Copyright ©The Author(s) 2019.
World J Clin Oncol. Jan 10, 2019; 10(1): 1-13
Published online Jan 10, 2019. doi: 10.5306/wjco.v10.i1.1
Table 2 Amifostine: Xerostomia
AuthorType of studynInterventionXerostomia symptomsEffect Size
Bardet et al[46], 2011Phase III randomized trial291Amifostine IV vs SCRTOG grading: G2+ xero significantly higher in SC at 1 yr, but not at 2-3 yr37% IV vs 62% SC
Haddad et al[45], 2009Phase II randomized trial58SC amifostine 500 mg daily (for median 28 doses) no amifostineCTCAE: no significant difference in Gr2+ xero (minimum follow up 26 mo)41% both arms
Law et al[44], 2007Phase II prospective nonrandomized trial20SC 500 mg amifostine 30-60 min before RTG2 xero 42% at 12 mo, 29% at 18 mo; no G3+ xero. G3+ mucositis in 30% of pts.
Anné et al[43], 2007Phase II single arm multicenter trial54SC amifostineRTOG scoring: G2+ xero = 56%; late G2+ in 45% ; G3+ acute 33%
Jellema et al[23], 2006Phase II randomized trial91No amifostine vs 200 mg/m2 IV daily (3 wk) vs 5 wkRTOG scoring: significant difference in late G2+ xero at 6 mo between arms; no difference in xero at 12 mo or 24 mo; no dif in acute xeroLate G2+ xero 74% vs 67% vs 52%
EORTC QLQ-H and N35: significantly higher mean xerostomia score in no amifostine group
Buentzel et al[41], 2006Phase III randomized placebo-controlled trial132IV amifostine 300 mg/m2 days 1-5 and 21-25, 200 mg/m2 on other days vs placeboRTOG criteria: no significant difference in G2+ acute or late xero39% amifostine vs 34% placebo (acute); 39% amifostine vs 24% placebo (late)
Wasserman et al[42], 2005Phase III randomized trial303IV amifostine 200 mg/m2 15-30 prior to each RT fraction vs no amifostineRTOG scoring: significantly lower G2+ xero in amifostine group on longitudinal analysis20% vs 36% at 24 mo
Thorstad et al[47], 2004Pilot clinical trial27Amifostine concurrent with RT (500 mg SC daily)not reportedNA
Antonadou et al[40], 2002Randomized controlled trial50Amifostine 300 mg/m2 15-30 min prior to RT (daily) vs no amifostineRTOG/EORTC scoring: significantly lower xero in amifostine group at 18 mo (G1+)30.4% vs 4.5%
Brizel et al[39], 2000Phase III multiinstitutional randomized trial303Amifostine 200 mg/m2 15-30 min prior to each RT tx vs no amifostineRTOG scoring: significantly higher G2+ xero (acute and late) in control vs amifostine; higher dose required to cause G2 xero in amifostine pts (60 Gy vs 42 Gy);78% vs 51% (acute); 57% 43% (1 yr)
Büntzel et al[38], 1998Phase II randomized trial39Amifostine IV 500mg prior to carboplatin (days 1-5 and 21-25) vs no amifostineAcute G2 xero, G3 mucositis, and G3 thrombocytopenia all significantly decreased with amifostine; at 12 mo, trend toward xero improvement with amifostineXero: G2 100% vs 12% (acute); 55% vs 17% (late; P = 0.05)