Post-radiation severe xerostomia relieved by pilocarpine: a prospective French cooperative study

• Published in: Radiotherapy and oncology 2000-06, Vol.55 (3), p.233-239
• Main Authors: Horiot (Dijon), Jean-Claude, Lipinski (Bayonne), François, Schraub (Besançon), Simon, Maulard-Durdux (Paris St Louis), Catherine, Bensadoun (Nice), René Jean, Ardiet (Lyon-Sud), Jean Michel, Bolla (Grenoble), Michel, Coscas (Boulogne), Yvan, Baillet (Paris Pitié-Salpétrière), François, Coche-Dequéant (Lille), Bernard, Urbajtel (Argenteuil), Michel, Montbarbon (Lyon Léon Bérard), Xavier, Bourdin (Nantes), Sylvain, Wibault (Villejuif), Pierre, Alfonsi (Avignon), Marc, Calais (Tours), Gilles, Desprez (Vannes), Patrick, Pene (Paris Tenon), Françoise, Lapeyre (Nancy), Michel, Vinke, Jens, Maral (Chiron B.V. The Netherlands), Jean
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Aged; Aged, 80 and over; Female; Head and Neck Neoplasms - radiotherapy; Humans; Male; Middle Aged; Muscarinic Agonists - administration & dosage; Muscarinic Agonists - therapeutic use; Pilocarpine; Pilocarpine - administration & dosage; Pilocarpine - therapeutic use; Prospective Studies; Quality of Life; Radiation Injuries - drug therapy; Radiation Injuries - etiology; Radiotherapy - adverse effects; Saliva - metabolism; Salivary flow measurement; Salivary glands; Salivary Glands - drug effects; Salivary Glands - metabolism; Salivary Glands - radiation effects; Severity of Illness Index; Xerostomia; Xerostomia - drug therapy; Xerostomia - etiology
• ISSN: 0167-8140; 1879-0887
• DOI: 10.1016/S0167-8140(99)00018-3

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, 15 mg per day with a 5 mg optional increase at 5 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 seven patients (67%) reported a significant relief of symptoms of xerostomia at 12 weeks. Within 12 weeks, the size of the subgroup with 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.