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• W4283399428 abstract "Background: First-line treatment for central nervous system lymphoma (CNSL) consists of high-dose methotrexate (HD-MTX) combination therapy, a potentially curative strategy. Administration of HD-MTX typically requires inpatient hospital admission for monitoring and aggressive hydration to prevent toxicity. During the height of the COVID-19 pandemic, patients were reluctant to present for this potentially curative chemotherapy out of concern for increased risk of COVID exposure during hospital admission. Aims: This study explores the feasibility of planned-use glucarpidase, a recombinant bacterial enzyme that rapidly reduces serum MTX levels, to facilitate the outpatient administration of HD-MTX for patients with CNSL. Methods: Eligible adult patients had lymphoma isolated to the CNS, normal renal function, and had previously tolerated standard inpatient HD-MTX. After informed consent was obtained, MTX 3.5 g/m2 was administered in the outpatient setting along with intravenous hydration. Patients returned 24 hours after MTX administration for glucarpidase 2000u and additional hydration. MTX level was determined by high pressure liquid chromatography (HPLC) 48 hours following start of administration. Results: Twenty outpatient treatments of HD-MTX with glucarpidase were administered to a total of 7 patients (men=3, women=4). Patients had a median age of 71 (range, 47-73) and baseline Karnofsky Performance Status of 90 (range 70-90). They received either one (n=1), two (n=3), three (n=2), or seven (n=1) treatments on study. MTX levels were reduced to <100 nmol/L at 48 hours following 20/20 treatments (100%). Adverse events at least possibly attributed to glucarpidase included grade 1 and 2 fatigue (n=3). Events possibly attributed to MTX included grade 1 and 2 fatigue (n=2), nausea (n=2), and vomiting (n=1). Five treatments were associated with an elevated creatinine, one of which was grade 2 and resolved to baseline following additional hydration. There was one grade 3 decreased lymphocyte count attributed to MTX. Remaining lab abnormalities were grade 1 or 2, also attributed to MTX, and included elevated alanine aminotransferase (n=3), elevated aspartate aminotransferase (n=3), anemia (n=1), hypocalcemia (n=1), hypokalemia (n=3), and decreased lymphocyte count (n=4). Out of an abundance of caution, all patients received leucovorin prior to documentation of MTX clearance. None of the patients required hospital admission during treatment. Anti-glucarpidase antibody data from enrolled patients is being analyzed. Summary/Conclusion: This study demonstrates feasibility of outpatient HD-MTX administration with planned-use glucarpidase for a select patient population during the COVID-19 pandemic. We are currently enrolling to a larger study of planned-use glucarpidase for repeated doses of outpatient HD-MTX (NCT03684980)." @default.
• W4283399428 created "2022-06-25" @default.
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• W4283399428 date "2022-06-01" @default.
• W4283399428 modified "2023-10-18" @default.
• W4283399428 title "PB2136: PLANNED-USE GLUCARPIDASE FOR OUTPATIENT HIGH DOSE METHOTREXATE (HD-MTX) ADMINISTRATION IN PATIENTS WITH CNS LYMPHOMA (CNSL) DURING THE COVID-19 PANDEMIC" @default.
• W4283399428 doi "https://doi.org/10.1097/01.hs9.0000851376.34315.4f" @default.
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