Abstract

Background: FOLFIRINOX is an active yet toxic regimen against intestinal cancers. Improving its tolerability could widen its use in routine clinical practice. Circadian-based chrono administration of this triplet can be performed using a multichannel programmable-in-time pump. Here, we show the safety of chronoIFLO4 at home, through real-time multidimensional telemonitoring of circadian rest-activity rhythm (CircAct), sleep, patient-reported outcome measures (PROM) and body weight changes (BWC) using 1st generation e-Health platform inCASA. Methods: Pts received Day (D)1 chrono I (180 mg/m2, over 6-h; peak rate at 5:00), and D 2-4 chrono O (25 mg/m2/d, over 11.5-h; peak rate at 16:00) and F-L (800 mg/m2/d and 400 mg/m2/d, respectively, over 11.5-h; peak rate at 04:00), q2 weeks at home. Pts completed the 19-item MD Anderson Symptom Inventory (MDASI) on an interactive electronic screen, weighed themselves on a dedicated scale, and continuously wore a watch-sized wrist-accelerometer for CircAct and sleep monitoring. Daily data were securely teletransmitted via Internet to a specific server accessible by the hospital team. The validated and clinically-relevant CircAct parameter I<O and sleep efficiency (SE) were calculated. The dynamic patterns over time of PROMs, BWC, I<O and SE inform the oncology team on tolerance in real time. Results: Eleven patients (48-72 years; 45% males; 27% PS = 0) received 26 cycles (cy) of chronoIFLO4, and provided 5,891 data points/8,736 expected (67.4%). No grade 3-4 clinical toxicity occurred. The most severe MDASI scores remained low: interference with work (mean: 5.1/10) or general activity (4.9); fatigue (4.9); distress (4.2) and appetite loss (3.6). Mean BWC was -0.9% and mean SE remained above 82%. CircAct disruption (I<O ≤97.5%) was observed in 4 (15%) cys before chronoIFLO4 start and in 5 (19%) cys at D14. Conclusions: ChronoIFLO4 represents a safe therapeutic option at home, and the pt-centered multidimentional telemonitoring solution allows the design of innovative management approaches, ultimately improving pt experience with chemotherapy, safety and outcomes. Legal entity responsible for the study: INSERM and European Commission Funding: None Disclosure: All authors have declared no conflicts of interest.

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