Observational study investigating Tolerance Of Anticancer Systemic Therapy In the Elderly (TOASTIE): a protocol

Abstract

Introduction The number of older adults diagnosed with cancer is increasing. Older adults are more likely to have pre-existing frailty, which is associated with greater chemotherapy-related toxicity. Early identification of those at risk of toxicity is important to reduce patient morbidity and mortality. Current chemotherapy toxicity prediction tools including the Cancer and Ageing Research Group (CARG) tool exist but are not in routine clinical use and have not been prospectively validated in a UK population. This study is the first prospective study to investigate the CARG tool in a UK population with cancer.Methods and analysis Tolerance Of Anticancer Systemic Therapy In the Elderly is a prospective observational study of patients, aged ≥65 years, commencing first-line (any indication) chemotherapy for a solid-organ malignancy. Patients receiving other systemic anticancer agents or radiotherapy will be excluded. The primary objective will be to validate the ability of the CARG score to predict grade 3+ toxicity in this population. Secondary objectives include describing the feasibility of screening for frailty, as well as the prevalance of frailty in this population and assessing patient and clinician perception of chemotherapy toxicity risk. 500 patients will be recruited over a two year period. Baseline assessments will be recorded. At the end of the 6-month follow-up period, toxicity data will be retrospectively collected. A descriptive analysis of the recruited population will be performed. The validity of the CARG model will be analysed using receiver-operating characteristic curves and calculation of the area under the curve (c-statistic).Ethics and dissemination The study has received ethical approval from the East of Scotland Research Ethics Service 20/ES/0114. Results will be reported in peer-reviewed scientific journals and disseminated to patient organisations and media.