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

Table 1 Pilocarpine and Cevimeline

Author	Type of study	n	Intervention	Xerostomia symptoms	Salivary Function	Toxicity
Burlage et al[34], 2008	Double-blind, randomized, placebo-controlled trial	170	PC during RT vs placebo	LENT SOMA: no difference at 1 yr; Patient-reported xero: significantly lower scores in pilocarpine group at 12 mo only if mean parotid dose > 40 Gy	Parotid flow rate complication probability (PFCP): at 1 yr, no diff between arms (except in subset of pts with > 40 Gy mean parotid dose-reduced loss of flow in pilocarpine group)	2 patients didn't complete treatment, excessive sweating for PC and suspected AE for placebo pt; 1 G2 excessive sweating
Mateos et al[35], 2001	Prospective non-randomized study	49	PC 5 mg TID during RT and for 1 yr vs no PC	No significant difference in visual analogue scale between groups	Dynamic salivary scintigraphy: no SS differences between groups	NA
Valdez et al[36], 1993	Double-blind, randomized, placebo-controlled trial	9	PC 5 mg four times daily for 3 mo during RT vs placebo	Significantly fewer subjective oral symptoms in pilocarpine group on survey during treatment; no difference at 1 yr (25% in both arms)	Salivary flow rate (resting and stimulated): smaller losses in stim function in PC group at 3 mo (SS)	none reported
Chambers et al[37], 2007	Open-label prospective single-arm study	255	Cevimeline for 1 yr 45 mg TID orally	Used mean global eval. score (0-3), at final eval. 59.2% improved, 37.3% no change, 3.5% worse compared with first visit (P < 0.0001 change from baseline to visit 8)	NA	20.4% G3 AE, most common was sweating; 7.1% severe AE, one possibly attributed to study drug (miscarriage)

PC: Pilocarpine; G: Grade; AE: Adverse event; xero: Xerostomia; pts: Patients.