{
  "abstract": "Background: For advanced urothelial carcinoma treatment, immune checkpoint inhibitor regimens centered on the PD-1/PD-L1 signaling axis are now widely adopted as first-line core therapies. Nevertheless, reliable and clinically verified predictive biomarkers tailored for pathologically confirmed pathologically confirmed node-negative (pN0) patients with postoperative recurrence and distant metastasis are still lacking. This retrospective matched-cohort study aimed to investigate the prognostic and predictive significance of PD-1 expression on tumor-infiltrating lymphocytes (TILs) in pN0 bladder cancer patients treated with ICIs, with a focus on its role in guiding personalized treatment.\n\nMethods: A total of 120 pN0 bladder cancer patients with postoperative recurrence or metastasis were enrolled. After 1:1 propensity score matching (PSM), 50 patients (25 per group) were included. CD8⁺ T cells, FOXP3⁺ Tregs, and serum IL-6, TNF-α, CRP levels were detected. Primary endpoints were objective response rate (ORR) and disease control rate (DCR); secondary endpoints included early progressive disease (EPD), progression-free survival (PFS), and overall survival (OS).\n\nResults: After PSM, the baseline characteristics of the two groups were well balanced. The high PD-1 expression group (≥ 5%) showed higher CD8⁺ T cell infiltration and CD8⁺/FOXP3⁺ ratio, as well as lower FOXP3⁺ Treg infiltration and serum inflammatory marker levels (all P < 0.01). The high-expression group had higher ORR (48.0% vs. 24.0%) and DCR (76.0% vs. 52.0%), lower EPD incidence (12.0% vs. 48.0%), and longer median PFS (8.1 vs. 4.3 months) and OS (21.9 vs. 13.7 months) (all P < 0.05). The predictive accuracy of PD-1 combined with CD8⁺/FOXP3⁺ ratio or IL-6 was higher than that of PD-1 alone (AUC 0.825 and 0.802 vs. 0.681, P < 0.05). High PD-1 expression was an independent protective factor for PFS (HR = 0.49) and OS (HR = 0.52).\n\nConclusion: High PD-1 expression in TILs is a potential independent candidate predictive biomarker for better favorable ICI response and survival outcomes in patients with pN0 recurrent/metastatic bladder cancer. Combining PD-1 with CD8⁺/FOXP3⁺ ratio or IL-6 enhances predictive accuracy, providing a basis for personalized immunotherapy. Due to the retrospective single-center design, limited sample size after PSM, and lack of full-cohort immune phenotyping to confirm PD-1 cellular origin, this biomarker remains a candidate indicator requiring further prospective multi-center validation.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Urology, Urology & Nephrology Center, Zhejiang Provincial People’s Hospital(Affiliated People’s Hospital), Hangzhou Medical College, No.158, Shangtang Road, Hangzhou, Zhejiang Province 310000 China",
    "The Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province 310053 China",
    "Postgraduate Training Base Alliance of Zhejiang Provincial People’s Hospital, Wenzhou Medical University, Hangzhou, Zhejiang Province 310000 China",
    "The Second School of Clinical Medicine, Hangzhou Normal University, Hangzhou, Zhejiang Province 311121 China"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 4,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Wei Zheng"
    },
    {
      "affs": [
        1
      ],
      "name": "Cenchao Yao"
    },
    {
      "affs": [
        2
      ],
      "name": "Zhida Wang"
    },
    {
      "affs": [
        3
      ],
      "name": "Chunnan Zhang"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/c5en1ee4cnena.bib",
  "cited_by": 0,
  "doi": "10.1186/s12885-026-16674-z",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13733007/",
  "id": "c5en1ee4cnena",
  "issns": [
    "1471-2407"
  ],
  "landing_url": "https://doi.org/10.1186/s12885-026-16674-z",
  "language": "en",
  "licence": "CC-BY-NC-ND-4.0",
  "licence_label": "CC BY-NC-ND 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Research"
    ],
    [
      "openalex",
      "2730|Cancer Immunotherapy and Biomarkers"
    ]
  ],
  "openalex": "W7201850895",
  "pdf_url": null,
  "pmcid": "PMC13733007",
  "pmid": "42983323",
  "published": "2026-08-07",
  "publisher": "BMC",
  "ris": "https://research.draconitic.com/paper/c5en1ee4cnena.ris",
  "sources": [
    {
      "first_seen": "2026-11-08T12:22:53Z",
      "native_id": "PMC13733007",
      "source": "pmc",
      "url": "https://doi.org/10.1186/s12885-026-16674-z"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2730|Cancer Immunotherapy and Biomarkers",
      "subfield": "oncology"
    }
  ],
  "title": "The predictive value of PD-1 for the response to immune checkpoint inhibitor therapy in patients with bladder cancer without lymph node metastasis and its association with survival outcomes",
  "title_text": "The predictive value of PD-1 for the response to immune checkpoint inhibitor therapy in patients with bladder cancer without lymph node metastasis and its association with survival outcomes",
  "type": "peer-reviewed",
  "updated_at": "2026-11-08T12:22:53Z",
  "url": "https://research.draconitic.com/paper/c5en1ee4cnena",
  "venue": "BMC Cancer",
  "versions": []
}