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

Identifieur interne : 005632 ( Istex/Corpus ); précédent : 005631; suivant : 005633

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

Auteurs : Jean-Claude Horiot Dijon ; François Lipinski Bayonne ; Simon Schraub Besançon ; Catherine Maulard-Durdux Paris St Louis ; René Jean Bensadoun Nice ; Jean Michel Ardiet Lyon-Sud ; Michel Bolla Grenoble ; Yvan Coscas Boulogne ; François Baillet Paris Pitié-Salpétrière ; Bernard Coche-Dequéant Lille ; Michel Urbajtel Argenteuil ; Xavier Montbarbon Lyon Léon Bérard ; Sylvain Bourdin Nantes ; Pierre Wibault Villejuif ; Marc Alfonsi Avignon ; Gilles Calais Tours ; Patrick Desprez Vannes ; Françoise Pene Paris Tenon ; Michel Lapeyre Nancy ; Jens Vinke ; Jean Maral Chiron B. V. The Netherlands

Source :

RBID : ISTEX:AD3035EEAD6D57D9DDEC2F69CF6F853F090BB88E

English descriptors

Abstract

Abstract: 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.

Url:
DOI: 10.1016/S0167-8140(99)00018-3

Links to Exploration step

ISTEX:AD3035EEAD6D57D9DDEC2F69CF6F853F090BB88E

Le document en format XML

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<name sortKey="Desprez Vannes, Patrick" sort="Desprez Vannes, Patrick" uniqKey="Desprez Vannes P" first="Patrick" last="Desprez Vannes">Patrick Desprez Vannes</name>
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<name sortKey="Pene Paris Tenon, Francoise" sort="Pene Paris Tenon, Francoise" uniqKey="Pene Paris Tenon F" first="Françoise" last="Pene Paris Tenon">Françoise Pene Paris Tenon</name>
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<name sortKey="Maral Chiron B V The Netherlands, Jean" sort="Maral Chiron B V The Netherlands, Jean" uniqKey="Maral Chiron B V The Netherlands J" first="Jean" last="Maral Chiron B. V. The Netherlands">Jean Maral Chiron B. V. The Netherlands</name>
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<term>Action mechanism</term>
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<div type="abstract" xml:lang="en">Abstract: 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.</div>
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<name>Simon Schraub (Besançon)</name>
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<name>Catherine Maulard-Durdux (Paris St Louis)</name>
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<name>René Jean Bensadoun (Nice)</name>
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<name>Jean Michel Ardiet (Lyon-Sud)</name>
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<name>Yvan Coscas (Boulogne)</name>
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<name>Bernard Coche-Dequéant (Lille)</name>
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<abstract>Abstract: 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.</abstract>
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<note type="content">Fig. 1: Evaluation of solid food ingestion: all patients at baseline and week 12 (n = 145).</note>
<note type="content">Fig. 2: Evaluation of psychological impact of xerostomia: all patients at baseline and week 12 (n = 145).</note>
<note type="content">Table 1: From June 1995 to December 1995: 156 eligible patients from 19 participating centres</note>
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<note type="content">Table 3: Side effects (n=156, all who started treatment)a,b,c</note>
<note type="content">Table 4: Summary of primary reasons for study termination at week 12</note>
<note type="content">Table 5: Improvement of xerostomia status per radiation group at week 12 (n=145)</note>
<note type="content">Table 6: Evolution of xerostomia status from week 12 to week 24</note>
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<ce:text>Corresponding author. Radiation Therapy Department, Centre Georges-François Leclerc, B.P. 1544, 21034 Dijon Cedex, France</ce:text>
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<namePart type="given">Jean</namePart>
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<abstract lang="en">Abstract: 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.</abstract>
<note type="content">Fig. 1: Evaluation of solid food ingestion: all patients at baseline and week 12 (n = 145).</note>
<note type="content">Fig. 2: Evaluation of psychological impact of xerostomia: all patients at baseline and week 12 (n = 145).</note>
<note type="content">Table 1: From June 1995 to December 1995: 156 eligible patients from 19 participating centres</note>
<note type="content">Table 2: Baseline characteristics (n=156)</note>
<note type="content">Table 3: Side effects (n=156, all who started treatment)a,b,c</note>
<note type="content">Table 4: Summary of primary reasons for study termination at week 12</note>
<note type="content">Table 5: Improvement of xerostomia status per radiation group at week 12 (n=145)</note>
<note type="content">Table 6: Evolution of xerostomia status from week 12 to week 24</note>
<note type="content">Table 7: Improvement of xerostomia status per radiation subgroup at week 12</note>
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<genre>Keywords</genre>
<topic>Xerostomia</topic>
<topic>Salivary glands</topic>
<topic>Salivary flow measurement</topic>
<topic>Pilocarpine</topic>
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<dateIssued encoding="w3cdtf">20000601</dateIssued>
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<identifier type="ISSN">0167-8140</identifier>
<identifier type="PII">S0167-8140(00)X0065-5</identifier>
<part>
<date>20000601</date>
<detail type="volume">
<number>55</number>
<caption>vol.</caption>
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<detail type="issue">
<number>3</number>
<caption>no.</caption>
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<extent unit="issue-pages">
<start>203</start>
<end>333</end>
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<identifier type="DOI">10.1016/S0167-8140(99)00018-3</identifier>
<identifier type="PII">S0167-8140(99)00018-3</identifier>
<accessCondition type="use and reproduction" contentType="copyright">©2000 Elsevier Science Ireland Ltd</accessCondition>
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