AI Article Synopsis
- Researchers are reevaluating the maximum tolerated dose (MTD) of idarubicin for treating acute myeloid leukemia (AML), considering recent advances in supportive care.
- A phase I clinical study tested escalating doses of idarubicin combined with cytarabine, starting at 12 mg/m²/day and increasing to 18 mg/m²/day.
- Although grade 4 hematologic toxicities were reported, they didn't reach the defined criteria for dose-limiting toxicity, and no grade 4 non-hematologic toxicities were observed, indicating that the MTD was not reached.
Article 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.
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| http://dx.doi.org/10.3109/10428194.2016.1138294 | DOI Listing |
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