Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Division of Environmental Health Sciences, University of Minnesota School of Public Health and Masonic Cancer Center, Minneapolis, MN, USA.
J Natl Cancer Inst. 2022 Jul 11;114(7):1040-1043. doi: 10.1093/jnci/djac027.
The landmark Centers for Medicare & Medicaid Services (CMS) decision memo on blood-based biomarkers to screen for colorectal cancer (CRC) sets thresholds of 74% or higher for sensitivity and 90% or higher for specificity for CRC. This approach does not consider detection of advanced precancerous lesions as true positives. We contrasted the impact of counting advanced precancerous lesions as true vs false positives and projected CRC outcomes under contrasting tests in a validated model. A test with the threshold performance set by CMS decreased CRC incidence by 30% and CRC mortality by 48% in individuals aged 45 years. If this test also detected advanced precancerous lesions with 30% sensitivity, CRC incidence decreased by 45% and mortality by 58%, but the CRC specificity of the test of only 88% would not satisfy the CMS threshold. CMS should reconsider its definition of threshold specificity for CRC screening biomarkers. Future coverage determinations on biomarkers to screen for cancer should consider detection of relevant precursor lesions and projected outcomes.
美国医疗保险和医疗补助服务中心（CMS）关于血液生物标志物筛查结直肠癌（CRC）的具有里程碑意义的决策备忘录为 CRC 设置了灵敏度阈值为 74%或更高，特异性阈值为 90%或更高。这种方法并未将检测到的高级癌前病变视为真正的阳性。我们对比了将高级癌前病变视为真阳性与假阳性的影响，并在经过验证的模型中根据对比试验预测了 CRC 的结果。CMS 设定的阈值性能的检测方法可使 45 岁人群的 CRC 发病率降低 30%，CRC 死亡率降低 48%。如果该检测还能以 30%的灵敏度检测到高级癌前病变，CRC 的发病率会降低 45%，死亡率降低 58%，但检测的 CRC 特异性为 88%，将不符合 CMS 的阈值。CMS 应重新考虑其 CRC 筛查生物标志物阈值特异性的定义。未来对用于癌症筛查的生物标志物的覆盖范围决定应考虑到相关的前体病变的检测和预测的结果。
