title: Prospective randomised trial of amifostine cytoprotection in myeloma patients undergoing high-dose melphalan conditioned autologous stem cell transplantation.
abstract: 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.
authors.affiliation: Clinical Haematology & BMT, The Alfred Hospital, Melbourne, Australia. aspencer@netspace.net.au
authors.forename: A
authors.initials: A
authors.lastname: Spencer
authors.forename: N
authors.initials: N
authors.lastname: Horvath
authors.forename: J
authors.initials: J
authors.lastname: Gibson
authors.forename: H M
authors.initials: HM
authors.lastname: Prince
authors.forename: R
authors.initials: R
authors.lastname: Herrmann
authors.forename: J
authors.initials: J
authors.lastname: Bashford
authors.forename: D
authors.initials: D
authors.lastname: Joske
authors.forename: A
authors.initials: A
authors.lastname: Grigg
authors.forename: J
authors.initials: J
authors.lastname: McKendrick
authors.forename: I
authors.initials: I
authors.lastname: Prosser
authors.forename: R
authors.initials: R
authors.lastname: Lowenthal
authors.forename: S
authors.initials: S
authors.lastname: Deveridge
authors.forename: K
authors.initials: K
authors.lastname: Taylor
mesh_terms: D000328:Adult; D000368:Aged; D004999:Amifostine / Q000009:adverse effects / Q000627:therapeutic use*; D019610:Cytoprotection; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008297:Male; D008558:Melphalan / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009061:Mouth Mucosa; D009101:Multiple Myeloma / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D013280:Stomatitis / Q000517:prevention & control; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous
chemical_list: D004999:Amifostine; D008558:Melphalan