Abstract

138 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. We found that providing a GA summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients with advanced cancer receiving high risk treatment (presented at ASCO2020). Herein, we report on the effects of the GA intervention on symptomatic toxicities measured by Patient-Reported Outcomes Common Terminology Criteria for Adverse Events [PRO-CTCAE]. Methods: In the national cluster randomized clinical trial eligible patients (n=718) had age>70, advanced solid tumors or lymphoma, 1+ GA impairment, and were initiating a new treatment regimen with high risk of toxicity. Severity grade of 24 PRO-CTCAE items was collected on a 0-4 scale at enrollment, 4-6 weeks, 3, and 6 months. Of 24 items, 11 (e.g. fatigue, dyspnea) were classified as core (Reeve 2014). Baseline adjusted method (Basch 2016) was used to determine symptomatic toxicities: if the severity of any item increased after baseline to grade 2 or higher, the patient was classified as experiencing grade ≥2 event (similarly for grade ≥ 3 events). The effects of GA intervention on symptomatic toxicities were assessed using generalized linear mixed model (GLMM) with random effect for the practice cluster. Results: Mean age was 77 years (range 70-96); 43% female, 87% white; 34% had gastrointestinal and 25% had lung cancer; 27% received prior chemotherapy. 710 patients provided PRO-CTCAE data (366 usual care, 344 intervention), 85.6% reported grade ≥2 and 49.4% grade ≥3 events at baseline. After baseline, compared to usual care, patients in the GA intervention arm reported fewer grade ≥2 overall symptomatic toxicities (76.5% vs. 84.7%) and fewer core symptomatic toxicities (grade ≥2: 71.8% vs. 82.0%; grade ≥3: 46.2% vs. 53.6%). Specifically, less dyspnea and less fatigue was reported in GA-arm (Table). Conclusions: GA intervention resulted in fewer symptomatic toxicities as evaluated by PRO-CTCAE. Clinical trial information: NCT02054741 . [Table: see text]

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