Measuring Quality of Life in Ovarian Cancer Clinical Trials-Can We Improve Objectivity and Cross Trial Comparisons?

Abstract

Simple SummaryRegarded as the “disease that whispers” ovarian cancer remains difficult to diagnose and treat due to other complex conditions that may occur together. As research into new treatments for ovarian cancer continues, growing efforts to understand how treatments may be impact the day to day lives of women is also growing. Known as Patient Reported Outcomes or PROs and quality of life (QoL), the research community is improving how this important information communicated by women with ovarian cancer is captured across their cancer journey, and importantly, how this information can be used further refine treatments. Understanding the impact treatment has on day to day living is important, as new treatments should not only help control cancer cells, but also help keep women living with ovarian cancer living their lives to the fullest.Epithelial ovarian cancer (EOC) remains a lethal disease for the majority of women diagnosed with it worldwide. For the majority of patients, diagnosis occurs late, in the advanced setting. Disease-induced as well as treatment-related adverse events can negatively impact quality of life (QoL). Research to date has captured these data through use of patient-related outcomes (PROs) and, increasingly, has become an area of increased attention and focus in clinical trial reporting. QoL/PRO measurements in EOC clinical trials at different transition points in a patient’s journey are increasingly being recognized by patients, clinicians and regulatory agencies as the key determinants of treatment benefit. Various context-specific PROs and PRO endpoints have been described for clinical trials in EOC. Standardized approaches and checklists for incorporating PRO endpoints in clinical trials have been proposed. In a real-world clinical practice setting, PRO/QoL measures, which are meaningful, valid, reliable, feasible and acceptable to patients and clinicians, need to be implemented and used. These may assist by serving as screening tools; helping with the identification of patient preferences to aid in decision making; improving patient–provider communication; facilitating shared decision making. Importantly, they may also improve quality of care through an increasingly patient-centered approach. Potential areas of future research include assessment of anxiety, depression and other mental health issues. In good prognostic groups, such as maintenance clinical trials, following patients beyond progression will capture possible downstream effects related to delaying the psychological trauma of relapse, symptoms due to disease progression and side-effects of subsequent chemotherapy. Identifying PRO endpoints in next-generation-targeted therapies (including immunotherapies) also warrants investigation.