Risk of gastrointestinal cancer in a symptomatic cohort after a complete colonoscopy: Role of faecal immunochemical test

Table 1 Characteristics of the different faecal immunochemical tests evaluated

Ref.	Country	Analytical system for estimation of faecal haemoglobin concentration
Cubiella et al[9], 2016 (DC)	Spain	OC-Sensor: 100%
Rodríguez-Alonso et al[8], 2015	Spain	OC-Sensor: 100%
Cubiella et al[9], 2016 (VC)	Spain	OC-Sensor: 49.7%; OC-Auto 3 Latex 13.8%; FOB Gold 2.4%; Linear i-FOB 34.1%
Overall	Spain	OC-Sensor: 81.8%; OC-Auto 3 Latex 5.0%; FOB Gold 0.9%; Linear i-FOB 12.3%

DC: Derivation cohort; VC: Validation cohort.

Table 2 Characteristics of the individuals included in the analysis, n (%)

Characteristics	Overall (n = 2709)	FIT < 10 µg/g (n = 1979)	FIT ≥ 10 µg/g (n = 730)	P value8
Demographic
Age (yr)	62.9 ± 13.5	62.0 ± 13.5	65.5 ± 13.0	< 0.001
Female sex	1432 (52.9)	1084 (54.8)	348 (47.7)	0.001
Primary healthcare referral1	617 (24.2)	397 (21.2)	220 (32.2)	< 0.001
Previous colonoscopy2	444 (25.9)	287 (25.8)	157 (26.0)	0.9
Daily using ASA2	330 (19.2)	193 (17.3)	137 (22.7)	0.01
Indications
Rectal bleeding1	1234 (48.3)	843 (45.1)	391 (57.2)	< 0.001
Change of bowel habit1	1271 (49.8)	913 (48.8)	358 (52.4)	0.1
Anaemia3,4	368 (16.2)	236 (13.9)	132 (23.1)	< 0.001
Abdominal pain5	766 (41.3)	587 (41.8)	179 (40.0)	0.4
Weight loss5	391 (21.1)	301 (21.4)	90 (20.1)	0.6
Basal colonoscopy findings
Benign anorectal lesion2	756 (44.0)	495 (44.4)	261 (43.3)	0.6
Significant colonic lesions6	480 (17.7)	204 (10.3)	276 (37.8)	< 0.001
Advanced adenoma1,7	337 (13.2)	139 (7.4)	198 (29.0)	< 0.001
Follow-up (mo)	45.5 ± 20.0	47.9 ± 21.2	39.2 ± 14.1	< 0.001

Missing data in

¹156,

²992,

³441 and

⁴Defined as < 11 g/100 mL in men and < 10 g/100 mL in non-menstruating women.

⁵856 patients.

⁶Advanced adenoma (≥ 10 mm, villous histology, high-grade dysplasia), polyposis (> 10 polyps of any histology), colitis (any aetiology), polyps ≥ 10 mm, complicated diverticular disease, colonic ulcer and/or bleeding angiodysplasia.

⁷Adenoma ≥ 10 mm, villous histology or high-grade dysplasia.

⁸Differences between both groups in the Chi-square test in the qualitative variables and in the student t test in the quantitative variables. Differences with P < 0.05 are considered statistically significant. Qualitative variables are expressed as absolute numbers and percentages. Quantitative variables are expressed as mean and standard deviation. ASA: Acetyl salicylic acid; FIT: Faecal immunochemical test.

Table 3 Risk of cancer and death according to faecal immunochemical test result

Event	Risk	Overall (n = 2709)	FIT < 10 µg/g (n = 1979)	FIT ≥10 µg/g (n = 730)	RR1 (95%CI)	HR2 (95%CI)
GIC	Cumulative3	2.1% (1.6-2.6)	1.7% (1.1-2.3)	3.2% (1.9-4.4)	1.9 (1.1-3.2)	1.5 (0.8-2.7)
GIC	Density4	5.6 (4.1-7.0)	4.3 (2.9-5.8)	9.7 (5.8-13.7)
GIC	Cumulative death3	1.3% (0.9-1.8)	1.0% (0.5-1.4)	2.3% (1.2-3.4)	2.5 (1.3-4.7)	2.2 (1.1-4.3)
GIC	Death density4	3.5 (2.4-4.6)	2.4 (1.3-3.5)	7.1 (3.7-10.5)
Up GIC5	Cumulative3	1.3% (0.9-1.7)	1.2% (0.7-1.6)	1.6% (0.7-2.6)	1.4 (0.7-2.8)	1.0 (0.5-2.2)
Up GIC5	Density4	3.4 (2.3-4.6)	2.9 (1.7-4.1)	5.1 (2.2-8.0)
Up GIC5	Cumulative death3	0.8% (0.5-1.2)	0.7% (0.3-1.0)	1.2% (0.4-2.0)	1.6 (0.7-3.7)	1.4 (0.6-3.3)
Up GIC5	Death density4	2.1 (1.2-3.0)	1.6 (0.8-2.5)	3.8 (1.3-6.2)
CRC	Cumulative3	0.5% (0.2-0.8)	0.3% (0.1-0.5)	1.1% (0.3-1.9)	3.6 (1.3-10.5)	3.8 (1.2-11.9)
CRC	Density4	1.4 (0.7-2.1)	0.8 (0.2-1.4)	3.4 (1.0-5.7)
CRC	Cumulative death3	0.3% (0.1-0.5)	0.1% (0.0-0.2)	1.0% (0.3-1.7)	9.5 (2.0-46.2)	10.8 (2.1-57.1)
CRC	Death density4	0.9 (0.3-1.4)	0.3 (-0.1-0.6)	2.9 (0.8-5.1)
Cancer	Cumulative3	7.6% (6.6-8.6)	7.3% (6.2-8.5)	8.2% (6.2-10.2)	1.1 (0.8-1.5)	1.1 (0.8-1.5)
Cancer	Density4	20.5 (17.7-23.3)	18.8 (15.8-21.9)	25.9 (19.4-32.5)
Cancer	Cumulative death3	3.6% (2.9-4.3)	3.2% (2.4-4.0)	4.8% (3.2-6.3)	1.5 (1.0-2.3)	1.4 (0.9-2.2)
Cancer	Death density4	9.5 (7.6-11.4)	8.0 (6.0-9.9)	14.7 (9.8-19.6)
Death	Cumulative3	7.3% (6.3-8.2)	7.0% (5.9-8.1)	7.9% (6.0-9.9)	1.1 (0.8-1.5)	1.1 (0.8-1.5)
Death	Density4	19.2 (16.5-21.8)	17.6 (14.7-20.5)	24.3 (18.1-30.6)

¹Differences in cumulative incidence were analysed with the Chi-square and the Cochran–Mantel–Haenszel statistics and expressed as the RR and its 95%CI in the qualitative variables.

²Differences in the risk of cancer and death adjusted by age, sex and presence of significant colonic lesion were analysed with a Cox multivariate regression and expressed as HR and its 95%CI.

³Cumulative risk is expressed as percentage and its 95%CI.

⁴Risk density rate is expressed per 1000 patient-years and its 95%CI.

⁵Defined as a cancer located in the oesophagus, stomach, duodenum or ampulla. CI: Confidence interval; CRC: Colorectal cancer; FIT: Faecal immunochemical test; GIC: Gastrointestinal cancer RR: Risk ratio; Up GIC: Upper gastrointestinal cancer.

Table 4 Factors associated with upper gastrointestinal cancer detection the first year after baseline colonoscopy, n (%)

	Upper gastrointestinal cancer	Odds ratio (95 %CI)1	Odds ratio (95 %CI)2
Sex
Female (n = 1432)	10 (0.7)	1
Male (n = 1277)	12 (0.9)	1.3 (0.6-3.1)
Age
< 70 yr (n = 1757)	8 (0.5)	1	1
≥ 70 yr (n = 952)	14 (1.5)	3.3 (1.4-7.8)	2.7 (1.1-7.0)
Primary healthcare referral
No (n = 1936)	19 (1.0)	1
Yes (n = 617)	3 (0.5)	0.5 (0.1-1.7)
Rectal bleeding
No (n = 1319)	16 (1.2)	1
Yes (n = 1234)	6 (0.5)	0.4 (0.1-1.0)
Change of bowel habit
No (n = 1282)	12 (0.9)	1
Adequate (n = 1271)	10 (0.8)	0.8 (0.4-1.9)
Anaemia3
No (n = 2077)	13 (0.6)	1	1
Yes (n = 191)	8 (4.2)	6.9 (2.8-17.0)	5.6 (2.2-13.9)
Abdominal pain
No (n = 1319)	12 (1.1)	1
Yes (n = 1234)	5 (0.7)	0.6 (0.2-1.7)
Weight loss
No (n = 1462)	12 (0.8)	1
Yes (n = 391)	5 (1.3)	1.5 (0.5-4.4)
Faecal immunochemical test
< 10 µg/g (n = 1979)	14 (0.7)	1
≥ 10 µg/g (n = 730)	8 (1.1%)	1.5 (0.6-3.7)
Benign anorectal lesion
No (n = 961)	7 (0.7)	1
Yes (n = 756)	6 (0.8)	1.1 (0.4-3.2)
Significant colonic lesion4
No (n = 2216)	16 (0.7)	1
Yes (n = 480)	6 (1.3)	(0.7-4.5)
Advanced adenoma5
No (n = 2968)	16 (0.7)	1
Yes (n = 337)	6 (1.8)	2.5 (1.0-6.4)

¹Differences were analysed with the Chi-square and Cochran–Mantel–Haenszel statistics and expressed as the odds ratio and its 95%CI.

²Variables with statistically significant differences were introduced in a multivariate logistic regression analysis. The association is expressed as odds ratio and its 95 %CI.

³Defined as < 11 g/100 mL in men and < 10 g/100 mL in non-menstruating women.

⁴Advanced adenoma (≥ 10 mm, villous histology, high-grade dysplasia), polyposis (> 10 polyps of any histology), colitis (any aetiology), polyps ≥ 10 mm, complicated diverticular disease, colonic ulcer and/or bleeding angiodysplasia.

⁵Adenoma ≥ 10 mm with villous histology or high-grade dysplasia.