A randomized trial of amifostine as a cytoprotectant for patients receiving myeloablative therapy for allogeneic hematopoietic stem cell transplantation

Bone Marrow Transplant. 2004 Jul;34(1):51-6. doi: 10.1038/sj.bmt.1704521.

Abstract

We initiated a randomized study of amifostine (the organic thiophosphate formerly known as WR-2721) given to patients during myeloablative conditioning therapy for allogeneic bone marrow transplantation. Amifostine was given at a dose of 1000 mg/day of conditioning and was well tolerated if attention was given to serum calcium levels, blood pressure and antiemetics. Since August 1998, 60 patients (30 on each arm) have completed the study. There was no significant difference in the days to neutrophil or platelet engraftment in either arm of the study. Significantly, the duration of grade I-IV mucositis was decreased in the group that received amifostine (P=0.02). Also grade III or IV infections (P=0.008), duration of antibiotic therapy (P=0.03) and duration of fever (P=0.04) were significantly reduced with amifostine. However, there were no differences in the incidence of grade III or IV mucositis, liver toxicity or renal toxicity. There were also no differences in early mortality, relapse and long-term survival. We conclude that amifostine, while reducing the duration of mucositis and infections (possibly through some preservation of gut mucosal integrity), has a modest effect in allogeneic bone marrow transplants given the multiplicity of factors influencing organ toxicity and survival in this setting.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Amifostine / administration & dosage*
  • Amifostine / toxicity
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Female
  • Graft Survival
  • Hematologic Neoplasms / complications
  • Hematologic Neoplasms / mortality
  • Hematologic Neoplasms / therapy
  • Hematopoietic Stem Cell Transplantation / adverse effects
  • Hematopoietic Stem Cell Transplantation / methods*
  • Hematopoietic Stem Cell Transplantation / mortality
  • Humans
  • Infections / etiology
  • Kidney Diseases / etiology
  • Kidney Diseases / prevention & control
  • Liver Diseases / etiology
  • Liver Diseases / prevention & control
  • Male
  • Middle Aged
  • Mouth Mucosa
  • Myeloablative Agonists / administration & dosage
  • Myeloablative Agonists / adverse effects*
  • Protective Agents / administration & dosage
  • Protective Agents / toxicity
  • Stomatitis / etiology
  • Stomatitis / prevention & control
  • Transplantation, Homologous
  • Whole-Body Irradiation / adverse effects

Substances

  • Myeloablative Agonists
  • Protective Agents
  • Amifostine