Time to Colonoscopy After a Positive Fecal Test and Risk of Colorectal Cancer Outcomes

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1 Time to Colonoscopy After a Positive Fecal Test and Risk of Colorectal Cancer Outcomes Douglas Corley MD, PhD Kaiser Permanente, Northern California For Corley DA, Jensen CD, Quinn VP, Doubeni CA, Zauber AG, Lee JK, Schottinger JE, Marks AR, Zhao WK, Ghai NR, Lee AT, Contreras R, Quesenberry CP, Fireman BH, Levin TR. Kaiser Permanente Northern California, Division of Research Kaiser Permanente Southern California, Research & Evaluation University of Pennsylvania, Perelman School of Medicine Memorial Sloan Kettering Cancer Center

2 Possible conflicts of interest None Name of presenter

3 Background Programs that include both FIT and colonoscopy have higher screening rates than single modality Positive fecal immunochemical tests (FIT) require a follow-up colonoscopy Longer follow-up intervals may result in precancerous polyps progressing to cancer, or cancer progressing to more advanced stage disease Little data exist regarding consequences of different times to follow-up

4 Study objective Evaluate the associations between the time from positive FIT to colonoscopy and risks of colorectal outcomes: Any colorectal cancer Advanced-stage cancer (stage III or IV) Cancer by stage Adenomas with advanced histology (villous and tubullovillous)

5 Methods Cohort: 71,439 FIT-positive patients Ages years in From two large community-based healthcare organizations: Kaiser Permanente Northern California Kaiser Permanente Southern California Only included patients with at least 12 months of follow-up after a positive FIT, unless a colonoscopy exam was performed sooner.

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7 Fig. Time to colonoscopy 64.1% received a diagnostic colonoscopy within 60 days 74.6% within 90 days 80.9% within 180 days 83.4% within 12 months 13.8% had no record of colonoscopy during follow-up

8 Methods Using multivariate logistic regression models, time to colonoscopy was examined in 6 categories selected a priori: 8-30 days (reference group) days days days days >365 days Excluded those with exams <8 days; may represent diagnostic rather than screening exams

9 Methods Odds ratios and 95% confidence intervals were adjusted for the following covariates selected a priori: Sex Age Race/ethnicity Body mass index Charlson comorbidity score in year before FIT (0 or 1, and 2) Health plan region (Northern or Southern California) FIT screening year Previous FIT screening (ever and in the prior year)

10 Risk of any cancer increased after 180 days (polyp to cancer transition) p<0.05 CRC, colorectal cancer.

11 Risk of higher cancer stages mainly increased after 365 days p<0.05 CRC, colorectal cancer.

12 Risk increases were in healthier patients p<0.05 CRC, colorectal cancer; Charlson, Charlson comorbidity score (OR 44.9)

13 Sensitivity analyses Increased risk for exams >180 days and >365 days persisted with different definitions of the reference group: i.e., exams 1-30, 15-30, 8-60, and 8-90 days after FIT+ Pattern remained similar when follow-up exams performed >18 or >24 months FIT+ excluded. Including 81 cancer cases diagnosed by methods other than colonoscopy.

14 Study strengths Large, community-based, diverse population Comprehensive capture of FIT results Validated and comprehensive approaches for capturing pathology data and follow-up colonoscopy Histological confirmation of adenomas Comprehensive capture of cancers and stage Large number of colorectal cancer outcomes Ability to evaluate confounding and evaluate effect modifiers Sensitivity analyses

15 Study limitations Potential influence of unmeasured confounders, particularly for delaying examinations. However, large number of patients allowed well-powered evaluations for the main factors (age and comorbidity) that might delay exams.

16 Conclusions Time to colonoscopy after a positive FIT was associated with increased risks of colorectal cancer outcomes: Starting with exams performed >180 days after FIT screening among all patients Starting with exams performed >90 days among patients years of age with few comorbidities Risks were highest among those years of age with few comorbid conditions.

17 It takes a village Thank You!

18 Table. Time to colonoscopy after a positive FIT and adjusted risk of colorectal cancer outcomes Advanced- Villous Time to Any CRC Stage CRC Adenoma Colonoscopy n=2,118 n=568 n=6,632 (days) n OR (95% CI) n OR (95% CI) n OR (95% CI) 8 to 30 (ref) , to (0.80, 0.99) (0.68, 1.04) 2, (1.03, 1.16) 61 to (0.78, 1.05) (0.57, 1.03) (0.98, 1.15) 91 to (0.72, 1.04) (0.63, 1.23) (0.88, 1.08) 181 to (1.03, 1.64) (0.96, 2.17) (0.93, 1.26) > (1.84, 2.66) (2.37, 4.25) (1.21, 1.57) Time to CRC Stage 0 CRC Stage I CRC Stage II CRC Stage III CRC Stage IV Colonoscopy n=341 n=802 n=393 n=446 n=122 (days) n OR (95% CI) n OR (95% CI) n OR (95% CI) n OR (95% CI) n OR (95% CI) 8 to 30 (ref) to (0.75, 1.25) (0.76, 1.07) (0.68, 1.13) (0.65, 1.04) (0.56, 1.39) 61 to (0.60, 1.25) (0.83, 1.30) (0.55, 1.14) (0.65, 1.22) (0.09, 0.70) 91 to (0.77, 1.70) (0.47, 0.87) (0.70, 1.51) (0.52, 1.13) (0.64, 2.28) 181 to (0.72, 2.22) (0.51, 1.22) (1.29, 3.06) (0.79, 2.05) (0.85, 4.02) > (0.88, 2.40) (0.82, 1.64) (1.89, 3.94) (1.87, 3.72) (2.48, 7.35) CI, confidence interval; CRC, colorectal cancer; n, number; OR, odds ratio. ORs were adjusted for sex, age, race/ethnicity, body mass index, Charlson comorbidity score in the year before screening, health plan region, year of fecal immunochemical test (FIT) screening, whether the patient was previously FIT screened and FIT screened in the prior year. 14 patients with CRC of unknown stage are not included in the by-stage analyses.

19 Table. Crude incidence rates: any colorectal cancer and advanced-stage disease Advanced-Stage Any CRC CRC Time to Colonoscopy (days) Cases/Total per 1,000 Cases/Total per 1,000 8 to 30 (reference) 778/27, /27, to /24, /24, to /8, /8, to /5, /5, to /2, /2, > /2, /2, Total 2,118/70, /70, CRC, colorectal cancer. Denominator for advanced-stage CRC excludes 2 cases with unknown stage.

20 Table. Time to colonoscopy after a positive FIT and adjusted risk of any colorectal cancer and advanced-stage disease: stratified by Charlson comorbidity score and median age Charlson Score 0-1, Charlson Score 2, Charlson Score 0-1, Charlson Score 2, Age years Age years Age years Age years (n=28,533) (n=5,849) (n=22,714) (n=12,960) n OR (95% CI) n OR (95% CI) n OR (95% CI) n OR (95% CI) CRC 8-30 days (reference) (reference) ( reference) (reference) 31 to (0.69, 1.37) (0.67, 0.99) ( 0.78, 1.65) (0.75, 1.04) 61 to (0.93, 2.14) (0.63, 1.08) ( 0.55, 1.60) (0.68, 1.05) 91 to (0.70, 2.01) (0.38, 0.77) ( 1.04, 2.99) (0.71, 1.18) 181 to (1.53, 4.64) (0.44, 1.19) ( 4.44, 10.96) (0.42, 1.00) > (3.28, 7.56) (0.19, 0.68) ( 9.41, 19.60) (0.85, 1.60) Advanced CRC 8-30 days (reference) (reference) ( reference) (reference) 31 to (0.39, 4.31) (0.64, 1.23) ( 0.20, 2.33) (0.59, 1.06) 61 to (0.77, 9.61) (0.48, 1.24) ( 0.49, 5.85) (0.39, 0.95) 91 to (0.32, 8.78) (0.17, 0.76) ( 0.84, 10.11) (0.74, 1.71) 181 to (2.20, 32.24) (0.39, 1.91) ( 5.62, 42.39) (0.36, 1.57) > (8.39, 69.35) (0.17, 1.27) (19.40, ) (0.83, 2.41) CRC, colorectal cancer; CI, confidence interval; n, number; OR, odds ratio. ORs were adjusted for sex, age, race/ethnicity, body mass index, Charlson comorbidity score in the year before screening, health plan region, year of fecal immunochemical test (FIT) screening, whether the patient was previously FIT screened and FIT screened in the prior year.

21 Table. Patient characteristics Median time to colonoscopy: 37 days KPNC region: 62.3% Male: 52.7% Age: 61.0±7.3 years White: 56.0% Charlson comorbidity index score of 0: 53.1% Body mass index of 30.0 kg/m 2 : 42.2% Characteristics n (%) Total patients 71,439 (100.0) Time to exam (days) 1-7 1,383 (1.9) ,149 (38.0) ,622 (34.5) ,659 (12.1) ,248 (7.4) ,079 (2.9) >365 2,299 (3.2) Median (IQR) 37 (39.0) Region KPNC 44,499 (62.3) KPSC 26,940 (37.7) Sex Female 33,784 (47.3) Male 37,655 (52.7) Age (years) ,176 (24.0) ,862 (20.8) ,132 (21.2) ,690 (17.8) ,579 (16.2) Mean (SD) 61.0 (7.3) Race/Ethnicity Non-Hispanic White 39,988 (56.0) Hispanic 12,366 (17.3) Black 5,858 (8.2) Asian/Pacific Islander 10,723 (15.0) Other 2,504 (3.5)