Improving FOLFIRINOX safety in pancreatic cancer patients through multidimensional remote monitoring and proactive care using a domomedecine mobile platform.

Abstract

TPS4673 Background: Pancreatic cancer is a poor prognosis and fast-growing cancer, whose five-year survival is 6% in Europe and the US. FOLFIRINOX has been established as the reference medical treatment for this disease worldwide, yet it also causes leuko-neutropenia, thrombocytopenia, diarrhea, anorexia, asthenia, weight loss, and peripheral sensory neuropathy. Its indication is usually limited to patients having a WHO performance status of 0 or 1. This treatment is often interrupted once Grade 3-4 clinical or hematological toxicities occur, resulting in poor patient performance status and quality of life. Presently, no prospective study monitor and evaluate the qualitative and quantitative effects of FOLFIRINOX on the daily life of pancreatic cancer patients in real-time. Such monitoring would provide early warning signals for the identification of any improvement or deterioration of the patient condition. Whenever necessary, proactive interventions would be triggered to avoid emergency hospitalization for severe adverse events and to enhance treatment compliance. Methods: Our study involves the use of the mobile e-Health platform PiCADo (JMIR 2018) to track and analyse circadian rhythms, symptoms, and body weight in real time in 45 advanced pancreatic cancer patients at 4 centres. The patients are continuously telemonitored for rest-activity, temperature and 3D-orientation via a BLE sensor during the six weeks following the first FOLFIRINOX course. Patients weigh themselves daily on a BLE scale and self-rate their symptoms using a touchscreen on GPRS tablet. Alerts are generated according to preset yet modifiable thresholds of automatically computed critical parameters. From these data, we will evaluate the rate of emergency hospital admissions and the admission-free survival, the rates of severe adverse events, patients’ symptoms dynamics, and their relations with the disruption of the patients’ circadian rhythm. Patient satisfaction and research experience will also be assessed, since engagement is at the core of the success of the approach. The results will guide a future randomized trial comparing standard pancreatic cancer patient care with a personalized FOLFIRINOX approach, including chronotherapy delivery. Support: Ramsay-Sante, Altran.

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