A new measure of function in older adults with cancer

Abstract

In The Lancet Healthy Longevity, Wee Kheng Soo and colleagues introduce the Elderly Function Index (ELFI), a new 12-item tool summarising four facets of patient function and applicable to both research and clinical care of older adults with cancer.1Soo WK King M Pope A et al.The Elderly Functional Index (ELFI), a patient-reported outcome measure of functional status in patients with cancer: a multicentre, prospective validation study.Lancet Healthy Longev. 2020; (published online Dec 17.)https://doi.org/10.1016/S2666-7568(20)30036-2Summary Full Text Full Text PDF Scopus (2) Google Scholar The authors present the results of rigorous psychometric testing, validating the measure in a cohort of more than 600 adults with cancer. ELFI encompasses self-reported physical functioning, role functioning, social functioning, and mobility, captured by nine items from the European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) and three items from the QLQ-ELD14, a supplementary measure addressing age-specific concerns. The authors show excellent reliability (internal consistency and test–retest reliability) and construct validity of this new measure, as both a quality-of-life endpoint in clinical trials as well as a tool for clinicians in clinical practice to monitor and assess the effects of cancer treatments on older patients' general functioning. Is there really need for another measure of function? Performances status is a crude measure of function used by oncologists to categorise the proportion of time spent out of bed and the types of activity an individual is able to perform. Patient-reported performance status measures exist, but most commonly, health-care providers assign a performance status score, summarising their appraisal of the patient's daily function. While widely used in oncology clinics and nearly universally used as an eligibility criterion in cancer clinical trials, clinician-reported performance status has serious limitations for its utility as an outcome measure. Inter-rater reliability between different clinicians rating a patient's performance status is suboptimal, and clinicians tend to rate patients' function as better than patients would rate it themselves.2Schnadig ID Fromme EK Loprinzi CL et al.Patient-physician disagreement regarding performance status is associated with worse survivorship in patients with advanced cancer.Cancer. 2008; 113: 2205-2214Crossref PubMed Scopus (87) Google Scholar Physician-reported performance status tends to be statistically associated with patient-reported outcomes of function, but the associations are often moderate at best and underestimate the level of vulnerability or impairment in older adults.3Atkinson TM Andreotti CF Roberts KE Saracino RM Hernandez M Basch E The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review.Support Care Cancer. 2015; 23: 3645-3652Crossref PubMed Scopus (32) Google Scholar Thus, a measure of function that is patient reported and specific to older adults is greatly needed. ELFI represents a major stride forwards in the efforts to advance the science of geriatric oncology. Traditionally, oncology clinical trials have focused on disease-centric outcomes, such as tumour responses or time to progression or death. However, most older adults prioritise other health outcomes over length of survival. In seminal work by Terri Fried nearly two decades ago, three quarters of older adults with shortened life expectancy due to cancer stated that they would forego a low-burden treatment if it resulted in severe functional impairment.4Fried TR Bradley EH Towle VR Allore H Understanding the treatment preferences of seriously ill patients.N Engl J Med. 2002; 346: 1061-1066Crossref PubMed Scopus (963) Google Scholar More recently, in a cohort of older adults with cancer, Enrique Soto-Peres-de-Celis showed that 58% preferred maintaining the ability to care for themselves over living as long as possible.5Soto-Perez-de-Celis E Li D Sun C-L et al.Patient-defined goals and preferences among older adults with cancer starting chemotherapy.Proc Am Soc Clin Oncol. 2018; 36 (abstr).10009Crossref Google Scholar A number of organisations, including the International Society of Geriatric Oncology, the EORTC, the Cancer & Aging Research Group, and the Food and Drug Administration, have called for investigators to consider a broader view in designing clinical trials in order to encompass outcomes of importance to older adults, particularly function.6Wildiers H Mauer M Pallis A et al.End points and trial design in geriatric oncology research: a joint European Organisation for Research and Treatment of Cancer–Alliance for Clinical Trials in Oncology–International Society Of Geriatric Oncology position article.J Clin Oncol. 2013; 31: 3711-3718Crossref PubMed Scopus (180) Google Scholar, 7Hurria A Dale W Mooney M et al.Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations.J Clin Oncol. 2014; 32: 2587-2594Crossref PubMed Scopus (207) Google Scholar, 8Hurria A Levit LA Dale W et al.Improving the evidence base for treating older adults with cancer: American Society of Clinical Oncology statement.J Clin Oncol. 2015; 33: 3826-3833Crossref PubMed Scopus (239) Google Scholar, 9Levit LA Singh H Klepin HD Hurria A Expanding the evidence base in geriatric oncology: action items from an FDA-ASCO workshop.J Natl Cancer Inst. 2018; 110: 1163-1170Crossref PubMed Scopus (36) Google Scholar Unfortunately, uptake of this approach has been minimal. A 2017 review of more than 1000 trials specific to older adults found that survival and tumour-focused outcomes remained the most common primary outcomes, with only a few studies that evaluated functional status and none that examined cognitive function.10Le Saux O Falandry C Gan HK You B Freyer G Péron J Changes in the use of end points in clinical trials for elderly cancer patients over time.Ann Oncol. 2017; 28: 2606-2611Summary Full Text Full Text PDF PubMed Scopus (13) Google Scholar Thankfully, changes are coming. At the 2020 American Society of Clinical Oncology, four randomised trials examining geriatric interventions for older adults with cancer were presented. Among these was a clinical trial, also by Soo and colleagues, of 154 older adults with cancer, half of whom were randomly assigned to receive comprehensive geriatric assessment and management.11Soo WK King M Pope A Integrated geriatric assessment and treatment (INTEGERATE) in older people with cancer planned for systemic anticancer therapy.Proc Am Soc Clin Oncol. 2020; 38 (abstr).12011Crossref Google Scholar The primary outcome was health-related quality of life, measured using the ELFI, with results showing significantly higher ELFI scores in the intervention group than in the control group. As the authors point out, by design, ELFI will not provide a comprehensive assessment of all outcomes of importance to older adults.1Soo WK King M Pope A et al.The Elderly Functional Index (ELFI), a patient-reported outcome measure of functional status in patients with cancer: a multicentre, prospective validation study.Lancet Healthy Longev. 2020; (published online Dec 17.)https://doi.org/10.1016/S2666-7568(20)30036-2Summary Full Text Full Text PDF Scopus (2) Google Scholar It provides a multifaceted but still statistically robust approach to summarising function in older adults with cancer. It does not, however, provide information on cognitive or emotional functioning. In addition, responsiveness to change over time and the magnitude of change in ELFI scores that is clinically meaningful have yet to be explored. In summary, Soo and colleagues have shown the reliability and validity of a new, brief, self-reported measure that encompasses both physical function and activity participation. This work paves the way for the incorporation of patient-reported outcomes into both clinical trials and clinical care in geriatric oncology, allowing for a focus on outcomes of known importance to older adults with cancer. I report research funding from Janssen and consulting for Carevive Systems and Seattle Genetics, outside of the submitted work. The Elderly Functional Index (ELFI), a patient-reported outcome measure of functional status in patients with cancer: a multicentre, prospective validation studyELFI is a validated and simple person-reported multidimensional measure of functional status, which captures broad dimensions of functioning. ELFI has enhanced statistical efficiency relative to its components, reducing the sample size required to detect a given effect. ELFI could be used as a clinical trial endpoint to assess functional domains of health-related quality of life. Full-Text PDF Open Access