ABCL-032 Safety of Ambulatory High-Dose Methotrexate Administration Among Hematological Malignancies Patients in Tertiary Care Center

Abstract

High-dose methotrexate (HDMTX) is commonly used for solid malignancies, such as osteosarcoma, and hematological malignancies, such as acute lymphoblastic leukemia and non-Hodgkin lymphoma. Urine alkalinization using intravenous sodium bicarbonate and MTX clearance with calcium folinate are two crucial steps in MTX clearance and avoiding or minimizing side effects, such as nephrotoxicity and hepatotoxicity. To assess the safety of ambulatory HDMTX administration among adult patients with hematological malignancies in a tertiary care center. This is an open-label, single-arm trial that aims to evaluate the safety of HDMTX administration in an outpatient setting among patients with hematological malignancies. Tertiary care center. The study was IRB approved. Adult patients from 14 to 60 years of age; normal baseline kidney and liver function; cooperative and fully compliant; living nearby the hospital with access to medical services. Pregnant or breastfeeding women. Urine alkalinization with sodium bicarbonate and acetazolamide, as per protocol, was started the day prior to MTX infusion. The patients were well hydrated and their serum MTX was measured daily until it fell below 0.1 micromol/L. The safety of ambulatory HDMTX administration. Forty-three (n=43) cycles for 21 patients have been completed thus far. Approximately 72.09% of cycles were for patients diagnosed with diffuse large B-cell lymphoma. Twenty-one (48.84%) cycles achieved MTX levels less than 0.1 micromol/L by 48 hours, and 39 cycles (90.70%) achieved the same level by 72 hours. By 72 hours, 23.26% had reversible, asymptomatic elevation of creatinine and all were Grade 1. By 72 hours, approximately 27.91% had reversible, asymptomatic hepatotoxicity and all were Grade 1. Our preliminary results suggest that ambulatory HDMTX is safe, cost effective, and more comfortable for patients. These results encourage the use of this approach more frequently as it decreases hospitalization and thus reduces cost, increases patient satisfaction, and helps to solve the issue of bed crisis.