Prospective randomised trial of amifostine cytoprotection in myeloma patients undergoing high-dose melphalan conditioned autologous stem cell transplantation.

Author(s): Spencer A, Horvath N, Gibson J, Prince HM, Herrmann R, Bashford J, Joske D, Grigg A, McKendrick J, Prosser I, Lowenthal R, Deveridge S, Taylor K, Australasian Leukemia and Lymphoma Group

Affiliation(s): Clinical Haematology & BMT, The Alfred Hospital, Melbourne, Australia. aspencer@netspace.net.au

Publication date & source: 2005-05, Bone Marrow Transplant., 35(10):971-7.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

In this prospective multicentre trial, 90 patients undergoing autologous stem cell transplantation (ASCT) were randomised to receive (n=43) or not receive (n=47) amifostine 910 mg/m(2) prior to melphalan 200 mg/m(2). Patients were monitored for regimen-related toxicity, engraftment, supportive care, response and survival. Both groups underwent ASCT at a median of 8 months from diagnosis and were matched for disease characteristics, prior therapy and pre-ASCT disease responsiveness. Amifostine infusional side-effects were frequent, occurring in 65% of patients, but of mild severity. Amifostine use was associated with a reduction in the median grade of oral mucositis (1 vs 2, P=0.01) and the frequency of severe (WHO grades 3 or 4) mucositis (12 vs 33%, P=0.02), but no reduction in the requirement for parenteral nutrition or analgesic use. Conversion to complete remission post-ASCT occurred in 30 and 14% of the amifostine and control groups, respectively (P=0.09). With a median follow-up of 35 months, there was no statistically significant difference between the median progression-free or overall survival times for the two groups. We conclude that amifostine can be safely administered prior to high-dose melphalan and significantly reduces the frequency and severity of therapy-induced oral mucositis.