Efficacy and safety of Zolbetuximab plus chemotherapy for advanced CLDN18.2-positive gastric or gastro-oesophageal adenocarcinoma: a meta-analysis of randomized clinical trials

• Published in: BMC cancer Vol. 24; no. 1; p. 240
• Main Authors: de Moraes, Francisco Cezar Aquino, Pasqualotto, Eric, Chavez, Matheus Pedrotti, Ferreira, Rafael Oliva Morgado, De Castria, Tiago Biachi, Burbano, Rommel Mario Rodríguez
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 21-02-2024; BioMed Central; BMC
• Subjects: Adenocarcinoma; Adenocarcinoma of the gastro-oesophageal junction; Antibodies; Bias; Cancer; Care and treatment; Chemotherapy; Claudin-18 isoform 2; Clinical trials; Cytotoxicity; Diagnosis; Dosage and administration; Edema; Esophageal cancer; Gastric adenocarcinoma; Gastric cancer; Medical care; Medical prognosis; Meta-analysis; Metastases; Metastasis; Methods; Monoclonal antibodies; Needs assessment; Oesophageal adenocarcinoma; Patient outcomes; Patients; Response rates; Stomach cancer; Survival; Systematic review; Tumors; Zolbetuximab; Brazil; Adenocarcinoma of the gastro-oesophageal junction; Gastric adenocarcinoma; Zolbetuximab; Oesophageal adenocarcinoma; Claudin-18 isoform 2
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-024-11980-w

The benefit of adding Zolbetuximab to the treatment in patients with Claudin-18 isoform 2 (CLDN18.2)-positive, human epidermal growth factor receptor 2-negative, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GC/GEJ) is not yet fully elucidated.
We searched PubMed, Embase and Cochrane databases for randomized controlled trials (RCTs) that investigated Zolbetuximab plus chemotherapy versus chemotherapy alone for GC or GEJ adenocarcinoma. We computed hazard-ratios (HRs) or odds-ratios (ORs) for binary endpoints, with 95% confidence intervals (CIs).
Three studies and 1,233 patients were included. Comparing with Zolbetuximab plus chemotherapy versus chemotherapy alone, progression-free survival (PFS) rate (HR 0.64; 95% CI 0.49-0.84; p < 0.01) and overall survival (OS) rate (HR 0.72; 95% CI 0.62-0.83; p < 0.01) were significant in favor of the Zolbetuximab group. Regarding effectiveness, the Objective Response Rate (ORR) was (OR 1.15; 95% CI 0.87-1.53; p = 0.34).
In this comprehensive systematic review and meta-analysis of RCTs, the incorporation of Zolbetuximab alongside chemotherapy offers a promising prospect for reshaping the established treatment paradigms for patients diagnosed with advanced CLDN18.2-positive GC/GEJ cancer.