Establishment of baseline toxicity expectations with standard frontline chemotherapy in acute myelogenous leukemia. Blood 2007 Nov 15;110(10):3547-51
Date
08/04/2007Pubmed ID
17673605DOI
10.1182/blood-2007-06-095844Scopus ID
2-s2.0-36348930556 (requires institutional sign-in at Scopus site) 69 CitationsAbstract
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.
Author List
Atallah E, Cortes J, O'Brien S, Pierce S, Rios MB, Estey E, Markman M, Keating M, Freireich EJ, Kantarjian HAuthor
Ehab L. Atallah MD Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
Female
Humans
Leukemia, Myeloid, Acute
Male
Middle Aged
Neoadjuvant Therapy
Retrospective Studies
Survival Analysis
Time Factors
