Evidence map›Paper›PMID 31686784›Full record

Observational studyDrug design, development and therapy2019

Efficacy, Safety And Feasibility Of Antiemetic Prophylaxis With Fosaprepitant, Granisetron And Dexamethasone In Pediatric Patients With Hemato-Oncological Malignancies.

Karin Melanie Cabanillas Stanchi, Martin Ebinger, Ulrike Hartmann, Manon Queudeville, Judith Feucht, Michael Ost, Marie-Sarah Koch, Carmen Malaval, Markus Mezger, Sarah Schober and 6 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Drug design, development and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 21% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Antiemetic Prophylaxis with Fosaprepitant and 5-HTDrug design, development and therapy · 2020
    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

16 authors at 2 institutions in 1 country.

Karin Melanie Cabanillas Stanchi *Department of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.ORCID 0000-0002-7669-9159
Martin Ebinger *Department of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.ORCID 0000-0002-4229-8058
Ulrike HartmannUniversity Pharmacy, Eberhard-Karls-University of Tübingen, Tübingen 72076, Germany.
Manon QueudevilleDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Judith FeuchtDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Michael OstDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.ORCID 0000-0002-9780-603X
Marie-Sarah KochDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Carmen MalavalDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Markus MezgerDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.ORCID 0000-0002-0211-2343
Sarah SchoberDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Simone WeberDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Sebastian MichaelisDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Veit LangeDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Peter LangDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Rupert HandgretingerDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.
Michaela DöringDepartment of General Pediatrics, Hematology/Oncology, University Children's Hospital Tübingen, Tübingen 72076, Germany.ORCID 0000-0002-8134-7350
University Children's Hospital Tübingen · DEUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChemotherapy-induced nausea and vomiting (CINV) are a major burden for patients undergoing emetogenic chemotherapy. International guidelines recommend an antiemetic prophylaxis with corticosteroids, 5-HT

methodsThis non-interventional observation study analyzed 303 chemotherapy courses administered to 83 pediatric patients with a median age of 9 years (2-17 years), who received antiemetic prophylaxis either with fosaprepitant and granisetron with or without dexamethasone (fosaprepitant group/FG; n=41), or granisetron with or without dexamethasone (control group/CG; n=42), during moderately (CINV risk 30-90%) or highly (CINV risk>90%) emetogenic chemotherapy. The two groups' results were compared with respect to the safety and efficacy of the antiemetic prophylaxis during the acute (0-24hrs after chemotherapy), delayed (>24-120hrs after chemotherapy) and both CINV phases. Laboratory and clinical adverse events were compared between the two cohorts.

resultsAdverse events were not significantly different in the two groups (p>0.05). Significantly fewer vomiting events occurred during antiemetic prophylaxis with fosaprepitant in the acute (23 vs 142 events; p<0.0001) and the delayed (71 vs 255 events; p<0.0001) CINV phase. In the control group, the percentage of chemotherapy courses with vomiting was significantly higher during the acute (24%/FG vs 45%/CG; p<0.0001) and delayed CINV phase (28%/FG vs 47%/CG; p=0.0004). Dimenhydrinate (rescue medication) was administered significantly more often in the CG, compared to the FG (114/FG vs 320/CG doses; p<0.0001). Likewise, in the control group, dimenhydrinate was administered in significantly more (p<0.0001) chemotherapy courses during the acute and delayed CINV phases (79 of 150; 52.7%), compared to the fosaprepitant group (45 of 153; 29.4%).

conclusionAntiemetic prophylaxis with fosaprepitant and granisetron with or without dexamethasone was well tolerated, safe and effective in pediatric patients. However, larger prospective trials are needed to evaluate these findings.

Indexed as

AdolescentAntiemeticsAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolCohort StudiesDexamethasoneDrug Therapy, CombinationFemaleGranisetronHumansMaleMorpholinesNauseaVomitingAntiemeticsDexamethasonefosaprepitantGranisetronMorpholinesantiemetic prophylaxischemotherapy induced vomitingchildrenfosaprepitantgranisetronpediatric

Identifiers

PMID31686784
PMCPMC6777642
OpenAlexW2975638178

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.