title: 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.
abstract: 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 intensification. 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 10(9)/L, -7/7q-, -5/5q-, and/or complex karyotype. No new agent improved outcomes; experience may have contributed to better results time.
authors.affiliation: University of Pennsylvania School of Medicine and the Children's Hospital of Philadelphia, Division of Oncology, Philadelphia, PA, USA. lange@email.chop.edu
authors.forename: Beverly J
authors.initials: BJ
authors.lastname: Lange
authors.forename: Franklin O
authors.initials: FO
authors.lastname: Smith
authors.forename: James
authors.initials: J
authors.lastname: Feusner
authors.forename: Dorothy R
authors.initials: DR
authors.lastname: Barnard
authors.forename: Patricia
authors.initials: P
authors.lastname: Dinndorf
authors.forename: Stephen
authors.initials: S
authors.lastname: Feig
authors.forename: Nyla A
authors.initials: NA
authors.lastname: Heerema
authors.forename: Carola
authors.initials: C
authors.lastname: Arndt
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Arceci
authors.forename: Nita
authors.initials: N
authors.lastname: Seibel
authors.forename: Margie
authors.initials: M
authors.lastname: Weiman
authors.forename: Kathryn
authors.initials: K
authors.lastname: Dusenbery
authors.forename: Kevin
authors.initials: K
authors.lastname: Shannon
authors.forename: Sandra
authors.initials: S
authors.lastname: Luna-Fineman
authors.forename: Robert B
authors.initials: RB
authors.lastname: Gerbing
authors.forename: Todd A
authors.initials: TA
authors.lastname: Alonzo
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D007231:Infant, Newborn; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D011379:Prognosis; D015996:Survival Rate; D016896:Treatment Outcome; D014740:Vidarabine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D007376:Interleukin-2; D014740:Vidarabine; C024352:fludarabine; D015255:Idarubicin