{
  "abstract": "Introduction: Osimertinib is the standard first-line therapy for EGFR -mutated NSCLC. Nevertheless, the clinical significance of high programmed death-ligand 1 (PD-L1) expression in this setting remains unclear. This study aimed to evaluate the association between a high PD-L1 tumor proportion score (≥50%) and clinical outcomes in patients treated with first-line osimertinib. Methods: This multicenter retrospective study used the REAL-WIND database from 16 Japanese institutions. Among 486 patients with EGFR -mutated NSCLC treated with first-line osimertinib, 385 patients with known PD-L1 status formed the full cohort (cohort B). After excluding 185 patients who overlapped with the published OSI-FACT data set, 200 patients formed the non-overlapping validation cohort (cohort A). Patients were stratified by PD-L1 tumor proportion score (≥50% versus <50%). The primary end point was real-world progression-free survival (rwPFS), and secondary end points were overall survival (OS) and time to treatment failure. Outcomes were evaluated using unadjusted analyses and propensity score–based analyses to assess the robustness of the observed associations. Results: In cohort A, high PD-L1 expression was associated with shorter rwPFS (hazard ratio [HR] = 1.95, 95% confidence interval [CI]: 1.30–2.92, p = 0.001) and OS (HR = 1.72, 95% CI: 1.02–3.09, p = 0.044). Similar associations were observed in cohort B for rwPFS (HR = 1.76, 95% CI: 1.30–2.37, p < 0.001) and OS (HR = 1.92, 95% CI: 1.28–2.87, p = 0.002). These associations were consistent in unadjusted analyses and in propensity score–based analyses adjusting for baseline confounding, supporting the reproducibility of the findings in this real-world cohort. Conclusions: High PD-L1 expression was associated with reduced clinical benefit from first-line osimertinib in EGFR -mutated NSCLC. These findings should be interpreted as a consistent clinical association observed in real-world practice, rather than definitive evidence of a predictive biomarker.",
  "abstract_shown": true,
  "affiliations": [
    "Division of Respiratory Medicine, Saiseikai Kumamoto Hospital, Kumamoto, Japan; Corresponding author. Address for correspondence: Yoshihiko Sakata, MD, Division of Respiratory Medicine, Saiseikai Kumamoto Hospital, 5-3-1 Chikami, Minami-ku, Kumamoto 861-4193, Japan.",
    "Biostatistics Center, Kurume University, Fukuoka, Japan",
    "Department of Respiratory Medicine and Hematology, Hyogo Medical University, Hyogo, Japan",
    "Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan",
    "Department of Respiratory Medicine, Kurashiki Central Hospital, Okayama, Japan",
    "Department of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan",
    "Department of Thoracic Oncology, Aichi Cancer Center Hospital, Aichi, Japan",
    "Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan",
    "Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan",
    "Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan",
    "Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan",
    "Department of Respiratory Medicine, Juntendo University, Graduate School of Medicine, Tokyo, Japan",
    "Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Fukuoka, Japan",
    "Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Hyogo, Japan",
    "Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan; Department of Respiratory Medicine, Kumamoto University Hospital, Kumamoto, Japan",
    "Department of Thoracic Oncology, Kansai Medical University, Osaka, Japan",
    "Department of Respiratory Medicine, Hiroshima University Hospital, Hiroshima, Japan",
    "Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan",
    "Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan",
    "Department of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan",
    "Internal Medicine III, Wakayama Medical University, Wakayama, Japan"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 21,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Yoshihiko Sakata, MD"
    },
    {
      "affs": [
        1
      ],
      "name": "Kenta Murotani, PhD"
    },
    {
      "affs": [
        2
      ],
      "name": "Daichi Fujimoto, MD, PhD"
    },
    {
      "affs": [
        3
      ],
      "name": "Yukihiro Toi, MD"
    },
    {
      "affs": [
        4
      ],
      "name": "Toshihide Yokoyama, MD"
    },
    {
      "affs": [
        5
      ],
      "name": "Seigo Katakura, MD, PhD"
    },
    {
      "affs": [
        6
      ],
      "name": "Teppei Yamaguchi, MD, PhD"
    },
    {
      "affs": [
        7
      ],
      "name": "Kaoru Tanaka, MD, PhD"
    },
    {
      "affs": [
        8
      ],
      "name": "Satoru Miura, MD, PhD"
    },
    {
      "affs": [
        9
      ],
      "name": "Motohiro Tamiya, MD"
    },
    {
      "affs": [
        10
      ],
      "name": "Motoko Tachihara, MD, PhD"
    },
    {
      "affs": [
        11
      ],
      "name": "Takehito Shukuya, MD, PhD"
    },
    {
      "affs": [
        12
      ],
      "name": "Yuko Tsuchiya, MD, PhD"
    },
    {
      "affs": [
        13
      ],
      "name": "Yuki Sato, MD, PhD"
    },
    {
      "affs": [
        14
      ],
      "name": "Satoshi Ikeda, MD, PhD"
    },
    {
      "affs": [
        15
      ],
      "name": "Shinya Sakata, MD, PhD"
    },
    {
      "affs": [
        16
      ],
      "name": "Takeshi Masuda, MD, PhD"
    },
    {
      "affs": [
        17
      ],
      "name": "Shinnosuke Takemoto, MD, PhD"
    },
    {
      "affs": [
        18
      ],
      "name": "Hirotsugu Kenmotsu, MD, PhD"
    },
    {
      "affs": [
        19
      ],
      "name": "Isamu Okamoto, MD, PhD"
    },
    {
      "affs": [
        20
      ],
      "name": "Nobuyuki Yamamoto, MD, PhD"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/f0ghxarx713vy.bib",
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  "doi": "10.1016/j.jtocrr.2026.101054",
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  "pmcid": null,
  "pmid": "42964815",
  "published": "2026-07-24",
  "publisher": "Elsevier",
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  "title": "High PD-L1 Expression and Clinical Outcomes of First-Line Osimertinib in",
  "title_text": "High PD-L1 Expression and Clinical Outcomes of First-Line Osimertinib in",
  "type": "peer-reviewed",
  "updated_at": "2026-11-03T12:21:31Z",
  "url": "https://research.draconitic.com/paper/f0ghxarx713vy",
  "venue": "JTO Clinical and Research Reports",
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