Abstract
IntroductionMethotrexate (MTX) a folate antagonist is often given in high doses (≥500 mg/m2) to treat a variety of disease processes. While inpatient administration has been the norm, outpatient administration, has been shown to be safe, effective, and patient centered. Here in we describe development of an outpatient HDMTX protocol and our initial experience.MethodsAll patients were to receive their first cycle of HDMTX in the hospital to ensure they tolerate it well and also to use this time to assist in training for home administration. The outpatient protocol involved continuous IV sodium bicarbonate, along with oral leucovorin and acetazolamide. Patients were required to visit the infusion center daily for labs and methotrexate levels. Clear criteria for admission were developed in the case of delayed clearance or methotrexate toxicity.ResultsTwo patients completed the safety run-in phase. Both patients tolerated treatment well. There were no associated toxicity. Methotrexate cleared within 3 days for all cycles. Both patients were able to follow the preadmission instructions for sodium bicarbonate and acetazolamide. The patients reported adequate teaching on the protocol and were able to maintain frequency of urine dipstick checks.ConclusionWe developed and implemented an outpatient protocol for high dose methotrexate. This study largely details the development of this protocol and its initial safety evaluation. More work needs to be done to assess its feasibility on a larger number of patients who receive more cycles in the outpatient setting.
Highlights
Methotrexate (MTX) a folate antagonist is often given in high doses (≥500 mg/m2) to treat a variety of disease processes
High-dose methotrexate (HDMTX) consists of doses ≥500 mg/m2, used for the treatment of primary and secondary CNS lymphoma (PCNSL), leptomeningeal metastases, and osteosarcoma, as well as central nervous system (CNS) prophylaxis in patients with leukemia and high-risk lymphoma. These doses are potentially lethal without administration of intravenous and/or oral leucovorin to rescue normal cells from apoptosis, in the bone marrow and GI tract [2, 3]
Complete patient eligibility criteria are listed in the protocol, including a diagnosis of DLBCL requiring CNS prophylaxis, age 18-70 years, ECOG performance status ≤ 2, normal renal function (CrCl ≥60 mL/min), no history of color blindness, and adequate social support
Summary
Methotrexate (MTX) a folate antagonist is often given in high doses (≥500 mg/m2) to treat a variety of disease processes. High-dose methotrexate (HDMTX) consists of doses ≥500 mg/m2, used for the treatment of primary and secondary CNS lymphoma (PCNSL), leptomeningeal metastases, and osteosarcoma, as well as central nervous system (CNS) prophylaxis in patients with leukemia and high-risk lymphoma. These doses are potentially lethal without administration of intravenous and/or oral leucovorin to rescue normal cells from apoptosis, in the bone marrow and GI tract [2, 3]. For patients receiving HDMTX for Primary CNS lymphoma or CNS prophylaxis for DLBCL, these inpatient hospital admissions, which most commonly are scheduled every 2 weeks, have the potential to negatively impact a patient’s quality of life and contribute to the growing financial burden on the health care system
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