Factors Contributing to Non-Initiation of Planned Systemic Therapy Among Inpatients Evaluated for a Phase II Randomized Controlled Oncology Trial

Objectives: The Spine Patient Optimal Radiosurgery Treatment for Symptomatic MEtastatic Neoplasms (SPORTSMEN) multicenter phase II randomized controlled trial evaluates radiation therapy (RT) for symptomatic spinal metastases, with 3-month pain-relief as the primary endpoint. The Inpatient Metastatic Spine Score (IMSS) identifies inpatients with anticipated survival to meet this endpoint. Because systemic therapy eligibility is an IMSS component and contributes to survival, understanding the reversal of intended systemic treatment may refine RT patient selection. Methods: Inpatients at an NCI-designated cancer center evaluated for SPORTSMEN with planned but uninitiated systemic therapy were retrospectively evaluated. Clinical characteristics, trial status, RT, functional status, hospitalization events, IMSS, and treatment decisions were abstracted from the EMR. Oncology documentation and goals-of-care discussions identified treatment plan changes. Results: Three patients were identified. All met the SPORTSMEN eligibility criteria and had medical oncology plans for systemic therapy. Baseline ECOG ranged from 1 to 3. Performance status decline following evaluation (median of 5 d) and goals-of-care changes drove treatment noninitiation. Median time from systemic therapy support to noninitiation was 6 days, and median time from trial evaluation to transition in care goals was 10 days; 2 patients transitioned to hospice and 1 to palliative-intent care. Two patients would not have qualified for enrollment by IMSS if the initial treatment plan withheld systemic therapy. Conclusions: Among inpatients evaluated for SPORTSMEN, reversal of planned systemic therapy occurred over 6 days. This timeframe should inform evaluation for trial enrollment with regard to overall prognosis. Longitudinal functional assessment and early goals-of-care discussions with validated prognostic tools may improve identification of patients likely to benefit from RT.