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Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV)

PURPOSE: Preventing chemotherapy-induced nausea and vomiting (CINV) is integral to treatment success in patients with cancer. This analysis was undertaken to assess the relative efficacy and safety of palonosetron versus older 5HT(3) RAs in preventing CINV associated with moderately or highly emetog...

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Autores principales: Schwartzberg, Lee, Barbour, Sally Y., Morrow, Gary R., Ballinari, Gianluca, Thorn, Michael D., Cox, David
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3889920/
https://www.ncbi.nlm.nih.gov/pubmed/24141698
http://dx.doi.org/10.1007/s00520-013-1999-9
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author Schwartzberg, Lee
Barbour, Sally Y.
Morrow, Gary R.
Ballinari, Gianluca
Thorn, Michael D.
Cox, David
author_facet Schwartzberg, Lee
Barbour, Sally Y.
Morrow, Gary R.
Ballinari, Gianluca
Thorn, Michael D.
Cox, David
author_sort Schwartzberg, Lee
collection PubMed
description PURPOSE: Preventing chemotherapy-induced nausea and vomiting (CINV) is integral to treatment success in patients with cancer. This analysis was undertaken to assess the relative efficacy and safety of palonosetron versus older 5HT(3) RAs in preventing CINV associated with moderately or highly emetogenic chemotherapy. METHODS: Patient-level data from four randomized, double-blind, phase III trials comparing palonosetron 0.25 or 0.75 mg with ondansetron 32 mg, dolasetron 100 mg, or granisetron 40 μg/kg were analyzed. Endpoints included complete response (CR: no emesis and no rescue antiemetics) in the acute (0–24 h), delayed (>24–120 h), and overall (0–120 h) postchemotherapy periods (primary), complete control (CC: no emesis, no rescue antiemetics, and no more than mild nausea), number of emetic episodes, and nausea severity. RESULTS: CR rates were significantly higher for palonosetron (n = 1,787) versus older 5HT(3) RAs (n = 1,175) in the delayed (57 vs 45 %, P < 0.0001) and overall periods (51 vs 40 %, P < 0.0001); odds ratios (95 % CI) in the acute, delayed, and overall periods were 1.15 (0.98–1.34), 1.62 (1.40–1.88), and 1.56 (1.34–1.81), respectively. Significant differences in CC rates and nausea severity were observed for the delayed and overall periods and in emetic episodes for all three periods. The incidence of treatment-related adverse events was similar with palonosetron (0.25 mg, 20.0 %; 0.75 mg, 26.5 %) and older 5HT(3) RAs (27.5 %). CONCLUSIONS: Palonosetron is more effective than older 5HT(3) RAs for controlling CINV in the delayed and overall postchemotherapy periods.
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spelling pubmed-38899202014-01-28 Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) Schwartzberg, Lee Barbour, Sally Y. Morrow, Gary R. Ballinari, Gianluca Thorn, Michael D. Cox, David Support Care Cancer Original Article PURPOSE: Preventing chemotherapy-induced nausea and vomiting (CINV) is integral to treatment success in patients with cancer. This analysis was undertaken to assess the relative efficacy and safety of palonosetron versus older 5HT(3) RAs in preventing CINV associated with moderately or highly emetogenic chemotherapy. METHODS: Patient-level data from four randomized, double-blind, phase III trials comparing palonosetron 0.25 or 0.75 mg with ondansetron 32 mg, dolasetron 100 mg, or granisetron 40 μg/kg were analyzed. Endpoints included complete response (CR: no emesis and no rescue antiemetics) in the acute (0–24 h), delayed (>24–120 h), and overall (0–120 h) postchemotherapy periods (primary), complete control (CC: no emesis, no rescue antiemetics, and no more than mild nausea), number of emetic episodes, and nausea severity. RESULTS: CR rates were significantly higher for palonosetron (n = 1,787) versus older 5HT(3) RAs (n = 1,175) in the delayed (57 vs 45 %, P < 0.0001) and overall periods (51 vs 40 %, P < 0.0001); odds ratios (95 % CI) in the acute, delayed, and overall periods were 1.15 (0.98–1.34), 1.62 (1.40–1.88), and 1.56 (1.34–1.81), respectively. Significant differences in CC rates and nausea severity were observed for the delayed and overall periods and in emetic episodes for all three periods. The incidence of treatment-related adverse events was similar with palonosetron (0.25 mg, 20.0 %; 0.75 mg, 26.5 %) and older 5HT(3) RAs (27.5 %). CONCLUSIONS: Palonosetron is more effective than older 5HT(3) RAs for controlling CINV in the delayed and overall postchemotherapy periods. Springer Berlin Heidelberg 2013-10-19 2014 /pmc/articles/PMC3889920/ /pubmed/24141698 http://dx.doi.org/10.1007/s00520-013-1999-9 Text en © The Author(s) 2013 https://creativecommons.org/licenses/by-nc/2.0/ Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Article
Schwartzberg, Lee
Barbour, Sally Y.
Morrow, Gary R.
Ballinari, Gianluca
Thorn, Michael D.
Cox, David
Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV)
title Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV)
title_full Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV)
title_fullStr Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV)
title_full_unstemmed Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV)
title_short Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV)
title_sort pooled analysis of phase iii clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (cinv)
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3889920/
https://www.ncbi.nlm.nih.gov/pubmed/24141698
http://dx.doi.org/10.1007/s00520-013-1999-9
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