Outcome of local application of amifostine (WR-1065) on epirubicin-induced oral mucositis. A phase II study.
BACKGROUND
Intravenous administration of amifostine reduces chemotherapy-induced toxicity. Preclinical experiments showed a reduction in radiation-induced mucositis after local application of the active metabolite of amifostine (WR-1065). This study evaluated the effect of local application of WR-1065 on chemotherapy-induced oral mucositis.


METHODS
Non-small cell lung cancer patients treated with gemcitabine and epirubicin every 3 weeks for a maximum of five cycles were included. WR-1065 was administered during the second and third cycle as an oral rinse. Oral mucositis evaluation included WHO toxicity grading, a validated oral mucositis assessment scale (OMAS) and a questionnaire.


RESULTS
Twenty-four patients were evaluated for at least one control and one rinse cycle. Mucositis scores, pain and feeding difficulties increased from day 1 to day 15, and were not significantly different between the control and rinse cycles. Local application of WR-1065 leads to detectable quantities of WR-1065 in epithelial mucosa cells. A negative correlation between the WR-1065 concentration and OMAS score was found.


CONCLUSIONS
No clinical detectable influence of WR-1065 on oral mucositis was found.
Stokman
M A
MA
Department of Oral and Maxillofacial Surgery, University Hospital Groningen, The Netherlands. m.a.stokman@kchir.azg.nl
Wachters
F M
FM
Koopmans
P
P
Burgerhof
J G M
JG
Groen
H J M
HJ
Spijkervet
F K L
FK
Uges
D R A
DR
Hospers
G A P
GA
D000368:Aged; D004999:Amifostine / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015251:Epirubicin / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects* / Q000473:pathology; D010146:Pain / Q000209:etiology; D013280:Stomatitis / Q000139:chemically induced / Q000517:prevention & control*; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D015251:Epirubicin; D004999:Amifostine; D000093542:Gemcitabine