Chapter 6 Discussion
6.5 Conclusion
A new generalized non-linear measurement error regression models was developed
to model contributory causes of FIT and Colonoscopy interval cancers to estimate the impact of inter-screening interval on the reduction of deaths from CRC attributed to each type of interval cancer making use of the lead-time and truncation-adjusted survival model.
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Figure 1.1 Component and pathway for subsequent screen-detected CRC and FIT interval cancer A. subsequent screen-detected CRC
B. FIT interval cancer
Figure 2.1 Test sensitivity, episode sensitivity, and program sensitivity
Figure 2.2 Flow chart of literature search and selection for FOBT-based sensitivity
Figure 3.1 CRCs with different detection mode within FIT-based screening program
PSD: Prevalent screen-detected CRC SSD: Subsequent screen-detected CRC IC: Interval cancer
FIT: Fecal immunochemical test
Figure 4.1 The Bayesian directed acyclic graphic three-state Markov model
λ
2λ
1 Sen𝑃
00(𝑡) 𝑃
01(𝑡) 𝑃
12(𝑡) 𝑃
02(𝑡)
𝑃
𝑠(𝑡) 𝑛
𝑠⬚[i]
𝑟
𝑠⬚[𝑖]
𝑃𝑌[𝑖]
𝑟
𝑓𝑛.𝐼𝐶⬚[𝑖] 𝑟
𝑛𝑒𝑤𝑙𝑦. 𝐼𝐶⬚[𝑖]
𝑟
𝐼𝐶⬚[i]
For (i in 1:N)
𝑃
11(𝑡)
𝑑𝑃
02(𝑡)
Figure 4.2 Study design for comparing the components of FIT interval cancer (Newly developed interval CRC, False-negative interval CRC) for the effect of screening intervals (1-year, 2-year, and 3-year)*
*IC: interval cancer
Figure 4.3 Study design for comparing the components of interval CRC (Newly developed CRC, False-negative CRC) for FIT screening program and studies using gFOBT*
*IC: interval cancer
Figure 4.4 The procedure of time-dependent Cox model
Figure 5.2.1 Proportions of preclinical phase and clinical phase of CRC based on the empirical data on Taiwan CRC screening
Figure 5.2.2 Diagnosis plots for parameter estimation with applying the Gibbs sampling (b1: incidence rate of PCDP;b2: progress rate of PCDP; bs: parameter of sensitivity)
b1
iteration
5001 7500 10000 12500 15000
0.00146
5001 7500 10000 12500 15000
0.25
5001 7500 10000 12500 15000
0.8 0.9 1.0 1.1 1.2
Figure 5.2.3. Frequencies and proportions of newly developed and false-negative CRC by inter-screening intervals and characteristics of subjects
Figure 5.2.4 Interval CRC as a percentage of the expected incidence by g-FOBT (Funen, Nottingham, and Finland) and FIT (Taiwan) studies
Figure 5.3.1 Frequencies and proportions of newly developed and false-negative CRC of FIT IC and colonscopy IC by inter-screening intervals and characteristics of subjects*
*IC: interval cancer
Figure 5.4.1 Diagram showing CRC with different detection mode within FIT screening program in Taiwanese Nationwide CRC Screening Program*
*FIT: fecal immunochemical test; CRC: colorectal cancer; IC: interval cancer.
Figure 5.4.2 Stage distribution of CRC with different detection modes in screening participants
FIT: fecal immunochemical test; CRC: colorectal cancer; IC: interval cancer.
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Prevalent screen detected CRC
Subsequent screen detected CRC
Colonoscopy IC FIT IC CRC in colonoscopy noncompliers
Stage 4 Stage 3 Stage 2 Stage 1
Figure 5.4.3. Long-term outcomes of CRCs with different detection modes
FIT: fecal immunochemical test; CRC: colorectal cancer; IC: interval cancer.
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1
0 1 2 3 4 5 6 7 8 9 10
Surv iv a l
Time(years)
Subsequent screen-detected CRC Prevalent screen-detected CRC Colonoscopy IC
FIT IC
CRC in colonoscopy noncompliers CRC in screening nonparticipants
Table 2.2.1 Study and test characteristics of gFOBT studies
Study Country Time period
N. of stools/ n.
Denters et al. 2012 Netherla
nds 2006-2008 3/2 2,119 8 0.38 4 94 (35-251)
Levi et al. 2011 Israel 2008-2011 3/2 2,266 8 0.35 5 110 (46-265)
Table 2.2.2 Studies about the gFOBT screening and CRC mortality reduction
Table 2.2.3 Characteristics of randomized controlled trials for CRC screening program using gFOBT
Study Study period Country gFOBT kit Screening
Frequency
Age range (years) Funen(Kronborg et al. 1996) 1985-1995 Denmark Haemoccult-II Biennial 45-75 Nottingham(Hardcastle et al.
1996) 1981-1991 UK
Haemoccult (Rohm Pharma, weiterstadt, Germany)
Biennial 45-74 Finland(Malila et al. 2005,
Malila et al. 2008) 2004-2006 Finland Haemoccult
(Beckman Coulter, USA) Biennial 60-64
Table 2.2.4 Derivation of progress rate for the Funen, Nottingham, and Finland randomized controlled trial from literature
Funen (Kronborg et al.
1996) 0.00158 0.3247 0.2801 0.6478 64% 0.00158 2.48 0.40
Finland (Malila et al.
2005, Malila et al.
2008)
0.00111 0.4849 0.3214 0.7350 65% 0.00111
2.06 0.49
λ1 is the incidence rates of localized preclinical detectable phase (PCDP), λ2 is the progression rates from localized PCDP to non-localized PCDP, λ3 is the progression rate from localized PCDP to localized clinical CRC, and λ4 is the progression rate from non-localized PCDP to non-non-localized clinical CRC(Chiu et al. 2011, Chiu et al. 2017a). The dwelling time for Funen (Kronborg et al. 1996), Nottingham (Hardcastle et al. 1996), and Finland (Malila et al. 2005, Malila et al. 2008) randomized controlled trial was derived by
1
λ2+λ3+ 𝜆2
(𝜆2+λ3)×λ4
Table2.2.5 Study and test characteristics of FIT studies
Table 2.2.6 Comparisons of colorectal cancer–specific mortality between the colonoscopy and noncolonoscopy groups
Variables Relative risk* (95%CI)
Noncolonoscopy vs colonoscopy 1.64 (1.32 to 2.04)
Noncolonoscopy vs complete colonoscopy 2.31 (1.88 to 2.84) Incomplete colonoscopy vs complete colonoscopy 1.65 (1.26 to 2.16) Fecal hemoglobin concentration, μg Hb/g stool
20–49 1.00
50–99 2.10 (1.61 to 2.73)
≥100 4.61 (3.61 to 5.89)
*Adjusted with age, gender, and screening round
Table2.2.7 Hazard ratios and 95% confidence intervals from the accelerated failure time model for risk of CRC, colorectal adenoma
f-HbC (ng/ml)
CRC Adenoma
HR 95%CI HR 95%CI
Undetected 0.47 0.30-0.73 2.04 1.77-2.35
1-19 1.00 - 1.00 -
20-39 1.14 0.74-1.77 1.81 1.38-2.37
40-49 2.54 1.58-4.07 2.09 1.45-3.00
60-79 3.59 2.10-6.16 1.20 0.64-2.22
80-99 3.63 1.80-7.32 2.83 1.63-4.94
100-150 2.32 1.38-3.88 5.29 4.02-6.96
150-250 2.33 1.34-4.04 5.37 4.04-7.13
250-450 2.70 1.42-5.14 8.78 6.60-11.67
>450 14.00 10.20-19.22 11.19 8.87-14.12
Table 2.3.1 Incidence of adenoma and colorectal cancer
f-HbC Adenoma CRC Adenoma and CRC
Incidence (cases per 1000 person-years)
Undetected 1.36 0.32 1.67
1–19 ng/mL 1.18 0.55 1.74
20–39 ng/mL 2.20 0.59 2.78
40–59 ng/mL 2.64 1.27 3.90
60–79 ng/mL 1.70 2.32 4.01
80–99 ng/mL 3.80 3.33 7.08
≥100 ng/mL (non-referrals and
false-positives) 2.91 5.61 8.49
Table 2.3.2 Crude and adjusted HRs for risk of colorectal neoplasia
f-HbC Crude HRs adjusted HRs
¢adjusted HRs*
1–19 1.00 1.00 1.00
20–39 1.48 (1.13–1.95) 1.43 (1.08–1.88) 1.27 (0.74–2.17) 40–59 2.11 (1.47–3.01) 1.88 (1.31–2.71) 2.67 (1.47–4.84) 60–79 2.20 (1.35–3.57) 1.77 (1.06–2.94) 3.61 (1.81–7.23) 80–99 3.92 (2.36–6.51) 3.41 (2.02–5.75) 6.95 (3.47–13.90)
≥100 (non-referrals) 9.77 (7.07–13.51) 8.46 (6.08–11.76) 91.26 (65.61–126.94)
≥100 (false-positive cases) 0.93 (0.41–2.10) 0.70 (0.29–1.72)
¢ Adjusted with age, gender, family history of CRC, meat consumption, BMI
*Time-dependent Cox regression model
Table 2.3.3 Overview of studies on interval CRCs after colonoscopy in asymptomatic populations, showing that variation in the definitions used for an interval CRC affects the estimated rates
Studies Definition iCRC Design Outcomes Stage of CRC
(I–II vs. III–IV)
1–10 years after negative colonoscopy
Population-based; 1945 CRC
cases; 2399 controls
433 screen detected vs.
78 iCRCs
All CRCs after index colonoscopy
Retrospective; 8950 patients after screening CS
19 iCRCs in 47 725
45 026 patients in colonoscopy screening program
CRC incidence; 42 iCRCs in
188 788 person-years of follow-up
Not specified iCRC: 12 vs. 25 Macroscopic appearance
<36 months Observational, cohort study,
NPS; 5309 patients patients
Incidence of advanced neoplasms after CS: 13 iCRCs within 3 years
iCRC: 12 vs. 1 iCRC: 5 vs. 8 Macroscopic
Not defined Retrospective. screening cohort of 715 patients vs.
Not defined Retrospective. screening cohort of 715 patients vs.