Zolbetuximab管理的实际管理:VYLOY项目倡议。

IF 4.4 2区 医学 Q1 ONCOLOGY
Cancers Pub Date : 2025-06-15 DOI:10.3390/cancers17121996
Yukiya Narita, Taro Mizuno, Takato Suda, Junko Kurono, Yasunobu Ishizuka, Yumi Iida, Akiko Kondo, Kazuhiro Shimomura, Chisato Yamada, Eri Hotta, Koji Kuraishi, Kanae Tozaki, Makiko Kobara, Chihoko Takahata, Kei Muro
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引用次数: 0

摘要

背景:Zolbetuximab是一种靶向CLDN18.2 (CLDN18.2)的单克隆抗体,最近被批准作为晚期胃癌(AGC)的一线治疗药物,存在独特的安全性挑战,特别是输注相关的胃肠道毒性和低白蛋白血症。本研究旨在介绍我们在AGC患者中使用唑仑妥昔单抗的经验,重点关注我们在常规临床实践中的适应性方案的安全性和管理有效性。方法:本研究展示了我们的单机构实际经验,使用唑贝昔单抗实施主动管理方案(“VYLOY项目”)来减轻这些毒性。我们采用标准化的逐步输注方案和止吐前用药来减少输注相关的恶心和呕吐。cldn18.2阳性晚期胃或胃食管交界处腺癌患者接受唑仑妥昔单抗联合化疗。结果:共纳入24例患者。中位输注时间为215分钟,中断率为25.0%。在第1周期,62.5%的患者出现了输液相关不良事件,主要是1级恶心(54%)和呕吐(25%)。57%的一线患者出现低白蛋白血症(≥2级),可能与唑苯妥昔单抗诱发的胃炎和胃肠道蛋白丢失有关。主动止吐支持和输液速率调整大大减少了后续周期的输液中断(10.9%)。未进行胃切除术的患者有更高的恶心和呕吐率,证实了胃在介导毒性中的作用。结论:我们的研究结果表明,积极主动的管理可以提高唑苯妥昔单抗的安全性和耐受性,特别是在现实生活中减少输注相关的毒性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Practical Management of Zolbetuximab Administration: The Project VYLOY Initiative.

Background: Zolbetuximab, a monoclonal antibody targeting claudin-18.2 (CLDN18.2), which was recently approved as first-line treatment for advanced gastric cancer (AGC), presents unique safety challenges, particularly infusion-related gastrointestinal toxicity and hypoalbuminemia. This study aimed to present our experience with zolbetuximab administration in patients with AGC, focusing on the safety and management effectiveness of our adapted protocol in routine clinical practice. Methods: This study presents our single-institution real-world experience implementing a proactive management protocol ("Project VYLOY") using zolbetuximab to mitigate these toxicities. We adopted a standardized stepwise infusion protocol and antiemetic premedication to reduce infusion-related nausea and vomiting. Patients with CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma who received zolbetuximab combined with chemotherapy were included. Results: Twenty-four patients were included. The median infusion duration was 215 min, with an interruption rate of 25.0%. In cycle 1, 62.5% experienced infusion-associated adverse events, primarily grade 1 nausea (54%) and vomiting (25%). Hypoalbuminemia (grade ≥ 2) occurred in 57% of first-line patients, potentially linked to zolbetuximab-induced gastritis and gastrointestinal protein loss. Proactive antiemetic support and infusion rate adjustments substantially reduced infusion interruptions in subsequent cycles (10.9%). Patients without prior gastrectomy had higher nausea and vomiting rates, confirming the stomach's role in mediating toxicity. Conclusions: Our results suggest that proactive management can improve the safety and tolerability of zolbetuximab, especially by reducing infusion-related toxicity in real-world practice.

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来源期刊
Cancers
Cancers Medicine-Oncology
CiteScore
8.00
自引率
9.60%
发文量
5371
审稿时长
18.07 days
期刊介绍: Cancers (ISSN 2072-6694) is an international, peer-reviewed open access journal on oncology. It publishes reviews, regular research papers and short communications. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.
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