Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany.
Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Heidelberg, Germany; German Cancer Consortium, German Cancer Research Center, Heidelberg, Germany.
Clin Gastroenterol Hepatol. 2020 Dec;18(13):2920-2928.e6. doi: 10.1016/j.cgh.2020.01.025. Epub 2020 Jan 25.
BACKGROUND & AIMS: Fecal immunochemical tests (FITs) are widely used for colorectal cancer (CRC) screening. FITs detect most CRCs. Although detection of CRC at early stages is most relevant for reducing CRC mortality, there is limited evidence for the stage-specific sensitivity of the FIT in CRC detection. We estimated stage- and location-specific sensitivities of a quantitative FIT in a large cohort of patients with CRC.
Fecal samples were collected before treatment from 435 patients with newly diagnosed CRC. Sensitivities of a quantitative FIT (FOB Gold, Sentinel Diagnostics; Milano, Italy) for tumors of different T stages and overall TNM stages (according to Union for International Cancer Control) were calculated at the cutoff recommended by the manufacturer (17 μg/g feces) and at alternative cutoffs, ranging from 10 to 40 μg/g feces, overall and stratified by tumor location.
At the cutoff recommended by the manufacturer, the FIT detected T1 tumors with 52% sensitivity (95% CI, 37%-67%), T2 tumors with 79% sensitivity (95% CI, 68%-88%), T3 tumors with 93% sensitivity (95% CI, 89%-95%), and T4 tumors with 84% sensitivity (95% CI, 72%-92%) (P < .0001). The FIT detected stage I cancers with 68% sensitivity (95% CI, 57%-78%), stage II cancers with 92% sensitivity (95% CI, 87%-96%), stage III cancers with 82% sensitivity (95% CI, 73%-89%), and stage IV cancers with 89% sensitivity (95% CI, 80%-95%) (P 0.01). The FIT detected T1 colorectal tumors with sensitivity values that were 22%-52% lower than for tumors of other T stages and stage I CRC with sensitivity values that were 11%-33% lower than for later-stage CRCs, at any of the evaluated cutoff values. The FIT detected T1 and stage I CRCs in the distal colon with sensitivity values of 32% and 52%, respectively.
Although the FIT identifies patients with CRC with overall high sensitivity, it can miss approximately one-third of stage I CRCs. Studies are needed to increase noninvasive detection of early-stage CRC.
粪便免疫化学检测（FIT）广泛用于结直肠癌（CRC）筛查。FIT 检测到大多数 CRC。尽管早期检测 CRC 对于降低 CRC 死亡率最为重要，但 FIT 在 CRC 检测中的特定分期敏感性的证据有限。我们在一组患有 CRC 的大量患者中估计了定量 FIT 的分期和位置特异性敏感性。
在新诊断的 CRC 患者接受治疗前，从 435 名患者中收集粪便样本。根据国际癌症控制联盟（Union for International Cancer Control）的规定，使用定量 FIT（FOB Gold，Sentinel Diagnostics；意大利米兰）检测不同 T 分期和整体 TNM 分期（overall TNM stages）的肿瘤的敏感性，在制造商推荐的截止值（17μg/g 粪便）和从 10 到 40μg/g 粪便的替代截止值范围内进行计算，总体上和按肿瘤位置分层。
在制造商推荐的截止值处，FIT 检测到 T1 肿瘤的敏感性为 52%（95%CI，37%-67%），T2 肿瘤的敏感性为 79%（95%CI，68%-88%），T3 肿瘤的敏感性为 93%（95%CI，89%-95%），T4 肿瘤的敏感性为 84%（95%CI，72%-92%）（P<.0001）。FIT 检测到 I 期癌症的敏感性为 68%（95%CI，57%-78%），II 期癌症的敏感性为 92%（95%CI，87%-96%），III 期癌症的敏感性为 82%（95%CI，73%-89%），IV 期癌症的敏感性为 89%（95%CI，80%-95%）（P 0.01）。在任何评估的截止值处，FIT 检测到 T1 结直肠肿瘤的敏感性值比其他 T 分期的肿瘤低 22%-52%，而 T1 和 I 期 CRC 的敏感性值比晚期 CRC 低 11%-33%。FIT 在远端结肠中分别检测到 T1 和 I 期 CRC 的敏感性值为 32%和 52%。
尽管 FIT 总体上能够以较高的敏感性识别患有 CRC 的患者，但它可能会错过大约三分之一的 I 期 CRC。需要研究以提高对早期 CRC 的非侵入性检测。
