Table 1.
Main natural history assumptions in the MISCAN-Colon model
| Model parameter | Value | Source | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Distribution of risk for adenomas over the general population | Gamma distributed, mean 1, variance 2 | Fit to multiplicity distribution of adenomas in autopsy studies:7 | |||||||
| Age 60: | |||||||||
| 1 or more | 20% | ||||||||
| 2 or more | 6% | ||||||||
| 3 or more | 2% | ||||||||
| Age 90: | |||||||||
| 1 or more | 37% | ||||||||
| 2 or more | 17% | ||||||||
| 3 or more | 9% | ||||||||
| Adenoma incidence per year | Age, gender and race dependent | Fit to adenoma prevalence in autopsy and colonoscopy studies of 15% in age group 50-59 to 33% in age group 70+, 7-11 and to cancer incidence per 100,000 in 1997-2001 in SEER registry: 12 | |||||||
| White | Black | White | Black | ||||||
| Age: | Men | Women | Men | Women | Age | Men | Women | Men | Women |
| 0-30 years: | 0.0% | 0.0% | 0.0% | 0.0% | 0-20: | 0.1 | 0.1 | 0.1 | 0.0 |
| 30-39 years: | 0.2% | 0.1% | 0.2% | 0.2% | 20-24: | 0.7 | 0.6 | 0.4 | 1.3 |
| 40-44 years: | 0.4% | 0.4% | 1.0% | 0.6% | 25-29: | 1.5 | 1.8 | 2.1 | 1.9 |
| 45-49 years: | 0.9% | 0.6% | 1.3% | 1.2% | 30-34: | 3.6 | 3.5 | 3.1 | 3.8 |
| 50-54 years: | 1.6% | 1.0% | 2.0% | 1.5% | 35-39: | 7.1 | 5.8 | 8.5 | 8.1 |
| 55-59 years: | 2.9% | 1.8% | 3.0% | 2.3% | 40-44: | 12.9 | 11.1 | 17.5 | 14.8 |
| 60-64 years: | 3.2% | 2.2% | 3.3% | 2.4% | 45-49: | 26.3 | 22.2 | 36.9 | 33.1 |
| 65-69 years: | 3.2% | 2.2% | 3.7% | 2.5% | 50-54: | 51.5 | 37.8 | 74.1 | 57.3 |
| 70-74 years: | 3.2% | 2.3% | 4.3% | 2.5% | 55-59: | 91.4 | 60.5 | 111.4 | 97.3 |
| 75-84 years: | 1.8% | 1.2% | 1.3% | 1.0% | 60-64: | 150.0 | 103.5 | 198.4 | 140.1 |
| 85-100 years: | 1.4% | 1.1% | 1.1% | 0.5% | 65-69: | 226.5 | 151.8 | 231.9 | 193.9 |
| 70-74: | 302.8 | 212.8 | 315.3 | 237.8 | |||||
| 75-79: | 378.1 | 279.9 | 435.7 | 309.0 | |||||
| 80-84: | 457.4 | 338.4 | 488.1 | 361.2 | |||||
| 85-100: | 500.9 | 391.6 | 469.1 | 335.6 | |||||
| Probability that a new adenoma is progressive | Dependent on age at onset: | Fit to adenoma prevalence in autopsy studies,7-11 cancer incidence in SEER registry in 1978.12 | |||||||
| 0-65 years: 14% | |||||||||
| 65-100 years: linearly increasing from 14% to 96% | |||||||||
| Regression of adenomas | No significant regression of adenomas | Expert opinion | |||||||
| Mean duration of development of progressive adenomas to clinical cancer | 20 years | Expert opinion* | |||||||
| Mean duration of preclinical cancer | 3.6 years | Estimated from cancer detection rate at first screening and background cancer incidence in FOBT trials.13,14 | |||||||
| Mean duration of adenoma | 16.4 years | 20 years - 3.6 years | |||||||
| Percent of non-progressive adenomas that stay 6-9mm | 50% | Fit to size distribution of adenomas in autopsy studies: 7-11 | |||||||
| 1-5mm: | 56% | ||||||||
| 6-9 mm: | 24% | ||||||||
| 10+ mm: | 20% | ||||||||
| Percent of non-progressive adenoma that become 10mm or larger | 50% | Fit to size distribution of adenomas in autopsy studies:7-11 | |||||||
| 1-5mm: | 56% | ||||||||
| 6-9 mm: | 24% | ||||||||
| 10+ mm: | 20% | ||||||||
| Percent of cancers that develops from 6-9mm adenoma and from 10+mm adenoma | 30% of cancer develops from 6-9 mm, 70% from 10+mm | Expert opinion | |||||||
| Localization distribution of adenomas and cancer | Dependent on gender and race: | Directly estimated from SEER 1997-2001.6 | |||||||
| White | Black | ||||||||
| Men | Women | Men | Women | ||||||
| Rectum: | 22% | 17% | 19% | 15% | |||||
| Rectosigmoid junction: | 9% | 7% | 8% | 8% | |||||
| Sigmoid colon: | 23% | 21% | 20% | 20% | |||||
| Descending colon: | 5% | 4% | 6% | 6% | |||||
| Transverse colon (incl flexures): | 14% | 15% | 16% | 16% | |||||
| Ascending colon: | 12% | 14% | 14% | 15% | |||||
| Cecum: | 16% | 21% | 18% | 21% | |||||
| 10-year survival after clinical diagnosis of CRC | Dependent on stage, gender and race: | Directly estimated from SEER 1997-2001.6 | |||||||
| White | Black | ||||||||
| Men | Women | Men | Women | ||||||
| Stage I: | 95% | 96% | 71% | 89% | |||||
| Stage II: | 76% | 80% | 73% | 68% | |||||
| Stage III: | 58% | 52% | 40% | 43% | |||||
| Stage IV: | 7% | 4% | 5% | 3% | |||||
| Sensitivity colonoscopy | Van Rijn 2007.15 | ||||||||
| Adenoma < 5 mm: | 75% | ||||||||
| Adenoma 6-9 mm: | 85% | ||||||||
| Adenoma 10+ mm: | 95% | ||||||||
| Cancer: | 95% | ||||||||
| Cecal intubation rate with colonoscopy | 95% | Aslinia 2006,16 Cotterill 2005,17 Rex 2002.18 | |||||||
| Complications with colonoscopy | Per 1,000 colonoscopies: | Levin 2006,19 Lieberman 2000,20 Pox 2007,21 | |||||||
| Perforations | 0.7 | Regula 2006,22 Jentschura 1994.23 | |||||||
| Fatal perforations | 0.1 | ||||||||
| Serosal burn | 0.3 | ||||||||
| Bleeds with transfusion | 0.4 | ||||||||
| Bleeds without transfusion | 1.1 | ||||||||
*
To be estimated from randomized controlled endoscopy trials, data not yet available.