Evidence map›Paper›PMID 24603643›Full record

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

A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy.

M Aapro, H Rugo, G Rossi, G Rizzi, M E Borroni, I Bondarenko, T Sarosiek, C Oprean, S Cardona-Huerta, V Lorusso and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized 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 2 registered trials, which are not on this map. Cited by 120 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed, 11 pooled it
29.9field-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.

NCT01339260 phase3completednot on this map

A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy

TypeinterventionalSponsorHelsinn Healthcare SARan2011Enrolled1,455ConditionsChemotherapy-Induced Nausea and VomitingArmsNetupitant and Palonosetron, Palonosetron, Dexamethasone
NCT03237611 phase2terminatednot on this mapstarted 2018, after this paper: background citation

Phase II Trial Testing the Antiemetic Efficacy of a Single-day Low Dose Aprepitant (or Fosaprepitant) Added to a 5-HT3 Receptor Antagonist Plus Dexamethasone in Patients Receiving Carboplatin

TypeinterventionalSponsorAlbert Einstein College of MedicineRan2018 to 2021Enrolled15ConditionsChemotherapy-induced Nausea and VomitingArmsAprepitant 125 mg, Fosaprepitant 115 MG, Dexamethasone, Ondansetron 16 MG
3 · Its place in the literature

Who cites it

120 citing papers in PubMed, 11 syntheses or guidelines pooled it, 244 citations in OpenAlex.

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  8. Should palonosetron be a preferred 5-HTSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
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  10. 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
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  11. Defining the efficacy of neurokinin-1 receptor antagonists in controlling chemotherapy-induced nausea and vomiting in different emetogenic settings-a meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
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60 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 6 countries.

M AaproInstitut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland. Electronic address: maapro@genolier.net.
H RugoComprehensive Cancer Center, University of California San Francisco, San Francisco, USA.
G RossiCorporate Clinical Development, Statistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.
G RizziCorporate Clinical Development, Statistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.
M E BorroniCorporate Clinical Development, Statistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.
I BondarenkoDepartment of Oncology, Dnepropetrovsk Medical Academy, Dnepropetrovsk, Ukraine.
T SarosiekNzoz Magodent, Warsaw, Poland.
C OpreanOncomed SRL, Timisoara, Romania.
S Cardona-HuertaHospital Universitario, Universidad Autonoma de Nuevo León, Monterrey, Mexico.
V LorussoNational Cancer Institute Giovanni Paolo II, Bari, Italy.
M KarthausDepartment of Hematology, Oncology and Palliative Medicine, Staedt. Klinikum Neuperlach and Harlaching, München, Germany.
L SchwartzbergThe West Clinic, Memphis.
S GrunbergFletcher Allen Health Care, Burlington, USA.
Helsinn (Switzerland) · CHAllen Hospital · USCampbell Clinic · USClinique de Genolier · CHDnipropetrovsk State Medical Academy · UAIstituto Tumori Bari · ITNZOZ Centrum Alergologii · PLUCSF Helen Diller Family Comprehensive Cancer Center · USUniversidad Autónoma de Nuevo León · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntiemetic guidelines recommend co-administration of agents that target multiple molecular pathways involved in emesis to maximize prevention and control of chemotherapy-induced nausea and vomiting (CINV). NEPA is a new oral fixed-dose combination of 300 mg netupitant, a highly selective NK1 receptor antagonist (RA) and 0.50 mg palonosetron (PALO), a pharmacologically and clinically distinct 5-HT3 RA, which targets dual antiemetic pathways. PATIENTS AND

methodsThis multinational, randomized, double-blind, parallel group phase III study (NCT01339260) in 1455 chemotherapy-naïve patients receiving moderately emetogenic (anthracycline-cyclophosphamide) chemotherapy evaluated the efficacy and safety of a single oral dose of NEPA versus a single oral dose (0.50 mg) of PALO. All patients also received oral dexamethasone (DEX) on day 1 only (12 mg in the NEPA arm and 20 mg in the PALO arm). The primary efficacy end point was complete response (CR: no emesis, no rescue medication) during the delayed (25-120 h) phase in cycle 1.

resultsThe percentage of patients with CR during the delayed phase was significantly higher in the NEPA group compared with the PALO group (76.9% versus 69.5%; P = 0.001), as were the percentages in the overall (0-120 h) (74.3% versus 66.6%; P = 0.001) and acute (0-24 h) (88.4% versus 85.0%; P = 0.047) phases. NEPA was also superior to PALO during the delayed and overall phases for all secondary efficacy end points of no emesis, no significant nausea and complete protection (CR plus no significant nausea). NEPA was well tolerated with a similar safety profile as PALO.

conclusionsNEPA plus a single dose of DEX was superior to PALO plus DEX in preventing CINV following moderately emetogenic chemotherapy in acute, delayed and overall phases of observation. As a fixed-dose antiemetic drug combination, NEPA along with a single dose of DEX on day 1 offers guideline-based prophylaxis with a convenient, single-day treatment.

Indexed as

AntiemeticsAntineoplastic AgentsBenzeneacetamidesDrug CombinationsFemaleHumansIsoquinolinesMaleMiddle AgedNauseaPalonosetronPiperazinesPyridinesQuinuclidinesVomitingAntiemeticsAntineoplastic AgentsBenzeneacetamidesDrug CombinationsIsoquinolinesnetupitantPalonosetronPiperazinesPyridinesQuinuclidinesCINVmoderately emetogenicNEPAnetupitantneurokinin-1 receptor antagonistpalonosetron

Identifiers

PMID24603643
PMCPMC4071754
OpenAlexW2120970263

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.