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.
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
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
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.
Clinical trial identification
Legal entity responsible for the study
INSERM and European Commission
All authors have declared no conflicts of interest.