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Eligibility gap scoring across first-line targeted and immunotherapy trials and real-world cohorts in metastatic renal cell carcinoma

Year: 2026

Type: article

Abstract: First-line treatment for metastatic renal cell carcinoma (mRCC) has shifted toward immune checkpoint inhibitor-based combinations, but pivotal trial populations may differ from patients treated in routine practice. We developed an eligibility gap (EG) score to visualize selected eligibility-related baseline characteristics across first-line mRCC studies. Phase III randomized controlled trials (RCTs), published real-world data (RWD) cohorts, and the original AGEHA-JPN cohort were analyzed. The EG score integrated median age, prior nephrectomy rate, and IMDC risk distribution on a 0–99.9 scale. Thirty-six datasets were included: 10 RCTs, 25 published RWD cohorts, and AGEHA-JPN. Median EG scores were higher in RCTs than RWD cohorts (74.0 vs 60.3; p < 0.001), mainly reflecting younger age and higher prior nephrectomy rates, whereas IMDC-domain scores were similar. Asian RWD cohorts had lower median scores than non-Asian RWD cohorts (50.7 vs 64.5). Sensitivity analyses using alternative domain and sample-size weighting preserved the RCT–RWD separation. The EG score provides a descriptive framework for contextualizing selected baseline differences between trial and real-world populations. However, it does not capture factors such as histology, comorbidity, or metastatic burden and is not a comprehensive measure of trial eligibility, generalizability, or prognosis.

Source: Scientific Reports

DOI: 10.1038/s41598-026-78088-y

Authors: Marino Sawai, Takuma Narita, Yuya Sekine, Masanao Shinohara, Yohei Kawashima, Hiromi Sato, Kazuyuki Numakura, Jotaro Mikami, Naoki Fujita, Teppei Okamoto, Hayato Yamamoto, Shintaro Narita, Satoshi Sato, Tomonori Habuchi, Chikara Ohyama, Shingo Hatakeyama

Institutions: Hirosaki University, Akita University, Ageo Central General Hospital, Asahikawa Medical University, Asahikawa University, Osaka Red Cross Hospital

Language: English

Topic: Renal cell carcinoma treatment

Subfield: Oncology

Field: Medicine

Domain: Health Sciences

Open Access status: gold

Estimated APC paid: $2,690

OpenAlex ID: W7225660491

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