Hwang, W.Y., Koh, L.P., Ng, H.J., Tan, P.H., Chuah, C.T., Fook, S.C., … Goh, Y.-T. (2004). A randomized trial of amifostine as a cytoprotectant for patients receiving myeloablative therapy for allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplantation, 34, 51–56.

Patients were given 1,000 mg/day IV amifostine (740 mg/m²) once a day or divided (depending on frequency of chemotherapy or total body irradiation [TBI]), rounded to nearest 500 mg, and given over 15 minutes prior to chemotherapy or TBI. 

• The study reported on 60 patients (30 in the amifostine group and 30 in the control group).
• Median age was 28 years in the amifostine group and 30 years in the control group. Ages ranged from 15–47 years old.
• Patients were receiving allogeneic hematopoietic stem cell transplant (HSCT).
• Treatment regimens were busulfan and cyclophosphamide, cyclophosphamide and TBI, or etoposide.

This was a single-institution, randomized, open-label trial conducted between August 1998 and October 2003.

The World Health Organization (WHO) Mucositis grading scale was used daily during the study, followed by the Common Toxicity Criteria in Cancer Therapy Evaluation Program (CTEP).

• No significant differences were found between the groups in grades of mucositis; however, duration of all grades of mucositis was significantly reduced in the amifostine group. Patients in the amifostine group experienced a shorter overall duration (16 days versus 21 days, p < 0.02). They also had a shorter duration of grade 3 or 4 mucositis (0 days versus 5 days), but this difference was not significant (p = 0.3).
• Patients who received amifostine had lower incidence of grade 3 or 4 mucositis (41% versus 63%), but this difference was not significant (p = 0.44).
• Side effects included nausea and vomiting, hypotension, and hypocalcemia.

• The exact dosing of amifostine was difficult to determine when divided doses were given.
• Only used sibling allogeneic transplants.