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Single‐dose NEPA versus an aprepitant regimen for prevention of chemotherapy‐induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy

INTRODUCTION: Non‐inferiority of NEPA (fixed combination of NK(1) receptor antagonist (RA), netupitant, and 5‐HT(3)RA, palonosetron) versus an aprepitant regimen was previously shown in a pragmatic study in patients receiving anthracycline cyclophosphamide (AC) and non‐AC moderately emetogenic chemo...

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Autores principales: Zelek, Laurent, Navari, Rudolph, Aapro, Matti, Scotté, Florian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10469631/
https://www.ncbi.nlm.nih.gov/pubmed/37537943
http://dx.doi.org/10.1002/cam4.6121
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author Zelek, Laurent
Navari, Rudolph
Aapro, Matti
Scotté, Florian
author_facet Zelek, Laurent
Navari, Rudolph
Aapro, Matti
Scotté, Florian
author_sort Zelek, Laurent
collection PubMed
description INTRODUCTION: Non‐inferiority of NEPA (fixed combination of NK(1) receptor antagonist (RA), netupitant, and 5‐HT(3)RA, palonosetron) versus an aprepitant regimen was previously shown in a pragmatic study in patients receiving anthracycline cyclophosphamide (AC) and non‐AC moderately emetogenic chemotherapy (MEC). In the MEC group a numerically higher complete response (CR: no emesis, no rescue) rate was seen for NEPA during the overall 0–120 h phase (NEPA 76.1% vs. 63.1% aprepitant). As NEPA exhibits long‐lasting efficacy, this study evaluated a prolonged period up to 144 h, beyond the traditional 120 h post‐chemotherapy. In this post‐hoc analysis we explore the comparative efficacy of NEPA versus the aprepitant regimen in the MEC group up to 144 h, while also assessing the impact of risk factors on CINV prevention. METHODS: This was a pragmatic, multicenter, randomized, prospective study. Oral NEPA was administered as a single dose on day 1, while aprepitant was given on days 1–3 + ondansetron on day 1; all patients were to receive dexamethasone on days 1–4. Patients were chemotherapy‐naïve and receiving MEC, with a subset evaluation of those with a risk factor for developing CINV (i.e., female, male <60 years, male ≥60 years who received carboplatin, or male ≥60 years with anxiety). CR rates were compared during the extended overall (0–144 h) phase. RESULTS: The MEC group included 211 patients; of these 181 were in the risk factor subset. Significantly higher CR rates were seen for NEPA than aprepitant during the extended overall phase for the total MEC group (NEPA 77.1%, aprepitant 57.8%, p = 0.003) and also in the subset of patients with CINV risk factors (NEPA 73.9%, aprepitant 56.2%, p = 0.012). CONCLUSION: A single dose of NEPA, administered on day 1 only, was more effective than a 3‐day aprepitant regimen in preventing CINV for an extended duration in patients receiving MEC and in those with emetic risk factors.
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spelling pubmed-104696312023-09-01 Single‐dose NEPA versus an aprepitant regimen for prevention of chemotherapy‐induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy Zelek, Laurent Navari, Rudolph Aapro, Matti Scotté, Florian Cancer Med RESEARCH ARTICLES INTRODUCTION: Non‐inferiority of NEPA (fixed combination of NK(1) receptor antagonist (RA), netupitant, and 5‐HT(3)RA, palonosetron) versus an aprepitant regimen was previously shown in a pragmatic study in patients receiving anthracycline cyclophosphamide (AC) and non‐AC moderately emetogenic chemotherapy (MEC). In the MEC group a numerically higher complete response (CR: no emesis, no rescue) rate was seen for NEPA during the overall 0–120 h phase (NEPA 76.1% vs. 63.1% aprepitant). As NEPA exhibits long‐lasting efficacy, this study evaluated a prolonged period up to 144 h, beyond the traditional 120 h post‐chemotherapy. In this post‐hoc analysis we explore the comparative efficacy of NEPA versus the aprepitant regimen in the MEC group up to 144 h, while also assessing the impact of risk factors on CINV prevention. METHODS: This was a pragmatic, multicenter, randomized, prospective study. Oral NEPA was administered as a single dose on day 1, while aprepitant was given on days 1–3 + ondansetron on day 1; all patients were to receive dexamethasone on days 1–4. Patients were chemotherapy‐naïve and receiving MEC, with a subset evaluation of those with a risk factor for developing CINV (i.e., female, male <60 years, male ≥60 years who received carboplatin, or male ≥60 years with anxiety). CR rates were compared during the extended overall (0–144 h) phase. RESULTS: The MEC group included 211 patients; of these 181 were in the risk factor subset. Significantly higher CR rates were seen for NEPA than aprepitant during the extended overall phase for the total MEC group (NEPA 77.1%, aprepitant 57.8%, p = 0.003) and also in the subset of patients with CINV risk factors (NEPA 73.9%, aprepitant 56.2%, p = 0.012). CONCLUSION: A single dose of NEPA, administered on day 1 only, was more effective than a 3‐day aprepitant regimen in preventing CINV for an extended duration in patients receiving MEC and in those with emetic risk factors. John Wiley and Sons Inc. 2023-08-03 /pmc/articles/PMC10469631/ /pubmed/37537943 http://dx.doi.org/10.1002/cam4.6121 Text en © 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle RESEARCH ARTICLES
Zelek, Laurent
Navari, Rudolph
Aapro, Matti
Scotté, Florian
Single‐dose NEPA versus an aprepitant regimen for prevention of chemotherapy‐induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy
title Single‐dose NEPA versus an aprepitant regimen for prevention of chemotherapy‐induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy
title_full Single‐dose NEPA versus an aprepitant regimen for prevention of chemotherapy‐induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy
title_fullStr Single‐dose NEPA versus an aprepitant regimen for prevention of chemotherapy‐induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy
title_full_unstemmed Single‐dose NEPA versus an aprepitant regimen for prevention of chemotherapy‐induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy
title_short Single‐dose NEPA versus an aprepitant regimen for prevention of chemotherapy‐induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy
title_sort single‐dose nepa versus an aprepitant regimen for prevention of chemotherapy‐induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy
topic RESEARCH ARTICLES
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10469631/
https://www.ncbi.nlm.nih.gov/pubmed/37537943
http://dx.doi.org/10.1002/cam4.6121
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