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Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy
PURPOSE: Dexamethasone, plus a 5-HT3 receptor antagonist and an NK-1 receptor antagonist are recommended for controlling the chemotherapy-induced nausea and vomiting (CINV) of highly emetogenic chemotherapy. Several days of dexamethasone are effective for CINV; however, dexamethasone also has side e...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4729792/ https://www.ncbi.nlm.nih.gov/pubmed/26349772 http://dx.doi.org/10.1007/s00520-015-2905-4 |
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author | Kosaka, Yoshimasa Tanino, Hirokazu Sengoku, Norihiko Minatani, Naoko Kikuchi, Mariko Nishimiya, Hiroshi Waraya, Mina Katoh, Hiroshi Enomoto, Takumo Sato, Takeo Kuranami, Masaru Watanabe, Masahiko |
author_facet | Kosaka, Yoshimasa Tanino, Hirokazu Sengoku, Norihiko Minatani, Naoko Kikuchi, Mariko Nishimiya, Hiroshi Waraya, Mina Katoh, Hiroshi Enomoto, Takumo Sato, Takeo Kuranami, Masaru Watanabe, Masahiko |
author_sort | Kosaka, Yoshimasa |
collection | PubMed |
description | PURPOSE: Dexamethasone, plus a 5-HT3 receptor antagonist and an NK-1 receptor antagonist are recommended for controlling the chemotherapy-induced nausea and vomiting (CINV) of highly emetogenic chemotherapy. Several days of dexamethasone are effective for CINV; however, dexamethasone also has side effects. The purpose of this trial was to investigate whether the use of a second-generation 5-HT3 receptor antagonist and an NK-1 receptor antagonist could allow a reduced dose of dexamethasone for breast cancer patients receiving highly emetogenic chemotherapy. METHODS: Eighty breast cancer patients who received an anthracycline-cyclophosphamide combination regimen were enrolled. The patients were randomized to arm A (dexamethasone days 1–3) and arm B (dexamethasone day 1). The primary endpoint was complete response (CR) (no emetic episodes and no rescue medication) during the overall phase (days 1–5). The secondary endpoints were the CR during the delayed phase (days 2–5), complete control (CC) (no emetic episodes, no rescue medication, and no more than mild nausea) during the overall phase, and the safety of this antiemetic therapy. RESULTS: There were no significant differences in the rates of CR and CC between arm A and B as follows: CR overall phase—arm A: 82.9 %, 90 % confidence interval [CI] 71.3–90.5 % vs arm B: 82.1 %, 90 % CI 70.0–90.0 %; p = 1.00; CR delayed phase—arm A: 87.8 %, 90 % CI 77.0–93.9 % vs arm B: 94.9 %, 90 % CI 85.6–98.3 %; p = 0.43; CC overall phase—arm A: 48.8 %, 90 % CI 36.4–61.3 % vs arm B: 61.5 %, 90 % CI 48.4–73.2 %; p = 0.27. There were very few adverse events and no severe adverse events associated with this antiemetic therapy. CONCLUSIONS: The results suggest that the antiemetic effect provided by dexamethasone administered for 3 days can be obtained by dexamethasone administered for 1 day. |
format | Online Article Text |
id | pubmed-4729792 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-47297922016-02-04 Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy Kosaka, Yoshimasa Tanino, Hirokazu Sengoku, Norihiko Minatani, Naoko Kikuchi, Mariko Nishimiya, Hiroshi Waraya, Mina Katoh, Hiroshi Enomoto, Takumo Sato, Takeo Kuranami, Masaru Watanabe, Masahiko Support Care Cancer Original Article PURPOSE: Dexamethasone, plus a 5-HT3 receptor antagonist and an NK-1 receptor antagonist are recommended for controlling the chemotherapy-induced nausea and vomiting (CINV) of highly emetogenic chemotherapy. Several days of dexamethasone are effective for CINV; however, dexamethasone also has side effects. The purpose of this trial was to investigate whether the use of a second-generation 5-HT3 receptor antagonist and an NK-1 receptor antagonist could allow a reduced dose of dexamethasone for breast cancer patients receiving highly emetogenic chemotherapy. METHODS: Eighty breast cancer patients who received an anthracycline-cyclophosphamide combination regimen were enrolled. The patients were randomized to arm A (dexamethasone days 1–3) and arm B (dexamethasone day 1). The primary endpoint was complete response (CR) (no emetic episodes and no rescue medication) during the overall phase (days 1–5). The secondary endpoints were the CR during the delayed phase (days 2–5), complete control (CC) (no emetic episodes, no rescue medication, and no more than mild nausea) during the overall phase, and the safety of this antiemetic therapy. RESULTS: There were no significant differences in the rates of CR and CC between arm A and B as follows: CR overall phase—arm A: 82.9 %, 90 % confidence interval [CI] 71.3–90.5 % vs arm B: 82.1 %, 90 % CI 70.0–90.0 %; p = 1.00; CR delayed phase—arm A: 87.8 %, 90 % CI 77.0–93.9 % vs arm B: 94.9 %, 90 % CI 85.6–98.3 %; p = 0.43; CC overall phase—arm A: 48.8 %, 90 % CI 36.4–61.3 % vs arm B: 61.5 %, 90 % CI 48.4–73.2 %; p = 0.27. There were very few adverse events and no severe adverse events associated with this antiemetic therapy. CONCLUSIONS: The results suggest that the antiemetic effect provided by dexamethasone administered for 3 days can be obtained by dexamethasone administered for 1 day. Springer Berlin Heidelberg 2015-09-08 2016 /pmc/articles/PMC4729792/ /pubmed/26349772 http://dx.doi.org/10.1007/s00520-015-2905-4 Text en © The Author(s) 2015 Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided 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. |
spellingShingle | Original Article Kosaka, Yoshimasa Tanino, Hirokazu Sengoku, Norihiko Minatani, Naoko Kikuchi, Mariko Nishimiya, Hiroshi Waraya, Mina Katoh, Hiroshi Enomoto, Takumo Sato, Takeo Kuranami, Masaru Watanabe, Masahiko Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy |
title | Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy |
title_full | Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy |
title_fullStr | Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy |
title_full_unstemmed | Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy |
title_short | Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy |
title_sort | phase ii randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in japanese breast cancer patients receiving anthracycline-based chemotherapy |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4729792/ https://www.ncbi.nlm.nih.gov/pubmed/26349772 http://dx.doi.org/10.1007/s00520-015-2905-4 |
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