1. ¹Clinical Haematology & BMT, The Alfred Hospital, Melbourne, Australia
2. ²Division of Haematology, Institute of Medical & Veterinary Science, Adelaide, Australia
3. ³Haematology Department, Royal Prince Alfred Hospital, Camperdown, Australia
4. ⁴Haematology Service, Peter MacCallum Cancer Centre, Melbourne, Australia
5. ⁵Department of Haematology, Royal Perth Hospital, Perth, Australia
6. ⁶Wesley Medical Centre, Auchenflower, Australia
7. ⁷Haematology Clinics, Sir Charles Gardiner Hospital, Nedlands, Australia
8. ⁸BMT Service, Royal Melbourne Hospital, Parkville, Australia
9. ⁹Department of Oncology, Box Hill Hospital, Box Hill, Australia
10. ¹⁰Haematology Department, The Canberra Hospital, Woden, Australia
11. ¹¹Clinical Haematology & Medical Oncology Unit, Royal Hobart Hospital, Hobart, Australia
12. ¹²Hunter Haematology Unit, Newcastle Mater Misericordiae Hospital, Newcastle, Australia
13. ¹³Department of Haematology, Mater Hospital, Brisbane, Australia

Correspondence: Associate Professor A Spencer, Clinical Haematology & BMT, The Alfred Hospital, Commercial Road, Melbourne, Victoria 3004, Australia. E-mail: aspencer@netspace.net.au

Received 29 June 2004; Accepted 31 December 2004; Published online 21 March 2005.

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/m² prior to melphalan 200 mg/m². 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.