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Blood, 15 November 2007, Vol. 110, No. 10, pp. 3547-3551. Prepublished online as a Blood First Edition Paper on August 2, 2007; DOI 10.1182/blood-2007-06-095844. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2007-06-095844v1 110/10/3547    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Atallah, E. Articles by Kantarjian, H. Search for Related Content PubMed PubMed Citation Articles by Atallah, E. Articles by Kantarjian, H. Related Collections Neoplasia Clinical Trials and Observations Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Establishment of baseline toxicity expectations with standard frontline chemotherapy in acute myelogenous leukemia Ehab Atallah1, Jorge Cortes1, Susan O'Brien1, Sherry Pierce1, Mary Beth Rios1, Elihu Estey1, Maurie Markman2, Michael Keating1, Emil J. Freireich1, and Hagop Kantarjian1 Departments of1 Leukemia and 2 Gynecologic Malignancies, University of Texas M. D. Anderson Cancer Center, Houston, TX 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. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: AML: treatment-related toxicity or not? Giuseppe Avvisati Blood 2007 110: 3491. [Full Text] [PDF] This article has been cited by other articles: S. Faderl, F. Ravandi, X. Huang, G. Garcia-Manero, A. Ferrajoli, Z. Estrov, G. Borthakur, S. Verstovsek, D. A. Thomas, M. Kwari, et al. A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome Blood, September 1, 2008; 112(5): 1638 - 1645. [Abstract] [Full Text] [PDF]

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