BACKGROUND: High-dose methotrexate (HD MTX) is usually administered as an inpatient to those with osteosarcoma. We prospectively tested the safety and feasibility of administering HD MTX in the ambulatory setting. MATERIALS AND METHODS: In this single arm prospective observational study, eligible patients had previously completed 2 courses of HD MTX as an inpatient. On study, patients received MTX in hospital, discharged home and returned for daily assessment. Criteria to determine safety and feasibility included: (1) parent compliance with home instructions, (2) pump functioning/failure, and/or (3) admission for toxicity/noncompliance. Outpatient therapy was deemed feasible if <25% courses resulted in study event. Patient satisfaction was assessed. RESULTS: Six patients (median age, 13.5 y) with extremity osteosarcoma completed 35 courses of MTX. There were no study events-no hospitalizations or pump failures and all parents were compliant. The Data and Safety Committee concluded that with zero events in 35 courses, it was unlikely for outpatient MTX to be infeasible; study was thus terminated early. Participants reported value to stay out of hospital, permitted life to feel "more normal"; however, burden of daily commute to hospital was cited. CONCLUSIONS: The delivery of HD MTX is safe and feasible in patients with osteosarcoma.
BACKGROUND: High-dose methotrexate (HDMTX) is usually administered as an inpatient to those with osteosarcoma. We prospectively tested the safety and feasibility of administering HDMTX in the ambulatory setting. MATERIALS AND METHODS: In this single arm prospective observational study, eligible patients had previously completed 2 courses of HDMTX as an inpatient. On study, patients received MTX in hospital, discharged home and returned for daily assessment. Criteria to determine safety and feasibility included: (1) parent compliance with home instructions, (2) pump functioning/failure, and/or (3) admission for toxicity/noncompliance. Outpatient therapy was deemed feasible if <25% courses resulted in study event. Patient satisfaction was assessed. RESULTS: Six patients (median age, 13.5 y) with extremity osteosarcoma completed 35 courses of MTX. There were no study events-no hospitalizations or pump failures and all parents were compliant. The Data and Safety Committee concluded that with zero events in 35 courses, it was unlikely for outpatientMTX to be infeasible; study was thus terminated early. Participants reported value to stay out of hospital, permitted life to feel "more normal"; however, burden of daily commute to hospital was cited. CONCLUSIONS: The delivery of HDMTX is safe and feasible in patients with osteosarcoma.
Authors: Kelsey Sokol; Kelley Yuan; Maria Piddoubny; Ellen Sweeney; Anne Delengowski; Katlin Fendler; Gloria Espinosa; Judith Alberto; Patricia Galanis; Carol Gung; Meghan Stokley; Mercy George; Mary Harris; Ubaldo Martinez-Outschoorn; Onder Alpdogan; Pierluigi Porcu; Adam F Binder Journal: Front Oncol Date: 2022-01-20 Impact factor: 6.244