A new policy review published by Tannock et al in The Lancet Oncology emphasizes the critical role of health-related quality-of-life (HRQoL) data in the evaluation of treatments for people with advanced cancer. The publication highlights the importance of having standardized responder criteria when evaluating HRQoL in clinical trials to improve patient care and clinical decision-making.
The review was put together by an international team of oncologists, statisticians, patients, and patient-reported outcomes experts from Common Sense Oncology (CSO) and the European Organisation for Research and Treatment of Cancer (EORTC).
Key findings of the review include:
- Focus on patient-centered outcomes: The paper highlights the need for clinical trials to evaluate HRQoL as at least a key secondary outcome for people with advanced cancer alongside traditional clinical endpoints like overall survival. This approach evaluates whether new treatments not only extend life but also improve the quality of life for patients.
- Defining HRQoL as symptoms, functioning, and overall HRQoL: The authors advocate for defining HRQoL as a patient-reported multidimensional outcome that should include assessment of symptoms (disease- and/or treatment-related), different functioning domains (eg, physical, role, social) and an overall HRQoL measure (to assess the net clinical benefit of the benefits/harms of a treatment).
- Responder criteria for HRQoL: The researchers recommend using responder criteria to report HRQoL data. This means evaluating the proportion of patients who experience significant improvement or deterioration in their quality of life, making the data more relevant and understandable for both clinicians and patients.
- Involvement of patients in trial design: The study underscores the importance of involving patients in the design of clinical trials, particularly in defining which HRQoL domains to measure. This ensures that the outcomes assessed are those that matter most to patients.
- Reporting and interpretation of HRQoL data: The review calls for having HRQoL results published in the main trial publication, highlighting the proportion of patients who show meaningful improvements in HRQoL. It also advocates for clear and consistent reporting of HRQoL data in clinical trial publications, which can aid in better clinical decision-making.
“Our goal is to ensure that the benefits of cancer treatments are fully understood not just in terms of survival, but also in how they impact patients’ day-to-day lives,” said Ian F. Tannock, MD, PhD, co-lead author of the study.
“By bringing oncologists, patient representatives, statisticians, and patient-reported outcomes experts to the table, we were able to reach common ground on how the HRQoL results should be presented. This will allow oncologists to discuss with their patients the impact of treatments on quality of life, supporting shared decision-making,” added Madeline Pe, PhD, co-lead author of the policy review and head of the EORTC Quality of Life Department.
Disclosure: For full disclosures of the study authors, visit thelancet.com.
