Purpose: Precision oncology requires biomarker testing from tumor tissue for clinical decision-making and selection of targeted therapies. We systematically evaluated the role of tissue biomarker testing within interventional clinical trials for locally advanced and metastatic urothelial carcinoma (UC). Methods: A systematic search within the publicly available ClinicalTrials.gov database was performed for the period 1995 to January 2020. We searched for all interventional studies on systemic treatments for advanced UC. Two investigators independently screened the records and extracted the data for statistical analyses. Results: We included 356 studies out of 827 initial records in the final analysis. The overall number of interventional trials in UC patients significantly increased during the past 25 years. Forty-three studies (12.1%) required specific biomarker testing as a prerequisite for inclusion. Of the remaining 313 trials, explorative biomarkers of interest were studied in 83 studies (23.3%). In trials with obligate biomarker testing as a precondition for study inclusion, only 3 studies (7%) required an actual fresh pretreatment biopsy, while the majority of studies did not state any tissue requirements (55.8%) or accepted archival tissue samples (37.3%). Among studies without biomarker prerequisites, freshly obtained tissue samples were required in 16.3% of studies evaluating immune checkpoint inhibition and 5.7% evaluating targeted therapy. The collection of archival tissue was allowed in 67.4% and 20% of studies evaluating immune checkpoint inhibitors and targeted therapies, respectively. Conclusion: There has been an increase in the number of studies using biomarker-guided interventions for the treatment of advanced UC over the past 25 years. Studies investigating druggable targets in actual UC biopsies immediately before treatment are still rare. Standardized criteria for tissue-based biomarker testing may further accelerate personalized treatment of patients with advanced UC.
Urol Int

中文翻译：

---

增加生物标志物对尿路上皮癌治疗的指导：国际临床试验的系统评价

目的：精准肿瘤学需要对肿瘤组织进行生物标志物检测，以用于临床决策和靶向治疗的选择。我们系统地评估了组织生物标志物检测在局部晚期和转移性尿路上皮癌 (UC) 介入临床试验中的作用。方法：在公开的 ClinicalTrials.gov 数据库中进行了 1995 年至 2020 年 1 月期间的系统搜索。我们搜索了所有关于晚期 UC 全身治疗的介入研究。两名研究者独立筛选记录并提取数据进行统计分析。结果：我们在最终分析中纳入了 827 项初始记录中的 356 项研究。在过去 25 年中，UC 患者的介入试验总数显着增加。43 项研究 (12.1%) 需要特定的生物标志物测试作为纳入的先决条件。在其余 313 项试验中，83 项研究 (23.3%) 研究了感兴趣的探索性生物标志物。在以强制性生物标志物检测作为研究纳入先决条件的试验中，只有 3 项研究 (7%) 需要实际的新鲜治疗前活检，而大多数研究没有说明任何组织要求 (55.8%) 或接受的档案组织样本 (37.3%) ). 在没有生物标志物先决条件的研究中，16.3% 的评估免疫检查点抑制的研究和 5.7% 的评估靶向治疗的研究需要新鲜获得的组织样本。结论：在过去 25 年中，使用生物标志物指导的干预措施治疗晚期 UC 的研究数量有所增加。在治疗前即刻调查实际 UC 活检中的药物靶标的研究仍然很少。基于组织的生物标志物测试的标准化标准可能会进一步加速晚期 UC 患者的个性化治疗。
尿素