A comprehensive evaluation of the effectiveness of the Geriatric 8 screening tool in Japanese patients with non–small cell lung cancer: Results from the ENSURE-GA study, a cluster-randomized phase III clinical trial.

8599 Background: The Geriatric 8 (G8) is a widely utilized screening tool globally for assessing functional status in elderly cancer patients, with a score of 14 or lower indicating a positive result. Previous studies have reported that G8-positive patients are at a higher risk of mortality and experiencing Grade 3 or higher adverse events (AEs). At ASCO 2024, we reported that the G8 positivity rate exceeded 80% among Japanese patients aged 75 and older with non-small cell lung cancer (NSCLC), suggesting a potential issue with its sensitivity in this population. In the present study, we conducted a further detailed analysis of the scoring patterns for individual G8 items and their association with the incidence of AEs. Methods: The ENSURE-GA study was a cluster-randomized phase III clinical trial involving 1,021 patients aged 75 years and older with non-small cell lung cancer (NSCLC). Participating institutions were cluster-randomized into either the intervention group or the control group. All patients underwent a standardized Geriatric Assessment (GA) prior to the initiation of treatment. From this cohort, 1,001 patients who underwent G8 assessment were identified for analysis. We evaluated the association between the scoring patterns (loss of points) for each G8 item and the frequency and severity of adverse events. Results: The ROC curve for G8 regarding the occurrence of grade 3 or higher adverse events in cases receiving cytotoxic chemotherapy yielded an AUC of 0.525, indicating no discriminatory ability. Among the eight components of the G8 screening tool, self-rated health status ("In comparison with other people of the same age, how does the patient consider their health status?") showed the highest rate of point loss at 72.0% (656/911), followed by polypharmacy at 67.5% (615/911) and Body Mass Index (BMI) at 61.9% (564/911).The G8 score did not correlate with the severity of adverse events. Conclusions: The G8 is a valuable screening instrument, but our findings suggest the need for optimization, including the establishment of cancer-specific and race-specific cut-offs, as well as the implementation of weighted scoring for its components. Clinical trial information: UMIN0000037590.