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Patient-derived Orthotopic Xenograft Models for Human Urothelial Cell Carcinoma and Colorectal Cancer Tumor Growth and Spontaneous Metastasis
Published on: May 12, 2019
Visualizing Baseline Eligibility Across Locally Advanced or Metastatic Urothelial Cancer Trials and Real-World
Takaki Ichiyama1, Takuma Narita1, Hiroyuki Sato1
1Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Summary
The eligibility gap (EG) score quantifies patient eligibility differences between clinical trials and real-world practice for metastatic urothelial carcinoma (mUC). This metric shows clinical trials often enroll healthier patients than those in routine care.
Area of Science:
- Oncology
- Clinical Trials
- Health Services Research
Background:
- Clinical trials for metastatic urothelial carcinoma (mUC) often lack real-world applicability due to selective patient enrollment.
- A significant gap exists between the characteristics of patients in clinical trials and those receiving routine care.
- This disparity limits the generalizability of trial findings to broader patient populations.
Purpose of the Study:
- To develop and validate a simple metric, the eligibility gap (EG) score, to compare patient eligibility between clinical trials and real-world cohorts.
- To provide a standardized method for assessing and summarizing baseline eligibility differences.
- To enhance the understanding of how patient selection in trials impacts real-world applicability.
Main Methods:
- The eligibility gap (EG) score was developed using three key domains: age, Eastern Cooperative Oncology Group (ECOG) performance status, and cisplatin eligibility.
- Data from pivotal clinical trials and three real-world datasets (Japan, US, Spain) were analyzed.
- The score's robustness was evaluated using various statistical methods, including sensitivity analyses and simulations.
Main Results:
- EG scores were consistently higher in cisplatin-based trials (74.8-90.1) and immune checkpoint inhibitor (ICI)-based trials (52.3-81.2) compared to real-world cohorts (35.1-45.5).
- The cisplatin-ineligible trial had the lowest EG score (24.5).
- The EG score demonstrated stable cohort ordering across different model specifications and weighting schemes, indicating robustness.
Conclusions:
- The eligibility gap (EG) score offers a straightforward method to summarize eligibility criteria across metastatic urothelial carcinoma studies.
- The score's stability across various analytical models supports its utility in comparing trial and real-world populations.
- This metric can aid in better interpreting clinical trial results within the context of routine practice.
