Amifostine (A) in the prevention of xerostomia of irradiated head & neck tumors (HNT): Preliminary results of a multicentric outcome study. Year: 2003 Abstract No: 2184 Category: Outcomes Research Author(s): G. Pavanato, C. Polico, A. Ferrarese, L. Tomio, A. Bolner, M. Busetto, G. Pizzi, A. Gava, P. Zorat, L. Loreggian; RT Unit, Rovigo, Italy; Pharmacy Unit, Rovigo, Italy; RT Unit, Trento, Italy; RT Unit, Mestre, Italy; RT Unit, Treviso, Italy; RT Unit, Padova, Italy Abstract: A is a cyto-protective drug for the prevention of xerostomia in irradiated HNT. Due to the high costs of treatment an adequate monitoring of treated patients seems to be convenient in terms of surveillance on outcomes. We performed a study to document the protective clinical activity of A and to verify the safety profile and costs of treatment compared with the potential benefits. From 1/01 to 6/02 90 patients (pts) £ 70 years with HNT were registered. Pts underwent adjuvant or definitive radiotherapy(RT) with the salivary gland volumes totally or partially included in the planning. Median age was 58 years (r 20-70); m/f ratio 75/15; median KPS 100; 48/90 pts had been operated; 72% were squamous cell carcinomas. All pts received RT at 1.8-2 Gy daily with total dose 62 Gy (r 50-72);A 375 mg iv bolus was administered 15 min before each RT session. Drug tolerability was registered every day of treatment; the salivary T was registered weekly during RT (RTOG scale) and at 6,9,12 months (ms) after RT (RTOG/LENT-SOMA); mucosal T was registered in the same interval (RTOG). All pts were evaluated for radio-induced salivary T; 5 pts were lost at follow-up. Acute T was G0-G1 in 87% (74/85 pts); late T at 6 ms was G0-G1 in 75% (63/85 pts); at 9 ms was G0-G1 in 58% (37/65 pts); > 12 months was G0-G1 in 75% (48/65 pts). Mucosal T was frequent with G1-2 RTOG score in 90% . On the whole drug tolerability was substantially good. Our preliminary results do not allow to draw any significative conclusions, however it is possible to point out a clear trend for low grade salivary T both in acute and late period and they seem to support the gain in terms of reduced late side effects after RT. A administration was feasible, without substantial severe side effects. Being a greater number of patients and an adequate follow-up required, at present a cost-benefit analysis may not be performed. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.