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Background <p>Zolbetuximab frequently causes infusion-related nausea and vomiting, which may lead to infusion interruption in routine practice. We developed and implemented a standardized institutional protocol for zolbetuximab administration and chemotherapy-induced nausea and vomiting (CINV) management.</p> Methods <p>This single-center retrospective descriptive cohort study included all consecutive eligible patients with unresectable or recurrent, HER2-negative, CLDN18.2-positive advanced gastric, or gastroesophageal junction adenocarcinoma who received zolbetuximab-containing chemotherapy between June 2024 and December 2025. The protocol incorporated structured antiemetic prophylaxis and real-time nausea assessment using the Wong–Baker FACES® Rating Scale (FRS). FRS ≥ 3 was used as an institutional operational threshold for temporary interruption and stepwise re-initiation; it was not intended to be formally equivalent to CTCAE grade 2 nausea.</p> Results <p>Seventeen consecutive patients were included, and no eligible patients were excluded after screening. During cycle 1, the acute-phase total control (TC) rate was 70.6% (12/17; 95% CI, 44.0–89.7). TC rates during the delayed, ultra-delayed, and overall phases were 70.6%, 82.4%, and 70.6%, respectively. Complete response rates were 100.0% in the acute phase and remained above 94% across all phases. Temporary infusion interruption occurred in 4 patients (23.5%); 3 interruptions (17.6%) were attributed to nausea and 1 (5.9%) to severe epigastric pain. All planned infusions were completed. Serum albumin showed a transient decline during early cycles followed by gradual recovery.</p> Conclusions <p>In this small, non-comparative retrospective cohort, protocol-based zolbetuximab administration was feasible in routine practice, and all patients completed the planned cycle 1 infusion. Albumin findings and survival outcomes should be interpreted as exploratory and hypothesis-generating.</p>

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Real-world implementation of a standardized administration protocol for zolbetuximab-associated nausea and vomiting: a retrospective supportive-care cohort study

  • 期刊论文

  • 发表日期：

    2026年7月21日

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  • Tamotsu Sagawa,
  • Kengo Umehara,
  • Miho Izumi,
  • Masahiro Hirakawa,
  • Shutaro Oiwa,
  • Hayato Watabe,
  • Atsushi Uesugi,
  • Makoto Yoshida,
  • Hiroyuki Nagashima,
  • Koshi Fujikawa

摘要

Background

Zolbetuximab frequently causes infusion-related nausea and vomiting, which may lead to infusion interruption in routine practice. We developed and implemented a standardized institutional protocol for zolbetuximab administration and chemotherapy-induced nausea and vomiting (CINV) management.

Methods

This single-center retrospective descriptive cohort study included all consecutive eligible patients with unresectable or recurrent, HER2-negative, CLDN18.2-positive advanced gastric, or gastroesophageal junction adenocarcinoma who received zolbetuximab-containing chemotherapy between June 2024 and December 2025. The protocol incorporated structured antiemetic prophylaxis and real-time nausea assessment using the Wong–Baker FACES® Rating Scale (FRS). FRS ≥ 3 was used as an institutional operational threshold for temporary interruption and stepwise re-initiation; it was not intended to be formally equivalent to CTCAE grade 2 nausea.

Results

Seventeen consecutive patients were included, and no eligible patients were excluded after screening. During cycle 1, the acute-phase total control (TC) rate was 70.6% (12/17; 95% CI, 44.0–89.7). TC rates during the delayed, ultra-delayed, and overall phases were 70.6%, 82.4%, and 70.6%, respectively. Complete response rates were 100.0% in the acute phase and remained above 94% across all phases. Temporary infusion interruption occurred in 4 patients (23.5%); 3 interruptions (17.6%) were attributed to nausea and 1 (5.9%) to severe epigastric pain. All planned infusions were completed. Serum albumin showed a transient decline during early cycles followed by gradual recovery.

Conclusions

In this small, non-comparative retrospective cohort, protocol-based zolbetuximab administration was feasible in routine practice, and all patients completed the planned cycle 1 infusion. Albumin findings and survival outcomes should be interpreted as exploratory and hypothesis-generating.