Evidence map›Paper›PMID 29808377›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2018

Evaluation of factors contributing to the response to fosaprepitant in a heterogeneous, moderately emetogenic chemotherapy population: an exploratory analysis of a randomized phase III trial.

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

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2018. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 19% 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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. 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 5 institutions in 3 countries.

Cindy WeinsteinClinical Research, Merck & Co., Inc., Kenilworth, NJ, USA. cindy.l.weinstein@merck.com.
Karin JordanDepartment of Hematology/Oncology, Martin Luther University Halle-Wittenberg, Halle, Germany.
Stuart A GreenClinical Development, Merck & Co., Inc., Kenilworth, NJ, USA.
Elber CamachoDepartment of Hematology and Medical Oncology, Comprehensive Care Center at the Desert Regional Medical Center, Palm Springs, CA, USA.
Saleem KhananiDepartment of Hematology/Oncology, Reliant Medical Group, Worcester, MA, USA.
Elizabeth Beckford-BrathwaiteClinical Development, Merck & Co., Inc., Kenilworth, NJ, USA.
Annpey PongClinical Research, Merck & Co., Inc., Kenilworth, NJ, USA.
Stephen J NogaDepartment of Oncology, Weinberg Cancer Institute, Baltimore, MD, USA.
Bernardo L RapoportDepartment of Medical Oncology, Medical Oncology Center of Rosebank, Johannesburg, South Africa.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USDesert Regional Medical Center · USMartin Luther University Halle-Wittenberg · DEReliant Medical Group · USThe Medical Oncology Centre of Rosebank · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFosaprepitant improved prevention of chemotherapy-induced nausea and vomiting (CINV) in a randomized, double-blind phase III trial (PN031). This post hoc analysis explored factors that may have influenced response.

methodsAdult subjects (N = 1000) scheduled to receive non-anthracycline and cyclophosphamide (AC) moderately emetogenic chemotherapy (MEC) on day 1 were randomly assigned 1:1 to a single-dose, 150-mg intravenous fosaprepitant regimen or a control regimen. Both regimens included dexamethasone and ondansetron on day 1, with ondansetron continuing through day 3 in the control arm only. Complete response (CR; no vomiting and no rescue medication) rates in the acute, delayed, and overall phases (0-25, 25-120, and 0-120 h, respectively) were analyzed by chemotherapy type (carboplatin-based vs non-carboplatin-based), chemotherapy duration (single-day vs multiple-day), and baseline characteristics.

resultsMost subjects received single-day chemotherapeutic regimens (70.6%), which were mainly carboplatin-based (67.6%). CR with fosaprepitant was consistent (76-80%) during the delayed and overall phases in carboplatin-based and non-carboplatin-based subgroups and in subgroups receiving single-day or multiple-day MEC regimens. Treatment effects favored fosaprepitant for the carboplatin-based versus the non-carboplatin-based group during the delayed phase (14.1 vs 6.5%; p = 0.06), and for the single-day versus the multiple-day subgroup during the delayed (13.2 vs 3.2%; p = 0.02) and overall phases (12.8 vs 4.0%; p = 0.06).

conclusionsThis exploratory analysis confirms that single-dose fosaprepitant is effective for the prevention of CINV in subjects receiving carboplatin or non-carboplatin in both single- and multiple-day non-AC MEC chemotherapy regimens. This trial is registered at ClinicalTrials.gov , number NCT01594749.

Indexed as

AdultAgedAntiemeticsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCyclophosphamideDexamethasoneDouble-Blind MethodFemaleHumansInduction ChemotherapyMaleMiddle AgedMorpholinesNauseaNeoplasmsAntiemeticsCarboplatinCyclophosphamideDexamethasonefosaprepitantMorpholinesOndansetronFosaprepitant dimeglumineModerately emetogenic chemotherapyNauseaNeurokinin 1 receptor antagonistsVomiting

Identifiers

PMID29808377
OpenAlexW2807600093

What OpenQuestion holds

Textmetadata
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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.