Kaiser Permanente Division of Research, Oakland, California; Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland.
University of California-San Francisco, San Francisco, California.
Gastroenterology. 2019 Dec;157(6):1494-1505. doi: 10.1053/j.gastro.2019.08.023. Epub 2019 Aug 22.
BACKGROUND & AIMS: Quantitative fecal immunochemical tests (FITs) for hemoglobin are commonly used for colorectal cancer (CRC) screening. We aimed to quantify the change in CRC and advanced adenoma detection and number of positive test results at different positivity thresholds and by sex and age.
We searched MEDLINE and EMBASE, selecting articles of FIT for CRC detection in asymptomatic adults undergoing screening. We calculated sensitivity and specificity, as well as detected number of cancers, advanced adenomas, and positive test results at positivity thresholds ≤10 μg hemoglobin/g feces, 10 to ≤20 μg/g, 20 to ≤30 μg/g, and >30 μg/g. We also analyzed results from stratified by patient sex, age, and reference standard.
Our meta-analysis comprised 46 studies with 2.4 million participants and 6478 detected cancers. Sensitivity for detection of CRC increased from 69% (95% confidence interval [CI], 63%-75%) at thresholds >10 μg/g and ≤20 μg/g to 80% (95% CI, 76%-83%) at thresholds ≤10 μg/g. At these threshold values, sensitivity for detection of advanced adenomas increased from 21% (95% CI, 18%-25%) to 31% (95% CI, 27%-35%), whereas specificity decreased from 94% (95% CI, 93%-96%) to 91% (95% CI, 89%-93%). In 3 studies stratified by sex, sensitivity of CRC detection was 77% in men (95% CI, 75%-79%) and 81% in women (95% CI, 60%-100%) (P = .68). In 3 studies stratified by age groups, sensitivity of CRC detection was 85% for ages 50-59 years (95% CI, 71%-99%) and 73% for ages 60-69 years (95% CI, 71%-75%) (P = .10). All studies with colonoscopy follow-up had similar sensitivity levels for detection of CRC to studies that analyzed 2-year registry follow-up data (74%; 95% CI, 68%-78% vs 75%; 95% CI, 73%-77%).
In a meta-analysis of studies that analyzed detection of CRC and advanced adenomas at different FIT positivity thresholds, we found the sensitivity and specificity of detection to vary with positive cutoff value. It might be possible to decrease positive threshold values for centers with sufficient follow-up colonoscopy resources. More research is needed to precisely establish FIT thresholds for each sex and age subgroup.
PROSPERO CRD42017068760.
定量粪便免疫化学检测（FIT）常用于血红蛋白的结直肠癌（CRC）筛查。本研究旨在定量分析不同阳性阈值和不同性别、年龄的CRC和高级腺瘤检测以及阳性检测结果的数量变化。
我们检索了 MEDLINE 和 EMBASE，选择了用于无症状成年人筛查的 FIT 检测 CRC 的文章。我们计算了敏感性和特异性，以及在阳性阈值≤10μg血红蛋白/g粪便、10-≤20μg/g、20-≤30μg/g 和>30μg/g时癌症、高级腺瘤和阳性检测结果的检测数量。我们还分析了按患者性别、年龄和参考标准分层的结果。
我们的荟萃分析包括 46 项研究，涉及 240 万参与者和 6478 例检测到的癌症。CRC 检测的敏感性从阈值>10μg/g 和≤20μg/g时的 69%（95%置信区间[CI]，63%-75%）增加到阈值≤10μg/g时的 80%（95% CI，76%-83%）。在这些阈值下，高级腺瘤检测的敏感性从 21%（95% CI，18%-25%）增加到 31%（95% CI，27%-35%），而特异性从 94%（95% CI，93%-96%）下降到 91%（95% CI，89%-93%）。在按性别分层的 3 项研究中，CRC 检测的敏感性在男性为 77%（95% CI，75%-79%），在女性为 81%（95% CI，60%-100%）（P=0.68）。在按年龄组分层的 3 项研究中，CRC 检测的敏感性在 50-59 岁年龄组为 85%（95% CI，71%-99%），在 60-69 岁年龄组为 73%（95% CI，71%-75%）（P=0.10）。所有具有结肠镜随访的研究与分析 2 年登记随访数据的研究相比，CRC 检测的敏感性水平相似（74%；95% CI，68%-78%与 75%；95% CI，73%-77%）。
在对不同 FIT 阳性阈值的 CRC 和高级腺瘤检测进行的荟萃分析中，我们发现检测的敏感性和特异性随阳性截断值而变化。对于有足够结肠镜随访资源的中心，可能可以降低阳性阈值。需要进一步研究以准确为每个性别和年龄亚组建立 FIT 阈值。
PROSPERO CRD42017068760。
