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.

Keywords:

• ovarian cancer
• patient-reported outcomes
• clinical trials
• clinical practice

Access to PRO Measures for Ovarian Cancer

• FACT-G: https://www.facit.org/measures/FACT-G

• FACT-O: https://www.facit.org/measures/FACT-O

• FOSI: https://www.facit.org/measures/FOSI

• MOST-S26: https://gcigtrials.org/content/most

• MOST-T35: https://gcigtrials.org/content/most

• MOST-T24: https://gcigtrials.org/content/most

• PRO-CTCAE: https://healthcaredelivery.cancer.gov/pro-ctcae/

• QLQ-C30: https://qol.eortc.org/questionnaire/eortc-qlq-c30/

• QLQ-OV28: https://qol.eortc.org/questionnaire/qlq-ov28/

Acknowledgments

We would like to acknowledge the key role of both the Australia New Zealand Gynecological Group (ANZGOG), NHMRC Clinical Trials Centre and the Gynecological Cancer InterGroup (GCIG) in supporting the GCIG Symptom Benefit Study and the development of the Measure of Ovarian Symptoms and Treatment concerns (MOST).

Disclosure

Professor Martin R Stockler reports grants from AMGEN, grants from ASTELLAS, grants from AstraZeneca, grants from Bayer, grants from Beigene, grants from BMS, grants from Medivation, grants from MSD, grants from Novartis, grants from Pfizer, grants from Roche, grants from Sanofi, grants from Tilray, outside the submitted work. Professor Michael L Friedlander reports grants, personal fees, is a member of Advisory boards received fees for lectures and travel from ASTRA ZENECA, personal fees from MSD, personal fees from TAKEDA, personal fees from LILLY, personal fees from EISEI, is an Advisory Board-not compensated for INCYCLIX, personal fees from GSK, grants from Novartis, grants from BEIGENE, outside the submitted work; The authors report no other conflicts of interest in this work.

Additional information

Funding

This review was supported by an NHMRC program grant (APP1092856).