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

Background 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. Materials and methods 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. Results 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. Conclusion This study highlights the clinical significance of developing severe hypoalbuminemia during treatment with zolbetuximab plus chemotherapy and identifies possible risk factors.