ArticleESMO gastrointestinal oncology2026
Clinical implications of zolbetuximab-associated hypoalbuminemia in CLDN18.2-positive gastric or gastroesophageal junction cancer.
Article in ESMO gastrointestinal oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Zolbetuximab enhances outcomes in human epidermal growth factor receptor 2-negative, claudin 18 isoform 2-positive advanced gastric cancer; nevertheless, the clinical implications of zolbetuximab-related hypoalbuminemia are not fully understood. Materials and methods: We conducted a single-center retrospective study of 70 patients treated with zolbetuximab plus chemotherapy. We evaluated serial changes in albumin and their clinical implications, including associated on-target toxicities, changes in ascites, and antitumor activity. Results: All patients exhibited some level of albumin decrease. The lowest hypoalbuminemia was grades 0-1 in 28 patients (40%), grade 2 in 27 (39%), and grade 3 in 15 (21%). The occurrence of grade ≥2 hypoalbuminemia peaked between cycles 1 and 3 (36%-49%) and then decreased. The median time to grade 3 hypoalbuminemia was 28.0 days, with recovery to grade ≤2 occurring after a median of 16.5 days. Grade 3 hypoalbuminemia correlated with advanced age, poorer performance status, and lower baseline albumin levels; it did not manifest in patients who had previously undergone gastrectomy. It frequently coincided with limb edema (100%), anorexia (93%), endoscopic gastritis (47%), and new or worsening ascites (60%). Most patients who temporarily paused zolbetuximab treatment resumed without recurrent grade 3 hypoalbuminemia. The antitumor activity did not significantly differ in patients with grade 3 events compared with those with grades 0-2 events, with an objective response rate of 71.4% versus 51.7% and a median overall survival of not reached versus 18.0 months (hazard ratio 1.16, Conclusions: Zolbetuximab-associated hypoalbuminemia typically manifests early, is frequently reversible, and is accompanied by transient ascites.
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