Quality of Life Endpoints in Advanced Gastrointestinal Cancer Trials: Systematic Review of Inclusion, Challenges, and Implications (2020-2024).
S Kalantri, B Kelley, J Q Freeman et al.
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In 30 seconds
This systematic review examined the inclusion of quality of life (QoL) endpoints in 80 phase III clinical trials for advanced gastrointestinal cancers. It found that 60% of trials included QoL as an endpoint, primarily as secondary or exploratory. Notably, multi-country trials had a significantly higher QoL inclusion rate of 81.1% compared to single-country trials at 41.9%.
Key findings
- 60% of the analyzed trials included QoL as an endpoint, with none as a primary endpoint.
- Multi-country trials had a QoL inclusion rate of 81.1% versus 41.9% for single-country trials (aOR, 0.15).
- Trials published in high-impact journals showed a 65.4% QoL inclusion rate compared to 48.0% in lower-impact journals.
- Biliary tract cancers had the highest QoL inclusion rate at 100%, followed by gastric and GE junction cancers at 78.6%.
Why it matters
Incorporating QoL endpoints in clinical trials is essential for understanding the holistic impact of treatments on patients with advanced gastrointestinal cancers. This review highlights significant disparities in QoL assessment inclusion, which could inform future trial designs and improve patient-centered care.