Post-radiation severe xerostomia relieved by pilocarpine: a prospective French cooperative study.
Author(s): Horiot JC, Lipinski F, Schraub S, Maulard-Durdux C, Bensadoun RJ, Ardiet JM, Bolla M, Coscas Y, Baillet F, Coche-Dequeant B, Urbajtel M, Montbarbon X, Bourdin S, Wibault M, Alfonsi M, Calais G, Desprez P, Pene F, Lapeyre M, Vinke J, Maral J
Affiliation(s): Radiation Therapy Department, Centre Georges-Francois Leclerc, Dijon, France.
Publication date & source: 2000-06, Radiother Oncol., 55(3):233-9.
Publication type: Clinical Trial; Randomized Controlled Trial
BACKGROUND AND PURPOSE: The aim of the study was: (1) to confirm the action of pilocarpine hydrochloride (Salagen) against xerostomia: (2) to correlate the response to dose/volume radiotherapy parameters. MATERIALS AND METHODS: From June 1995 to February 1996, 156 patients with severe radiation induced xerostomia received pilocarpine hydrochloride orally. IS mg per day with a 5 mg optional increase at S weeks up to a daily dose of 25 mg beyond 9 weeks. RESULTS: One hundred and forty five patients are fully evaluable. Treatment compliance was 75%. Thirty eight patients (26%) stopped treatment before week 12 for acute intolerance (sweating, nausea, vomiting) or no response. No severe complication occurred. Ninety ses en patients (67%) reported a significant relief of symptoms of xerostomia at 12 weeks. Within 12 weeks, the size of the subgroup ith normal food intake almost doubled (13-24 patients) while the size of the subgroup with (nearly) impossible solid food ingestion decreased by 38% (47 vs. 29 patients). The impact on quality of life was considered important or very important by 77% of the responders. CONCLUSIONS: No difference was found according to dose/volume radiotherapy parameters suggesting that oral pilocarpine hydrochloride: (1) acts primarily by stimulating minor salivary glands: (2) can be of benefit to patients suffering of severe xerostomia regardless of radiotherapy dose/volume parameters: (3) all responders are identified at 12 weeks.
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