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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.
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 Group1 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.
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