ABCL-030: Safety of Ambulatory High-Dose Methotrexate (HDMTX) Administration Among Hematological Malignancies Patients in a Tertiary Care Center

Abstract

<h3>Context</h3> The utilization of HDMTX is commonly used in solid malignancies such as osteosarcoma and hematological malignancies such as acute lymphoblastic leukemia and non-Hodgkin lymphoma. Urine alkalinization using intravenous sodium bicarbonate and calcium folinate to facilitate clearance of MTX are two crucial steps in MTX clearance and avoiding or minimizing side effects such as nephrotoxicity and hepatotoxicity. <h3>Objective</h3> To assess the safety of ambulatory HDMTX administration among adult patients with hematological malignancies in a tertiary care center. <h3>Design</h3> 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 in a tertiary care center. <h3>Setting</h3> Tertiary care center. <h3>Patients or Other Participants</h3> IRB approved. Inclusion criteria: Adult patients from 14 to 60 years of age; normal baseline kidney and liver function; cooperative and fully compliant patients; living nearby the hospital and has access to medical service. Exclusion criteria: Pregnant or breastfeeding women. <h3>Interventions</h3> Urine alkalinization with sodium bicarbonate and acetazolamide as per protocol, starting the day prior to methotrexate infusion. Good hydration. Daily serum MTX until below 0.1 micromol/L. <h3>Main Outcomes Measures</h3> The safety of ambulatory HDMTX administration. <h3>Results</h3> Thirty-four (n=34) cycles for 16 patients have been completed thus far. Approximately 67.65% of cycles were for patients diagnosed with DLBCL. Sixteen (47.1%) of the total cycles achieved MTX level less than 0.1 micromol/L by 48 hours, and 30 cycles (91.2%) achieved the same level by 72 hours. By 72 hours, 23.5% had reversible asymptomatic elevation of creatinine, and all were Grade 1. By 72 hours, approximately 35.3% had reversible asymptomatic hepatotoxicity, and all were Grade 1. <h3>Conclusions</h3> 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.