Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After High-Dose Cytarabine Consolidation Chemotherapy (the REMEDY Trial)

Presenting Authors: Emily Behren Ketchum, PharmD, BCOP, Wellstar-MCG Health Georgia Cancer Center, Augusta, GA; Amber B. Clemmons, PharmD, BCOP, FHOPA, University of Georgia College of Pharmacy, Augusta, GA

Co-Authors: Stephanie Daniels, PA-C, and Sarah Jimenez, DNP, APN-BC, AGACNP, AOCNP, Wellstar-MCG Health Georgia Cancer Center, Augusta, GA; Mohammad Mian, MD, PhD, MPH, and Locke J. Bryan, MD, Department of Medicine, Hematology and Oncology, Wellstar-MCG Health Georgia Cancer Center, Augusta, GA

BACKGROUND: Febrile neutropenia (FN) is a common and potentially life-threatening complication of high-dose cytarabine (HiDAC) consolidation for patients with acute myeloid leukemia (AML). Early detection may limit negative sequelae. Although continuous temperature monitoring via commercially available remote temperature monitoring transdermal patch (RTM-patch) is reported to detect FN earlier than intermittent manual monitoring in hospitalized patients, evaluation in the outpatient oncology setting is lacking.

OBJECTIVE: To examine the feasibility and effectiveness of a remote continuous temperature monitoring device for early detection of FN after HiDAC.

METHODS: This institutional review board–approved pilot study compared a prospective cohort (July 2021-May 2023) of patients utilizing RTM-patch for 15 days after HiDAC or until hospitalization for FN, with a historical cohort (January 2015-July 2021) who used manual intermittent monitoring with a thermometer. The subjects included were aged ≥18 years and received HiDAC consolidation monotherapy for AML. The subjects in the prospective cohort signed informed consent and were provided transdermal patches, a phone if needed, instruction on patch placement and smartphone application, and an end-of-study satisfaction survey. The outcomes measured included the incidence of FN, hospital and intensive care unit (ICU) admission and length of stay, and death. The descriptive statistics are reported.

RESULTS: Most subjects in the retrospective and prospective cohorts received HiDAC 3 gm/m² (68% vs 50%) with growth factor (95% vs 100%) and antibiotic prophylaxis (83% vs 79%). The retrospective cohort included 41 cycles for 21 patients. In the retrospective cohort, admission for FN occurred after 13 cycles (32%), 4 (9.8%) patients required transfer to the ICU, 28 (68%) had microbiologically defined infection, and none died. In the prospective cohort, 17 subjects over 22 cycles were screened, resulting in 12 subjects and 14 cycles enrolled. Two (14%) subjects self-discontinued early for technical difficulties. Eight patients had fever, but 2 (25%) refused to go to the hospital. Admission for FN occurred after 6 cycles (43%), and 1 (7%) subject had documentation of sepsis per an outside hospital. None of the patients in the prospective cohort required ICU transfer, had microbiologically defined infection, or died. Of the 9 surveys completed, all reported ease of use of patches and application; however, 1 of the 9 subjects reported skin irritation, and 8 cycles had at least 1 technical difficulty (patch misplacement or malfunction, distance from smartphone app, etc).

CONCLUSION: Limited data from this pilot study suggest a remote temperature monitoring device is feasible and potentially beneficial in mitigating the negative outcomes of FN in the outpatient setting; however, various technology issues should be considered when devising further studies and evaluating the clinical benefit of these devices in the ambulatory cancer population.

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