-April 2013) were screened for inclusion. Study Selection and Data Extraction: Clinical Phase 1, 2, and 3 studies reported in English evaluating the safety and efficacy of bosutinib in patients with CML were reviewed. Data Synthesis: Bosutinib is a TKI of the breakpoint cluster region\/Abelson murine leukemia ( BCR-ABL) gene approved by the Food and Drug Administration on September 4, 2012, for second-line treatment of chronic phase, accelerated phase, and blast phase CML. In the second-line setting, bosutinib is effective in some patients with CML resistant or intolerant to imatinib, dasatinib, and\/or nilotinib, but it is not effective in patients whose disease expresses the T315I point mutation in BCR-ABL. Bosutinib also has been compared with imatinib, the standard first-line treatment, in 502 patients with newly diagnosed chronic phase CML in a Phase 3 trial. Complete cytogenetic response at 12 months, the primary efficacy end point, is similar between bosutinib and imatinib (p = 0.601); therefore, bosutinib is not indicated in the first-line setting. Common adverse events associated with bosutinib include diarrhea, nausea, and vomiting. Grade 3 and 4 adverse events reported in at least 5% of bosutinib-treated patients include elevated serum lipase and liver aminotransferases, anemia, thrombocytopenia, neutropenia, and diarrhea. Conclusions: Currently available clinical trials suggest that bosutinib is generally a safe and effective treatment option for patients with CML who have failed first-line TKIs and who do not express the T315I mutation; however, tolerability may be problematic for some patients.<\/jats:p>","DOI":"10.1177\/1060028013503124","type":"journal-article","created":{"date-parts":[[2014,1,6]],"date-time":"2014-01-06T14:16:10Z","timestamp":1389017770000},"page":"1703-1711","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":18,"title":["Bosutinib"],"prefix":"10.1177","volume":"47","author":[{"given":"Lindsay","family":"Stansfield","sequence":"first","affiliation":[{"name":"National Institutes of Health Clinical Center, Bethesda, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas E","family":"Hughes","sequence":"additional","affiliation":[{"name":"National Institutes of Health Clinical Center, Bethesda, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tracey L","family":"Walsh-Chocolaad","sequence":"additional","affiliation":[{"name":"National Institutes of Health Clinical Center, Bethesda, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2014,1,6]]},"reference":[{"key":"bibr1-1060028013503124","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21166"},{"key":"bibr2-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra013339"},{"key":"bibr3-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.25690"},{"key":"bibr4-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa022457"},{"key":"bibr5-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1205127"},{"key":"bibr6-1060028013503124","unstructured":"National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia. Version 3.2013. http:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/cml.pdf (accessed 2012 Dec 10)."},{"key":"bibr7-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0912614"},{"key":"bibr8-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1002315"},{"key":"bibr9-1060028013503124","unstructured":"Kantarjian H, Flinn IW, Goldberg S. Nilotinib versus imatinib in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): ENESTnd 3-year (yr) follow-up (f\/u) (poster). Presented at: 2012 American Society of Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago, IL. http:\/\/www.asco.org\/ASCOv2\/MultiMedia\/Virtual+Meeting?&vmview=vm_session_presentations_view&confID=114&sessionID=4845 (accessed 2013 Feb 12)."},{"key":"bibr10-1060028013503124","unstructured":"Hochhaus A, Shah NP, Cortes JE, Dasatinib versus imatinib (IM) in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): DASISION 3-year follow-up (poster). Presented at: 2012 American Society of Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago, IL. http:\/\/www.asco.org\/ASCOv2\/MultiMedia\/Virtual+Meeting?&vmview=vm_session_presentations_view&confID=114&sessionID=4821 (accessed 2013 Feb 12)."},{"key":"bibr11-1060028013503124","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2012.0184"},{"key":"bibr12-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2141.2007.06582.x"},{"key":"bibr13-1060028013503124","unstructured":"Product information. Bosulif (bosutinib). New York, NY: Pfizer Inc., September 2012."},{"key":"bibr14-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-06-1199"},{"key":"bibr15-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-011-1688-7"},{"key":"bibr16-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-012-1987-7"},{"key":"bibr17-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-05-355594"},{"key":"bibr18-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V120.21.3779.3779"},{"key":"bibr19-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-11-390120"},{"key":"bibr20-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V120.21.3785.3785"},{"key":"bibr21-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2010.28.15_suppl.6509"},{"key":"bibr22-1060028013503124","unstructured":"Gambacorti-Passerini C, Cortes JE, Khoury HJ, Safety and efficacy of bosutinib in patients with AP and BP CML and ph+ ALL following resistance\/intolerance to imatinib and other TKIs: update from study SKI-200 (poster). Presented at: 2010 American Society of Clinical Oncology Annual Meeting; June 4-8, 2010; Chicago, IL. http:\/\/www.asco.org\/ASCOv2\/MultiMedia\/Virtual+Meeting?&vmview=vm_session_presentations_view&confID=74&trackID=22&sessionID=3436 (accessed 2013 Feb 12)."},{"key":"bibr23-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.38.7522"},{"key":"bibr24-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2012.30.15_suppl.6512"},{"key":"bibr25-1060028013503124","unstructured":"Gambacorti-Passerini C, Lipton JH, Tee GY, BELA trial update: Bosutinib (BOS) versus imatinib (IM) in patients (pts) with newly diagnosed chronic phase chronic myeloid leukemia (CP CML) after 30 months of follow-up (poster). Presented at: 2012 American Society of Clinical Oncology Annual Meeting; June 1-5, 2012; Chicago, IL. http:\/\/www.asco.org\/ASCOv2\/MultiMedia\/Virtual+Meeting?&vmview=vm_session_presentations_view&confID=114&sessionID=4845 (accessed 2013 Feb 12)."},{"key":"bibr26-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2006-02-005686"},{"key":"bibr27-1060028013503124","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2006-01-0092"},{"key":"bibr28-1060028013503124","unstructured":"National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0. DCTD, NCI, NIH, DHHS. 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