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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.
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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.
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