SEARCH:   Advanced

Blood, 1 February 2008, Vol. 111, No. 3, pp. 1044-1053. Prepublished online as a Blood First Edition Paper on November 13, 2007; DOI 10.1182/blood-2007-04-084293. This Article Full Text Full Text (PDF) Supplemental Appendix and Figure All Versions of this Article: blood-2007-04-084293v1 111/3/1044    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 CrossRef Google Scholar Articles by Lange, B. J. Articles by Alonzo, T. A. PubMed PubMed Citation Articles by Lange, B. J. Articles by Alonzo, T. A. Related Collections Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Outcomes in CCG-2961, a Children's Oncology Group Phase 3 Trial for untreated pediatric acute myeloid leukemia: a report from the Children's Oncology Group Beverly J. Lange1, Franklin O. Smith2, James Feusner3, Dorothy R. Barnard4, Patricia Dinndorf5, Stephen Feig6, Nyla A. Heerema7, Carola Arndt8, Robert J. Arceci9, Nita Seibel10, Margie Weiman6, Kathryn Dusenbery11, Kevin Shannon12, Sandra Luna-Fineman13, Robert B. Gerbing14, and Todd A. Alonzo14,15 1 University of Pennsylvania School of Medicine and the Children's Hospital of Philadelphia, Division of Oncology, Philadelphia; 2 Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine, OH; 3 Children's Hospital of Oakland, CA; 4 Izaak W. Killam Hospital for Children, Halifax, NS; 5 Food and Drug Administration, Silver Spring, MD; 6 University of California Los Angeles School of Medicine; 7 Ohio State School of Medicine, Columbus; 8 Mayo Clinic, Rochester, MN; 9 Johns Hopkins University School of Medicine, Baltimore, MD; 10 Children's National Medical Center, Washington, DC; 11 University of Minnesota School of Medicine, Minneapolis; 12 University of California San Francisco School of Medicine; 13 California Pacific Medical Center, San Francisco; 14 Children's Oncology Group, Arcadia, CA; and 15 University of Southern California, Los Angeles CCG-2961 incorporated 3 new agents, idarubicin, fludarabine and interleukin-2, into a phase 3 AML trial using intensive-timing remission induction/consolidation and related donor marrow transplantation or high-dose cytarabine intensifi-cation. Among 901 patients under age 21 years, 5-year survival was 52%, and event-free survival was 42%. Survival improved from 44% between 1996 and 1998 to 58% between 2000 and 2002 (P = .005), and treatment-related mortality declined from 19% to 12% (P = .025). Partial replacement of daunomycin with idarubicin in the 5-drug induction combination achieved a remission rate of 88%, similar to historical controls. Postremission survival was 56% in patients randomized to either 5-drug reinduction or fludarabine/cytarabine/idarubicin. For patients with or without a related donor, respective 5-year disease-free survival was 61% and 50% (P = .021); respective survival was 68% and 62% (P = .425). Donor availability conferred no benefit on those with inv(16) or t(8;21) cytogenetics. After cytarabine intensification, patients randomized to interleukin-2 or none experienced similar outcomes. Factors predictive of inferior survival were age more than 16 years, non-white ethnicity, absence of related donor, obesity, white blood cell count more than 100 000 x 109/L, –7/7q–, –5/5q–, and/or complex karyotype. No new agent improved outcomes; experience may have contributed to better results time. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

	Blood Online is supported in part by Genentech BioOncology and Biogen Idec
	Copyright © 2008 by American Society of Hematology         Online ISSN: 1528-0020