Phase II study of combination human recombinant GM-CSF with intermediate-dose cytarabine and mitoxantrone chemotherapy in patients with high-risk myelodysplastic syndromes (RAEB, RAEBT, and CMML): an Eastern Cooperative Oncology Group Study

Am J Hematol. 2001 Jan;66(1):23-7. doi: 10.1002/1096-8652(200101)66:1<23::AID-AJH1002>3.0.CO;2-B.

Abstract

A Phase II study of GM-CSF with intermediate-dose cytarabine and mitoxantrone was conducted in patients with high-risk myelodysplastic syndrome. It was designed to evaluate if priming with growth factor could increase the efficiency of chemotherapy. In this older population only two of 10 patients achieved a bone marrow CR, including one patient whose leukemic blasts had an "S" phase increase of 2.55x at 48 hr. Unexpected hepatotoxicity was noted. This regimen cannot be recommended for this elderly population of patients.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • Anemia, Refractory, with Excess of Blasts / drug therapy
  • Anemia, Refractory, with Excess of Blasts / mortality
  • Anemia, Refractory, with Excess of Blasts / pathology
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bone Marrow / pathology
  • Chemical and Drug Induced Liver Injury / etiology
  • Cytarabine / administration & dosage
  • Cytarabine / adverse effects
  • DNA Replication / drug effects
  • Female
  • Granulocyte-Macrophage Colony-Stimulating Factor / pharmacology
  • Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use*
  • Humans
  • Hyperbilirubinemia / chemically induced
  • Leukemia, Myelomonocytic, Chronic / drug therapy
  • Leukemia, Myelomonocytic, Chronic / mortality
  • Leukemia, Myelomonocytic, Chronic / pathology
  • Male
  • Middle Aged
  • Mitoxantrone / administration & dosage
  • Mitoxantrone / adverse effects
  • Myelodysplastic Syndromes / drug therapy*
  • Myelodysplastic Syndromes / mortality
  • Myelodysplastic Syndromes / pathology
  • Pancytopenia / chemically induced
  • Pancytopenia / drug therapy
  • Pilot Projects
  • Recombinant Proteins
  • Remission Induction
  • S Phase / drug effects
  • Treatment Failure

Substances

  • Recombinant Proteins
  • Cytarabine
  • sargramostim
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Mitoxantrone