Evidence map›Paper›PMID 37801678›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Importance of Low- and Moderate-Grade Adverse Events in Patients' Treatment Experience and Treatment Discontinuation: An Analysis of the E1912 Trial.

Nathaniel S O'Connell, Fengmin Zhao, Ju-Whei Lee, Edward H Ip, John Devin Peipert, Noah Graham, Mary Lou Smith, Ilana F Gareen, Ruth C Carlos, Samilia Obeng-Gyasi and 6 more

Open access · hybridAbstract read
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
14.7field-weighted citation impact, top 1% 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

24 citing papers in PubMed, 44 citations in OpenAlex.

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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

16 authors at 9 institutions in 1 country.

Nathaniel S O'ConnellWake Forest University School of Medicine, Winston-Salem, NC.ORCID 0000-0002-3827-5152
Fengmin ZhaoDana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, MA.
Ju-Whei LeeDana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, MA.ORCID 0000-0003-2068-8511
Edward H IpWake Forest University School of Medicine, Winston-Salem, NC.ORCID 0000-0002-4811-4205
John Devin PeipertNorthwestern University Feinberg School of Medicine, Chicago, IL.ORCID 0000-0001-5762-7881
Noah GrahamDana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, MA.
Mary Lou SmithResearch Advocacy Network, Chicago, IL.
Ilana F GareenDepartment of Epidemiology and the Center for Statistical Sciences, Brown University School of Public Health, Providence, RI.ORCID 0000-0002-0457-5595
Ruth C CarlosUniversity of Michigan Comprehensive Cancer Center, Ann Arbor, MI.ORCID 0000-0001-7055-7662
Samilia Obeng-GyasiThe Ohio State University, Columbus, OH.ORCID 0000-0002-5330-7247
Joseph A SparanoIcahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY.ORCID 0000-0002-9031-2010
Tait D ShanafeltStanford Center Institute Palo Alto, Stanford, CA.ORCID 0000-0002-7106-5202
Mary L ThomasVA Palo Alto Health Care System, Palo Alto, CA.
David CellaNorthwestern University Feinberg School of Medicine, Chicago, IL.ORCID 0000-0002-9881-4541
Lynne I WagnerWake Forest University School of Medicine, Winston-Salem, NC.ORCID 0000-0001-9685-4796
Robert GrayDana Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, MA.ORCID 0000-0002-5724-4917
ECOG-ACRIN Cancer Research Group · USWake Forest University · USNorthwestern University · USBrown University · USResearch Advocacy Network · USThe Ohio State University · USTisch Cancer InstituteUniversity of Michigan · USVA Palo Alto Health Care System · US

Funding

ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
Analysis of ECOG-ACRIN adverse event data to optimize strategies for the longitudinal assessment of tolerability in the context of evolving cancer treatment paradigms (EVOLV)U01CA233169 · NCI · DANA-FARBER CANCER INST · PI GRAY, ROBERT J, WAGNER, LYNNE I. · 2018 to 2023
$3.4M
NCI NIH HHS U01 CA233169NCI NIH HHS U10 CA180820NCI NIH HHS UG1 CA189828NCI NIH HHS UG1 CA233160NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

purposeDespite defined grades of 1 to 5 for adverse events (AEs) on the basis of Common Terminology Criteria for Adverse Events criteria, mild (G1) and moderate (G2) AEs are often not reported in phase III trials. This under-reporting may inhibit our ability to understand patient toxicity burden. We analyze the relationship between the grades of AEs experienced with patient side-effect bother and treatment discontinuation

methodsWe analyzed a phase III Eastern Cooperative Oncology Group-American College of Radiology Imaging Network trial with comprehensive AE data. The Likert response Functional Assessment of Cancer Therapy-GP5 item, "I am bothered by side effects of treatment" was used to define side-effect bother. Bayesian mixed models were used to assess the impact of G1 and G2 AE counts on patient side-effect bother and treatment discontinuation. AEs were further analyzed on the basis of symptomatology (symptomatic or asymptomatic). The results are given as odds ratios (ORs) and 95% credible interval (CrI).

resultsEach additional G1 and G2 AEs experienced during a treatment cycle increased the odds of increased self-reported patient side-effect bother by 13% (95% CrI, 1.06 to 1.21) and 35% (95% CrI, 1.19 to 1.54), respectively. Furthermore, only AEs defined as symptomatic were associated with increased side-effect bother, with asymptomatic AEs showing no association regardless of grade. Count of G2 AEs increased the odds of treatment discontinuation by 59% (95% CrI, 1.32 to 1.95), with symptomatic G2 AEs showing a stronger association (OR, 1.75; 95% CrI, 1.28 to 2.39) relative to asymptomatic G2 AEs (OR, 1.45; 95% CrI, 1.12 to 1.89).

conclusionLow- and moderate-grade AEs are related to increased odds of increased patient side-effect bother and treatment discontinuation, with symptomatic AEs demonstrating greater magnitude of association than asymptomatic. Our findings suggest that limiting AE capture to grade 3+ misses important contributors to treatment side-effect bother and discontinuation.

Indexed as

Bayes TheoremHumansSelf Report

Identifiers

PMID37801678
PMCPMC10824381
OpenAlexW4387396510

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.