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Purpose <p>Zolbetuximab plus chemotherapy is standard first-line therapy for HER2-negative, CLDN18.2-positive advanced gastric or gastroesophageal junction cancer (GC/GEJC), but the incidence, course, and clinical correlations of zolbetuximab-related gastric mucosal injury and hypoalbuminemia remain unclear. We thus evaluated these relationships and the clinical course in real-world practice.</p> Methods <p>We retrospectively analyzed 38 patients with HER2-negative, CLDN18.2-positive, advanced GC/GEJC treated with zolbetuximab plus chemotherapy at a single center. Associations between endoscopic findings and albumin changes from baseline were analyzed.</p> Results <p>Median albumin decreased from 3.7 to 2.6&#xa0;g/dL. The median albumin decline was greater in patients without gastrectomy (− 1.0&#xa0;g/dL) or with partial gastrectomy (− 1.1&#xa0;g/dL) than in those with total gastrectomy (− 0.3&#xa0;g/dL; <i>P</i> = 0.009 and 0.007). Albumin levels fell rapidly at weeks 1–3 and recovered toward baseline by weeks 19–27. Upper gastrointestinal endoscopies were performed in patients with a remaining stomach, showing peak abnormalities within 7–12 weeks; no cases with grade ≥ 2 gastric mucosal injury were observed after week 25. White exudate was associated with albumin decline (− 0.9 vs. −0.4&#xa0;g/dL, <i>P</i> = 0.023).</p> Conclusions <p>The presence of white exudate demonstrated a significant association with a marked decrease in serum albumin levels. The risk of hypoalbuminemia appeared to be lower in patients after total gastrectomy. Serum albumin levels decreased after treatment initiation and subsequently showed a tendency to recover over time. Gastric mucosal abnormalities were most frequently observed during the early phase of treatment and were less common in examinations performed after week 25.</p>

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Zolbetuximab-induced gastric mucosal injury and hypoalbuminemia: a mechanism-informed clinical analysis

  • 期刊论文

  • 发表日期：

    2026年7月20日

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  • Yoshitomo Yanagimoto,
  • Kazuyoshi Yamamoto,
  • Kei Yamamoto,
  • Yasunori Masuike,
  • Yuki Ushimaru,
  • Takeshi Omori,
  • Daisuke Sakai,
  • Toshihiro Kudo,
  • Norihiro Matsuura,
  • Takahito Sugase,
  • Takashi Kanemura,
  • Ryota Mori,
  • Masahiko Kubo,
  • Yasunari Fukuda,
  • Masatoshi Kitakaze,
  • Hisateru Komatsu,
  • Masaaki Miyo,
  • Toshinori Sueda,
  • Junichi Nishimura,
  • Yoshinori Kagawa,
  • Kunihito Goto,
  • Shogo Kobayashi,
  • Hiroshi Miyata

摘要

Purpose

Zolbetuximab plus chemotherapy is standard first-line therapy for HER2-negative, CLDN18.2-positive advanced gastric or gastroesophageal junction cancer (GC/GEJC), but the incidence, course, and clinical correlations of zolbetuximab-related gastric mucosal injury and hypoalbuminemia remain unclear. We thus evaluated these relationships and the clinical course in real-world practice.

Methods

We retrospectively analyzed 38 patients with HER2-negative, CLDN18.2-positive, advanced GC/GEJC treated with zolbetuximab plus chemotherapy at a single center. Associations between endoscopic findings and albumin changes from baseline were analyzed.

Results

Median albumin decreased from 3.7 to 2.6 g/dL. The median albumin decline was greater in patients without gastrectomy (− 1.0 g/dL) or with partial gastrectomy (− 1.1 g/dL) than in those with total gastrectomy (− 0.3 g/dL; P = 0.009 and 0.007). Albumin levels fell rapidly at weeks 1–3 and recovered toward baseline by weeks 19–27. Upper gastrointestinal endoscopies were performed in patients with a remaining stomach, showing peak abnormalities within 7–12 weeks; no cases with grade ≥ 2 gastric mucosal injury were observed after week 25. White exudate was associated with albumin decline (− 0.9 vs. −0.4 g/dL, P = 0.023).

Conclusions

The presence of white exudate demonstrated a significant association with a marked decrease in serum albumin levels. The risk of hypoalbuminemia appeared to be lower in patients after total gastrectomy. Serum albumin levels decreased after treatment initiation and subsequently showed a tendency to recover over time. Gastric mucosal abnormalities were most frequently observed during the early phase of treatment and were less common in examinations performed after week 25.