Evidence map›Paper›PMID 33766818›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

Interim Analysis of the Phase II Study: Noninferiority Study of Doxorubicin with Upfront Dexrazoxane plus Olaratumab for Advanced or Metastatic Soft-Tissue Sarcoma.

Brian A Van Tine, Angela C Hirbe, Peter Oppelt, Ashley E Frith, Richa Rathore, Joshua D Mitchell, Fei Wan, Shellie Berry, Michele Landeau, George A Heberton and 8 more

Open access · bronzeAbstract readClinical Trial, Phase IIEquivalence Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

15 citing papers in PubMed, 20 citations in OpenAlex.

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  14. Fatal heart disease in patients with bone and soft tissue sarcoma.Frontiers in cardiovascular medicine · 2022
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 3 institutions in 1 country.

Brian A Van TineDivision of Medical Oncology, Washington University in St. Louis, St. Louis, Missouri. bvantine@dom.wustl.edu rkrone@wustl.edu.ORCID 0000-0003-4572-6668
Angela C HirbeDivision of Medical Oncology, Washington University in St. Louis, St. Louis, Missouri.ORCID 0000-0003-1719-0771
Peter OppeltDivision of Medical Oncology, Washington University in St. Louis, St. Louis, Missouri.
Ashley E FrithDivision of Medical Oncology, Washington University in St. Louis, St. Louis, Missouri.
Richa RathoreDivision of Medical Oncology, Washington University in St. Louis, St. Louis, Missouri.ORCID 0000-0003-3708-8758
Joshua D MitchellSiteman Cancer Center, St. Louis, Missouri.ORCID 0000-0001-7371-5742
Fei WanDepartment of Biostatistics, Washington University in St. Louis, St. Louis, Missouri.
Shellie BerryDivision of Medical Oncology, Washington University in St. Louis, St. Louis, Missouri.
Michele LandeauDivision of Medical Oncology, Washington University in St. Louis, St. Louis, Missouri.
George A HebertonTexas Heart Institute/Baylor College of Medicine, Houston, Texas.ORCID 0000-0002-6203-5562
John GorcsanEchocardiographic Core Laboratory, Washington University in St. Louis, St. Louis, Missouri.
Peter R HuntjensEchocardiographic Core Laboratory, Washington University in St. Louis, St. Louis, Missouri.ORCID 0000-0002-1845-6837
Yoku SoyamaEchocardiographic Core Laboratory, Washington University in St. Louis, St. Louis, Missouri.
Justin M VaderDivision of Cardiology, Washington University in St. Louis, St. Louis, Missouri.ORCID 0000-0002-8198-3437
Jose A Alvarez-CardonaCardio-Oncology Center of Excellence, Washington University in St. Louis, St. Louis, Missouri.
Kathleen W ZhangCardio-Oncology Center of Excellence, Washington University in St. Louis, St. Louis, Missouri.ORCID 0000-0002-5033-6798
Daniel J LenihanSiteman Cancer Center, St. Louis, Missouri.ORCID 0000-0001-9458-0154
Ronald J KroneCardio-Oncology Center of Excellence, Washington University in St. Louis, St. Louis, Missouri. bvantine@dom.wustl.edu rkrone@wustl.edu.
Washington University in St. Louis · USSt. Louis Children's Hospital · USBaylor College of Medicine · US

Funding

Washington University Center for Cellular ImagingP30CA091842 · NCI · WASHINGTON UNIVERSITY · PI AIMEE S JAMES · 2001 to 2026
$128.0M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
USING ARGININE METABOLIC THERAPIES FOR SARCOMAR01CA227115 · NCI · WASHINGTON UNIVERSITY · PI VAN TINE, BRIAN ANDREW · 2019 to 2023
$1.8M
NCATS NIH HHS UL1 TR002345NCI NIH HHS P30 CA091842NCI NIH HHS R01 CA227115
6 · The paper itself

Abstract

purposeTo report the interim analysis of the phase II single-arm noninferiority trial, testing the upfront use of dexrazoxane with doxorubicin on progression-free survival (PFS) and cardiac function in soft-tissue sarcoma (STS). PATIENTS AND

methodsPatients with metastatic or unresectable STS who were candidates for first-line treatment with doxorubicin were deemed eligible. An interim analysis was initiated after 33 of 65 patients were enrolled. Using the historical control of 4.6 months PFS for doxorubicin in the front-line setting, we tested whether the addition of dexrazoxane affected the efficacy of doxorubicin in STS. The study was powered so that a decrease of PFS to 3.7 months would be considered noninferior. Secondary aims included cardiac-related mortality, incidence of heart failure/cardiomyopathy, and expansion of cardiac monitoring parameters including three-dimensional echocardiography. Patients were allowed to continue on doxorubicin beyond 600 mg/m

resultsAt interim analysis, upfront use of dexrazoxane with doxorubicin demonstrated a PFS of 8.4 months (95% confidence interval: 5.1-11.2 months). Only 3 patients were removed from study for cardiotoxicity, all on > 600 mg/m

conclusionsAt interim analysis, dexrazoxane did not reduce PFS in patients with STS treated with doxorubicin. Involvement of cardio-oncologists is beneficial for the monitoring and safe use of high-dose anthracyclines in STS.

Indexed as

AgedAntibodies, MonoclonalAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDexrazoxaneDisease-Free SurvivalDoxorubicinFemaleHeartHumansMaleMiddle AgedNeoplasm StagingProspective StudiesSarcomaSoft Tissue NeoplasmsAntibodies, MonoclonalAntineoplastic AgentsDexrazoxaneDoxorubicinolaratumab

Identifiers

PMID33766818
PMCPMC8282681
OpenAlexW3136371246

What OpenQuestion holds

Textmetadata
LicenceTDM
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.