Prospective randomised trial of amifostine cytoprotection in myeloma patients undergoing high-dose melphalan conditioned autologous stem cell transplantation.
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.
Spencer
A
A
Clinical Haematology & BMT, The Alfred Hospital, Melbourne, Australia. aspencer@netspace.net.au
Horvath
N
N
Gibson
J
J
Prince
H M
HM
Herrmann
R
R
Bashford
J
J
Joske
D
D
Grigg
A
A
McKendrick
J
J
Prosser
I
I
Lowenthal
R
R
Deveridge
S
S
Taylor
K
K
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
D004999:Amifostine; D008558:Melphalan