Evidence map›Paper›PMID 40542609›Full record

ArticleInternational journal of cancer2025

Patient-reported outcome thresholds and their associations with survival, adverse events, and quality of life in a pooled analysis of breast cancer trials.

Bradley D Menz, Natansh D Modi, Ahmad Y Abuhelwa, Nicole M Kuderer, Gary H Lyman, Sandra M Swain, Ganessan Kichenadasse, Adel Shahnam, Mark Haseloff, Agnes Vitry and 7 more

Abstract read
In one paragraph

Article in International journal of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

17 authors.

Bradley D MenzCollege of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.ORCID 0000-0002-0855-5081
Natansh D ModiCollege of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.
Ahmad Y AbuhelwaDepartment of Pharmacy Practice and Pharmacotherapeutics, College of Pharmacy, University of Sharjah, Sharjah, United Arab Emirates.ORCID 0000-0002-4182-065X
Nicole M KudererAdvanced Cancer Research Group, Kirkland, Washington, USA.
Gary H LymanDepartment of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Sandra M SwainGeorgetown Lombardi Comprehensive Cancer Center and MedStar Health, Washington, DC, USA.
Ganessan KichenadasseCollege of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.
Adel ShahnamMedical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.
Mark HaseloffConsumer Advisory Group, Clinical Cancer Epidemiology Group, College of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.
Agnes VitryConsumer Advisory Group, Clinical Cancer Epidemiology Group, College of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.
Elke RammantDepartment of Human Structure and Repair, Ghent University, Ghent, Belgium.
Imogen RamseyCaring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, Australia.
Raymond J ChanCaring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, Australia.
Ross A McKinnonCollege of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.
Andrew RowlandCollege of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.
Michael J SorichCollege of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.ORCID 0000-0003-1999-866X
Ashley M HopkinsCollege of Medicine and Public Health, Flinders Health and Medical Research Institute, Flinders University, Adelaide, Australia.ORCID 0000-0001-7652-4378

Funding

Hospital Research Foundation 2023-S-DTFA-005Medical Research CouncilNational Health and Medical Research Council APP2008119National Health and Medical Research Council APP2030913Tour de Cure RSP-117-FY2023
6 · The paper itself

Abstract

Researchers at the EORTC recently recommended clinical thresholds for the QLQ-C30 to facilitate actionable insights in clinical practice. We evaluate the distribution of these thresholds and associations with outcomes in breast cancer. Data were pooled from two early-stage and six advanced-stage breast cancer trials. EORTC thresholds were applied to available QLQ-C30 data to identify clinically important PRO domains. Associations between the number of clinically important PRO domains at baseline with overall survival (OS), invasive-disease-free survival (IDFS), progression-free survival (PFS), grade ≥3 adverse events (AEs), and serious AEs were evaluated using Cox-regression. Data from 8544 breast cancer patients, of whom 2428 (41%) of the 5893 early-stage and 1486 (56%) of the 2651 advanced-stage patients reported ≥3 clinically important PRO domains. In the early-stage, each additional clinically important PRO domain was associated with worsened grade ≥3 AEs (HR, 1.03 [95%CI, 1.01-1.04], p = 0.001) and serious AEs (1.05 [1.03-1.07], p < 0.001). In the advanced-stage, each additional clinically important PRO domain was associated with worsened OS (1.05 [1.03-1.07], p < 0.001), PFS (1.03 [1.01-1.04], p = 0.002), grade ≥3 AEs (1.04 [1.02-1.06], p < 0.001), and serious AEs (1.07 [1.04-1.11], p < 0.001). A substantial proportion of breast cancer patients report clinically important PRO domains at baseline, with increasing numbers associated with worsening AEs, survival, and quality-of-life.

Indexed as

Breast NeoplasmsPatient Reported Outcome MeasuresQuality of LifeAdultAgedFemaleHumansMiddle AgedProgression-Free Survivalbreast cancercancerEORTCpatient‐reported outcomessurvival outcomes

Identifiers

PMID40542609
PMCPMC12439079

What OpenQuestion holds

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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.