ArticleCancer2025
Overall side-effect bother consistently associated with early treatment discontinuation due to adverse events in four clinical trials with various cancer types and treatments.
Article in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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.
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.
Who cites it
3 citing papers in PubMed.
- Case Report: A case of superficial spreading malignant melanoma with sentinel lymph node metastasis misdiagnosed as "pigmented nevus".Frontiers in immunology · 2026Article
- National Cancer Institute Cancer Treatment Tolerability Consortium: Current status and future directions.Cancer · 2025Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
Abstract
backgroundOverall side-effect impact, the aggregated experience of multiple toxicities, can be captured with the single Functional Assessment of Cancer Therapy (FACT) item GP5 ("I am bothered by side effects of treatment"). The objective of this study was to evaluate the ability of item GP5 to indicate treatment tolerability by examining its association with early treatment discontinuation (ETD) due to adverse events (AEs) in four cancer trials.
methodsThe authors analyzed data from four clinical trials coordinated by the ECOG-ACRIN Cancer Research Group, covering breast cancer (E1Z11, all patients received anastrozole; E1Z03, compared anastrozole vs. exemestane), melanoma (E1609, compared ipilimumab vs. high-dose interferon α), and chronic lymphocytic leukemia (E1912, compared ibrutinib-rituximab bs. standard chemoimmunotherapy). In each trial, GP5 responses were categorized as severe bother (i.e., "very much"/"quite a bit") versus moderate/low bother ("somewhat"/"a little bit"/"not at all").
resultsAt 3 months, significant associations were observed in each trial, indicating approximately 2.8-6.8 times greater odds of ETD among patients reporting severe bother (E1Z03: adjusted odds ratio [aOR], 2.82; 95% confidence interval [95% CI], 1.10-7.28; E1Z11: aOR, 4.10; 95% CI, 1.69-10.00; E1609: aOR, 6.77; 95% CI, 2.88-15.92; E1912: aOR, 4.15; 95% CI, 1.64-10.49).
conclusionsThese results support prior research demonstrating an association between severe side-effect bother, as reported on responses to the GP5 item, and ETD among patients with newly diagnosed multiple myeloma. The consistent association between GP5 responses and ETD suggests the GP5's ability to capture how well patients tolerate treatment, especially when side-effect bother is observed early in the course of treatment, and signals an opportunity to develop interventions to promote treatment adherence.
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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.