Effect of geriatric co-management on independence, quality of life, and severe toxicity in vulnerable older patients with cancer: Results of a randomized clinical trial

INTRODUCTION: Cancer treatment puts older adults with cancer at increased risk for functional decline, impaired quality of life (QOL), and treatment-related toxicity. Geriatric co-management has been proposed as a strategy to improve outcomes in this vulnerable population. MATERIALS AND METHODS: This prospective, randomized (1:1) trial evaluated the impact of geriatric co-management and intervention in patients aged ≥70 years with a G8 score < 15 initiating new systemic outpatient treatment. The aim was to assess the efficacy of targeted interventions versus standard care. Two primary endpoints were chosen: independence (no restrictions in instrumental activities of daily living (IADL)) and QOL (global health scale of the European Organisation for the Research and Treatment of Cancer questionnaire: EORTC QLQ-C30) at 12 weeks (T2). Secondary endpoint was "incidence of severe adverse events" (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, grade ≥ 3). A multiprofessional team performed the geriatric assessment and co-management in the intervention group (IG). RESULTS: A total of 217 patients were enrolled (207 in full analysis set; median age 75 (range 70-89) years; 42% female). For both primary endpoints, a tendency for improvement in the IG was observed: an adjusted odds ratio (OR) of 1.34 (97.5% CI 0.60-2.98; p = 0.42) for regaining independence, and an adjusted difference in global QOL T2 scores of 1.82 (CI -4.44-8.07; p = 0.51). Statistical significance could not be demonstrated. Geriatric co-management reduced grade ≥ 3 toxicities compared with standard care (15.5% vs 30.8% of patients, risk difference - 15.2%, 95% CI -26.5%; -3.9%) and lowered unplanned hospitalizations (21.4% vs 28.8% of patients, risk difference - 7.5%, 95% CI -19.3%; 4.3%). DISCUSSION: The interventions showed a consistent, yet statistically insignificant, impact on quality of life and independence. Importantly, it was associated with a reduction in severe toxicity and may have led to fewer unplanned hospitalizations. Findings support further integration of geriatric co-management into routine oncology care for older adults with cancer.