Evidence map›Paper›PMID 34793245›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Randomized, Double-Blind, Phase III Study of Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: CONSOLE.

Akito Hata, Isamu Okamoto, Naoki Inui, Morihito Okada, Masahiro Morise, Kohei Akiyoshi, Masayuki Takeda, Yasutaka Watanabe, Shunichi Sugawara, Naofumi Shinagawa and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05881486 (The Effects of Intravenous Fosaprepitant and Ondansetron for the Prevention of Postoperative Nausea and Vomiting in Thoracicsurgery Patients), which is not on this map. Cited by 43 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 7 pooled it
8.6field-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.

NCT05881486 naunknown statusnot on this mapstarted 2023, after this paper: background citation

The Effects of Intravenous Fosaprepitant and Ondansetron for the Prevention of Postoperative Nausea and Vomiting in Thoracicsurgery Patients: A Single-center, Randomized, Double-Blinded Clinical Study

TypeinterventionalSponsorQilu Hospital of Shandong UniversityRan2023 to 2023Enrolled234ConditionsPostoperative Nausea and Vomiting, Anesthesia Complication, Thoracic DiseasesArmsOndansetron 8mg, Fosaprepitant 150 mg
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 7 syntheses or guidelines pooled it, 66 citations in OpenAlex.

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  5. Guideline
  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. Prevalence and predictors of long-delayed (> 120 h) chemotherapy-induced nausea and vomiting (CINV)-a systematic review and individual patient data meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Pooled it
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  19. 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
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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

13 authors at 12 institutions in 1 country.

Akito HataDepartment of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan.ORCID 0000-0001-7035-7249
Isamu OkamotoResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID 0000-0002-7587-6096
Naoki InuiSecond Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.ORCID 0000-0002-4624-7119
Morihito OkadaDepartment of Surgical Oncology, Hiroshima University, Hiroshima, Japan.
Masahiro MoriseDepartment of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.ORCID 0000-0001-6576-3349
Kohei AkiyoshiDepartment of Clinical Oncology, Osaka City General Hospital, Osaka, Japan.
Masayuki TakedaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.ORCID 0000-0002-2950-0960
Yasutaka WatanabeDepartment of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.ORCID 0000-0002-3679-4864
Shunichi SugawaraDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.ORCID 0000-0002-3427-4558
Naofumi ShinagawaDepartment of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Kaoru KubotaDepartment of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Toshiaki SaekiDepartment of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Tomohide TamuraThoracic Center, St Luke's International Hospital, Tokyo, Japan.
Hamamatsu University School of Medicine · JPHiroshima University · JPHokkaido University · JPKindai University · JPKyushu University · JPNagoya University · JPNippon Medical School · JPOsaka City General Hospital · JPSaitama Cancer Center · JPSaitama Medical University · JPSendai Kousei Hospital · JPSt. Luke's International Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe evaluated the efficacy and safety of fosnetupitant (FosNTP) versus fosaprepitant (FosAPR) for preventing highly emetogenic chemotherapy-induced nausea and vomiting. This phase III study was the first head-to-head comparison between two different neurokinin-1 receptor antagonists in combination with palonosetron and dexamethasone. PATIENTS AND

methodsPatients scheduled to receive cisplatin-based chemotherapy were randomly assigned 1:1 to FosNTP 235 mg or FosAPR 150 mg in combination with palonosetron 0.75 mg and dexamethasone. The primary end point was overall (0-120 hours) complete response (CR; no emetic event and no rescue medication) rate, stratified by sex and age category, to show the noninferiority of FosNTP to FosAPR (noninferiority margin, -10% for the difference in the overall CR rate).

resultsOverall, 795 patients were randomly assigned, of whom 785 received the study drug (FosNTP [N = 392]

conclusionFosNTP demonstrated noninferiority to FosAPR, with a favorable safety profile and lower risk for injection site reactions. Thus, FosNTP is valuable in the prophylaxis of acute, delayed, and beyond delayed chemotherapy-induced nausea and vomiting.

Indexed as

AdultAgedAged, 80 and overAntiemeticsAntineoplastic AgentsCisplatinDexamethasoneDouble-Blind MethodDrug CombinationsFemaleHumansIsoquinolinesJapanMaleMiddle AgedMorpholinesAntiemeticsAntineoplastic AgentsCisplatinDexamethasoneDrug CombinationsfosaprepitantIsoquinolinesMorpholinesnetupitant, palosentron drug combinationNeurokinin-1 Receptor AntagonistsPyridinesQuinuclidines

Identifiers

PMID34793245
PMCPMC8718175
OpenAlexW3214379913

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.