A new policy review published in The Lancet Oncology and led by Ian Tannock and Madeline Pe,¹ together with an international team of oncologists, statisticians, patients and patient-reported outcomes (PRO) experts from Common Sense Oncology (CSO) and the European Organisation for Research and Treatment of Cancer (EORTC), emphasises the critical role of health-related quality of life (HRQoL) data in the evaluation of treatments for people with advanced cancer.

This publication highlights the importance of having standardised responder criteria when evaluating HRQoL in clinical trials to improve patient care and clinical decision-making.

Key findings:

1. Focus on patient-centred 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.

2. Defining HRQoL as symptoms, functioning and overall HRQoL: The authors advocate for defining HRQoL as a patient-reported multi-dimensional outcome that should include assessment of symptoms (disease- and/or treatment-related), different functioning domains (e.g. physical, role, social) and an overall HRQoL measure (to assess the net clinical benefit of the benefits/harms of a treatment).
3. 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.
4. 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.
5. 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 Prof. Ian F.Tannock, co-lead author of the study.

"By bringing oncologists, patient representatives, statisticians and PRO 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 Dr Madeline Pe, co-lead author of the policy review and head of the EORTC Quality of Life Department.

"At EORTC, we strive to build global collaborations to drive progress in cancer research and patient care, including in the challenging situation of metastatic disease or non-resectable cancer. Our mission is to improve both the survival and quality of life of cancer patients, and we are proud to publish this new policy review encompassing some of the EORTC key priorities for the future," concluded Prof. Winette van der Graaf, EORTC President and last author.

¹ Ian F Tannock, Madeline Pe et al., Importance of responder criteria for reporting health-related quality-of-life data in clinical trials for advanced cancer: recommendations of Common Sense Oncology and the European Organisation for Research and Treatment of Cancer, The Lancet Oncology, Volume 26, Issue 9,2025, Pages e499-e507, ISSN 1470-2045, https://doi.org/10.1016/S1470-2045(25)00288-8.

Source: European Organisation for Research and Treatment of Cancer