The rates of expected serious adverse events in patients with acute
leukemia on
chemotherapy far exceed those in patients with solid
tumors. Regulatory authorities require similar reporting criteria, which overburden the investigators and infrastructure with unnecessary documentation. To establish a baseline for expected toxicities before and during
leukemia therapy, we reviewed 1534 adults with
acute myeloid leukemia (AML; excluding
acute promyelocytic leukemia) from 1990 to 2006 who received frontline intensive
chemotherapy; 723 (47%) were 60 years or older. Prior to
therapy, grade 3/4
cytopenias were observed in 86% of patients. All patients developed one or more grade 3/4
cytopenias during
therapy, and more than 90% had a febrile episode. Admission to the intensive care unit,
mechanical ventilation, and dialysis were required in 28%, 16%, and 7%, respectively. Mortality during induction, 2-week mortality, and 6-week mortality were 20%, 5%, and 16%, respectively. Grade 3/4 renal or hepatic toxicities were observed in 3% and 22% of patients, respectively. Other grade 3 or 4 toxicities were also common before treatment and during
therapy. This paper establishes a baseline toxicity rate for patients with AML during induction
therapy, and this could be used as a control group for future reference. Guidelines for reporting adverse events in
leukemia studies should be revisited.