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document
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 .
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Intervention_Pharmacological
amifostine cytoprotection
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Intervention_Pharmacological
high-dose melphalan
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Intervention_Pharmacological
amifostine 910 mg/m ( 2 ) prior to melphalan 200 mg/m ( 2 )
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Intervention_Pharmacological
Amifostine
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Intervention_Pharmacological
Amifostine
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Intervention_Pharmacological
amifostine
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Intervention_Pharmacological
amifostine
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Outcome_Physical
regimen-related toxicity , engraftment , supportive care , response and survival .
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Outcome_Pain
reduction
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Outcome_Mental
median grade of oral mucositis
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Outcome_Pain
frequency of severe ( WHO grades 3 or 4 ) mucositis
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Outcome_Physical
post-ASCT
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Outcome_Physical
median progression-free or overall survival times
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Outcome_Physical
frequency and severity of therapy-induced oral mucositis .
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Participant_Sample-size
90
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Participant_Condition
autologous stem cell transplantation ( ASCT )