Evidence map›Paper›PMID 35045185›Full record

Trial reportCancer2022

A phase 3 safety study of fosnetupitant as an antiemetic in patients receiving anthracycline and cyclophosphamide: CONSOLE-BC.

Kazuo Matsuura, Junji Tsurutani, Kenichi Inoue, Yuko Tanabe, Tetsuhiko Taira, Kaoru Kubota, Tomohide Tamura, Toshiaki Saeki

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
3.9field-weighted citation impact, top 6% 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, 4 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. 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
  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. Observational
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Article
  14. Cost-effectiveness analysis of fosnetupitant in patients receiving cisplatin in Japan: analysis based on real-world data.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  15. Review
  16. 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

8 authors at 7 institutions in 1 country.

Kazuo MatsuuraDepartment of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
Kenichi InoueDepartment of Breast Oncology, Saitama Cancer Center, Saitama, Japan.
Yuko TanabeDepartment of Medical Oncology, Toranomon Hospital, Tokyo, Japan.
Tetsuhiko TairaDepartment of Medical Oncology, Sagara Hospital, Kagoshima, Japan.
Kaoru KubotaDepartment of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Tomohide TamuraThoracic Center, St. Luke's International Hospital, Tokyo, Japan.
Toshiaki SaekiDepartment of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.ORCID 0000-0002-8893-9519
Saitama Medical University · JPNational Sagamihara Hospital · JPNippon Medical School · JPSaitama Cancer Center · JPShowa University · JPSt. Luke's International Hospital · JPToranomon Hospital · JP

Funding

Taiho Pharmaceutical
6 · The paper itself

Abstract

backgroundFosnetupitant (FosNTP), an intravenous neurokinin 1 receptor antagonist, demonstrated a favorable safety profile with a potentially low risk of injection site reactions (ISRs) and promising antiemetic efficacy in patients receiving cisplatin-based highly emetogenic chemotherapy in a previous phase 2 study. We conducted a randomized, double-blind safety study to evaluate the safety profile of FosNTP, including ISRs, in patients receiving doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide (AC/EC) chemotherapy.

methodsPatients scheduled to receive AC/EC were randomized 1:1 to receive 235 mg of FosNTP or 150 mg of fosaprepitant (FosAPR), both in combination with 0.75 mg of intravenous palonosetron and 9.9 mg of dexamethasone on day 1. The stratification factors were age category (<55 vs ≥55 years) and study site. The primary end point was the incidence of treatment-related adverse events (TRAEs) with FosNTP.

resultsOverall, 102 patients were randomized to FosNTP (n = 52) or FosAPR (n = 50), and all were treated with the study drug and evaluated for safety. The primary end point, the incidence of TRAEs, was similar with FosNTP (21.2%; 95% confidence interval [CI], 11.1%-34.7%) and FosAPR (22.0%; 95% CI, 11.5%-36.0%), with any-cause ISRs observed in 5.8% and 26.0% of patients, respectively, and treatment-related ISRs observed in 0% and 10.0%, respectively. The overall (0-120 hour) complete response (defined as no emetic event and no rescue medication) rate, standardized by age category in the full analysis set, was 45.9% (23 of 51 patients) with FosNTP and 51.3% (25 of 49 patients) with FosAPR.

conclusionsFosNTP demonstrated a favorable safety profile with a very low risk of ISRs in the AC/EC setting.

Indexed as

AntiemeticsAnthracyclinesCyclophosphamideDexamethasoneDouble-Blind MethodHumansMiddle AgedNauseaVomitingAnthracyclinesAntiemeticsCyclophosphamideDexamethasoneanthracyclinescyclophosphamidefosaprepitantinjection site reactionnauseaneurokinin 1 receptor antagonistsvomiting

Identifiers

PMID35045185
PMCPMC9306508
OpenAlexW4205481491

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.