{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T22:11:15Z","timestamp":1772748675354,"version":"3.50.1"},"reference-count":26,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2001,2,1]]},"abstract":"<jats:p> PURPOSE: To investigate the toxicity profile, activity, and pharmacokinetics of a novel l-nucleoside analog, troxacitabine (BCH-4556), in patients with advanced leukemia. <\/jats:p><jats:p> PATIENTS AND METHODS: Patients with refractory or relapsed acute myeloid (AML) or lymphocytic (ALL) leukemia, myelodysplastic syndromes (MDS), or chronic myelogenous leukemia in blastic phase (CML-BP). Troxacitabine was given as an intravenous infusion over 30 minutes daily for 5 days. The starting dose was 0.72 mg\/m<jats:sup>2<\/jats:sup>\/d (3.6 mg\/m<jats:sup>2<\/jats:sup>\/course). Courses were given every 3 to 4 weeks according to toxicity and antileukemic efficacy. The dose was escalated by 50% until grade 2 toxicity was observed, and then by 30% to 35% until the dose-limiting toxicity (DLT) was defined. <\/jats:p><jats:p> RESULTS: Forty-two patients (AML: 31 patients; MDS: six patients [five MDS + one CMML]; ALL: four patients; CML-BP: one patient) were treated. Median age was 61 years (range, 23 to 79 years), and 29 patients were males. Stomatitis and hand-foot syndrome were the DLTs. The MTD was defined as 8 mg\/m<jats:sup>2<\/jats:sup>\/d. The pharmacokinetic behavior of troxacitabine is linear over the dose range of 0.72 to 10.0 m\/m<jats:sup>2<\/jats:sup>. Approximately 69% of troxacitabine was excreted as unchanged drug in the urine. Marrow hypoplasia occurred between days 14 and 28 in 73% of AML patients. Three complete remissions and one partial remission were observed in 30 assessable AML patients. One MDS patient achieved a hematologic improvement. A patient with CML-BP achieved a return to chronic phase disease. <\/jats:p><jats:p> CONCLUSION: Troxacitabine has a unique metabolic and pharmacokinetic profile and significant antileukemic activity. DLTs were stomatitis and hand-foot syndrome. Troxacitabine merits further study in hematologic malignancies. <\/jats:p>","DOI":"10.1200\/jco.2001.19.3.762","type":"journal-article","created":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T08:12:12Z","timestamp":1487923932000},"page":"762-771","source":"Crossref","is-referenced-by-count":87,"title":["Troxacitabine, A Novel Dioxolane Nucleoside Analog, Has Activity in Patients With Advanced Leukemia"],"prefix":"10.1200","volume":"19","author":[{"given":"Francis J.","family":"Giles","sequence":"first","affiliation":[{"name":"From the Departments of Leukemia and Biomathematics, The University of Texas M.D. Anderson Cancer Center, Houston; Department of Clinical Research, Institute for Drug Development, San Antonio, TX; and BioChem Pharma Inc, Laval, Quebec, Canada."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge E.","family":"Cortes","sequence":"additional","affiliation":[{"name":"From the Departments of Leukemia and Biomathematics, The University of Texas M.D. Anderson Cancer Center, Houston; 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