Evidence map›Paper›PMID 24631949›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2014

A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy.

R J Gralla, S M Bosnjak, A Hontsa, C Balser, G Rizzi, G Rossi, M E Borroni, K Jordan

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01376297 (A Phase III, Multicenter, Randomized, Double-blind, Unbalanced), which is not on this map. Cited by 89 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 9 pooled it
25.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01376297 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-blind, Unbalanced (3:1) Active Control Study to Assess the Safety and Describe the Efficacy of Netupitant and Palonosetron for the Prevention of Chemotherapy-induced Nausea and Vomiting in Repeated Chemotherapy Cycles.

TypeinterventionalSponsorHelsinn Healthcare SARan2011Enrolled413ConditionsChemotherapy-Induced Nausea and VomitingArmsNetupitant and Palonosetron, Aprepitant, Palonosetron, Dexamethasone
3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 9 syntheses or guidelines pooled it, 188 citations in OpenAlex.

  1. Pooled it
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  3. SEOM clinical guideline emesis (2021).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022
    Guideline
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  8. 2016 Updated MASCC/ESMO Consensus Recommendations: Prevention of Nausea and Vomiting Following High Emetic Risk Chemotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017
    Pooled it
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  10. A phase 2 pharmacokinetic and pharmacodynamic dose-finding study of oral NEPA for chemotherapy-induced nausea and vomiting in pediatric patients with cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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29 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 5 countries.

R J GrallaDepartment of Medical Oncology, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, USA. Electronic address: richard.gralla@nbhn.net.
S M BosnjakDepartment of Supportive Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.
A HontsaChernivtsi Regional Cancer Hospital, Chernivtsi, Ukraine.
C BalserOnkoNet Marburg GmbH, Marburg, Germany.
G RizziDepartment of Statistics and Data Management.
G RossiDepartment of Corporate Clinical Development, Helsinn Healthcare SA, Lugano, Switzerland.
M E BorroniDepartment of Corporate Clinical Development, Helsinn Healthcare SA, Lugano, Switzerland.
K JordanDepartment of Hematology and Oncology, University of Halle-Wittenberg, Halle, Germany.
Helsinn (Switzerland) · CHChernivtsi National University · UAJacobi Medical Center · USMartin Luther University Halle-Wittenberg · DEOncology Institute of Vojvodina · RS

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSafe, effective and convenient antiemetic regimens that preserve benefit over repeated cycles are needed for optimal supportive care during cancer treatment. NEPA, an oral fixed-dose combination of netupitant, a highly selective NK1 receptor antagonist (RA), and palonosetron (PALO), a distinct 5-HT3 RA, was shown to be superior to PALO in preventing chemotherapy-induced nausea and vomiting after a single cycle of highly (HEC) or moderately (MEC) emetogenic chemotherapy in recent trials. This study was designed primarily to assess the safety but also to evaluate the efficacy of NEPA over multiple cycles of HEC and MEC. PATIENTS AND

methodsThis multinational, double-blind, randomized phase III study (NCT01376297) in 413 chemotherapy-naïve patients evaluated a single oral dose of NEPA (NETU 300 mg + PALO 0.50 mg) given on day 1 with oral dexamethasone (DEX). An oral 3-day aprepitant (APR) regimen + PALO + DEX was included as a control (3:1 NEPA:APR randomization). In HEC, DEX was administered on days 1-4 and in MEC on day 1. Safety was assessed primarily by adverse events (AEs), including cardiac AEs; efficacy by complete response (CR: no emesis, no rescue).

resultsPatients completed 1961 total chemotherapy cycles (76% MEC, 24% HEC) with 75% completing ≥4 cycles. The incidence/type of AEs was comparable for both groups. Most frequent NEPA-related AEs included constipation (3.6%) and headache (1.0%); there was no indication of increasing AEs over multiple cycles. The majority of AEs were mild/moderate and there were no cardiac safety concerns based on AEs and electrocardiograms. The overall (0-120 h) CR rates in cycle 1 were 81% and 76% for NEPA and APR + PALO, respectively, and antiemetic efficacy was maintained over repeated cycles.

conclusionsNEPA, a convenient single oral dose antiemetic targeting dual pathways, was safe, well tolerated and highly effective over multiple cycles of HEC/MEC.

Indexed as

Antineoplastic AgentsBenzeneacetamidesDouble-Blind MethodDrug CombinationsHumansIsoquinolinesNauseaNeoplasmsPalonosetronPiperazinesPyridinesQuinuclidinesVomitingAntineoplastic AgentsBenzeneacetamidesDrug CombinationsIsoquinolinesnetupitantPalonosetronPiperazinesPyridinesQuinuclidinesCINVmultiple chemotherapy cyclesNEPAnetupitantneurokinin-1 receptor antagonistpalonosetron

Identifiers

PMID24631949
PMCPMC4071753
OpenAlexW2156319350

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.