Patient-Reported Outcomes in Ovarian Cancer: Facilitating and Enhancing the Reporting of Symptoms, Adverse Events, and Subjective Benefit of Treatment in Clinical Trials and Clinical Practice

Abstract

Patient-reported outcomes (PROs) provide a valid, standardized way of assessing symptoms, adverse events and the subjective benefit of treatment from the patient's perspective. Assessment of PROs is critical in ovarian cancer due to the high morbidity of the disease and its treatments. Several well-validated PRO measures are available to assess PROs in ovarian cancer. Their inclusion in clinical trials can provide evidence on the benefits and harms of new treatments based on patients' experiences to guide improvements in clinical practice and health policy. Aggregate PRO data collected in clinical trials can be used to inform patients about likely treatment impacts and assist them to make informed treatment decisions. In clinical practice, PRO assessments can facilitate monitoring of a patient's symptoms throughout treatment and follow-up to guide their clinical management; in this context, an individual patient's responses can facilitate communication with their treating clinician about troublesome symptoms and their impact on their quality of life. This literature review aimed to provide clinicians and researchers with a better understanding of why and how PROs can be incorporated into ovarian cancer clinical trials and routine clinical practice. We discuss the importance of assessing PROs throughout the ovarian cancer disease and treatment trajectory in both clinical trials and clinical practice, and provide examples from existing literature to illustrate the uses of PROs as the goals of treatment change in each setting.

Hidden in plain sight – Survival consequences of baseline symptom burden in women with recurrent ovarian cancer

“…We tested for the difference in score distributions between PRR-ROC versus PPS-ROC≥3 groups with the Wilcoxon-rank sum tests. Second, we calculated the proportion of patients who rated their experience as 'none at all' (0), mild [1][2][3], moderate [4][5][6], and severe [7][8][9][10], testing differences between the groups with ordinal Chi-squared tests. Third, we summarised cumulative symptom burden by calculating the number of symptoms each patient reported as moderate or severe (i.e.…”

“…The high symptom burden experienced by patients with ROC underscores the importance of collecting, documenting and addressing patient reported symptoms not only in clinical trials but in routine clinical practice as well [7]. Many of these symptoms may be controlled or reduced if recognised and effort taken to manage them rather than rely on chemotherapy alone to palliate symptoms given the relatively low response rates.…”

“…The MOST-T35 contains 35 items: 2 assess abdominal symptoms most likely caused by ovarian cancer, 18 assess symptoms that may be caused by ovarian cancer and chemotherapy, 6 assess chemotherapy-related side-effects, 6 assess treatment-related concerns, and 3 assess well-being (physical, emotional, and overall) [16]. Symptoms and treatment-related concerns are rated on a numeric rating scale with integers from zero to 10, with five verbal anchors: 'No trouble at all' (0), 'Mild' [1][2][3], 'Moderate' [4][5][6], 'Severe' [7][8][9][10], and 'Worst I can imagine' [10]. The 3 well-being items range from 0 ('worst possible') to 10 ('best possible').…”

“…Furthermore, there is discordance between clinician and patient reporting, rating/grading of cancer related symptoms and adverse effects of treatment which argues for prioritising analysing and reporting patient reported outcomes in clinical trials [4,5]. There is growing evidence to support the importance of recognising and treating troublesome symptoms experienced by patients receiving palliative treatment as prompt and effective interventions can lead to improved HRQL, reduced hospitalisations and allow patients to continue systemic therapy for longer [6,7]. For example, in patients with advanced lung cancer, early involvement of the palliative care team, and prompt management of symptoms not only resulted in improved HRQL, but also was associated with an increase in survival [8].…”

The comparison of functional status and health-related parameters in ovarian cancer survivors with healthy controls

“…The development of various treatment strategies also improved survival rates in OC during the last 20 years [ 3 ]. Thus, the importance of evaluating short- and long-term consequences of disease-related conditions and treatment side effects increases as both a clinical and a research endpoint with increased early detection and survival rates in OC [ 4 , 5 ].…”