Safety and Feasibility of Outpatient Zolbetuximab Administration in Community Cancer Care: A Mixed-methods Analysis.

Abstract

Background/aim: Zolbetuximab, a CLAUDIN18.2-targeted antibody, traditionally requires inpatient administration due to potential adverse events. This study evaluated the safety and feasibility of outpatient administration in a community cancer center setting.

Patients and methods: Five patients with CLAUDIN18.2-positive advanced gastric cancer received outpatient zolbetuximab between July and November 2024. We implemented a structured protocol incorporating standardized premedication, hospital-pharmacy collaboration, and comprehensive monitoring. Safety, treatment adherence, economic outcomes, and patient experiences were analyzed using mixed methods.

Results: No grade 3 or higher adverse events were observed, with mild nausea being the most common toxicity. Treatment adherence was high, with only two patients experiencing non-toxicity-related delays. Outpatient administration reduced costs by approximately 10-15% compared to inpatient administration. Qualitative analysis revealed that while anticipated clinical challenges were effectively managed, practical aspects such as transportation and financial considerations emerged as primary patient concerns. One patient proceeded to conversion surgery, one discontinued due to financial constraints, and three continue treatment.

Conclusion: Outpatient zolbetuximab administration proved safe and feasible in a community setting when implemented with appropriate protocols and support systems. This implementation model could serve as a template for delivering complex cancer therapies in resource-limited settings.