Hypoalbuminemia during zolbetuximab plus chemotherapy for claudin 18.2-positive advanced gastric cancer: a need for caution?

<h3>Background</h3> Despite several studies highlighting the importance of zolbetuximab-induced gastrointestinal toxicity, the incidence of and risk factors for severe hypoalbuminemia during zolbetuximab plus chemotherapy for the treatment of claudin 18.2-positive advanced gastric cancer have not been fully elucidated. <h3>Materials and methods</h3> We retrospectively evaluated 29 patients (median age, 62 years; men, 45%; diffuse-type histology, 76%; prior total gastrectomy, 24%). Severe hypoalbuminemia was defined as a serum albumin level ≤2.5 g/dl during or a maximum decrease of ≥1.0 g/dl from baseline during cycle 1 day 1 and cycle 3 day 1 in this cohort. <h3>Results</h3> Median serum albumin levels at baseline, cycle 2, and cycle 3 day 1 were 4.0, 3.1, and 3.4 g/dl, respectively. The median maximum change in serum albumin from baseline was –1.0 (range –1.6 to 0.3) g/dl. Grade 3 hypoalbuminemia was observed in two patients (6.9%). The absence of a history of total gastrectomy before systemic treatment, the use of oxaliplatin and capecitabine, body mass index ≥19.8, and nausea/vomiting during zolbetuximab infusion at cycle 1 were identified as predictive biomarkers for developing severe hypoalbuminemia. <h3>Conclusion</h3> This study highlights the clinical significance of developing severe hypoalbuminemia during treatment with zolbetuximab plus chemotherapy and identifies possible risk factors.