Long-term outcomes of interventions for radiation-induced xerostomia: A review

Table 3 Amifostine: Salivary function, quality of life, toxicity

Author	Salivary Production	QOL	Toxicity
Bardet et al[46], 2011	No difference in unstimulated and stimulated salivary flow rate =	No difference in patient-reported salivary function or Gr 2+ xero	No difference in compliance between arms (69% IV vs 71% SC). Acute toxicity 25% IV vs 27% SC (NS). SS higher rate of hypotension in IV arm; significantly higher skin rash and local pain in SC arm.
Haddad et al[45], 2009	No difference in unstimulated or stimulated saliva at all endpoints (up to 1 yr)	No difference in penetration, aspiration, and pharyngeal residue on swallow eval.	G3 mucositis in 75% (amifostine) and 70% (no amifostine); Gr3 skin toxicity in 12 patients in amifostine group (main reason for withholding amifostine)
Law et al[44], 2007	NA	NA	G2 weight loss for all pts, Gr2 or less N/V in 7 pts (35%). No grade 3+ amifostine-related AEs.
Anné et al[43], 2007	NA	PBQ: mean score 8.5 baseline, 6.1 at 4 wk, 7.5 at 1 yr	Nausea, emesis, injection site reaction most common G1-2; G3 dehydration 11%, rash 6%, weight decrease, mucositis, dyspnea, allergic reaction 4% each; one G4 anaphylaxis
Jellema et al[23], 2006	NA	QLQ-C30, QLQ-H and N35: no differences in sticky saliva or other QOL data	Significantly higher N/V in amifostine groups; 28% of patients discontinued amifostine early
Buentzel et al[41], 2006	not assessed: fewer than one-third in each arm had salivary assessment at 1 yr	NA	42% G3+ toxicity (amifostine) vs 20% (placebo) (SS)
Wasserman et al[42], 2005	no dif. in stimulated; unstimulated higher in amifosine group at 12 mo (SS)	PBQ: amifostine group had SS better mouth dryness at 12, 18, and 24 mo; better score for "use of oral comfort aids" with amifostine at 24 mo	not enough to analyze
Thorstad et al[47], 2004	not reported	not reported	reasons for discontinuing amifostine: nausea (33%), rash (15%), fever (7%), other (11%)
Antonadou et al[40], 2002	NA	NA	SS lower acute mucositis and acute dysphagia in amifostine group; in amifostine group, 1 pt had N/V, 3 pts had transient hypotension
Brizel et al[39], 2000	Whole saliva production higher in amifostine pts at 1 yr (SS)	PBQ: overall score favored amifostine at 1 yr (SS)	53% nausea and vomiting (5% of total administrations; 3% G3 N, 5% G3 V)); G3 N/V in 7% of pts; median weight loss higher in control group (SS); hypotension 15% (3% G3; < 1% of all doses); venous catheter complications 5%; infections 14%; clotting/vascular 3% (1 pt G4); allergic reaction 5%
Büntzel et al[38], 1998	NA	NA	No significant difference in N/V between groups; hypotension 40% amifostine arm (max drop 20 mmHg)

QOL: Quality of life; SC: Subcutaneous; G: Grade; AE: Adverse event; xero: Xerostomia; NA: Not available; PBQ: Patient benefit questionnaire; pts: Patients.