Managing zolbetuximab-induced nausea and vomiting: a proposal for a pragmatic approach in clinical practice
Keitaro Shimozaki, Akira Ooki, Yoshihiro Yamahata, Takeshi Aoyama, Kei Yoshino, Moritake Tamba, S. Udagawa, Shota Fukuoka, Hiroki Osumi, T. Wakatsuki, Eiji Shinozaki, Mariko Ogura, Keisho Chìn, Kensei Yamaguchi
Abstract
Background: The global phase III SPOTLIGHT and GLOW trials confirmed the superiority of zolbetuximab plus chemotherapy over chemotherapy alone for claudin 18.2-positive advanced gastric cancer (AGC). However, severe nausea/vomiting during zolbetuximab infusion remains a significant safety concern. Our study aimed to evaluate the safety management strategy's applicability in our institution. Patients and methods: -receptor antagonist in patients receiving zolbetuximab plus chemotherapy. The initial zolbetuximab infusion rate was set at 75 ml/h for the first 60 min, and then 250 ml/h thereafter. The primary endpoint was the feasibility of our management and vomiting prevention during cycle 1. Results: Among 21 patients (median age 61 years; male 48%; diffuse-type histology 81%; prior gastrectomy 38%; peritoneal metastases 57%), the incidence of nausea/vomiting during zolbetuximab initiation in cycle 1 was 62%/9.5%, with a 62% infusion interruption rate. The median time to first nausea was 93 min (range 77-127 min); median interruption time was 40 min (16-68 min); and median total infusion time of zolbetuximab was 257 min (154-343 min). All patients successfully completed zolbetuximab administration in cycle 1, with an 81% vomiting prevention rate. At cycle 2 day 1, 3 of 14 patients (21%) experienced nausea, with no vomiting. Conclusion: First-line zolbetuximab plus chemotherapy was safely introduced to real-world patients with claudin 18.2-positive AGC, with effective management of nausea and vomiting, applicable in clinical practice.