{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["17"],"submitter":["Zhang F"],"pubmed_abstract":["<h4>Background</h4>The effect of claudin 18.2 (CLDN18.2) expression on the outcomes of a first-line immune checkpoint inhibitor (ICI)-containing chemotherapy (ICI-chemo) in patients with human epidermal growth factor receptor 2 (HER2)-negative, proficient mismatch repair (pMMR), and programmed death-ligand 1 (PD-L1)-expressing metastatic or recurrent gastric or gastroesophageal junction cancers (mGC/GEJC) remains unclear.<h4>Objectives</h4>We assessed the effects of CLDN18.2 expression on the outcomes of first-line ICI-containing chemotherapy in patients with HER2-negative, pMMR, and PD-L1-expressing mGC/GEJC.<h4>Patients and methods</h4>Medical records of patients with HER2-negative, pMMR, and PD-L1 combined positive score (CPS) ⩾1 unresectable/metastatic or recurrent GC/GEJC who received first-line ICI-chemo or chemotherapy alone (chemo-alone) between January 2016 and August 2024 were retrospectively analyzed. The impact of CLDN18.2 status on the clinical outcomes was evaluated in patients receiving ICI-chemo and chemo-alone to assess the prognostic significance of CLDN18.2 in the absence of ICI.<h4>Results</h4>A total of 150 patients were treated with ICI-chemo, whereas 313 patients received chemo-alone. CLDN18.2 positivity (⩾2+ in ⩾75% tumor cells) was identified in 42 patients (28.0%) in the ICI-chemo group and 94 patients (30.0%) in the chemo-alone group. There were no significant differences in the objective response rate (ORR; 68.3% vs 70.3%, <i>p</i> = 0.842), disease control rate (DCR; 92.7% vs 94.1%, <i>p</i> = 0.718), progression-free survival (PFS; hazard ratio (HR) 1.01, <i>p</i> = 0.955), or overall survival (OS; HR 1.12, <i>p</i> = 0.615) between CLDN18.2-positive and CLDN18.2-negative patients in the ICI-chemo group. Similarly, the DCR, ORR, PFS, and OS outcomes were comparable between the CLDN18.2-positive and -negative patients in the chemo-alone group.<h4>Conclusion</h4>CLDN18.2 expression exerted no impact on outcomes of first-line ICI-chemo and chemo-alone in patients with HER2-negative, pMMR, and PD-L1 CPS ⩾1 mGC/GEJC."],"journal":["Therapeutic advances in medical oncology"],"pagination":["17588359251369042"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12450271"],"repository":["biostudies-literature"],"pubmed_title":["Impact of claudin 18.2 expression on treatment outcomes of first-line immunochemotherapy in patients with HER2-negative, proficient MMR, PD-L1 CPS ⩾1 metastatic gastric/gastroesophageal junction cancer."],"pmcid":["PMC12450271"],"pubmed_authors":["Miyashita Y","Zhang F","Yamamoto K","Nakayama I","Ushiyama S","Kojima T","Kawazoe A","Sakamoto N","Shitara K","Okemoto D","Matsubara Y","Okazaki U","Mishima S","Kobayashi A","Sato S","Hashimoto T","Jubashi A","Kuboki Y","Nakamura Y","Kotani D","Kuwata T","Bando H","Yoshino T"],"additional_accession":[]},"is_claimable":false,"name":"Impact of claudin 18.2 expression on treatment outcomes of first-line immunochemotherapy in patients with HER2-negative, proficient MMR, PD-L1 CPS ⩾1 metastatic gastric/gastroesophageal junction cancer.","description":"<h4>Background</h4>The effect of claudin 18.2 (CLDN18.2) expression on the outcomes of a first-line immune checkpoint inhibitor (ICI)-containing chemotherapy (ICI-chemo) in patients with human epidermal growth factor receptor 2 (HER2)-negative, proficient mismatch repair (pMMR), and programmed death-ligand 1 (PD-L1)-expressing metastatic or recurrent gastric or gastroesophageal junction cancers (mGC/GEJC) remains unclear.<h4>Objectives</h4>We assessed the effects of CLDN18.2 expression on the outcomes of first-line ICI-containing chemotherapy in patients with HER2-negative, pMMR, and PD-L1-expressing mGC/GEJC.<h4>Patients and methods</h4>Medical records of patients with HER2-negative, pMMR, and PD-L1 combined positive score (CPS) ⩾1 unresectable/metastatic or recurrent GC/GEJC who received first-line ICI-chemo or chemotherapy alone (chemo-alone) between January 2016 and August 2024 were retrospectively analyzed. The impact of CLDN18.2 status on the clinical outcomes was evaluated in patients receiving ICI-chemo and chemo-alone to assess the prognostic significance of CLDN18.2 in the absence of ICI.<h4>Results</h4>A total of 150 patients were treated with ICI-chemo, whereas 313 patients received chemo-alone. CLDN18.2 positivity (⩾2+ in ⩾75% tumor cells) was identified in 42 patients (28.0%) in the ICI-chemo group and 94 patients (30.0%) in the chemo-alone group. There were no significant differences in the objective response rate (ORR; 68.3% vs 70.3%, <i>p</i> = 0.842), disease control rate (DCR; 92.7% vs 94.1%, <i>p</i> = 0.718), progression-free survival (PFS; hazard ratio (HR) 1.01, <i>p</i> = 0.955), or overall survival (OS; HR 1.12, <i>p</i> = 0.615) between CLDN18.2-positive and CLDN18.2-negative patients in the ICI-chemo group. Similarly, the DCR, ORR, PFS, and OS outcomes were comparable between the CLDN18.2-positive and -negative patients in the chemo-alone group.<h4>Conclusion</h4>CLDN18.2 expression exerted no impact on outcomes of first-line ICI-chemo and chemo-alone in patients with HER2-negative, pMMR, and PD-L1 CPS ⩾1 mGC/GEJC.","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025","modification":"2026-06-03T17:17:30.72Z","creation":"2026-04-29T03:12:45.063Z"},"accession":"S-EPMC12450271","cross_references":{"pubmed":["40985041"],"doi":["10.1177/17588359251369042"]}}