Abstract 115TiP
Background
Osteosarcoma treatment can entail up to 44 nights in hospital and may result in significant social isolation and restriction of normal activities for young patients. In Australia, high dose methotrexate (HDM) is currently delivered under inpatient settings as it requires intensive fluid hydration and supportive care measures. We hypothesised that: 1. HDM could be delivered safely through an ambulatory care program (ACP) with patient satisfaction and health economic benefits; 2. outpatient care would be preferable to inpatient admission and could improve health related quality of life, and 3. demonstration of 1 and 2 would support national implementation of ACPs for delivery of HDM and other complex regimens.
Trial Design
A prospective multi-centre single arm intervention study of an ACP for delivery of HDM in Adolescent and Young Adult (AYA) osteosarcoma patients. We aim to recruit 10-15 patients over 24 months. The primary objectives are to evaluate the safety and feasibility of an ACP. Secondary objectives are to evaluate the acceptability and impact to patients and carers of an ACP and to undertake a health economic assessment of an ACP compared with inpatient delivery. Selection criteria include a diagnosis of osteosarcoma, age 15-39, successful completion of two inpatient cycles of HDM without complication, the ability to attend hospital for review daily while receiving HDM and willingness to comply with study requirements. The ACP will entail daily bloods and clinician reviews until the methotrexate level is <0.1μmol/L. AYAs will receive 3L of intravenous fluids daily provided in a backpack. Patients/carers will be required to complete urine pH monitoring, record fluid balance, and use oral leucovorin and other medications as required. To measure safety and feasibility, we will record the number of admissions, medication errors, adverse events (compliance and CTCAE toxicity), pump failures, and percentage achieving HDM clearance in 72 and 96 hours. Qualitative interviews and cost consequence analysis will be used for acceptability and economic assessment. Recruitment commenced in August 2022 in an adult sarcoma centre and a paediatric hospital.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
This trial is supported by the Australia New Zealand Sarcoma Association (ANZSA), and Kicking goals for Xav, Sarcoma Research Grant (2022).
Disclosure
M.C. Strach: Non-Financial Interests, Personal, Advisory Board, received personal fees: Specialised Therapeutics; Non-Financial Interests, Personal, Funding, fellowship funding from ESMO for unrelated research: ESMO; Non-Financial Interests, Personal, Funding, for unrelated work: RPAH Cancer Services, The Royal Australasian College of Physicians, The Christie Charitable Funds; Non-Financial Interests, Personal, Funding, ANZSA Clinical Research Fellowship and acknowledges funding of this award by Rainbows for Kate Foundation and The Kids Cancer Project: ANZSA. All other authors have declared no conflicts of interest.