Low-dose planned glucarpidase allows safe outpatient high-dose methotrexate treatment for CNS lymphoma Journal Article
| Authors: | Schaff, L. R.; Carlow, D.; Schofield, R.; Wongchai, V.; Madzsar, J.; Hyde, A.; Reiner, A. S.; Panageas, K. S.; DeAngelis, L. M.; Mellinghoff, I. K.; Lobbous, M.; Nabors, L. B.; Grommes, C. |
| Article Title: | Low-dose planned glucarpidase allows safe outpatient high-dose methotrexate treatment for CNS lymphoma |
| Abstract: | PURPOSEHigh-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.METHODSThis 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.RESULTSTwenty 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.CONCLUSIONOutpatient HD-MTX with glucarpidase is safe and well-Tolerated and has the potential to alter standard treatment for CNS lymphoma. © American Society of Clinical Oncology. |
| Keywords: | adult; aged; middle aged; methotrexate; prospective study; prospective studies; antimetabolites, antineoplastic; central nervous system tumor; central nervous system neoplasms; recombinant proteins; recombinant protein; lymphoma; outpatient; drug therapy; antineoplastic antimetabolite; outpatients; carboxypeptidase g2; gamma-glutamyl hydrolase; gamma glutamyl hydrolase; humans; human; male; female |
| Journal Title: | JCO Oncology Practice |
| Volume: | 20 |
| Issue: | 10 |
| ISSN: | 2688-1527 |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2024-10-01 |
| Start Page: | 1384 |
| End Page: | 1390 |
| Language: | English |
| DOI: | 10.1200/op.24.00080 |
| PUBMED: | 38917404 |
| PROVIDER: | scopus |
| PMCID: | PMC11587339 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledge in the PDF -- Corresponding authors is MSK author: Lauren R. Schaff -- Source: Scopus |
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