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Mobile devices for patients to report symptoms associated with immune checkpoint inhibitors address an unmet need.
Technology-enabled monitoring of patient-reported outcomes can help manage the immune-related toxic effects patients receiving immune checkpoint inhibitors may experience, according to an interim analysis of a study published in JAMA Open Network.
Investigators hypothesized that a patient-reported outcomes system that could be accessed with mobile devices might facilitate prompt communication between patients at risk for immune toxic effects and their healthcare teams.
They conducted an open-label cohort study at the University of Texas MD Anderson Cancer Center in Houston from September 6, 2019, to September 3, 2020. Fifty patients with genitourinary cancers treated with immune checkpoint inhibitors were enrolled. The primary end point was feasibility of the technology, as measured by patient and care team adherence, and lack of increase in care team staffing.
Of the 50 patients enrolled, 47 had at least one follow-up visit and were included in the analysis; 39 patients (83%) were men, and 39 patients (83%) had metastatic cancer, with the most common being urothelial cell carcinoma and renal cell carcinoma (47% of patients for each).
One week before the initiation of immune checkpoint inhibitor therapy and between treatment visits, patients were prompted on their smartphones to complete the symptom check-in a minimum of three times per week. Patients not reporting three times a week received phone call reminders from research staff.
Each time a particular symptom report triggered a prespecified symptom alert threshold, the remote monitoring app informed patients to call their clinical care team and simultaneously sent automated emails to the care team.
Symptom reports led to 409 automatic alerts. The median response time from the care team was 19 hours, and 73% of automated alerts were reviewed within three days by the clinic team.
Because an alert could contain more than one symptom, the 409 symptom reports contained a total of 593 individual symptoms. Of the 593 symptom reports, 51 (9%) were linked to an adverse event.
Among symptoms that triggered alerts, 7% were linked to a treatment course correction that included advice to withhold therapy, adjust dosing, initiate a supportive remedy, or undergo emergency center evaluation.
“Our results appear to support the hypothesis that technology-enabled integration of (patient reported outcomes) via the platform we developed enables electronic monitoring followed by automated alerts and specific responses to toxic effects in patients treated with ICIs,” the investigators wrote. “Adherence to the protocol by patients and care teams suggests that this technology-enabled platform addressed an unmet need.”
The study authors said the platform has now been expanded beyond the department of genitourinary medical oncology to other MD Anderson Houston area locations, and for use in other indications, such as clinical trials of novel inpatient cellular immunotherapies for genitourinary cancers. Accrual is ongoing and these analyses will be reported separately.