Multicenter open-label randomized trial of the utility of electronic patient-reported outcome monitoring system in patients with advanced solid tumors (PRO-MOTE).

11004 Background: Randomized trials have suggested that electronic patient-reported outcome (ePRO) monitoring during systemic therapy may improve health-related quality of life (HR-QOL) and overall survival (OS) in patients with advanced cancer. However, evidence remains limited outside Western healthcare settings. Here, we evaluated the utility of ePRO monitoring for OS and HR-QOL in Japanese patients with advanced solid tumors receiving systemic therapy. Methods: This multicenter, open-label, randomized trial enrolled patients aged ≥18 years with advanced solid tumors, ECOG performance status (PS) 0–2, and receiving systemic therapy. Patients were randomized 1:1 to ePRO monitoring plus usual care or usual care alone. In the ePRO monitoring group, patients completed weekly symptom monitoring using PRO-CTCAE. Predefined severity thresholds were applied, and symptom reports exceeding thresholds automatically generated e-mail alerts to the study physicians. Primary endpoints were OS and global health status (GHS) assessed by EORTC QLQ-C30. Superiority for GHS was tested at a two-sided α of 4%, and for OS at α=5% if GHS was significant or α=1% otherwise. Based on a linear mixed-effects model, 400 patients provided 91% power to detect a 5-point between-group difference in GHS. Target sample size was set at 500, allowing for 20% attrition. Results: Between June 2021 and February 2024, 501 patients were enrolled (control n=250; ePRO n=251), with a median age of 63 years (21–82) and ECOG PS 0/1/2 of 362/127/12. Major cancer types included colorectal (27%), lung (22%), breast (19%), and gastric cancer (17%). QOL analysis was conducted in 485 patients due to missing baseline data in 16. Questionnaire completion rates were high (QLQ-C30: baseline 97%, week 24: 92%). In the ePRO group, weekly PRO-CTCAE completion rates were 86% at baseline and 85% at week 24, generating 13,500 symptom reports and 1,918 alerts (14%), with a median of 4 alerts per patient. At the planned interim analysis, between-group difference in change in GHS over 24 weeks was −0.61 (95% CI −3.03 to 1.82; p=0.625), showing no superiority of ePRO monitoring. OS did not differ between groups (HR 0.91; 95% CI 0.70–1.19; p=0.240). Bayesian predictive power of eventual OS benefit was 0.3%, below the futility threshold of 10%, and the trial was terminated early. Conclusions: In contrast to previous reports from Western countries, PRO-MOTE failed to demonstrate the superiority of ePRO monitoring for GHS or OS in patients with advanced solid tumors receiving systemic therapy in Japan. Despite high feasibility, the clinical benefit of ePRO monitoring might depend on cancer type, treatment context, or healthcare system. Further subgroup and exploratory analyses are ongoing. Clinical trial information: NCT05931445 .