{
  "abstract": "Purpose\n\nVitamin D exerts pleiotropic immunomodulatory effects, yet its relationship with immune-related adverse events (irAEs) during PD-1/PD-L1 inhibitor therapy remains unclear. We examined the association between serum 25-hydroxyvitamin D [25(OH)D] concentrations and documented irAEs in a real-world cohort.Patients and methods\n\nIn this single-center retrospective study, we analyzed 46 serum 25(OH)D test records from 35 patients treated with PD-1/PD-L1 inhibitors between October 2023 and April 2026; lung cancer was the predominant tumor type. Documented irAEs were adverse events recorded in the dataset, adjudicated as immunotherapy-related by the treating clinicians and graded according to CTCAE version 5.0. Vitamin D status was classified as deficient (<30 nmol/L), insufficient (30 to <50 nmol/L), or sufficient (≥50 nmol/L). Because repeated records from the same patient are not statistically independent, record-level analyses were treated as exploratory, whereas the primary analysis was performed at the patient level using each patient's first available 25(OH)D measurement to ensure independence of observations.Results\n\nEleven record-level irAEs were documented in 9 patients; after exclusion of one event with unverifiable immune-mediated attribution (isolated hypokalemia), 8 patients had adjudicated irAEs in the primary analysis. At the exploratry record level, irAE proportions decreased stepwise across vitamin D categories: 60.0% (deficient), 20.0% (insufficient), and 6.3% (sufficient) (Cochran-Armitage trend, P=0.003). In the primary patient-level analysis, proportions were 62.5%, 13.3%, and 8.3%, respectively (trend P=0.008); first-test 25(OH)D concentrations were lower in patients with irAEs than in those without (median 26.70 vs 45.50 nmol/L; P=0.007), although the binary comparison (deficient/insufficient vs sufficient) was not statistically significant (P=0.216; OR=4.813, 95% CI: 0.517-44.824). In 10 of the 11 event-positive records, the documented event preceded the linked vitamin D measurement.Conclusion\n\nLower serum 25(OH)D concentrations were associated with documented irAEs in this small exploratory dataset. Given the temporal ambiguity and residual confounding, the findings are hypothesis-generating and cannot establish causality or prediction; whether vitamin D status can help risk-stratify patients for irAEs-rather than merely reflecting immune activation or nutritional status-requires prospective studies with protocol-defined pretreatment sampling.",
  "abstract_shown": true,
  "affiliations": [
    "College of Pharmaceutical Sciences, Changxing People's Hospital, Zhejiang Chinese Medical University, Huzhou, Zhejiang, People's Republic of China.",
    "Key Laboratory of Intelligent Pharmacy and Individualized Therapy of Huzhou, Huzhou, People's Republic of China.",
    "Department of Pulmonary and Critical Care Medicine, Changxing People's Hospital, Zhejiang Chinese Medical University, Huzhou, Zhejiang, People's Republic of China."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 5,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Yue Zhang"
    },
    {
      "affs": [
        2
      ],
      "name": "Peng Zeng"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Weibin Fan",
      "orcid": "0000-0002-2831-8358"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Bin Lin",
      "orcid": "0000-0003-2222-8228"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Jing Fan"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/9ysj4pxqwew9v.bib",
  "cited_by": 0,
  "doi": "10.2147/dddt.s654669",
  "fulltext_url": "https://europepmc.org/articles/PMC13695904",
  "id": "9ysj4pxqwew9v",
  "issns": [
    "1177-8881"
  ],
  "landing_url": "https://europepmc.org/article/MED/42928853",
  "language": "eng",
  "licence": "CC-BY-NC",
  "licence_label": "CC BY-NC",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2730|Cancer Immunotherapy and Biomarkers"
    ]
  ],
  "openalex": "W7223041656",
  "pdf_url": "https://europepmc.org/articles/PMC13695904?pdf=render",
  "pmcid": "PMC13695904",
  "pmid": "42928853",
  "published": "2026-10-21",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/9ysj4pxqwew9v.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:21:18Z",
      "native_id": "MED:42928853",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42928853"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2730|Cancer Immunotherapy and Biomarkers",
      "subfield": "oncology"
    }
  ],
  "title": "Association Between Serum 25-Hydroxyvitamin D Levels and Immune-Related Adverse Events During PD-1/PD-L1 Inhibitor Therapy: A Retrospective Study.",
  "title_text": "Association Between Serum 25-Hydroxyvitamin D Levels and Immune-Related Adverse Events During PD-1/PD-L1 Inhibitor Therapy: A Retrospective Study.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:21:18Z",
  "url": "https://research.draconitic.com/paper/9ysj4pxqwew9v",
  "venue": "Drug design, development and therapy",
  "versions": []
}