Factors contributing to non-initiation of planned systemic therapy among inpatients evaluated for a phase II randomized controlled oncology trial.

Abstract

e23353 Background: The Spine Patient Optimal Radiosurgery Treatment for Symptomatic MEtastatic Neoplasms (SPORTSMEN) multicenter phase II randomized controlled trial (clinicaltrials.gov ID NCT05617716) evaluates radiation therapy (RT) for symptomatic spinal metastases with the primary endpoint of pain relief at 3 months post-treatment. Among inpatients, a validated Inpatient Metastatic Spine Score (IMSS) (PMID 40025847) identifies patients with sufficient anticipated survival to meet the SPORTSMEN primary endpoint. Because receipt of systemic therapy strongly contributes to survival in metastatic disease, patient eligibility to receive systemic therapy is a component of the IMSS. Understanding why intended systemic treatment does not occur may refine identification of patients most likely to benefit from RT. Methods: Inpatients at a National Cancer Institute-designated cancer center evaluated for SPORTSMEN initially planned for but ultimately not receiving systemic therapy were retrospectively evaluated. Clinical characteristics, trial enrollment status, radiation treatment, functional status, hospitalization events, IMSS (based on initial documented intent for systemic therapy), and treatment decisions were abstracted from the electronic medical record. Review of medical oncology documentation and goals of care discussions identified changes in treatment planning. Results: Three patients were identified. All patients met SPORTSMEN eligibility criteria (including documented IMSS prognosticating life expectancy > 3 months) and had documented Medical Oncology plans for systemic therapy at the time of trial enrollment consideration. Baseline ECOG performance status ranged from 1 to 3. Documented decline in performance status following evaluation (occurring over a median of 5 days) and changes in goals of care primarily drove treatment non-initiation. Changes from initial support of systemic therapy to documented non-initiation occurred over a median of 6 days. Two patients transitioned to hospice shortly after evaluation, and one transitioned to palliative-intent care. The median time from SPORTSMEN evaluation to transition in care goals was 10 days. Two of these three patients would not have qualified for SPORTSMEN enrollment by IMSS had the decision to withhold systemic therapy been initially communicated. Conclusions: Among inpatients evaluated for the SPORTSMEN trial where initial Medical Oncology documented intent for systemic therapy was withdrawn, reversal occurred over a period of six days. This timeframe should be considered for inpatients being considered for trial enrollment with regard to overall prognosis. Integration of longitudinal functional assessments and early goals of care discussions alongside validated prognostic tools may improve identification of patients most likely to benefit from RT.