Comparison of an Established Simple Office-Based Immunological FOBT With Fecal Tumor Pyruvate Kinase Type M2 (M2-PK) for Colorectal Cancer Screening: Prospective Multicenter Study

Shastri, Yogesh M.; Loitsch, Stefan; Hoepffner, N.; Povse, Nada; Hanisch, E.; Rösch, Wolfgang; Mössner, Joachim; Stein, Jürgen M.

doi:10.1111/j.1572-0241.2008.01824.x

Cited by 48 publications

(55 citation statements)

References 44 publications

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“…Their study further supports the previous smaller studies in patients with more-than-average risk of harbouring colorectal cancer (CRC) (Shastri et al, 2006(Shastri et al, , 2008, in which the suboptimal performances of faecal pyruvate kinase M2 (M2-PK) for detecting the precursors for CRC (the colorectal adenomas) have already been demonstrated. However, we have certain comments to make about this study:…”

Section: Sirsupporting

confidence: 86%

Faecal tumour pyruvate kinase M2: not a good marker for the detection of colorectal adenomas

Shastri

Stein

2008

Br J Cancer

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Sir,We read with great interest the article by Haug et al (2008) and would like to complement them for such interesting clinical work. Their study further supports the previous smaller studies in patients with more-than-average risk of harbouring colorectal cancer (CRC) (Shastri et al, 2006(Shastri et al, , 2008, in which the suboptimal performances of faecal pyruvate kinase M2 (M2-PK) for detecting the precursors for CRC (the colorectal adenomas) have already been demonstrated. However, we have certain comments to make about this study:(1) As per the study design, they performed CRC screening in all the asymptomatic patients older than 55 years (as per the screening guidelines in Germany). But in Table 1, the first two groups of patients were in the range of 30 -49 and 50 -59 years. How can this be explained when only patients older than 55 years were included in the study? (2) In this study, all those average-risk patients scheduled for colonoscopic CRC screening were included and were requested to provide stool samples for performing faecal M2-PK. They included close to 1100 patients undergoing screening colonoscopy in 20 participating centres over a period of nearly 2 years. Thus on an average 28 colonoscopies/ year (about two screening colonoscopies/month) were performed in each centre for this study. Are these not a small number of CRC screenees undergoing colonoscopies in these centres! (3) In the Materials and Methods section it is mentioned that 'Patients with insufficient knowledge of German language were excluded'. What could have been the reason for this? As there is not much history taking required when suitable asymptomatic screenees undergo CRC screening?We agree with the authors of the study (Haug et al, 2008) that faecal M2-PK has poor test characteristics (especially low sensitivity and specificity) in distinguishing between patients having colorectal adenomas or no clinical findings at colonoscopy. This has also been reported in a previous prospective study (Mulder et al, 2007). This knowledge further consolidates the case for not recommending faecal M2-PK as a biomarker for CRC screening, as detecting and removing the precursors of CRC is one of the major aims of any CRC screening modality. REFERENCES

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Section: Sirsupporting

confidence: 86%

Faecal tumour pyruvate kinase M2: not a good marker for the detection of colorectal adenomas

Shastri

Stein

2008

Br J Cancer

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“…However, results were obtained on a sample size of 5 patients. When Shastri and colleagues (29) conducted sensitivities of M2-PK for adenoma detection for a larger sample size, sensitivities obtained were much lower at 37%.…”

Section: Fecal Biomarkersmentioning

confidence: 98%

“…These studies used a sandwich ELISA to measure TuM2-PK activity, obtaining overall sensitivities ranging from 68% to 91%. In the 2 studies by Shastri and colleagues (29,33), they compared tumor M2-PK activity and guaiac based FOBT in the first study and subsequently immunologic FOBT in the second study. They found that although measuring tumor M2-PK activity was more sensitive than FOBT screening, when compared with iFOBT, the latter was more sensitive, cheaper, and faster than tumor M2-PK activity assays.…”

Section: Fecal Biomarkersmentioning

confidence: 99%

“…However, 3,746 patients would achieve a false-negative test, leading to a PPV for gFOBT of 0.31% (Supplementary Table S1). If a different screening tool was implemented with a higher sensitivity and specificity for colorectal cancer detection, for example iFOBT, with a sensitivity of 70.9% and specificity of 96.3% (29), the number of patients undergoing further investigation for false-positive results would reduce to 327,313 and patients with colorectal cancer being missed through the screening program with a false-negative result would fall to 1,717. This increases the PPV to 1.26%, while maintaining a high-negative predictive value of 99.98% (Supplementary Table S2).…”

Section: Positive and Negative Predictive Values Of Biomarkers Withinmentioning

confidence: 99%

See 1 more Smart Citation

Biomarkers for Early Detection of Colorectal Cancer and Polyps: Systematic Review

Shah

Jones

Vidart

et al. 2014

Cancer Epidemiology, Biomarkers &Amp; Prevention

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There is growing interest in early detection of colorectal cancer as current screening modalities lack compliance and specificity. This study systematically reviewed the literature to identify biomarkers for early detection of colorectal cancer and polyps. Literature searches were conducted for relevant papers since 2007. Human studies reporting on early detection of colorectal cancer and polyps using biomarkers were included. Methodologic quality was evaluated, and sensitivity, specificity, and the positive predictive value (PPV) were reported. The search strategy identified 3,348 abstracts. A total of 44 papers, examining 67 different tumor markers, were included. Overall sensitivities for colorectal cancer detection by fecal DNA markers ranged from 53% to 87%. Combining fecal DNA markers increased the sensitivity of colorectal cancer and adenoma detection. Canine scent detection had a sensitivity of detecting colorectal cancer of 99% and specificity of 97%. The PPV of immunochemical fecal occult blood test (iFOBT) is 1.26%, compared with 0.31% for the current screening method of guaiac fecal occult blood test (gFOBT). A panel of serum protein biomarkers provides a sensitivity and specificity above 85% for all stages of colorectal cancer, and a PPV of 0.72%. Combinations of fecal and serum biomarkers produce higher sensitivities, specificities, and PPVs for early detection of colorectal cancer and adenomas. Further research is required to validate these biomarkers in a well-structured population-based study. Cancer Epidemiol Biomarkers Prev; 23(9); 1712-28. Ó2014 AACR.

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“…In two studies tumor pyruvate kinase isoenzyme M2 was shown to have no supplemental value for screening because of a lower sensitivity and specificity [27,28] compared to iFOBT.…”

Section: Immunological Fecal Occult Blood Testmentioning

confidence: 99%

Perspectives of colorectal cancer screening in Germany 2009

Sieg

Friedrich²

2009

WJGE

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Adequate screening methods can decrease colorectal cancer (CRC) mortality. The guaiac test for fecal occultblood (FOBT) is part of the German CRC Screening Program since 1970 and has evidence level Ia. In randomized multicenter-studies FOBT has an average sensitivity of 24% and decreases CRC mortality up to 30%. Immunological tests for human haemoglobin (iFOBT) show better performance characteristics than guaiac FOBT, with augmented sensitivity and specificity. However, the single tests show wide differences in diagnostic performance and iFOBT is not yet covered by insurance companies although it should replace the guaiac test for CRC screening. Visual colonoscopy, which was introduced to the German National Cancer Screening Program in 2002, is the gold standard for the diagnosis of colorectal neoplasia. From 2003 to 2007 more than 2.8 million examinations have been documented in Germany. The prevalence of adenomas is around 20% and of CRC about 0.7% to 1.0% of the screenings. Seventy percent of the carcinomas detected during screening are in an early stage (UICC Ⅰ and Ⅱ). Furthermore, screening colonoscopy is a cost saving procedure with a low complication rate (0.25% overall). Insurance companies save 216€ for each screening colonoscopy mainly by prevention of neoplasia due to polypectomy. In Germany, virtual colonography by computed tomography (CT) or magnetic resonance imaging still lacks standardization of the hard and software. In experienced centres the sensitivity for CRC and large polyps of CT colonography is comparable to colonoscopy but in meta-analyses the ranking is lower. New technologies like computer-aided colonoscopies with sheath or double balloon techniques are coming up as well as capsule colonoscopy, which sensitivity for large polyps is about 70%. Advised by his physician, the patient can choose his most acceptable examination method from this whole set of screening tools.

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Comparison of an Established Simple Office-Based Immunological FOBT With Fecal Tumor Pyruvate Kinase Type M2 (M2-PK) for Colorectal Cancer Screening: Prospective Multicenter Study

Abstract: This office-based IFOBT was found to have significantly higher specificity, PPV, and positive LR as compared with M2-PK. IFOBT proved to be a convenient, noncumbersome, quick, and cheap tool in patients with above-average risk for detection of CRN.

Cited by 48 publications

References 44 publications

Faecal tumour pyruvate kinase M2: not a good marker for the detection of colorectal adenomas

Faecal tumour pyruvate kinase M2: not a good marker for the detection of colorectal adenomas

Biomarkers for Early Detection of Colorectal Cancer and Polyps: Systematic Review

Perspectives of colorectal cancer screening in Germany 2009

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