Yakuwa Erina, Shoji Yuko, Oizumi Takashi, Kobayashi Yuka, Motoishi Taichi, Katagiri Takuto, Suzuki Shuhei
Department of Nursing, Yamagata Prefectural Shinjo Hospital, Yamagata, Japan.
Department of Pharmacology, Yamagata Prefectural Shinjo Hospital, Yamagata, Japan.
In Vivo. 2025 Mar-Apr;39(2):951-960. doi: 10.21873/invivo.13900.
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.
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.
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.
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.
背景/目的：佐贝妥昔单抗是一种靶向CLaudin18.2的抗体，由于潜在的不良事件，传统上需要住院给药。本研究评估了在社区癌症中心环境中门诊给药的安全性和可行性。
2024年7月至11月期间，5例CLaudin18.2阳性晚期胃癌患者接受了门诊佐贝妥昔单抗治疗。我们实施了一项结构化方案，纳入标准化的预处理、医院药房协作和全面监测。采用混合方法分析安全性、治疗依从性、经济结果和患者体验。
未观察到3级或更高等级的不良事件，轻度恶心是最常见的毒性反应。治疗依从性较高，只有2例患者出现与毒性无关的延误。与住院给药相比，门诊给药使成本降低了约10-15%。定性分析表明，虽然预期的临床挑战得到了有效管理，但交通和经济考虑等实际问题成为患者的主要担忧。1例患者进行了转化手术，1例因经济限制停药，3例继续治疗。
在适当的方案和支持系统下，门诊给予佐贝妥昔单抗在社区环境中被证明是安全可行的。这种实施模式可以作为在资源有限的环境中提供复杂癌症治疗的模板。
