TY - JOUR
T1 - Establishment of baseline toxicity expectations with standard frontline chemotherapy in acute myelogenous leukemia
AU - Atallah, Ehab
AU - Cortes, Jorge
AU - O'Brien, Susan
AU - Pierce, Sherry
AU - Rios, Mary Beth
AU - Estey, Elihu
AU - Markman, Maurie
AU - Keating, Michael
AU - Freireich, Emil J.
AU - Kantarjian, Hagop
PY - 2007/11/15
Y1 - 2007/11/15
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=36348930556&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=36348930556&partnerID=8YFLogxK
U2 - 10.1182/blood-2007-06-095844
DO - 10.1182/blood-2007-06-095844
M3 - Article
C2 - 17673605
AN - SCOPUS:36348930556
SN - 0006-4971
VL - 110
SP - 3547
EP - 3551
JO - Blood
JF - Blood
IS - 10
ER -