Evidence map›Paper›PMID 40145359›Full record

Trial reportCancer medicine2025

NEPA (Netupitant/Palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving Highly or Moderately Emetogenic Chemotherapy Who Experienced Breakthrough CINV in Cycle 1 of Chemotherapy: A Phase II Clinical Trial.

Rudolph M Navari, Erminio Bonizzoni

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06065722 (Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT06065722 phase2unknown statusnot on this map

Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy

TypeinterventionalSponsorSimon Williamson ClinicRan2023 to 2023Enrolled100ConditionsChemotherapy Induced Nausea and VomitingArmsAkynzeo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Rudolph M NavariWorld Health Organization, Mount Olive, Alabama, USA.ORCID https://orcid.org/0000-0002-8513-896X
Erminio BonizzoniRIDE2Med Foundation, Milan, Italy.

Funding

Helsinn TherapeuticsWorld Health Organization 001
6 · The paper itself

Abstract

backgroundAlthough control of chemotherapy-induced nausea and vomiting (CINV) is substantially improved with guideline-directed antiemetic prophylaxis, breakthrough CINV remains a significant clinical patient problem. In subsequent cycles after breakthrough occurs, antiemetic guidelines recommend adding agents not used in the initial cycle. This study was designed to evaluate the use of NEPA (netupitant/palonosetron) plus dexamethasone with or without olanzapine for the prevention of CINV in the second cycle of chemotherapy for patients receiving highly (HEC) or moderately emetogenic chemotherapy (MEC) who developed breakthrough CINV in their first cycle despite guideline-directed prophylactic antiemetics.

methodsThis was a Phase 2, single center, open-label study. Patients received guideline-recommended prophylactic antiemetics in Cycle 1 based on the chemotherapy emetogenicity. Patients who experienced breakthrough CINV in Cycle 1 received intravenous (IV) NEPA (Day 1) plus dexamethasone (Days 1-4) and olanzapine (Days 1-4) for HEC or IV NEPA (Day 1) plus dexamethasone (Days 1-4) for MEC in Cycle 2.

resultsOf the 227 patients enrolled in Cycle 1, 100 patients (n = 37 HEC, 63 MEC) experienced breakthrough CINV and received the NEPA-based treatments in Cycle 2. The complete response (no emesis/no rescue use) rates [95% confidence intervals] during the overall (0-120 h) phase were 76% [59%, 88%] and 79% [67%, 89%] in the HEC and MEC groups, respectively.

conclusionThese results show that NEPA with or without olanzapine is an effective approach for CINV prevention for patients receiving HEC or MEC who develop breakthrough CINV after their first course of chemotherapy. The results support the antiemetic guideline recommendations.

trial registrationclinicaltrials.gov identifier: NCT06065722.

Indexed as

AntiemeticsAntineoplastic Combined Chemotherapy ProtocolsNauseaNeoplasmsPalonosetronPyridinesVomitingAdultAgedAntineoplastic AgentsBenzeneacetamidesDexamethasoneDrug CombinationsFemaleHumansIsoquinolinesAntiemeticsAntineoplastic AgentsBenzeneacetamidesDexamethasoneDrug CombinationsIsoquinolinesnetupitantOlanzapinePalonosetronPiperazinesPyridinesbreakthrough CINVNEPAnetupitantolanzapine

Identifiers

PMID40145359
PMCPMC11947742

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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.