Screening for colorectal cancer improves outcomes and is cost effective. Stool-based tests have the highest participation rates in screening programmes. Their efficacy is limited by the relatively low sensitivity and specificity compared with colonoscopy. Stool levels of M2-PK, a dimeric form of the enzyme pyruvate kinase, correlate with colorectal cancer and neoplasia. A combination of stool markers may enhance screening performance; however, it remains to be determined whether an additional test would affect participation rates negatively.
The aim of this study was to assess the performance of faecal M2-PK and faecal immunochemical test (FIT) and their combined effect in a screening programme.
Materials and methods
Within round 2 of our biennial FIT-based pilot, all invitations additionally included an M2-PK kit. A FIT greater than 100 ngHb/ml and/or an M2-PK greater than 4 U/ml were considered positive. FIT-positive or M2-PK-positive patients were offered a colonoscopy.
In all, 1800 combined M2-PK and FIT invites were sent out, and 879 (49%) samples were analysed. Overall positivity was 27% (n=245). Only 23 (2.6%) patients were positive for both tests. In all, 186 (88%) screening colonoscopies were performed. The adenoma detection rate for M2-PK-positive patients (n=157) was significant at 25% (n=40), and 3% (n=5) had advanced lesions. In FIT-positive patients (n=51), the adenoma detection rate was 29% (n=15), with significantly more, 21% (n=11), having advanced lesions (P<0.001, confidence interval 0.117–0.156). Had FIT only been tested, 70% (n=35) fewer patients would have had polyps removed.
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.