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

17 Scopus citations

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

Keywords

  • Acute myeloid leukemia
  • Interleukin-11
  • Myelodysplastic syndrome

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.

  • Cite this

    Giles, F. J., Kantarjian, H. M., Cortes, J. E., Faderl, S., Verstovsek, S., Thomas, D., Garcia-Manero, G., Wierda, W., Ferrajoli, A., Kornblau, S., Mattiuzzi, G. N., Tsimberidou, A. M., Albitar, M., O'Brien, S. M., & 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, 29(6), 649-652. https://doi.org/10.1016/j.leukres.2004.11.013