Analysis of the Geriatric Assessment for Patients 70 Years and Older (GAP70+) study addresses important gaps in understanding the symptom experience of older patients with advanced cancer receiving systemic treatment. It is the first nationwide cluster-randomised study to demonstrate that a geriatric assessment intervention can decrease patient-reported symptomatic toxicities. It is the first study to systematically describe baseline symptom burden as measured by the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) in older adults with advanced cancer. This study is one of a very few to report patient-reported symptomatic toxicities as an outcome in a randomised controlled trial. The results reinforce the feasibility of collecting PRO-CTCAE longitudinally from older adults with advanced cancer and aging-related conditions. Findings are reported by Marie Anne Flannery, PhD, RN of the School of Nursing, University of Rochester in Rochester, NY, US and colleagues on 10 November in the Journal of Clinical Oncology.
More than 25% of all new cancer cases are diagnosed in older patients. However, they remain under-represented in cancer clinical trials, limiting knowledge of the safety and efficacy of treatments. Older patients with aging-related conditions such as disability and comorbidity and advanced cancer experience a high prevalence of treatment-related symptomatic toxicities.
Geriatric assessment uses patient-reported and objective measures to evaluate aging-related domains. The GAP70+ cluster randomised study demonstrated that providing a geriatric assessment summary with geriatric assessment-guided management recommendations to community oncologists significantly reduces serious treatment toxicity, as measured by clinician-rated CTCAE, in older patients with advanced cancer and aging-related conditions.
The aims of the secondary analysis of the GAP70+ study were to evaluate patient-reported symptoms at the initiation of a new regimen and to assess the effect of the geriatric assessment intervention on patient-reported symptomatic toxicities as measured by PRO-CTCAE. The analysis was guided by the US National Cancer Institute (NCI) Cancer Moonshot Cancer Treatment Tolerability consortium, which provided the opportunity to share methods and resources across investigative groups.
From 2014 to 2019, the study enrolled patients age ≥ 70 years, with advanced solid tumours or lymphoma and at least 1 geriatric assessment domain impairment, who were initiating a regimen with high prevalence of toxicity. Patients completed PRO-CTCAEs, including the severity of 24 symptoms (11 classified as core symptoms) at enrolment, 4-6 weeks, 3 months, and 6 months. Symptoms were scored as grade ≥ 2 (at least moderate) and grade ≥ 3 (severe/very severe). Symptomatic toxicity was determined by an increase in severity during treatment. A generalized estimating equation model was used to assess the effects of the geriatric assessment intervention on symptomatic toxicity.
Mean age in the study was 77 years (range, 70-96 years), 43% were female, and 88% were White, 59% had gastrointestinal or lung cancers, and 27% received prior chemotherapy. In 706 patients who provided PRO-CTCAEs at baseline, 86.1% reported at least one moderate symptom and 49.7% reported severe/very severe symptoms at regimen initiation.
In 623 patients with follow-up PRO-CTCAE data, compared with usual care, fewer patients in the geriatric assessment intervention arm reported grade ≥ 2 symptomatic toxicity, overall 88.9% versus 94.8% (p = 0.035) and for core symptoms 83.4% versus 91.7% (p = 0.001). The results for grade ≥ 3 toxicity were comparable, but not significant (p > 0.05).
The authors concluded that in the presence of a high baseline symptom burden, a geriatric assessment intervention for older patients with advanced cancer reduces patient-reported symptomatic toxicity. Future studies should examine whether geriatric assessment-based models of care that integrate symptom monitoring and management can further improve outcomes of older patients with advanced cancer and aging-related conditions.
The study was supported by the US NCI and the National Institute on Aging.
Culakova E, Mohile SG, Peppone L, et al. Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. JCO; Published online 10 November. DOI: 10.1200/JCO.22.00738