Systematic review with meta‐analysis: faecal occult blood tests show lower colorectal cancer detection rates in the proximal colon in colonoscopy‐verified diagnostic studies

Hirai, Hoyee W.; Tsoi, Kelvin K.; Chan, Joyce Y.C.; Wong, Samuel S. Y.; Ching, Jessica Y. L.; Wong, Martin C.S.; Wu, Justin C.; Chan, Francis K.L.; Sung, Joseph J.Y.; Ng, Siew C.

doi:10.1111/apt.13556

Cited by 59 publications

(60 citation statements)

References 49 publications

(75 reference statements)

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“…Therefore, the cancer location (right-sided vs. left-sided) might affect FIT sensitivity. 26,[30][31][32][33] In the present study, the frequency of right-sided location was significantly higher in Negative advanced CRC than in First advanced CRC, indicating that FIT is not accurate enough to detect advanced CRC in the right-sided colon. Overall, these data are in agreement with previous studies that found a lower FIT accuracy for right-sided versus left-side advanced neoplasia.…”

Section: Discussioncontrasting

confidence: 71%

Characteristics of Advanced Colorectal Cancer Detected by Fecal Immunochemical Test Screening in Participants with a Negative Result the Previous Year

et al. 2020

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Background There is sufficient evidence to show the mortality reduction effect of colorectal cancer (CRC) screening programs using the fecal occult blood test (FOBT). However, we see cases that are found to be advanced CRC despite yearly FOBT screening. Methods The aim of this study was to investigate the characteristics of advanced CRC detected by a fecal immunochemical test (FIT) screening program in participants with a negative screening result the previous year, which we call "Negative advanced CRC". A total of 109,639 participants (10.0% required colonoscopy, of whom 76.9% received one) underwent a CRC screening program using a FIT from fiscal 2009 to 2017. Negative advanced CRC was compared with advanced CRC (First advanced CRC) found at the first visit in a person who had not had a FIT screening history for more than 3 years. In addition, we compared the characteristics of Negative advanced CRC with those of interval cancer: cancer cases detected after a negative screening result and before the date of the next recommended screening. Results A total of 339 cases of CRC (175 male: 164 female, 173 early stage: 166 advanced stage) were detected in the nine-year CRC screening period. The rate of right-sided CRCs was significantly higher in female (P < 0.01), advanced stage (P < 0.01), negative result previous year (P < 0.01), and symptom-negative (P < 0.01) participants than in each counterpart, respectively. The ratio of female (22/35; 62.9%) patients in Negative advanced CRCs tended to be high compared with that (40/83; 48.2%) in First advanced CRCs (P = 0.145). Overall, 22 (62.9%) of 35 Negative advanced CRCs and 28 (33.7%) of 83 First advanced CRCs were located in the right-sided colon, and the rate was significantly higher in Negative advanced CRCs (P < 0.01). In addition, the frequency of female patients was significantly higher in right-sided Negative advanced CRCs than in right-sided First advanced CRCs (P = 0.03). Conclusion The characteristics of Negative advanced CRC cases (female and right-sided colon) were similar to those of interval cancer reported so far. In the future, it will be necessary to introduce a screening program that is highly sensitive to right-sided CRC.

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Section: Discussioncontrasting

confidence: 71%

Characteristics of Advanced Colorectal Cancer Detected by Fecal Immunochemical Test Screening in Participants with a Negative Result the Previous Year

et al. 2020

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“…One potential explanation for this may be differences in the size, site and stage of CRCs detected through surveillance relative to screening. A systematic review with meta-analysis by Hirai et al 109 found lower sensitivity of FIT for proximal than distal CRC. Furthermore, faecal haemoglobin levels appear to be higher in patients with larger AAs and in those with a greater number of AAs.…”

Section: Discussionmentioning

confidence: 99%

Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study

Atkin

Cross

Kralj-Hans

et al. 2019

Health Technol Assess

100

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Background In the UK, patients with one or two adenomas, of which at least one is ≥ 10 mm in size, or three or four small adenomas, are deemed to be at intermediate risk of colorectal cancer (CRC) and referred for surveillance colonoscopy 3 years post polypectomy. However, colonoscopy is costly, can cause discomfort and carries a small risk of complications. Objectives To determine whether or not annual faecal immunochemical tests (FITs) are effective, acceptable and cost saving compared with colonoscopy surveillance for detecting CRC and advanced adenomas (AAs). Design Diagnostic accuracy study with health psychology assessment and economic evaluation. Setting Participants were recruited from 30 January 2012 to 30 December 2013 within the Bowel Cancer Screening Programme in England. Participants Men and women, aged 60–72 years, deemed to be at intermediate risk of CRC following adenoma removal after a positive guaiac faecal occult blood test were invited to participate. Invitees who consented and returned an analysable FIT were included. Intervention We offered participants quantitative FITs at 1, 2 and 3 years post polypectomy. Participants testing positive with any FIT were referred for colonoscopy and not offered further FITs. Participants testing negative were offered colonoscopy at 3 years post polypectomy. Acceptibility of FIT was assessed using discussion groups, questionnaires and interviews. Main outcome measures The primary outcome was 3-year sensitivity of an annual FIT versus colonoscopy at 3 years for detecting advanced colorectal neoplasia (ACN) (CRC and/or AA). Secondary outcomes included participants’ surveillance preferences, and the incremental costs and cost-effectiveness of FIT versus colonoscopy surveillance. Results Of 8008 invitees, 5946 (74.3%) consented and returned a round 1 FIT. FIT uptake in rounds 2 and 3 was 97.2% and 96.9%, respectively. With a threshold of 40 µg of haemoglobin (Hb)/g faeces (hereafter referred to as µg/g), positivity was 5.8% in round 1, declining to 4.1% in round 3. Over three rounds, 69.2% (18/26) of participants with CRC, 34.3% (152/443) with AAs and 35.6% (165/463) with ACN tested positive at 40 µg/g. Sensitivity for CRC and AAs increased, whereas specificity decreased, with lower thresholds and multiple rounds. At 40 µg/g, sensitivity and specificity of the first FIT for CRC were 30.8% and 93.9%, respectively. The programme sensitivity and specificity of three rounds at 10 µg/g were 84.6% and 70.8%, respectively. Participants’ preferred surveillance strategy was 3-yearly colonoscopy plus annual FITs (57.9%), followed by annual FITs with colonoscopy in positive cases (31.5%). FIT with colonoscopy in positive cases was cheaper than 3-yearly colonoscopy (£2,633,382), varying from £485,236 (40 µg/g) to £956,602 (10 µg/g). Over 3 years, FIT surveillance could miss 291 AAs and eight CRCs using a threshold of 40 µg/g, or 189 AAs and four CRCs using a threshold of 10 µg/g. Conclusions Annual low-threshold FIT with colonoscopy in positive cases achieved high sensitivity for CRC and would be cost saving compared with 3-yearly colonoscopy. However, at higher thresholds, this strategy could miss 15–30% of CRCs and 40–70% of AAs. Most participants preferred annual FITs plus 3-yearly colonoscopy. Further research is needed to define a clear role for FITs in surveillance. Future work Evaluate the impact of ACN missed by FITs on quality-adjusted life-years. Trial registration Current Controlled Trials ISRCTN18040196. Funding National Institute for Health Research (NIHR) Health Technology Assessment programme, NIHR Imperial Biomedical Research Centre and the Bobby Moore Fund for Cancer Research UK. MAST Group Ltd provided FIT kits.

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“…Prospective randomized controlled trials showed that FOBT screening reduced CRC-related mortality [23]. Furthermore, recent fecal immunochemical test (FIT) has shown high CRC detectability [24], while the utility of stool-based DNA assays has been reported as a new application for CRC diagnosis [25]. Nonetheless, FOBT has some limitations, such as its relatively low sensitivity for early-stage or proximal colon cancer [24, 26].…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, recent fecal immunochemical test (FIT) has shown high CRC detectability [24], while the utility of stool-based DNA assays has been reported as a new application for CRC diagnosis [25]. Nonetheless, FOBT has some limitations, such as its relatively low sensitivity for early-stage or proximal colon cancer [24, 26]. Moreover, adherence rate to the CRC screening program based on FOBT and colonoscopy remains low at around 50% [27, 28], and it is reported that many people who avoid current FOBT program prefer a simple blood-based test instead [29].…”

Section: Discussionmentioning

confidence: 99%

LINE-1 hypomethylation status of circulating cell-free DNA in plasma as a biomarker for colorectal cancer

et al. 2017

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Colorectal cancer (CRC) is a serious public health problem and non-invasive biomarkers improving diagnosis or therapy are strongly required. Circulating cell-free DNA (cfDNA) has been a promising target for this purpose. In this study, we evaluated the potential of long interspersed nuclear element-1 (LINE-1) hypomethylation as a blood biomarker for CRC. LINE-1 hypomethylation level in plasma cfDNA in 114 CRC patients was retrospectively examined by absolute quantitative analysis of methylated alleles real-time PCR, and was expressed using LINE-1 hypomethylation index (LHI) [unmethylated copy number/ (methylated copy number + unmethylated copy number)]. Greater LHI values indicated enhanced hypomethylation. In our clinicopathological analysis, CRC patients with large tumors (≥6.0 cm), advanced N stage (≥2), and distant metastasis (M1) had statistically significantly higher cfDNA LHI than other CRC patients, suggesting cfDNA LHI as a disease progression biomarker for CRC. Furthermore, early stage I/II (n = 57) as well as advanced stage III/IV (n =57) CRC patients had significantly higher cfDNA LHI than healthy donors (n=53) [stage I/II: median 0.369 (95% confidence interval, 0.360–0.380) vs. 0.332 (0.325–0.339), P < 0.0001; stage III/IV: 0.372 (0.365–0.388) vs. 0.332 (0.325–0.339), P < 0.0001]. The receiver operating characteristic analysis showed that cfDNA LHI had the detection capacity of CRC with area under the curve(AUC) of 0.79 and 0.83 in stage I/II and stage III/IV CRC patients, respectively. The present study demonstrated for the first time the potential of plasma cfDNA LHI as a novel biomarker for CRC, particularly for early stage detection.

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Systematic review with meta‐analysis: faecal occult blood tests show lower colorectal cancer detection rates in the proximal colon in colonoscopy‐verified diagnostic studies

Abstract: Faecal occult blood tests, both guaiac- and immunochemical-based, show better diagnostic performance for the relative detection of colorectal cancer in the distal colon than in the proximal bowel.

Cited by 59 publications

References 49 publications

Characteristics of Advanced Colorectal Cancer Detected by Fecal Immunochemical Test Screening in Participants with a Negative Result the Previous Year

Characteristics of Advanced Colorectal Cancer Detected by Fecal Immunochemical Test Screening in Participants with a Negative Result the Previous Year

Faecal immunochemical tests versus colonoscopy for post-polypectomy surveillance: an accuracy, acceptability and economic study

LINE-1 hypomethylation status of circulating cell-free DNA in plasma as a biomarker for colorectal cancer

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