Geriatric assessment and management with a question prompt list using a web-based application to reduce treatment toxicity in older patients with cancer: A randomized controlled trial (J-SUPPORT 2101 study).

1505 Background: Older adults with cancer experience aging-related physical, psychosocial and cognitive challenges that require comprehensive communication with their oncologists. Geriatric assessment (GA) can assess these aging-related problems and guide management. Communication support may further facilitate the implementation of GA-guided management (GAM). We report secondary outcomes of a single-blind, parallel-group, multicenter, randomized controlled trial evaluating the efficacy of a program combining GAM recommendations and communication support to facilitate aging-related communication between older Japanese patients with cancer and their oncologists. Methods: This study included patients aged ≥70 years with advanced or recurrent gastrointestinal cancers who were scheduled to receive first- or second-line systemic therapy and had impairment in at least one GA domain as assessed with a web-based application at baseline. In the intervention group, GAM recommendations and a question prompt list were given to patients by trained intervention providers to be shared with their oncologists at the first outpatient visit after randomization. During 5 months after the initial intervention, the implementation of the GAM recommendations was reviewed monthly by the intervention providers with the patients and their oncologists. The control group received usual care. Secondary outcomes included the incidence of grade 3-5 adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events, ver. 5.0), dose modifications, early treatment discontinuation, unplanned hospital utilization during 3 months, overall survival rate at 6 months, and health-related quality of life and patient satisfaction at 3 and 6 months. Results: Between September 2021 and September 2023, 215 patients (99 women, 116 men; median age 75 [range 70-88] years) were randomized (n=108/107 in the intervention/control group). No differences were found between the groups in patient background characteristics. The incidence of any grade 3-5 adverse event was significantly lower in the intervention group than in the control group (50.9% vs. 66.4%, P<0.05); the incidence of hematologic toxicities was significantly reduced (37.0% vs 55.1%, P<0.01), while that of non-hematologic toxicities remained similar (29.6% vs 36.4%, P=0.31). Early treatment discontinuation was also significantly lower in the intervention group than in the control group (26.9% vs. 43.0%, P<0.05). No significances were found in other secondary outcomes including overall survival rate at 6 months (77.7% vs 78.7%, P=0.88) Conclusions: Our program combining GAM recommendations with communication support significantly reduced severe treatment toxicity without compromising survival in older patients with cancer. Clinical trial information: UMIN000045428 .