Submitted June 14, 2007
Accepted July 31, 2007
Establishment of baseline toxicity expectations with standard frontline chemotherapy in acute myelogenous leukemia
Ehab Atallah, Jorge Cortes, Susan O'Brien, Sherry Pierce, Mary Beth Rios, Elihu Estey, Maurie Markman, Michael Keating, Emil J Freireich, and Hagop Kantarjian*
Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, TX, United States
Department of Gynecologic Malignancies, The University of Texas M. D. Anderson Cancer Center, Houston, TX, United States
* Corresponding author; email: hkantarj{at}mdanderson.org.
The rates of expected serious adverse events in patients with acute leukemia on chemotherapy far exceed those in solid tumors. Regulatory authorities require similar reporting criteria, which overburdens 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 1990-2006 who received frontline intensive chemotherapy; 723 (47%) were 
60 years old. Prior to therapy, Grade 3/4 cytopenias were observed in 86% of patients. All patients developed one or more Grade 3/4 cytopenia during therapy, and >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 pretreatment and during therapy. This paper establishes a baseline toxicity rate for patients with AML during induction therapy, and this should be used as a control group for future reference. Guidelines for reporting adverse events in leukemia studies should be revisited.
