Evidence map›Paper›PMID 37284847›Full record

Trial reportThe oncologist2023

Olanzapine With or Without Fosaprepitant for Preventing Chemotherapy Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial (ALLIANCE A221602).

Rudolph M Navari, Jennifer Le-Rademacher, Fabrice Smieliauskas, Kathryn J Ruddy, Thomas James Saphner, Heshan Liu, Elizabeth Harlos, Adedayo A Onitilo, Karthik Giridhar, Preet Paul Singh and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase IIIEquivalence Trial
In one paragraph

Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03578081 (Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 41% 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.

NCT03578081 phase3completednot on this map

Olanzapine With or Without Fosaprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2018 to 2023Enrolled690ConditionsMalignant NeoplasmArmsPalonosetron Hydrochloride, Ondansetron Hydrochloride, Dexamethasone, Fosaprepitant Dimeglumine, Olanzapine
3 · Its place in the literature

Who cites it

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

  1. Olanzapine (10 mg vs 5 mg vs 2.5 mg) for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) - a systematic review and network meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
  2. MASCC antiemetic consensus recommendations: resource-limited settings.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    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

15 authors at 9 institutions in 1 country.

Rudolph M NavariDepartment of Hematology Oncology, Simon Williamson Clinic, Birmingham, AL, USA.
Jennifer Le-RademacherAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
Fabrice SmieliauskasDepartment of Hematology Oncology, Wayne State University, Detroit, MI, USA.
Kathryn J RuddyDepartment of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
Thomas James SaphnerDepartment of Hematology Oncology, Aurora Cancer Care, Green Bay, WI, USA.
Heshan LiuAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
Elizabeth HarlosAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
Adedayo A OnitiloDepartment of Hematology Oncology, Marshfield Clinic-Weston Center, Marshfield, WI, USA.
Karthik GiridharDepartment of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
Preet Paul SinghDepartment of Hematology Oncology, Springfield Clinic, Heartland NCORP, Springfield, IL, USA.
Pavan S ReddyDepartment of Hematology Oncology, Cancer Center of Kansas, Wichita, KS, USA.
Selina ChowAlliance Protocol Operations Office, University of Chicago, Chicago, IL, USA.
Flavio KruterDepartment of Hematology Oncology, Carroll Regional Cancer Center, Westminster, MD, USA.
George RaptisDepartment of Hematology Oncology, Northwell Health Cancer Institute, Lake Success, NY, USA.
Charles L LoprinziDepartment of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
Mayo Clinic · USMayo Clinic in Arizona · USCancer Center of Kansas · USMarshfield Clinic Weston Center · USNorthwell Health · USRegional Cancer Center · USSpringfield Clinic · USUniversity of Chicago · USWayne State University · US

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
NCI Community Oncology Research Program (NCORP) - Community SitesUG1CA190140 · NCI · AURORA HEALTH CARE, INC. · PI Sigrun Hallmeyer, THOMAS J SAPHNER · 2014 to 2026
$20.0M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
NCI National Clinical Trials Network – Network Lead Academic Participating SiteUG1CA233163 · NCI · WAYNE STATE UNIVERSITY · PI FLAHERTY, LAWRENCE E, SHIELDS, ANTHONY FRANK · 2019 to 2025
$3.5M
Targeted Oral Anticancer Agents: Patterns of Indicated and Off-Label Use, the Associated Factors, and Economic ImplicationsR01CA225647 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI SHIH, YA-CHEN TINA · 2019 to 2023
$1.8M
NCI NIH HHS P30 CA015083NCI NIH HHS R01 CA225647NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA190140NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233163
6 · The paper itself

Abstract

purposeA protocol was developed to evaluate the value of an NK-1 receptor antagonist for preventing nausea and vomiting resulting from highly emetogenic chemotherapy when an olanzapine-based antiemetogenic regimen was used. MATERIALS AND

methodsA221602, a prospective double-blind, placebo-controlled clinical trial, was developed to compare 2 -olanzapine-containing antiemetic regimens, one with an NK-1 receptor antagonist (aprepitant or fosaprepitant) and one without. Trial patients had a malignant disease for which they received intravenous highly emetogenic chemotherapy (single day cisplatin ≥ 70 mg/m2 or doxorubicin plus cyclophosphamide on 1 day). Patients on both arms received commonly administered doses of a 5-HT3 receptor antagonist, dexamethasone, and olanzapine. Additionally, patients were randomized to receive an NK-1 receptor antagonist (fosaprepitant 150 mg IV or aprepitant 130 mg IV) or a corresponding placebo. The primary objective was to compare the proportion of patients with no nausea for 5 days following chemotherapy between the 2 study arms. This trial was designed to test for the noninferiority of deleting the NK-1 receptor antagonist, with noninferiority defined as a decrease in freedom from nausea by less than 10%.

resultsA total of 690 patients were entered on this trial, 50% on each arm. The proportion of patients without nausea for the complete 5-day study period was 7.4% lower (upper limit of the one-sided 95% confidence interval was 13.5%) in the arm without an NK-1 receptor antagonist compared with the arm with an NK-1 receptor antagonist.

conclusionThis trial did not provide sufficient evidence to support that deletion of the NK-1 receptor antagonist was as good as keeping it, as a part of a 4-drug antiemetic regimen for highly emetogenic chemotherapy (ClinicalTrials.gov Identifier: NCT03578081).

Indexed as

AntiemeticsAntineoplastic AgentsAprepitantDexamethasoneDouble-Blind MethodHumansMorpholinesNauseaOlanzapineProspective StudiesReceptors, Neurokinin-1VomitingAntiemeticsAntineoplastic AgentsAprepitantDexamethasonefosaprepitantMorpholinesOlanzapineReceptors, Neurokinin-1

Identifiers

PMID37284847
PMCPMC10400142
OpenAlexW4379598859

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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.