Frailty Assessment for Risk prediction in Gynecologic Oncology patients undergoing surgery and chemotherapy (FARGO) study protocol: Rationale and design of a multi-centre prospective cohort study

BACKGROUND: There is considerable variability in how older adults with cancer tolerate and recover from surgery and systemic treatments. A greater understanding of individual trajectories is crucial in guiding personalized treatment decisions. Frailty may explain these inter-individual differences. Despite emerging evidence on the association between perioperative frailty assessment and outcomes after noncardiac surgery, there is limited data in gynecologic oncology. A perioperative cardiovascular risk assessment, recommended by scientific guidelines, is widely adopted in noncardiac surgery, often as the only standardized perioperative risk stratification approach. While based on robust evidence on the association with cardiovascular complications and overall mortality, it might be insufficient to predict other essential surgical, oncologic and patient-important outcomes. METHODS: The FARGO study is a multi-centre prospective cohort study targeting 280 patients aged 55 or older undergoing surgery, with or without chemotherapy, for a suspected or confirmed gynecologic malignancy. The primary objective is to evaluate the predictive value of the Frailty Phenotype measured preoperatively, compared with the currently used perioperative risk assessment (cardiovascular risk assessment based on the Revised Cardiac Risk Index, age, and occurrence of myocardial injury after non-cardiac surgery) in predicting the composite outcome of all-cause death or new disability at six months after surgery. Secondary objectives include comparing the predictive value of the Frailty Phenotype with that of the Clinical Frailty Scale; evaluating the performance of a preoperative frailty assessments on other postoperative complications, chemotherapy tolerance, and 1-year recurrence-free survival; exploring the added predictive value of a dynamic perioperative frailty assessment repeated 28 days after surgery; assessing the acceptability of frailty assessments by physicians and patients; and establishing a biobank to investigate frailty biomarkers. DISCUSSION: The findings could have important implications for risk stratification, planning and tailoring surgical and oncologic care for older adults with gynecologic malignancies. Our study emphasizes patient-centered outcomes and stakeholders' perspectives. Trial registration: Clinicaltrials.gov Identifier: NCT05738252.