Low-Dose Planned Glucarpidase Allows Safe Outpatient High-Dose Methotrexate Treatment for CNS Lymphoma.

Autor:	Schaff, Lauren R., Carlow, Dean, Schofield, Ryan, Wongchai, Venissala, Madzsar, Juli, Hyde, Allison, Reiner, Anne S., Panageas, Katherine S., DeAngelis, Lisa M., Mellinghoff, Ingo K., Lobbous, Mina, Nabors, Louis B., Grommes, Christian
Předmět:	PROTEIN kinase inhibitors ANEMIA ANTIMETABOLITES PATIENT safety RESEARCH funding CREATININE ANTINEOPLASTIC agents METHOTREXATE CLINICAL trials PILOT projects SODIUM bicarbonate KARNOFSKY Performance Status FATIGUE (Physiology) ASPARTATE aminotransferase LYMPHOCYTE count LYMPHOMAS BLOOD cell count DESCRIPTIVE statistics RITUXIMAB CENTRAL nervous system tumors LONGITUDINAL method CARMUSTINE ETOPOSIDE VINCRISTINE HYPOCALCEMIA HYPOKALEMIA PROTEOLYTIC enzymes RECOMBINANT proteins ALANINE aminotransferase CLINICS VOMITING DRUG tolerance NAUSEA COVID-19 pandemic
Zdroj:	JCO Oncology Practice; 10/1/2024, Vol. 20 Issue 10, p1384-1390, 7p
Abstrakt:	PURPOSE: High-dose methotrexate (HD-MTX) is the backbone of curative therapy for CNS lymphoma. Because of toxicity, MTX is administered in the inpatient setting along with hyperhydration and monitoring until MTX clearance is documented (3-5 days). Frequent hospitalizations result in patient time away from work, home, and exposure to potential iatrogenic/nosocomial complications. Here, we aim to demonstrate feasibility of HD-MTX administration in the outpatient setting with low-dose glucarpidase facilitating clearance. METHODS: This is a prospective nonrandomized study of outpatient HD-MTX followed by glucarpidase 2000u (ClinicalTrials.gov identifier: NCT03684980). Eligible patients had CNS lymphoma, creatinine <1.3 mg/dL, and previously tolerated HD-MTX. Patients were enrolled between May 2020 December 2021 for one HD-MTX treatment. Patients could re-enroll for subsequent doses of HD-MTX as eligibility and slots permitted. MTX 3.5 g/m2 was administered once over 2 hours, preceded by standard hydration and followed by an additional 2 hours of dextrose 5% in water with NaHCO3 75 mEq at 150 cc/h. Glucarpidase 2000u was administered once in the clinic 24 hours later. The primary end point was MTX level 48 hours after HD-MTX. RESULTS: Twenty doses of outpatient HD-MTX with glucarpidase were administered to seven patients. After 20 of 20 (100%) treatments, serum MTX levels were reduced to <100 nmol/L. Treatments were well-tolerated, and no admissions were required. One patient received additional outpatient hydration for elevated creatinine. Development of antiglucarpidase antibody was rare and did not affect treatment. CONCLUSION: Outpatient HD-MTX with glucarpidase is safe and well-tolerated and has the potential to alter standard treatment for CNS lymphoma. CNS lymphoma patients received glucarpidase to avoid hospitalization for MTX therapy. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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