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. Lange, Franklin O. Smith, James Feusner, Dorothy R. Barnard, Patricia Dinndorf, Stephen Feig, Nyla A. Heerema, Carola A.S. Arndt, Robert J. Arceci, Nita Seibel, Margie Weiman, Kathryn Dusenbery, Kevin Shannon, Sandra Luna-Fineman, Robert B. Gerbing, Todd A. Alonzo

Research output: Contribution to journalArticle

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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 × 109/L, -7/7q-, -5/5q-, and/or complex karyotype. No new agent improved outcomes; experience may have contributed to better results time.

Original languageEnglish (US)
Pages (from-to)1044-1053
Number of pages10
JournalBlood
Volume111
Issue number3
DOIs
StatePublished - 2008

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Idarubicin
Pediatrics
Oncology
Cytarabine
Acute Myeloid Leukemia
Interleukin-2
Survival
Tissue Donors
Daunorubicin
Disease-Free Survival
Pharmaceutical Preparations
Consolidation
Blood
Remission Induction
Cells
Availability
Drug Combinations
Karyotype
Leukocyte Count
Cytogenetics

ASJC Scopus subject areas

  • Hematology

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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. / Lange, Beverly J.; Smith, Franklin O.; Feusner, James; Barnard, Dorothy R.; Dinndorf, Patricia; Feig, Stephen; Heerema, Nyla A.; Arndt, Carola A.S.; Arceci, Robert J.; Seibel, Nita; Weiman, Margie; Dusenbery, Kathryn; Shannon, Kevin; Luna-Fineman, Sandra; Gerbing, Robert B.; Alonzo, Todd A.

In: Blood, Vol. 111, No. 3, 2008, p. 1044-1053.

Research output: Contribution to journalArticle

Lange, BJ, Smith, FO, Feusner, J, Barnard, DR, Dinndorf, P, Feig, S, Heerema, NA, Arndt, CAS, Arceci, RJ, Seibel, N, Weiman, M, Dusenbery, K, Shannon, K, Luna-Fineman, S, Gerbing, RB & Alonzo, TA 2008, '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', Blood, vol. 111, no. 3, pp. 1044-1053. https://doi.org/10.1182/blood-2007-04-084293
Lange, Beverly J. ; Smith, Franklin O. ; Feusner, James ; Barnard, Dorothy R. ; Dinndorf, Patricia ; Feig, Stephen ; Heerema, Nyla A. ; Arndt, Carola A.S. ; Arceci, Robert J. ; Seibel, Nita ; Weiman, Margie ; Dusenbery, Kathryn ; Shannon, Kevin ; Luna-Fineman, Sandra ; Gerbing, Robert B. ; Alonzo, Todd A. / 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. In: Blood. 2008 ; Vol. 111, No. 3. pp. 1044-1053.
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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 × 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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T1 - Outcomes in CCG-2961, a Children's Oncology Group Phase 3 Trial for untreated pediatric acute myeloid leukemia

T2 - A report from the Children's Oncology Group

AU - Lange, Beverly J.

AU - Smith, Franklin O.

AU - Feusner, James

AU - Barnard, Dorothy R.

AU - Dinndorf, Patricia

AU - Feig, Stephen

AU - Heerema, Nyla A.

AU - Arndt, Carola A.S.

AU - Arceci, Robert J.

AU - Seibel, Nita

AU - Weiman, Margie

AU - Dusenbery, Kathryn

AU - Shannon, Kevin

AU - Luna-Fineman, Sandra

AU - Gerbing, Robert B.

AU - Alonzo, Todd A.

PY - 2008

Y1 - 2008

N2 - 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 × 109/L, -7/7q-, -5/5q-, and/or complex karyotype. No new agent improved outcomes; experience may have contributed to better results time.

AB - 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 × 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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