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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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Submitted April 19, 2007
Accepted September 29, 2007
Outcomes in CCG-2961, a Children's Oncology Group phase 3 trial for untreated pediatric acute myeloid leukemia (AML): a report from the Children's Oncology Group
Beverly J Lange*, Franklin O. Smith, James Feusner, Dorothy Barnard, Patricia Dinndorf, Stephen Feig, Nyla A Heerema, Carola Arndt, Robert J Arceci, Nita Seibel, Margie Weiman, Kathryn Dusenbery, Kevin Shannon, Sandra Luna-Fineman, Robert B Gerbing, and Todd A Alonzo
The University of Pennsylvania School of Medicine and The Children's Hospital of Philadelphia, Philadelphia, PA, United States
Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine, Cincinnati, OH, United States
Children's Hospital of Oakland, Oakland, CA, United States
Izaak W. Killam Hospital for Children, Nova Scotia, Canada
Food and Drug Administration, Silver Spring, MD, United States
University of California Los Angeles School of Medicine, Los Angeles, CA, United States
Ohio State School of Medicine, Columbus, OH, United States
Mayo Clinic, Rochester, MN, United States
Johns Hopkins University School of Medicine, Baltimore, MD, United States
Children's National Medical Center, Washington, D.C., United States
University of Minnesota School of Medicine, Minneapolis, MN, United States
University of California San Francisco School of Medicine, San Francisco, CA, United States
California Pacific Medical Center, San Francisco, CA, United States
Children's Oncology Group, Arcadia, CA, United States
University of Southern California, Los Angeles, CA, United States
* Corresponding author; email: lange{at}email.chop.edu.
CCG-2961 incorporated three new agents, idarubicin, fludarabine and interleukin-2, into a phase 3 AML trial based on intensive-timing remission induction/consolidation and related donor marrow transplantation or high-dose cytarabine intensification. Among 901 patients age <21 years, survival was 52±5%. Five-year survival improved from 43±7% for those enrolled between 1996 and1998 to 57±6% between 2000 and 2002 (P=0.005) while treatment-related mortality declined from 19±5% to 12±3% (P=0.025). Partial replacement of standard daunomycin with idarubicin in the five-drug induction combination achieved a remission rate of 88.5%, similar to historical controls. Post-remission randomization effected 56.4% survival at five years in patients receiving five-drug reinduction and those receiving fludarabine/cytarabine/ idarubicin. For patients with or without a related donor, five-year disease-free survival was 60±8% and 50±5% (P=0.021) respectively; respective survival was 67±8% and 62±5% (P=0.425). Donor availability conferred no benefit on those with inv(16) or t(8;21) cytogenetics. After high-dose cytarabine intensification, patients randomized to interleukin-2 or none experienced similar outcomes. Five-year event-free survival was 42±3%. Factors predictive of inferior survival were age >16 years, non-Caucasian ethnicity, absence of related donor, obesity, WBC >100,000x109/L, -7/7q-, -5/5q- and/or complex karyotype. The new agents did not effect significantly better outcomes; experience may have contributed to improvement over time. This study is registered at http://clinicaltrials.gov as NCT00002798.
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