Evidence map›Paper›PMID 31381152›Full record

Trial reportCancer2019

Multicenter, placebo-controlled, double-blind, randomized study of fosnetupitant in combination with palonosetron for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.

Shunichi Sugawara, Naoki Inui, Masashi Kanehara, Masahiro Morise, Kozo Yoshimori, Toru Kumagai, Tomoya Fukui, Koichi Minato, Akira Iwashima, Yuichiro Takeda and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
1.1field-weighted citation impact, top 22% 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

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Guideline
  2. 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
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. 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
  8. Article
  9. Article
  10. Article
  11. Article
  12. 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.

Shunichi SugawaraDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.ORCID https://orcid.org/0000-0002-3427-4558
Naoki InuiRespiratory Medicine, Hamamatsu University School of Medicine, Shizuoka, Japan.
Masashi KaneharaDepartment of Respiratory Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Masahiro MoriseDepartment of Respiratory Medicine, Nagoya University Graduate School of Medicine, Aichi, Japan.
Kozo YoshimoriDepartment of Clinical Oncology, Fukujuji Hospital, Tokyo, Japan.
Toru KumagaiDepartment of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan.
Tomoya FukuiDepartment of Respiratory Medicine, Kitasato University School of Medicine, Kanagawa, Japan.
Koichi MinatoDivision of Respiratory Medicine, Gunma Prefectural Cancer Center, Gunma, Japan.
Akira IwashimaDepartment of Respiratory Medicine, Nagaoka Chuo General Hospital, Niigata, Japan.
Yuichiro TakedaDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, 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.
Fukujuji Hospital · JPGunma Prefectural Cardiovascular Center · JPHamamatsu University School of Medicine · JPHiroshima City Asa Citizens Hospital · JPKitasato University · JPNagoya University · JPNational Center for Global Health and Medicine · JPNippon Medical School · JPOsaka International Cancer Institute · JPSaitama Medical University · JPSendai Kousei Hospital · JPSt. Luke's International Hospital · JP

Funding

Taiho Pharmaceutical
6 · The paper itself

Abstract

backgroundThe current randomized, double-blind, phase 2 study assessed the efficacy and safety profile of a single intravenous administration of fosnetupitant, a neurokinin 1 receptor antagonist prodrug, for the prevention of chemotherapy-induced nausea and vomiting in Japanese patients receiving cisplatin-based chemotherapy.

methodsPatients scheduled to receive cisplatin (at a dose of ≥70 mg/m

resultsA total of 594 patients were randomized. Of these, 194 patients, 195 patients, and 195 patients, respectively, in the placebo and fosnetupitant 81-mg and 235-mg dose groups were evaluable for efficacy. The overall CR rate was 54.7% for the placebo group, 63.8% for the fosnetupitant 81-mg dose group (adjusted difference, 9.1%; 95% CI, -0.4% to 18.6% [P = .061]), and 76.8% for the fosnetupitant 235-mg dose group (adjusted difference, 22.0%; 97.5% CI, 11.7% to 32.3% [P < .001]). Safety profiles were comparable between the 3 groups. The incidence of infusion site reactions related to fosnetupitant was ≤1% in each dose group.

conclusionsFosnetupitant at a dose of 235 mg provided superior prevention of chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based chemotherapy compared with the control group, and with a satisfactory safety profile.

Indexed as

AntiemeticsAntineoplastic AgentsIsoquinolinesNauseaNeoplasmsPyridinesQuinuclidinesVomitingAdultAgedDrug CombinationsFemaleHumansMaleMiddle AgedTreatment OutcomeAntiemeticsAntineoplastic AgentsDrug CombinationsIsoquinolinesnetupitant, palosentron drug combinationPyridinesQuinuclidineschemotherapy-induced nausea and vomitingfosnetupitanthighly emetogenic chemotherapyinjection site reactionneurokinin 1 receptor antagonistphase 2

Identifiers

PMID31381152
PMCPMC6900104
OpenAlexW2964946892

What OpenQuestion holds

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LicenceCC BY-NC
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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.