Adaptive randomized study of idarubicin and cytarabine alone or with interleukin-11 as induction therapy in patients aged 50 or above with acute myeloid leukemia or high-risk myelodysplastic syndromes

Francis J. Giles, Hagop M. Kantarjian, Jorge E. Cortes, Stephan Faderl, Srdan Verstovsek, Deborah Thomas, Guillermo Garcia-Manero, William Wierda, Alessandra Ferrajoli, Stephen Kornblau, Gloria N. Mattiuzzi, Apostolia M. Tsimberidou, Maher Albitar, Susan M. O'Brien, Elihu Estey

Research output: Contribution to journalArticle

Abstract

A higher complete remission (CR) rate was observed in patients with acute myeloid leukemia (AML) who, on a prior randomized study of induction therapy, received gemtuzumab ozogamicin (GO) plus interleukin-11 (IL-11) rather than GO alone. An adaptive randomized phase III study of the addition of IL-11 to idarubicin and cytarabine (IA) induction in 100 patients ≥50 years of age with AML or high-risk myelodysplastic syndrome (MDS) was conducted. Median patient age was 67 years (range 50-82). Twenty-four of the 45 (53%) patients randomized to IA plus IL-11 achieved CR. Eight (33%) subsequently relapsed, 4 (17%) died in CR; median time to treatment failure (TTF) was 37 weeks. Twenty-nine of the 55 (53%) patients treated without IL-11 achieved CR. Eight (28%) subsequently relapsed, 2 (7%) died in CR; median TTF was 46 weeks. Median overall survivals were 21 and 59 weeks for the IA plus IL-11 and IA cohorts, respectively (p = 0.271, log rank test; 0.435, Gehan-Breslow test). Ten episodes of the following grade 3 or 4 cardiopulmonary toxicities were observed in patients receiving IA plus IL-11, 12 such episodes in those receiving IA alone: atrial fibrillation, pleural effusions, myocardial infarction, bradycardia or hypotension. Two patients in each arm experienced grade 3 peripheral edema. There was no significant difference in incidence of any grade 3 or 4 adverse event, including thrombocytopenia, between treatment arms. There was no significant impact on CR rates, TTF, survival, or toxicity of adding an IL-11 regimen to IA induction in patients ≥50 years of age with AML.

Original languageEnglish (US)
Pages (from-to)649-652
Number of pages4
JournalLeukemia Research
Volume29
Issue number6
DOIs
StatePublished - Jun 2005
Externally publishedYes

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Idarubicin
Interleukin-11
Myelodysplastic Syndromes
Cytarabine
Acute Myeloid Leukemia
Treatment Failure
Therapeutics
Survival
Pleural Effusion
Interleukin-12
Bradycardia
Thrombocytopenia
Hypotension
Atrial Fibrillation
Edema
Myocardial Infarction

Keywords

  • Acute myeloid leukemia
  • Interleukin-11
  • Myelodysplastic syndrome

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Adaptive randomized study of idarubicin and cytarabine alone or with interleukin-11 as induction therapy in patients aged 50 or above with acute myeloid leukemia or high-risk myelodysplastic syndromes. / Giles, Francis J.; Kantarjian, Hagop M.; Cortes, Jorge E.; Faderl, Stephan; Verstovsek, Srdan; Thomas, Deborah; Garcia-Manero, Guillermo; Wierda, William; Ferrajoli, Alessandra; Kornblau, Stephen; Mattiuzzi, Gloria N.; Tsimberidou, Apostolia M.; Albitar, Maher; O'Brien, Susan M.; Estey, Elihu.

In: Leukemia Research, Vol. 29, No. 6, 06.2005, p. 649-652.

Research output: Contribution to journalArticle

Giles, FJ, Kantarjian, HM, Cortes, JE, Faderl, S, Verstovsek, S, Thomas, D, Garcia-Manero, G, Wierda, W, Ferrajoli, A, Kornblau, S, Mattiuzzi, GN, Tsimberidou, AM, Albitar, M, O'Brien, SM & Estey, E 2005, 'Adaptive randomized study of idarubicin and cytarabine alone or with interleukin-11 as induction therapy in patients aged 50 or above with acute myeloid leukemia or high-risk myelodysplastic syndromes', Leukemia Research, vol. 29, no. 6, pp. 649-652. https://doi.org/10.1016/j.leukres.2004.11.013
Giles, Francis J. ; Kantarjian, Hagop M. ; Cortes, Jorge E. ; Faderl, Stephan ; Verstovsek, Srdan ; Thomas, Deborah ; Garcia-Manero, Guillermo ; Wierda, William ; Ferrajoli, Alessandra ; Kornblau, Stephen ; Mattiuzzi, Gloria N. ; Tsimberidou, Apostolia M. ; Albitar, Maher ; O'Brien, Susan M. ; Estey, Elihu. / Adaptive randomized study of idarubicin and cytarabine alone or with interleukin-11 as induction therapy in patients aged 50 or above with acute myeloid leukemia or high-risk myelodysplastic syndromes. In: Leukemia Research. 2005 ; Vol. 29, No. 6. pp. 649-652.
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