Evidence map›Paper›PMID 29092012›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2018

A randomized phase III study evaluating the efficacy of single-dose NEPA, a fixed antiemetic combination of netupitant and palonosetron, versus an aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC).

L Zhang, S Lu, J Feng, A Dechaphunkul, J Chang, D Wang, S Chessari, C Lanzarotti, K Jordan, M Aapro

Open 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, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 8 pooled it
6.9field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 8 syntheses or guidelines pooled it, 105 citations in OpenAlex.

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  6. 2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high-emetic-risk antineoplastic agents.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Pooled it
  7. 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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  20. Global inequitable distribution of seminal studies of chemotherapy-induced nausea and vomiting.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 9 institutions in 4 countries.

L ZhangState Key Laboratory of Oncology in South China, Guangzhou, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China; Medical Oncology Department, Sun Yat-Sen University Cancer Center, Guangzhou, China. Electronic address: zhangli@sysucc.org.cn.
S LuShanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
J FengMedical Oncology, Jiangsu Cancer Hospital, Nanjing, China.
A DechaphunkulDivision of Medical Oncology, Internal Medicine, Prince of Songkla University, Songkhla, Thailand.
J ChangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
D WangCancer Center, Daping Hospital, Third Military Medical University, Chongqing, China.
S ChessariCorporate Clinical Development, Helsinn Healthcare, Lugano, Switzerland.
C LanzarottiStatistics and Data Management, Helsinn Healthcare, Lugano, Switzerland.
K JordanDepartment of Medicine V, University of Heidelberg, Heidelberg, Germany.
M AaproCancer Center, Clinique de Genolier, Genolier, Switzerland.
Helsinn (Switzerland) · CHClinique de Genolier · CHDaping Hospital · CNFudan University Shanghai Cancer Center · CNHeidelberg University · DEJiangsu Cancer Hospital · CNPrince of Songkla University · THShanghai Jiao Tong University · CNState Key Laboratory of Oncology in South China

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Co-administration of multiple antiemetics that inhibit several molecular pathways involved in emesis is required to optimize chemotherapy-induced nausea and vomiting (CINV) control in patients receiving highly emetogenic chemotherapy (HEC). NEPA, a fixed combination of a highly selective NK1 receptor antagonist, netupitant (300 mg), and the pharmacologically distinct 5-HT3RA, palonosetron (PALO 0.50 mg), has shown superior CINV prevention compared with PALO in cisplatin and anthracycline/cyclophosphamide-based settings. This study is the first head-to-head comparison of NEPA versus an aprepitant (APR)/granisetron (GRAN) regimen. Patients and methods: This randomized, double-blind phase III study conducted in Asia was designed with the primary objective to demonstrate non-inferiority of a single oral dose of NEPA compared with a 3-day oral APR/GRAN regimen in chemotherapy-naïve patients receiving cisplatin-based HEC. All patients also received oral dexamethasone (DEX) on days 1-4. The primary efficacy endpoint was complete response (CR: no emesis/no rescue medication) during the overall (0-120 h) phase. Non-inferiority was defined as a lower 95% CI greater than the non-inferiority margin set at - 10%. Secondary efficacy endpoints included no emesis, no rescue medication, and no significant nausea (NSN). Results: Treatment groups were comparable for the 828 patients analyzed: predominantly male (71%); mean age 54.5 years; ECOG 0-1 (98%); lung cancer (58%). NEPA demonstrated non-inferiority to APR/GRAN for overall CR [NEPA 73.8% versus APR/GRAN 72.4%, 95% CI (-4.5%, 7.5%)]. No emesis [NEPA 75.0% versus APR/GRAN 74.0%, 95% CI (-4.8%, 6.9%)] and NSN rates [NEPA 75.7% versus APR/GRAN 70.4%, 95% CI (-0.6%, 11.4%)] were similar between groups, but significantly more NEPA patients did not take rescue medication [NEPA 96.6% versus APR/GRAN 93.5%, 95% CI (0.2%, 6.1%)]. NEPA was well tolerated with a similar safety profile to APR/GRAN. Conclusions: In this first study comparing NK1RA regimens and DEX, NEPA administered only on day 1 was non-inferior to a 3-day oral APR/GRAN regimen in preventing CINV associated with HEC.

Indexed as

AdultAgedAntiemeticsAntineoplastic AgentsAprepitantAsiaCisplatinDexamethasoneDouble-Blind MethodDrug CombinationsFemaleHumansIsoquinolinesMaleMiddle AgedNauseaAntiemeticsAntineoplastic AgentsAprepitantCisplatinDexamethasoneDrug CombinationsIsoquinolinesnetupitant, palosentron drug combinationPyridinesQuinuclidines

Identifiers

PMID29092012
PMCPMC5834144
OpenAlexW2766471730

What OpenQuestion holds

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Registered trials

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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.