Evidence map›Paper›PMID 37665777›Full record

Trial reportThe oncologist2023

Left Ventricular Ejection Fraction in Patients With Ovarian Cancer Treated With Avelumab, Pegylated Liposomal Doxorubicin, or Both.

Marc P Bonaca, Javid J Moslehi, Jonathan A Ledermann, Elisabete Michelon, Caimiao Wei, Michael Moran, Bradley J Monk, Eric Pujade-Lauraine

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 NCT02580058 (A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.3field-weighted citation impact, top 34% 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.

NCT02580058 phase3completednot on this map

A phase 3, multicenter, randomized, open-label study of avelumab (msb0010718c) alone or in combination with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum-resistant/refractory ovarian cancer

TypeinterventionalSponsorPfizerRan2015 to 2022Enrolled566ConditionsOvarian CancerArmsavelumab, PLD
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

8 authors at 7 institutions in 4 countries.

Marc P BonacaColorado Prevention Center Clinical Research, Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
Javid J MoslehiSection of Cardio-Oncology and Immunology, Division of Cardiology and the Cardiovascular Research Institute, UCSF School of Medicine, Cardiovascular Research Institute (CVRI), San Francisco, CA, USA.
Jonathan A LedermannUCL Cancer Institute and UCL Hospitals, London, UK.
Elisabete MichelonPfizer, New York, NY, USA.
Caimiao WeiPfizer, Groton, CT, USA.
Michael MoranPfizer Pharma GmbH, Berlin, Germany (Affiliation at the time the research was conducted).
Bradley J MonkArizona Oncology (US Oncology Network), University of Arizona and Creighton University, Phoenix, AZ, USA.
Eric Pujade-LauraineARCAGY-GINECO, Paris, France.
Pfizer (United States) · USArcagy Gineco · FRCardiovascular Institute of the South · USPfizer (Germany) · DEUniversity College London · GBUniversity of Arizona · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the phase III JAVELIN Ovarian 200 trial, 566 patients with platinum-resistant/refractory ovarian cancer were randomized 1:1:1 to receive avelumab alone, avelumab plus pegylated liposomal doxorubicin (PLD), or PLD alone. Cardiac monitoring was included for all patients. We report left ventricular ejection fraction (LVEF) data from the trial. Grade ≥3 cardiac adverse events (AEs) occurred in 4 (2.1%), 1 (0.5%), and 0 patients in the avelumab, combination, and PLD arms, respectively. LVEF decreases of ≥10% to below institutional lower limit of normal at any time during treatment were observed in 1 (0.8%), 3 (1.9%), and 2 (1.5%) patients, respectively; 4 had subsequent assessments, and these showed transient decreases. No patient had a cardiovascular AE related to LVEF decrease. This analysis is, to our knowledge, the first analysis of LVEF in patients receiving immune checkpoint inhibitors. CLINICALTRIALS.GOV IDENTIFIER: NCT02580058.

Indexed as

Ovarian NeoplasmsVentricular Function, LeftAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialDoxorubicinFemaleHumansPolyethylene GlycolsStroke VolumeAntibodies, Monoclonal, HumanizedavelumabDoxorubicinliposomal doxorubicinPolyethylene Glycolscarcinomaclinical trialimmune checkpoint inhibitorsimmunotherapyleftovarian epithelialphase IIIventricular function

Identifiers

PMID37665777
PMCPMC10546816
OpenAlexW4386415056

What OpenQuestion holds

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LicenceCC BY
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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.