title: Phase I study of idarubicin dose escalation for remission induction therapy in acute myeloid leukemia.
abstract: The maximum tolerated dose (MTD) of idarubicin should be reevaluated in the treatment of acute myeloid leukemia (AML) in the era of granulocyte colony-stimulating factor and better supportive care. We conducted a phase I study to investigate the safety of escalating doses of idarubicin in combination with cytarabine 100 mg/m(2)/day for seven days for previously untreated AML. The starting dose of idarubicin was 12 mg/m(2)/day for three days with dose escalations by 3 mg/m(2)/day up to 18 mg/m(2)/day. The study design was adopted from traditional 3 + 3 design for phase I cancer clinical trials. The grade 4 hematologic toxicities were observed at all dose levels; however, these toxicities did not meet the criteria of the hematologic dose-limiting toxicities as defined in this study. There were no instances of grade 4 non-hematologic toxicities at any dose levels. The MTD of idarubicin was not reached in this trial.
authors.affiliation: a Division of Hematology-Oncology, Department of Internal Medicine , Konkuk University Medical Center , Seoul , Korea.
authors.forename: Mark Hong
authors.initials: MH
authors.lastname: Lee
authors.affiliation: a Division of Hematology-Oncology, Department of Internal Medicine , Konkuk University Medical Center , Seoul , Korea.
authors.forename: Sung-Yong
authors.initials: SY
authors.lastname: Kim
mesh_terms: D000328:Adult; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers; D002869:Chromosome Aberrations; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage* / Q000009:adverse effects; D015470:Leukemia, Myeloid, Acute / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D059005:Topoisomerase II Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000903:Antibiotics, Antineoplastic; D015415:Biomarkers; D059005:Topoisomerase II Inhibitors; D015255:Idarubicin
keywords: Acute myeloid leukemia; idarubicin; induction chemotherapy; maximum tolerated dose