PO.BCS01.11 · 生物信息与计算

使用Oncuria-Monitor（一种基于尿液的多重免疫分析）监测膀胱癌复发

Surveillance for recurrent bladder cancer using Oncuria-Monitor, a urine-based multiplex immunoassay

编号 98 展板 5 时间 4/19 02:00–05:00 区域 Section 5 主讲 Sunao Tanaka, PhD

分会场 Liquid Biopsy: Multi-Analyte and Multi-Omic

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作者与单位 Authors & Affiliations

Sunao Tanaka¹, Charles Rosser¹, Yair Lotan², Menghan Liu³, Takashi Kobayashi⁴, Sima P. Porten⁵, Yuki Kita⁶, Yingye Zheng⁷, Zhen Zhang⁸, Hideki Furuya¹

¹Cedars-Sinai Medical Center, Los Angeles, CA,²Associate Professor of Urology, UT Southwestern Medical Ctr., Dallas, TX,³Fred Hutchinson Cancer Center, Seattle, WA,⁴Postdoctral Research Fellow, Dept. of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan,⁵UCSF, San Francisco, CA,⁶Institute for Virus Research, Kyoto Univ., Kyoto, Japan,⁷Fred Hutchinson Cancer Research Ctr., Seattle, WA,⁸Associate Professor, Dept. of Pathology & Oncology, Johns Hopkins University School of Medicine, Baltimore, MD

摘要 Abstract

中文摘要

引言——超过50%的非肌层浸润性膀胱癌（NMIBC）患者会出现复发，因此需要严格的监测安排。由于尿细胞学的性能较差，膀胱镜检查是监测这类患者的标准治疗。Oncuria-Monitor是一种从单次自排尿样本中检测膀胱癌复发的液体活检，表现出良好的性能。方法——为研究Oncuria-Monitor（一种多重免疫分析，可检测自排尿液中由10种蛋白组成的膀胱癌相关诊断特征）能否在监测有膀胱癌病史的患者时改善膀胱癌的检出。2017年2月至2020年8月，美国和日本的7家学术、私人诊所和医院机构前瞻性地连续入组300例有膀胱癌病史的患者进入这项纵向研究，随访患者两年。以膀胱镜活检为依据的膀胱癌复发诊断被作为参考标准。在两年期间的每次膀胱镜门诊就诊时，患者提供尿液样本用于Oncuria-Monitor（以盲法分析）、BladderChek和尿细胞学分析。将Oncuria-Monitor的性能与BladderChek和尿细胞学作为膀胱镜辅助手段检测复发性膀胱癌的性能进行了比较。结果——300例患者中有93例（31%）经组织病理学评估诊断为复发性膀胱癌。Oncuria-Monitor检出了92例癌症中的61例，敏感性为74.2%（95% CI，67.5-81.8%），特异性为39.2%（95% CI，34.6-43.1%），阴性预测值（NPV）为73.9%（95% CI，68.6-79.9%）；而BladderChek的敏感性、特异性和NPV分别为12.9%（95% CI，7.9-17.8%）、99.1%（95% CI，98.1-99.8%）和66.1%（95% CI，63.9%-70.8%）；尿细胞学的敏感性、特异性和NPV分别为28.8%（95% CI，21.1-36.7%）、97.0%（95% CI，95.3-98.4%）和71.1%（95% CI，62.7%-83.8%）。结论——在这项大型前瞻性试验中，Oncuria-Monitor在检测复发性膀胱癌方面的敏感性显著优于BladderChek和尿细胞学。

查看英文原文 English abstract

Introduction - Over 50% of patients with non-muscle invasive bladder cancer (NMIBC) will have a recurrence, necessitating a rigorous surveillance schedule. As urinary cytology's performance is poor, cystoscopy is standard of care in surveilling these patients. Oncuria-Monitor, a liquid biopsy to detect recurrent bladder cancer from a single voided urine sample demonstrated favorable performance. Methods- To investigate whether Oncuria-Monitor, a multiplex immunoassay that detects a bladder cancer associated diagnostic signature composed of 10 proteins in voided urine could improve bladder cancer detection while surveilling patients with a history of bladder cancer. From February 2017 through August 2020, 7 academic, private practice, and hospital facilities in the US and Japan prospectively enrolled 300 consecutive patients with a history of bladder cancer into this longitudinal study, which followed patients for two years. Diagnosis of bladder cancer recurrence, based on cystoscopy with biopsy, was accepted as the reference standard. At each cystoscopic clinic visit during the two years, patients provided a urine sample for analysis of Oncuria-Monitor (analyzed in a blinded manner), BladderChek and urine cytology. The performance of Oncuria-Monitor was compared with BladderChek and urine cytology as an aid to cystoscopy to detect recurrent bladder cancer. Results - Recurrent bladder cancer was diagnosed in 93 of the 300 patients (31%) by histopathological evaluation. Oncuria-Monitor detected 61 of 92 cancers with a sensitivity 74.2% (95% CI, 67.5-81.8%), specificity of 39.2% (95% CI, 34.6-43.1%) and negative predictive value (NPV) of 73.9% (95% CI, 68.6-79.9%), while sensitivity, specificity and NPV of BladderChek were 12.9%% (95% CI, 7.9-17.8%), 99.1% (95% CI, 98.1-99.8%) and 66.1% (95% CI, 63.9%-70.8%), respectively and sensitivity, specificity and NPV of urinary cytology were 28.8% (95% CI, 21.1-36.7%), 97.0% (95% CI, 95.3-98.4%) and 71.1% (95% CI, 62.7%-83.8%), respectively. Conclusions - In this large prospective trial, Oncuria-Monitor, had a substantially superior sensitivity compared to both BladderChek and urinary cytology in detecting recurrent bladder cancers.

利益披露 Disclosure

S. Tanaka, None.

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