Evidence map›Paper›PMID 39778122›Full record

ArticleJCO oncology practice2025

Incomplete Toxicity Reporting and Use of Toxicity-Minimizing Language in Phase III Oncology Trials.

Avital M Miller, Adina H Passy, Alexander D Sherry, Ramez Kouzy, Joseph Abi Jaoude, Timothy A Lin, Gabrielle S Kupferman, Esther J Beck, Pavlos Msaouel, Ethan B Ludmir

Abstract read
In one paragraph

Article in JCO oncology practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

10 authors.

Avital M MillerDepartment of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0009-0007-4072-1442
Adina H PassyDepartment of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-8626-8969
Alexander D SherryDepartment of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-5115-1691
Ramez KouzyDepartment of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-1521-0495
Joseph Abi JaoudeDepartment of Radiation Oncology, Stanford University, Stanford, CA.
Timothy A LinDepartment of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-4183-9120
Gabrielle S KupfermanDepartment of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-2088-4395
Esther J BeckDepartment of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0009-0009-6821-8966
Pavlos MsaouelDepartment of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-6505-8308
Ethan B LudmirDepartment of Gastrointestinal Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-5472-5344

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeThis study aimed to determine complete toxicity reporting (CTR), and the use of subjective toxicity-minimizing language (TML) among phase III oncology trials.

methodsTwo-arm superiority-design phase III oncology trials published from 2002 to 2020 were reviewed for toxicity data. CTR was defined as reporting total adverse events (TAEs), total serious adverse events (SAEs), total deaths, and study therapy discontinuations because of toxicity. Guideline concordance was defined according to guidelines published in the

resultsA total of 407 trials enrolling 322,645 patients were included. Most (51%, n = 207) reported SAEs, 88% (n = 358) reported total deaths, and 84% (n = 340) reported study therapy discontinuation because of toxicity. Although 55% of trials (n = 223) reported TAEs, only 32% (n = 131; 95% credible interval, 28 to 37) fit the criteria for CTR. CTR was more common in trials with industry sponsorship (37%) than with cooperative group sponsorship (4%). All 131 trials where CTR was observed were industry-sponsored, and only 3% (4/131) were cooperative group-sponsored trials. TML was used in 46% of trials (n = 186; 95% credible interval, 41 to 51), with no trial-related factors (including sponsorship source) associated with the odds of TML use.

conclusionToxicity in phase III oncology clinical trials is often incompletely reported and is frequently minimized in its interpretation. Industry-sponsored trials more comprehensively report toxicity than do cooperative group-sponsored trials. CTR may improve patients' and oncologists' understanding of new treatments; thus, a more standardized approach to reporting toxicity data is needed.

Indexed as

Adverse Drug Reaction Reporting SystemsAntineoplastic AgentsClinical Trials, Phase III as TopicDrug-Related Side Effects and Adverse ReactionsMedical OncologyNeoplasmsHumansLanguageAntineoplastic Agents

Identifiers

PMID39778122
PMCPMC12247493

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.