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Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy

This randomized, double-blind, double-dummy parallel study compared the anti-emetic efficacy and tolerability of the serotonin antagonist granisetron with prednisolone plus the dopamine D(2) antagonist metopimazine during nine cycles of moderately emetogenic chemotherapy. Chemotherapy naive women wi...

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Autores principales: Sigsgaard, T, Herrstedt, J, Andersen, L J, Havsteen, H, Langer, S W, Kjærbøl, A-G, Lund, H, Kjær, M, Dombernowsky, P
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 1999
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362348/
https://www.ncbi.nlm.nih.gov/pubmed/10408847
http://dx.doi.org/10.1038/sj.bjc.6690372
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author Sigsgaard, T
Herrstedt, J
Andersen, L J
Havsteen, H
Langer, S W
Kjærbøl, A-G
Lund, H
Kjær, M
Dombernowsky, P
author_facet Sigsgaard, T
Herrstedt, J
Andersen, L J
Havsteen, H
Langer, S W
Kjærbøl, A-G
Lund, H
Kjær, M
Dombernowsky, P
author_sort Sigsgaard, T
collection PubMed
description This randomized, double-blind, double-dummy parallel study compared the anti-emetic efficacy and tolerability of the serotonin antagonist granisetron with prednisolone plus the dopamine D(2) antagonist metopimazine during nine cycles of moderately emetogenic chemotherapy. Chemotherapy naive women with stage I or II breast cancer scheduled to intravenous cyclophosphamide, fluorouracil and methotrexate or cyclophosphamide, epirubicin and fluorouracil every 3 weeks were included. Patients received a single intravenous dose of granisetron 3 mg or a 3-day oral treatment with prednisolone 25 mg once a day plus metopimazine 30 mg four times a day. A total of 223 women were enrolled and 218 patients (97.8%) were evaluable for efficacy. Granisetron (n = 109) was superior to prednisolone plus metopimazine (n = 109) in the prophylaxis of acute nausea and vomiting during the first cycle of chemotherapy (P < 0.001) and prednisolone plus metopimazine was superior on days 2–5 (P = 0.002). Overall, granisetron was superior on days 1–5 (P = 0.009). The median number of cycles completed with granisetron was five (95% confidence interval 4–6) compared with two (95% confidence interval 2–2) for prednisolone plus metopimazine (P = 0.0019). Constipation and rash were reported more frequently with granisetron (P < 0.001 and P = 0.043 respectively) and palpitations more frequently with prednisolone plus metopimazine (P = 0.015). In conclusion, the number of cycles completed with granisetron was significantly higher than the number completed with prednisolone plus metopimazine, but the anti-emetic efficacy of both treatments declined during multiple cycles of moderately emetogenic chemotherapy. © 1999 Cancer Research Campaign
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spelling pubmed-23623482009-09-10 Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy Sigsgaard, T Herrstedt, J Andersen, L J Havsteen, H Langer, S W Kjærbøl, A-G Lund, H Kjær, M Dombernowsky, P Br J Cancer Regular Article This randomized, double-blind, double-dummy parallel study compared the anti-emetic efficacy and tolerability of the serotonin antagonist granisetron with prednisolone plus the dopamine D(2) antagonist metopimazine during nine cycles of moderately emetogenic chemotherapy. Chemotherapy naive women with stage I or II breast cancer scheduled to intravenous cyclophosphamide, fluorouracil and methotrexate or cyclophosphamide, epirubicin and fluorouracil every 3 weeks were included. Patients received a single intravenous dose of granisetron 3 mg or a 3-day oral treatment with prednisolone 25 mg once a day plus metopimazine 30 mg four times a day. A total of 223 women were enrolled and 218 patients (97.8%) were evaluable for efficacy. Granisetron (n = 109) was superior to prednisolone plus metopimazine (n = 109) in the prophylaxis of acute nausea and vomiting during the first cycle of chemotherapy (P < 0.001) and prednisolone plus metopimazine was superior on days 2–5 (P = 0.002). Overall, granisetron was superior on days 1–5 (P = 0.009). The median number of cycles completed with granisetron was five (95% confidence interval 4–6) compared with two (95% confidence interval 2–2) for prednisolone plus metopimazine (P = 0.0019). Constipation and rash were reported more frequently with granisetron (P < 0.001 and P = 0.043 respectively) and palpitations more frequently with prednisolone plus metopimazine (P = 0.015). In conclusion, the number of cycles completed with granisetron was significantly higher than the number completed with prednisolone plus metopimazine, but the anti-emetic efficacy of both treatments declined during multiple cycles of moderately emetogenic chemotherapy. © 1999 Cancer Research Campaign Nature Publishing Group 1999-05 1999-05-01 /pmc/articles/PMC2362348/ /pubmed/10408847 http://dx.doi.org/10.1038/sj.bjc.6690372 Text en Copyright © 1999 Cancer Research Campaign https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.
spellingShingle Regular Article
Sigsgaard, T
Herrstedt, J
Andersen, L J
Havsteen, H
Langer, S W
Kjærbøl, A-G
Lund, H
Kjær, M
Dombernowsky, P
Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy
title Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy
title_full Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy
title_fullStr Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy
title_full_unstemmed Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy
title_short Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy
title_sort granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy
topic Regular Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362348/
https://www.ncbi.nlm.nih.gov/pubmed/10408847
http://dx.doi.org/10.1038/sj.bjc.6690372
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