Evidence map›Paper›PMID 41123586›Full record

ReviewCancer2025

Analyses of adverse events and patient-reported outcomes with the toxicity index in cancer clinical trials.

Gillian Gresham, N Lynn Henry, Hanna Bandos, Vinicius F Calsavara, Reena S Cecchini, Marcio A Diniz, Ron D Hays, Michael Luu, Sungjin Kim, André Rogatko and 3 more

Abstract readReview
In one paragraph

Review in Cancer, 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

13 authors.

Gillian GreshamCedars-Sinai Medical Center, Department of Medicine, Los Angeles, California, USA.
N Lynn HenryDepartment of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0002-4771-5930
Hanna BandosNRG Oncology SDMC and the University of Pittsburgh School of Public Health, Pittsburgh, Pennsylvania, USA.
Vinicius F CalsavaraCedars-Sinai Medical Center, Biostatistics Shared Resource, Department of Computational Biomedicine, Los Angeles, California, USA.
Reena S CecchiniNRG Oncology SDMC and the University of Pittsburgh School of Public Health, Pittsburgh, Pennsylvania, USA.
Marcio A DinizDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Ron D HaysUCLA Department of Medicine, Los Angeles, California, USA.ORCID https://orcid.org/0000-0001-6697-907X
Michael LuuCedars-Sinai Medical Center, Biostatistics Shared Resource, Department of Computational Biomedicine, Los Angeles, California, USA.
Sungjin KimCedars-Sinai Medical Center, Biostatistics Shared Resource, Department of Computational Biomedicine, Los Angeles, California, USA.
André RogatkoCedars-Sinai Medical Center, Biostatistics Shared Resource, Department of Computational Biomedicine, Los Angeles, California, USA.
Greg YothersNRG Oncology SDMC and the University of Pittsburgh School of Public Health, Pittsburgh, Pennsylvania, USA.
Patricia A GanzUCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, USA.ORCID https://orcid.org/0000-0002-1841-4143
Mourad TighiouartCedars-Sinai Medical Center, Biostatistics Shared Resource, Department of Computational Biomedicine, Los Angeles, California, USA.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Elaina Harper · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
NRG Oncology Biospecimen BankU24CA196067 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Tanner J. Freeman, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$42.6M
The paradoxical roles of beta hydroxy butyrate in the liver pro-metastatic nicheP01CA233452 · NCI · CEDARS-SINAI MEDICAL CENTER · PI BHOWMICK, NEIL A., LU, SHELLY CHI-LOO · 2020 to 2024
$9.5M
Advancing Analysis and Interpretation ofAdverse Events and PROs in Cancer Clinical TrialsU01CA232859 · NCI · CEDARS-SINAI MEDICAL CENTER · PI GANZ, PATRICIA A., TIGHIOUART, MOURAD · 2018 to 2023
$3.7M
NCATS NIH HHS UL1 TR001881NCI NIH HHS P01 CA233452NCI NIH HHS U01 CA232859NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA196067NCI NIH HHS UG1 CA189867NIH HHS U01 CA232859
6 · The paper itself

Abstract

backgroundAdvancements in cancer therapies and improvements in survival have led to an increasing need to understand the impact of treatment on both severe and low-grade persisting symptoms and treatment-related toxicities. The National Cancer Institute launched the Cancer Moonshot Tolerability Consortium in 2018 to develop methods to analyze clinical and patient-reported tolerability data.

methodsThrough this initiative, the toxicity index (TI) was applied in the analysis of clinical trial tolerability data, and its performance was compared to other existing scoring methods. The TI is a tool developed to quantify the cumulative burden of all levels of clinician-graded toxicity data using Common Terminology Criteria for Adverse Events and patient-reported toxicity. This review describes the statistical properties of the TI and highlights key findings on the utility of the TI in summarizing tolerability data and its applications to existing clinical trial data.

resultsCompared to other commonly used summary measures, the TI was shown to be more efficient and increased the statistical power to detect treatment differences. The TI was also applied to existing toxicity and patient-reported symptom data from selected trials, where it was used to predict dose-limiting toxicities and treatment discontinuation. Visualization methods were explored and incorporated into interactive web-based research and patient-facing tools to enhance the interpretability and clinical utility of the TI.

conclusionIn conclusion, the TI is a useful summary measure that can be applied to a range of adverse event and patient-reported data to maximize the information collected and provide a more accurate and complete account of the tolerability experience. Future research will focus on extending applications of the TI and exploring its use for the design of clinical trials.

Indexed as

Antineoplastic AgentsDrug-Related Side Effects and Adverse ReactionsNeoplasmsPatient Reported Outcome MeasuresClinical Trials as TopicHumansAntineoplastic Agentsbiostatisticscancer clinical trialspatient‐reported outcomestoxicitytoxicity indextreatment tolerability

Identifiers

PMID41123586
PMCPMC12823264

What OpenQuestion holds

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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.