Comparison of faecal M2-PK and FIT in a population-based bowel cancer screening cohort

Leen, Ronan; Seng-Lee, Chun; Holleran, Grainne; O’Moráin, Colm; McNamara, Deirdre

doi:10.1097/meg.0000000000000025

Cited by 14 publications

(7 citation statements)

References 7 publications

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“…Another possibility would be the use of both tests in combination although the cost effectiveness of this strategy needs to be determined. A study by Leen at al [ 23 ] found that the addition of the quantitative M2-PK test to the standard FIT detected additional adenomas at an earlier stage…”

Section: Discussionmentioning

confidence: 99%

The Diagnostic Accuracy of the M2 Pyruvate Kinase Quick Stool Test- A Rapid Office Based Assay Test for the Detection of Colorectal Cancer

2015

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BackgroundM2 pyruvate kinase (M2PK) is an oncoprotein secreted by colorectal cancers in stools. This the first report on the accuracy of a rapid stool test in the detection of colorectal cancer (CRC).ObjectiveTo determine the sensitivity, specificity and positive and negative predictive value of a rapid, point of care stool test M2 PK- the M2PK Quick.MethodsConsecutive cases of endoscopically diagnosed and histological proven CRC were recruited. Stools were collected by patients and tested with the immunochromatographic M2PK Quick Test (Schebo Biotech AC, Giessen, Germany). Controls were consecutively chosen from patients without any significant colorectal or gastrointestinal disease undergoing colonoscopy. CRC was staged according to the AJCC staging manual (7th Edition) and location of tumor defined as proximal or distal.ResultsThe sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy were: 93%, 97.5%, 94.9%, 96.5% and 96.0% respectively. The positive predictive value for proximal tumors was significantly lower compared to distal tumors. No differences were seen between the different stages of the tumor.ConclusionsThe M2-PK Quick, rapid, point-of-care test is a highly accurate test in the detection of CRC. It is easy and convenient to perform and a useful diagnostic test for the detection of CRC in a clinical practice setting.

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Section: Discussionmentioning

confidence: 99%

The Diagnostic Accuracy of the M2 Pyruvate Kinase Quick Stool Test- A Rapid Office Based Assay Test for the Detection of Colorectal Cancer

2015

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“…Overall, positivity was significantly increased by the addition of tM2-PK (27%). Had only i-FOBt been tested, 77% (n=189) fewer patients would have had a positive faecal test and been identified for a screening colonoscopy and 70% (n=35) fewer patients would have had polyps detected and removed [20]. This study also reported that 10% (n=99) of tM2-PK samples could not be analysed, because of a lapse in the 48 hour window required for its processing.…”

Section: Discussionmentioning

confidence: 92%

Correlation between Faecal Tumour M2 Pyruvate Kinase and Colonoscopy for the Detection of Adenomatous Neoplasia in a Secondary Care Cohort

Bond

Burkitt

Sawbridge

et al. 2016

JGLD

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Background & Aims: Colorectal cancer screening programmes that target detection and excision of adenomatous colonic polyps have been shown to reduce colorectal cancer related mortality. Many screening programmes include an initial faecal occult blood test (FOBt) prior to colonoscopy. To refine the selection of patients for colonoscopy other faecal-based diagnostic tools have been proposed, including tumour M2-pyruvate kinase (tM2-PK). To determine whether tM2-PK quantification may have a role in diverse settings we have assessed the assay in a cohort of patients derived from both the England bowel cancer screening programme (BCSP) and symptomatic individuals presenting to secondary care. Method. Patients undergoing colonoscopy provided faecal samples prior to bowel preparation. Faecal tM2-PK concentrations were measured by ELISA. Sensitivity, specificity, positive predictive value, negative predictive value and ROC analyses were calculated. Results. Ninety-six patients returned faecal samples: 50 of these with adenomas and 7 with cancer. Median age was 68. Median faecal tM2-PK concentration was 3.8 U/mL for individuals without neoplastic findings at colonoscopy, 7.7 U/mL in those with adenomas and 24.4 U/mL in subjects with colorectal cancer (both, p=0.01). ROC analysis demonstrated an AUROC of 0.66 (sensitivity 72.4%, specificity 48.7%, positive predictive value 67.7%, negative predictive value 36.7%). Amongst BCSP patients with a prior positive FOBt faecal tM2-PK was more abundant (median 6.4 U/mL, p=0.03) and its diagnostic accuracy was greater (AUROC 0.82). Conclusion. Our findings confirm that faecal tM2-PK ELISA may have utility as an adjunct to FOBt in a screening context, but do not support its use in symptomatic patients. Abbreviations: BCSP: Bowel cancer screening programme; EMR: Endoscopic mucosal resection; FAP: Familial adenomatous polyposis; FOBt: Faecal occult blood testing; NHS: National Health Service; tM2-PK: tumour M2-pyruvate kinase.

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“…However, previous studies were performed on symptomatic patients recruited in clinical settings. Leen and colleagues performed the first study to assess the performance of fecal M2-PK addition to FIT-based screening program ( 10 ). The authors reported a significant improvement in ADR leading to the identification and removal of 70% more polyps.…”

Section: Discussionmentioning

confidence: 99%

“…To date, several studies have evaluated fecal M2-PK levels for CRC detection in high-risk or symptomatic populations ( 6 , 9 ). However, only few studies have investigated the performance of fecal M2-PK in CRC screening programs involving potentially healthy subjects ( 10 ). Moreover, no data on fecal M2-PK efficacy in the first-round screening programs performed under real practice conditions are available.…”

Section: Introductionmentioning

confidence: 99%

Colorectal cancer detection in an asymptomatic population: fecal immunochemical test for hemoglobin vs. fecal M2-type pyruvate kinase

et al. 2016

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IntroductionScreening programs for colorectal cancer (CRC) are mainly based on a first-line fecal immunochemical test for hemoglobin (FIT). Fecal M2-type pyruvate kinase (M2-PK) has been evaluated in clinical settings showing promising results for early CRC detection. However, the impact of fecal M2-PK assessment on the performance of first-round CRC screening programs is not known. We investigated whether fecal M2-PK alone or in combination with FIT may improve CRC screening efficacy in the general population.Materials and methodsA total of 1027 asymptomatic subjects (median age 66 [59-74] years; females 504 [49.1%]), identified through the general practitioners’ rosters, were invited for the collection of 2 fecal samples for FIT and M2-PK evaluation. Participants with at least positive one fecal test were referred for colonoscopy. Quality indicators for screening performance were calculated and analyzed using Fisher’s exact test.ResultsOverall, 572 subjects underwent both FIT and M2-PK assessment (participation rate 55.7%): 93 participants showed positive results for at least one test (positivity rate 16.3%). Only 10 patients were positive for both tests. Attendance rate to colonoscopy was 86.0% and a total of 65 adenomas and 7 cancers were detected. Combined use of FIT and fecal M2-PK permitted the identification of 18 more neoplasm (25%) without improving colonoscopy workload, as deduced by the comparable number needed to scope (P = 0.402).ConclusionThe addition of M2-PK testing to FIT offers the potential to detect additional neoplasms that either do not bleed or only bleed intermittently without reducing participation rate and without increasing endoscopy workload.

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Comparison of faecal M2-PK and FIT in a population-based bowel cancer screening cohort

Abstract: The addition of M2-PK in a biennial bowel screening programme is acceptable to patients, feasible and detects additional adenomas, potentially at an earlier stage.

Cited by 14 publications

References 7 publications

The Diagnostic Accuracy of the M2 Pyruvate Kinase Quick Stool Test- A Rapid Office Based Assay Test for the Detection of Colorectal Cancer

The Diagnostic Accuracy of the M2 Pyruvate Kinase Quick Stool Test- A Rapid Office Based Assay Test for the Detection of Colorectal Cancer

Correlation between Faecal Tumour M2 Pyruvate Kinase and Colonoscopy for the Detection of Adenomatous Neoplasia in a Secondary Care Cohort

Colorectal cancer detection in an asymptomatic population: fecal immunochemical test for hemoglobin vs. fecal M2-type pyruvate kinase

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