Evidence map›Paper›PMID 32988373›Full record

Trial reportBMC cancer2020

Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type.

Cindy Weinstein, Karin Jordan, Stuart Green, Saleem Khanani, Elizabeth Beckford-Brathwaite, Waldimir Vallejos, Annpey Pong, Stephen J Noga, Bernardo L Rapoport

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01594749 (A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 26% 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.

NCT01594749 phase3completednot on this map

A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2012 to 2014Enrolled1,015ConditionsChemotherapy-Induced Nausea and Vomiting (CINV)ArmsFosaprepitant dimeglumine, Fosaprepitant Placebo, Dexamethasone, Ondansetron, Dexamethasone Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. 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

9 authors at 4 institutions in 3 countries.

Cindy WeinsteinMerck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, USA. cindy.l.weinstein@merck.com.
Karin JordanUniversity of Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Stuart GreenMerck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, USA.
Saleem KhananiHeywood Hospital, 242 Green Street, Gardner, MA, USA.
Elizabeth Beckford-BrathwaiteMerck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, USA.
Waldimir VallejosMerck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, USA.
Annpey PongMerck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, USA.
Stephen J NogaWeinberg Cancer Institute, 9103 Franklin Square Drive, Baltimore, MD, USA.
Bernardo L RapoportDepartment of Immunology, Faculty of Health Sciences, University of Pretoria, Corner Doctor Savage Road and Bophelo Road, Pretoria, 0002, South Africa.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USHeidelberg University · DEUniversity of Pretoria · ZAWeinberg Medical Physics (United States) · US

Funding

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA N/A
6 · The paper itself

Abstract

backgroundResults from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25-120 h after chemotherapy initiation), compared with a 3-day control regimen ( ClinicalTrials.gov , NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers).

methodsSubjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)-based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0-120 h and 0-24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed.

resultsCR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2-22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups.

conclusionsThis post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type.

trial registrationClinicalTrials.gov NCT01594749 , registered May 9, 2012.

Indexed as

AdultAgedAged, 80 and overAntiemeticsDouble-Blind MethodFemaleHumansMaleMiddle AgedMorpholinesNauseaNeoplasmsVomitingYoung AdultAntiemeticsfosaprepitantMorpholinesBreast cancerChemotherapy-induced nausea and vomiting (CINV)FosaprepitantGastrointestinal cancerGynecologic cancerLung cancer

Identifiers

PMID32988373
PMCPMC7523353
OpenAlexW3089851632

What OpenQuestion holds

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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.