International journal of urology : official journal of the Japanese Urological Association · 2026
Visualizing Baseline Eligibility Across Locally Advanced or Metastatic Urothelial Cancer Trials and Real-World Cohorts.
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Ichiyama Takaki, Narita Takuma, Sato Hiroyuki, Sekine Yuya, Shinohara Masanao, Kawashima Yohei, Kobayashi Mizuki, Numakura Kazuyuki, Mikami Jotaro, Fujita Naoki, Okamoto Teppei, Yamamoto Hayato, Yoneyama Takahiro, Narita Shintaro, Sato Satoshi, Habuchi Tomonori, Ohyama Chikara, Hatakeyama Shingo
Аннотация
BACKGROUND: Clinical trials in locally advanced or metastatic urothelial carcinoma (mUC) often enroll younger and fitter patients than those treated in routine practice, limiting applicability to real-world populations. We developed a simple descriptive metric, the eligibility gap (EG) score, to place trial and real-world cohorts on a common scale and summarize differences in baseline eligibility profiles.
METHODS: Pivotal clinical trials were identified through a PubMed search, and three real-world datasets from Japan, the United States, and Spain were included. The EG score used three consistently reported domains: age, ECOG performance status, and cisplatin eligibility. Each domain was scaled from 0 to 33.3 points and summed to yield a score from 0 to 99.9, with higher scores indicating younger, fitter populations. Robustness was assessed across alternative model specifications, including prespecified weighting schemes, random-weight simulations, alternative age and ECOG scoring functions, and one-domain-out analyses.
RESULTS: EG scores were generally higher in cisplatin-based trials (74.8-90.1) than in immune checkpoint inhibitors (ICI)-based trials (52.3-81.2) and real-world cohorts (35.1-45.5), while the cisplatin-ineligible trial had the lowest score (24.5). Alternative age transformations and a linear ECOG model did not change ranking. In one-domain-out analyses, omission of ECOG preserved ranking, whereas omission of age or cisplatin-fitness produced minor shifts. Across prespecified weighting schemes, rank-order concordance remained high (Spearman's rho = 0.982-1.000), and 10 000 random-weight simulations showed a median rho of 0.982.
CONCLUSIONS: The EG score may provide a simple descriptive summary of eligibility domains across mUC studies, with stable cohort ordering across alternative model specifications.
METHODS: Pivotal clinical trials were identified through a PubMed search, and three real-world datasets from Japan, the United States, and Spain were included. The EG score used three consistently reported domains: age, ECOG performance status, and cisplatin eligibility. Each domain was scaled from 0 to 33.3 points and summed to yield a score from 0 to 99.9, with higher scores indicating younger, fitter populations. Robustness was assessed across alternative model specifications, including prespecified weighting schemes, random-weight simulations, alternative age and ECOG scoring functions, and one-domain-out analyses.
RESULTS: EG scores were generally higher in cisplatin-based trials (74.8-90.1) than in immune checkpoint inhibitors (ICI)-based trials (52.3-81.2) and real-world cohorts (35.1-45.5), while the cisplatin-ineligible trial had the lowest score (24.5). Alternative age transformations and a linear ECOG model did not change ranking. In one-domain-out analyses, omission of ECOG preserved ranking, whereas omission of age or cisplatin-fitness produced minor shifts. Across prespecified weighting schemes, rank-order concordance remained high (Spearman's rho = 0.982-1.000), and 10 000 random-weight simulations showed a median rho of 0.982.
CONCLUSIONS: The EG score may provide a simple descriptive summary of eligibility domains across mUC studies, with stable cohort ordering across alternative model specifications.