本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2310336

摘要内容如下：

背景

下一代多靶点粪便DNA检测，包括DNA分子标志物和血红蛋白水平的评估，被开发用于提高结直肠癌筛查的性能，主要是在特异性方面。

方法

在一项前瞻性研究中，我们评估了新一代多靶点粪便DNA检测在40岁或以上接受结肠镜筛查的无症状成年人中的应用。主要结果是检测结直肠癌的敏感性和晚期肿瘤（结直肠癌或晚期癌前病变）的特异性。晚期癌前病变包括一个或多个腺瘤或最长直径至少为1 cm的无蒂锯齿状病变、具有绒毛状组织学特征的病变和高度异型增生。次要目标包括量化晚期癌前病变的敏感性和非肿瘤性发现或结肠镜检查阴性的特异性，以及比较多靶点粪便DNA检测和市售粪便免疫化学检测（FIT）对结直肠癌和晚期癌前病变的敏感性。

结果

在20，176名参与者中，98人患有结直肠癌，2144人患有进展期癌前病变，6973人患有非进展期腺瘤，10，961人患有非肿瘤性疾病或结肠镜检查阴性。在下一代检测中，结直肠癌的敏感性为93.9%（95%可信区间[CI]，87.1-97.7），晚期肿瘤的特异性为90.6%（95%CI，90.1-91.0）。晚期癌前病变的敏感性为43.4%（95%CI，41.3至45.6），非肿瘤发现或结肠镜检查阴性的特异性为92.7%（95%CI，92.2至93.1）。通过拟合，结直肠癌的敏感性为67.3%（95%CI，57.1-76.5），晚期癌前病变的敏感性为23.3%（95%CI，21.5-25.2）；晚期肿瘤的特异性为94.8%（95%CI，94.4至95.1），非肿瘤发现或结肠镜检查阴性的特异性为95.7%（95%CI，95.3至96.1）。与FIT相比，新一代检测对结直肠癌（P<0.001）和晚期癌前病变（P<0.001）具有更高的敏感性，但对晚期肿瘤（P<0.001）具有较低的特异性。无不良事件发生。

结论

与FIT相比，下一代多靶点粪便DNA检测对结直肠癌和晚期癌前病变的敏感性更高，但特异性较低。（由Exact Sciences资助；Blue-C ClinicalTrials.gov编号，NCT04144738。）

英文原文如下：

Abstracts

BACKGROUND  A next-generation multitarget stool DNA test, including assessments of DNA molecular markers and hemoglobin level, was developed to improve the performance of colorectal cancer screening, primarily with regard to specificity.

METHODS  In a prospective study, we evaluated a next-generation multitarget stool DNA test in asymptomatic adults 40 years of age or older who were undergoing screening colonoscopy. The primary outcomes were sensitivity of the test for colorectal cancer and specificity for advanced neoplasia (colorectal cancer or advanced precancerous lesions). Advanced precancerous lesions included one or more adenomas or sessile serrated lesions measuring at least 1 cm in the longest dimension, lesions with villous histologic features, and high-grade dysplasia. Secondary objectives included the quantification of sensitivity for advanced precancerous lesions and specificity for nonneoplastic findings or negative colonoscopy and comparison of sensitivities for colorectal cancer and advanced precancerous lesions between the multitarget stool DNA test and a commercially available fecal immunochemical test (FIT).

RESULTS  Of 20,176 participants, 98 had colorectal cancer, 2144 had advanced precancerous lesions, 6973 had nonadvanced adenomas, and 10,961 had nonneoplastic findings or negative colonoscopy. With the next-generation test, sensitivity for colorectal cancer was 93.9% (95% confidence interval [CI], 87.1 to 97.7), and specificity for advanced neoplasia was 90.6% (95% CI, 90.1 to 91.0). Sensitivity for advanced precancerous lesions was 43.4% (95% CI, 41.3 to 45.6), and specificity for nonneoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2 to 93.1). With the FIT, sensitivity was 67.3% (95% CI, 57.1 to 76.5) for colorectal cancer and 23.3% (95% CI, 21.5 to 25.2) for advanced precancerous lesions; specificity was 94.8% (95% CI, 94.4 to 95.1) for advanced neoplasia and 95.7% (95% CI, 95.3 to 96.1) for nonneoplastic findings or negative colonoscopy. As compared with FIT, the next-generation test had superior sensitivity for colorectal cancer (P<0.001) and for advanced precancerous lesions (P<0.001) but had lower specificity for advanced neoplasia (P<0.001). No adverse events occurred.

CONCLUSIONS  The next-generation multitarget stool DNA test showed higher sensitivity for colorectal cancer and advanced precancerous lesions than FIT but also showed lower specificity. (Funded by Exact Sciences; BLUE-C ClinicalTrials.gov number, NCT04144738.).

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