Noble, Brie

Abstract Background This secondary analysis of a phase I clinical trial illustrates integrated summary and visualization of Common Terminology Criteria for Adverse Events (CTCAE) data and Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) data at baseline and through the first cycle of treatment for tolerability review during dose-cohort evaluation in a phase I trial. Methods This study uses data from a phase I clinical trial of patients with relapsed or refractory acute myeloid leukemia. Through iterative feedback from clinicians and statisticians, we developed a summary of cycle 1 PRO-CTCAE and CTCAE data for the first dose-level cohort. This summary is intended to demonstrate reporting that would be reviewed to inform a decision about proceeding to the next dose level in a dose escalation trial. Results Cycle 1 CTCAE and PRO-CTCAE data for 4 patients enrolled in the first dose cohort are summarized as narrative and tabular summaries and visualized using swimmer and butterfly plots. In this cohort, 3/4 (75%) patients had at least one CTCAE grade 3 or higher adverse event, and all 4 (100%) patients had at least one PRO-CTCAE composite score of 3 during cycle 1. All 4 (100%) patients had at least one symptom for which PRO-CTCAE suggested greater symptom burden than was reflected in CTCAE. Conclusions In this illustrative summary of a dose cohort, PRO-CTCAE complemented CTCAE reporting by capturing patient-reported symptomatic burden that was not always fully reflected by clinician-graded adverse events. Reviewing PRO-CTCAE and CTCAE data together during dose-cohort evaluation may enrich discussions on safety and tolerability in phase I trials.

e13611 Background: Decentralized cancer care models may reduce treatment burden for patients with advanced prostate cancer (CaP), particularly those facing mobility, transportation, of scheduling challenges. However, prospective patient-reported experience and quality-of-life data comparing home- versus clinic-based oncology care remain limited. Mayo Clinic Cancer CARE Beyond Walls (CCBW) is a patient-centered program designed to deliver selected standard-of-care cancer therapies in the home with virtual clinical oversight. This observational study evaluated patient-reported experience, feasibility, safety, and quality of life among men with advanced or metastatic CaP receiving care at home. Methods: Men with advanced/metastatic CaP receiving active standard-of-care therapy including hormone-based treatments, oral anticancer therapies, anti-bone resorptive agents, or intravenous chemotherapy who were participating in a CCBW randomized trial were enrolled into a companion observational study. After confirmation of treatment tolerance in clinic, patients received home-based care for 24 weeks (Arm A) or in-clinic care for 8 weeks followed by home-based care for 16 weeks (Arm B). Patient-reported outcomes were collected at baseline and Weeks 8, 16, and 24, using CAHPS-based measures and CCBW-specific surveys assessing overall cancer care experience, patient preference for site of care, comfort with home infusions, functional/symptom assessment and quality of life. Descriptive analyses were performed. Results: Eighteen participants were analyzed (Arm A n = 10; Arm B n = 8). Participants were medically stable, and predominantly insured by Medicare. Survey completion was 100% at baseline and 83% at all follow-up time points. At Weeks 16 and 24 when all respondents had received home-based care, 100% and 92% reported being “quite a bit” or “very much” comfortable receiving treatment at home. Communication with at-home and remote nursing teams was rated highly, and most respondents reported transition, scheduling, and equipment use easy or very easy. At Weeks 16 and 24, 45% and 40% of respondents reported improved quality of life from receiving home-based care, with no reports of worsening. No emergency department visits, hospitalizations, or urgent care visits occurred in either arm. Conclusions: In this prospective, observational study, home-based oncology care delivered through CCBW was feasible, safe, and associated with high patient satisfaction among men with advanced CaP receiving diverse systemic therapies. These findings support further evaluation and expansion of decentralized care integrating home-based treatment with virtual clinical oversight.