{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:07:57Z","timestamp":1777421277470,"version":"3.51.4"},"reference-count":27,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2021,9,18]],"date-time":"2021-09-18T00:00:00Z","timestamp":1631923200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009744","name":"Eshelman Institute for Innovation, University of North Carolina","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009744","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Tyrosine kinase inhibitors (TKIs) are the front-line therapy for chronic myeloid leukemia (CML), where phase 3 clinical trials have demonstrated their safety and efficacy. However, trial patients may not be representative of real-world patients (RWPs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To evaluate RWP clinical factors associated with effectiveness and safety in CML patients treated with TKIs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Patients with CML treated with at least 30 days of imatinib, dasatinib, nilotinib, or bosutinib between 2014 and 2018 were included. Patients were stratified into categories based on the number of factors that would have precluded enrollment into pivotal TKI phase 3 trials (0, 1, \u22652). End points included complete hematologic response (CHR), early molecular response (EMR), major molecular response (MMR), adverse event (AE)-induced dose decreases, treatment interruptions, and treatment discontinuations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Final analyses included 174 patients. Patients with \u22652 factors had a higher risk of dose decreases (relative risk = 1.54; 95% CI = 1.02-2.34; P = 0.02) and a shorter time to dose decrease (hazard ratio = 2.43; 95% CI = 1.23-4.97; P = 0.006) compared with patients with 0 factors. Significant differences were observed in CHR at 1 month and MMR at 3 months between patients with 0 and \u22652 factors ( P = 0.03 and P = 0.04, respectively).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion and Relevance:<\/jats:title>\n                    <jats:p>Approximately 60% of our RWPs would have been excluded from the pivotal phase 3 TKI trials. These data suggest that RWPs require more precise dosing to achieve CML clinical milestones and to mitigate AEs, but findings should be validated prospectively.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280211044160","type":"journal-article","created":{"date-parts":[[2021,9,18]],"date-time":"2021-09-18T06:26:35Z","timestamp":1631946395000},"page":"753-763","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Response to Tyrosine Kinase Inhibitors in Real-World Patients With Chronic Myeloid Leukemia"],"prefix":"10.1177","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9195-6520","authenticated-orcid":false,"given":"Andy H.","family":"Szeto","sequence":"first","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tyler","family":"Bucci","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, UNC Medical Center, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allison","family":"Deal","sequence":"additional","affiliation":[{"name":"UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anqi","family":"Zhu","sequence":"additional","affiliation":[{"name":"UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Majd","family":"Ahmad","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, UNC Medical Center, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda S.","family":"Cass","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, UNC Medical Center, Chapel Hill, NC, USA"},{"name":"Department of Pharmaceutical Sciences, Vanderbilt University Medical Center, Nashville, TN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaret R.","family":"Sketch","sequence":"additional","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryan","family":"Kemper","sequence":"additional","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshua F.","family":"Zeidner","sequence":"additional","affiliation":[{"name":"UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew C.","family":"Foster","sequence":"additional","affiliation":[{"name":"UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benyam","family":"Muluneh","sequence":"additional","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA"},{"name":"Department of Pharmacy, UNC Medical Center, Chapel Hill, NC, USA"},{"name":"UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3742-8863","authenticated-orcid":false,"given":"Daniel J.","family":"Crona","sequence":"additional","affiliation":[{"name":"Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA"},{"name":"Department of Pharmacy, UNC Medical Center, Chapel Hill, 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