189P Early international uptake of an AI-powered oncology clinical trial knowledge platform

Abstract

Background: Uveal melanoma (UM) is the most common intraocular malignancy in adults.Despite effective local treatment, up to half of patients develop hepatic metastases, which are associated with poor prognosis.The CHOPIN trial (NCT04283890) was conducted to evaluate the safety and efficacy of melphalan percutaneous hepatic perfusion (M-PHP) combined with ipilimumab/nivolumab (M-PHP+I/N) versus M-PHP alone.A subgroup of participants used a mHealth platform to monitor quality of life (QoL) and time to physical recovery, aiming to assess feasibility, evaluate QoL and mobility among cohorts, and explore associations between digital and clinical outcomes. Methods:The mHealth platform included a patient-reported outcome app for QoL (EORTC-QLQ C30), a smartwatch and a smart scale.The watch measured heart rate, steps, and sleep data; the scale measured weight.Device monitoring lasted 6 months; follow-up ended 1 year post-inclusion with the final questionnaire.Clinical outcomes, including adverse events (AEs), were also collected.QoL was analyzed using mixed linear model regression.Results: A total of 19 patients participated in the remote monitoring program (12 men, 7 women; mean age 63, range 39-75).Eleven participants received M-PHP only and 8 received M-PHP+I/N.Ten patients completed the mHealth part of the study, 1 died, 3 stopped due to disease progression, 1 withdrew and 4 are still ongoing.All participants experienced at least one AE, 70% being grade 1 or 2. Patients receiving M-PHP+I/N experienced significantly more grade 2-4 AEs compared to M-PHP only (p=0.005).Mean Global Health/QoL scores were 75/100 for the M-PHP only arm and 65/100 for the M-PHP+I/N arm.Neither arm showed a significant change in QoL over time (p=0.96).Analyses of wearable data are ongoing and will be presented at the meeting.Conclusions: mHealth-based remote monitoring was feasible for patients with metastatic UM undergoing study treatment.Although QoL in the M-PHP+N/I group was lower since baseline, there was no evidence of a significant change over time between the treatment arms.Clinical trial identification: NCT04283890.

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