{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T02:45:02Z","timestamp":1761101102820},"reference-count":31,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2012,7,16]],"date-time":"2012-07-16T00:00:00Z","timestamp":1342396800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2012,9]]},"abstract":"<jats:p>We aimed to evaluate the efficacy and safety of allogeneic hematopoietic stem cell transplantation with targeted oral busulfan (<jats:styled-content style=\"fixed-case\">BU<\/jats:styled-content>) and cyclophosphamide (<jats:styled-content style=\"fixed-case\">CY<\/jats:styled-content>) in a phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study. Busulfan (1.0\u00a0mg\/kg) was given initially in six doses. Based on the estimated concentration at steady state after the first dose of <jats:styled-content style=\"fixed-case\">BU<\/jats:styled-content>, subsequent (7th\u201316th) doses were adjusted to obtain a targeted overall concentration at steady state of 700\u2013900\u00a0ng\/mL. The primary endpoint was 1\u2010year overall survival (<jats:styled-content style=\"fixed-case\">OS<\/jats:styled-content>). Fifty patients were registered and 46 (median age, 53\u00a0years; range, 18\u201362\u00a0years) received planned transplant, including 24 with <jats:styled-content style=\"fixed-case\">AML<\/jats:styled-content>, 16 with myelodysplastic syndrome, and six with <jats:styled-content style=\"fixed-case\">CML<\/jats:styled-content>. Fourteen patients were categorized as standard risk. Nineteen patients received transplant from human leukocyte antigen\u2010identical siblings, 27 from unrelated donors. The <jats:styled-content style=\"fixed-case\">BU<\/jats:styled-content> dose required reduction in 32 patients and escalation in six patients. One\u2010year <jats:styled-content style=\"fixed-case\">OS<\/jats:styled-content> was 65% (95% confidence interval, 50\u201377%). Cumulative incidence of hepatic sinusoidal obstruction syndrome was 11%. One\u2010year transplant\u2010related mortality was 18%. Both <jats:styled-content style=\"fixed-case\">OS<\/jats:styled-content> and transplant\u2010related mortality were favorable in this study, including patients of older age and with high risk diseases. Individual dose adjustment based on <jats:styled-content style=\"fixed-case\">BU<\/jats:styled-content> pharmacokinetics was feasible and effective in the current phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study. This trial is registered in the University Hospital Medical Information Network Clinical Trial Registry System (<jats:styled-content style=\"fixed-case\">UMIN<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">CTR<\/jats:styled-content>,<jats:styled-content style=\"fixed-case\"> ID<\/jats:styled-content>:C000000156).<\/jats:p>","DOI":"10.1111\/j.1349-7006.2012.02342.x","type":"journal-article","created":{"date-parts":[[2012,5,28]],"date-time":"2012-05-28T06:41:15Z","timestamp":1338187275000},"page":"1688-1694","source":"Crossref","is-referenced-by-count":10,"title":["Phase <scp>II<\/scp> study of dose\u2010modified busulfan by real\u2010time targeting in allogeneic hematopoietic stem cell transplantation for myeloid malignancy"],"prefix":"10.1111","volume":"103","author":[{"given":"Yachiyo","family":"Kuwatsuka","sequence":"first","affiliation":[{"name":"Department of Hematology Japanese Red Cross Nagoya First Hospital Nagoya Japan"},{"name":"Department of Hematology 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