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Patient-reported outcomes as end points and outcome indicators in solid tumours.
Angeles A Secord1, Robert L Coleman2, Laura J Havrilesky1
1Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, NC 27710, USA.
Patient-reported outcomes (PROs) are increasingly vital in cancer care, offering insights beyond traditional clinical endpoints. Integrating PROs with tumor data can improve understanding of treatment benefits for patients and clinicians.
Area of Science:
- Oncology
- Clinical Trials
- Health Outcomes Research
Background:
- Patient-reported outcome (PRO) measures, including quality of life, are linked to clinical endpoints and survival in adult solid cancers.
- PROs are gaining influence, challenging traditional endpoints that may not fully capture therapy benefits, risks, and costs.
Purpose of the Study:
- To review the correlation between PROs and treatment response and survival in cancer clinical trials.
- To explore composite endpoints that integrate tumor-related and patient-centric data.
Main Methods:
- Comprehensive literature review assessing the association of PROs with clinical outcomes.
- Exploration of composite endpoint methodologies in cancer clinical trials.
Main Results:
- PROs demonstrate prognostic value and association with clinical endpoints in various adult solid cancers.
- PROs provide a more holistic view of therapeutic impact compared to traditional endpoints alone.
Conclusions:
- Composite endpoints combining tumor-related and PRO data can enhance understanding of overall therapeutic benefit.
- These integrated endpoints can aid healthcare providers, patients, and decision-makers in evaluating cancer interventions.
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