ES19.05 Incorporating Patient Reported Outcomes into the Lung Cancer Registry

Abstract

Coupled with advances in early detection, the rapid pace of innovation in lung cancer research is beginning to improve survival rates and extend lives for those diagnosed with lung cancer. Many more people are surviving with the disease long-term and facing new challenges (Vavala et al., Respirology, 2020). As survivorship increases, there is a growing imperative to more completely understand health-related quality of life issues that people with lung cancer are facing. This is compounded by the plethora of new treatment options – many of which do not yet have sufficient follow-up data to understand long-term side-effects and impacts on health and well-being. Patient reported outcomes are an essential part of understanding the true patient experience. Physician and patient reporting of symptomatic toxicities are often not concordant (DiMaio et al., Journal of Clinical Oncology, 2015). Incorporating patient reported symptom reporting into clinical workflow has even been demonstrated to not only reduce emergency department visits but to improve overall survival (Basch et al, Journal of Clinical Oncology, 2016). Real-world data sources like the Lung Cancer Registry (www.lungcancerregistry.org) provide access to thousands of patients globally that are living with lung cancer. Multiple studies have now been incorporated into the Lung Cancer Registry to demonstrate the feasibility and accessibility of collecting patient reported outcomes in a real-world setting as well as to better understand quality of life issues. An initial study examining the feasibility of collecting patient-reported outcomes from people diagnosed with lung cancer taking PD-1/PD-L1 immune checkpoint inhibitors in a real-world setting was performed in the Registry in 2018-2019 (Jim et al., manuscript submitted). This examination of 226 people revealed that 25% of patients experienced a treatment delay, 12% had an emergency room visit, and 9% were hospitalized due to toxicity. There was no significant difference in health-related quality of life events between the four immune checkpoint inhibitors examined. Notably, patients reported a lower overall health related quality of life, functional well-being, and emotional well-being compared to general population and cancer norms (Brucker et al., Eval Health Prof, 2005). Fatigue, aching joints, aching muscles, insomnia, shortness of breath, itching, and skin dryness were reported by more than half of study participants. These data indicate key areas of concern for those who are may be living long-term on or after treatment with immune checkpoint inhibitor therapy and underscore the importance of appropriate palliative and survivorship care. After confirming the feasibility of the immunotherapy study, the Lung Cancer Registry incorporated longitudinal tracking of patient-reported outcomes on a quarterly basis, starting in late November, 2019. Multiple stakeholders, including patients, caregivers, academic, and industry collaborators were consulted in the design of the questionnaires. After providing informed consent for an IRB-approved, observational research study, participants are asked about symptoms and side-effects every three months and complete the EORTC QLQ-C30 quality of life survey instrument (Aaronsen et al, J Natl Cancer Inst, 1993) as well as the EORTC LC-29 survey (Koller et al., Lancet Oncol, 2020). This data is coupled with patient-provided information about changes in cancer status (such as stage, recurrence, and biomarker testing) and information on treatment changes. Early analyses of these data show that the questionnaires are feasible and demonstrate expected trends, such as reduced physical functioning in stage IV patients currently taking first or second line chemotherapy compared to similar patients currently taking a targeted therapy or immunotherapy. Finally, the Lung Cancer Registry has partnered with a multidisciplinary team of investigators (including patients and patient advocates) to launch a landmark study on Women’s sexual health (https://www.iaslc.org/iaslc-news/ilcn/shawl-largest-study-its-kind-evaluates-sexual-dysfunction-women-lung-cancer). Initially prompted by patient experiences that were expressed to the principal investigator, this study utilizes PROMIS measures assessing sexual health (Flynn et al., J Sex Med, 2013) to understand sexual side effects after lung cancer treatment. To date, there is very little known on this topic. Clinical trials for new lung cancer therapeutics generally do not collect this information. The study will be actively accruing until the end of Q1 2021. The investigators aim to learn more about the problems being faced with the goal of providing effective management strategies in the future. Taken together, all of these studies underscore the need to learn directly from people living with lung cancer to ensure that we are effectively designing and implementing appropriate supportive care and side-effect management within clinical care pathways. Utilizing real-world sources such as registries to complement quality of life data being collected in lung cancer clinical trials will improve knowledge around toxicities and side-effects and can lead to new management strategics and overall improved well-being for those diagnosed with lung cancer. patient reported outcomes, quality of life, Survivorship