{"title":"claudin 18.2表达对her2阴性、精通MMR、PD-L1 CPS大于或小于1转移性胃/胃食管结癌患者的一线免疫化疗治疗结果的影响。","authors":"Fei Zhang, Izuma Nakayama, Naoya Sakamoto, Dai Okemoto, Amane Jubashi, Yuki Matsubara, Yu Miyashita, Seiya Sato, Shinpei Ushiyama, Akinori Kobayashi, Ukyo Okazaki, Kazumasa Yamamoto, Saori Mishima, Daisuke Kotani, Akihito Kawazoe, Tadayoshi Hashimoto, Yoshiaki Nakamura, Yasutoshi Kuboki, Hideaki Bando, Takashi Kojima, Takayuki Yoshino, Takeshi Kuwata, Kohei Shitara","doi":"10.1177/17588359251369042","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Patients and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23053,"journal":{"name":"Therapeutic Advances in Medical Oncology","volume":"17 ","pages":"17588359251369042"},"PeriodicalIF":4.2000,"publicationDate":"2025-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450271/pdf/","citationCount":"0","resultStr":"{\"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.\",\"authors\":\"Fei Zhang, Izuma Nakayama, Naoya Sakamoto, Dai Okemoto, Amane Jubashi, Yuki Matsubara, Yu Miyashita, Seiya Sato, Shinpei Ushiyama, Akinori Kobayashi, Ukyo Okazaki, Kazumasa Yamamoto, Saori Mishima, Daisuke Kotani, Akihito Kawazoe, Tadayoshi Hashimoto, Yoshiaki Nakamura, Yasutoshi Kuboki, Hideaki Bando, Takashi Kojima, Takayuki Yoshino, Takeshi Kuwata, Kohei Shitara\",\"doi\":\"10.1177/17588359251369042\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Patients and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":23053,\"journal\":{\"name\":\"Therapeutic Advances in Medical Oncology\",\"volume\":\"17 \",\"pages\":\"17588359251369042\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2025-09-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12450271/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Medical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17588359251369042\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Medical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17588359251369042","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：在人表皮生长因子受体2 （HER2）阴性、精通错配修复（pMMR）和程序性死亡配体1 （PD-L1）表达的转移性或复发性胃癌或胃食管结癌（mGC/GEJC）患者中，claudin 18.2 （CLDN18.2）表达对一线免疫检查点抑制剂（ICI）含化疗（ICI-chemo）的影响尚不清楚。目的：我们评估CLDN18.2表达对her2阴性、pMMR和pd - l1表达的mGC/GEJC患者一线含ici化疗结果的影响。患者和方法：回顾性分析2016年1月至2024年8月期间接受一线ici -化疗或单独化疗（单独化疗）的her2阴性、pMMR和PD-L1联合阳性评分（CPS）大于或小于1的不可切除/转移性或复发性GC/GEJC患者的医疗记录。在接受ICI化疗和单独化疗的患者中评估CLDN18.2状态对临床结果的影响，以评估CLDN18.2在没有ICI的情况下的预后意义。结果：共150例患者接受了ici化疗，313例患者接受了单独化疗。在ici -化疗组的42名患者（28.0%）和单独化疗组的94名患者（30.0%）中确定了CLDN18.2阳性（在大于或小于75%的肿瘤细胞中大于或小于2+）。ci -化疗组cldn18.2阳性和cldn18.2阴性患者的客观缓解率（ORR: 68.3% vs 70.3%, p = 0.842）、疾病控制率（DCR: 92.7% vs 94.1%, p = 0.718）、无进展生存期（PFS；风险比（HR） 1.01, p = 0.955）和总生存期（OS; HR 1.12, p = 0.615）无显著差异。同样，单独化疗组cldn18.2阳性和阴性患者的DCR、ORR、PFS和OS结果具有可比性。结论：CLDN18.2表达对her2阴性、pMMR和PD-L1 CPS小于1 mGC/GEJC的患者的一线ici化疗和单独化疗的结果没有影响。
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.
Background: 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.
Objectives: 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.
Patients and methods: 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.
Results: 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%, p = 0.842), disease control rate (DCR; 92.7% vs 94.1%, p = 0.718), progression-free survival (PFS; hazard ratio (HR) 1.01, p = 0.955), or overall survival (OS; HR 1.12, p = 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.
Conclusion: 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.
期刊介绍：
Therapeutic Advances in Medical Oncology is an open access, peer-reviewed journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of cancer. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in medical oncology, providing a forum in print and online for publishing the highest quality articles in this area. This journal is a member of the Committee on Publication Ethics (COPE).
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