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1563.Full-Text.Pdf Published OnlineFirst July 12, 2011; DOI: 10.1158/1940-6207.CAPR-11-0076 Cancer Prevention Research Article Research See perspective on p. 1531 Test Performance of Immunologic Fecal Occult Blood Testing and Sigmoidoscopy Compared with Primary Colonoscopy Screening for Colorectal Advanced Adenomas Carolina A.J. Khalid-de Bakker1,2,3, Daisy M.A.E. Jonkers1, Silvia Sanduleanu1,3, Adriaan P. de Bruïne2,3, Gerrit A. Meijer4, Jan B.M.J. Janssen5, Manon van Engeland2,3, Reinhold W. Stockbrugger€ 1, and Ad A.M. Masclee1 Abstract Given the current increase in colorectal cancer screening, information on performance of screening tests is needed, especially in groups with a presumed lower test performance. We compared test performance of immunologic fecal occult blood testing (FIT) and pseudosigmoidoscopy with colonoscopy for detection of advanced adenomas in an average risk screening population. In addition, we explored the influence of gender, age, and location on test performance. FIT was collected prior to colonoscopy with a 50 ng/mL cutoff point. FIT results and complete colonoscopy findings were available from 329 subjects (mean age: 54.6 Æ 3.7 years, 58.4% women). Advanced adenomas were detected in 38 (11.6%) of 329 subjects. Sensitivity for advanced adenomas of FIT and sigmoidoscopy were 15.8% (95% CI: 6.0–31.3) and 73.7% (95% CI: 56.9–86.6), respectively. No sensitivity improvement was obtained using the combination of sigmoidoscopy and FIT. Mean fecal hemoglobin in FIT positives was significantly lower for partici- pants with only proximal adenomas versus those with distal ones (P ¼ 0.008), for women versus men (P ¼ 0.023), and for younger (<55 years) versus older (55 years) subjects (P ¼ 0.029). Sensitivities of FIT were 0.0% (95% CI: 0.0–30.9) in subjects with only proximal versus 21.4% (95% CI: 8.3–41.0) in those with distal nonadvanced adenomas; 5.3% (95% CI: 0.0–26.0) in women versus 26.3% (95% CI: 9.2–51.2) in men; 9.5% (95% CI: 1.2–30.4) in younger versus 23.5% (95% CI: 6.8–49.9) in older subjects. Sigmoid- oscopy had a significantly higher sensitivity for advanced adenomas than FIT. A single FIT showed very low sensitivity, especially in subjects with only proximal nonadvanced adenomas, in women, and in younger subjects. This points to the existence of "low" FIT performance in subgroups and the need for more tailored screening strategies. Cancer Prev Res; 4(10); 1563–71. Ó2011 AACR. Introduction in size, containing high-grade dysplasia and/or any villous component) is currently considered an important target of Several nationwide and opportunistic colorectal cancer CRC screening (2), as these lesions are associated with an (CRC) screening initiatives are currently available in West- increased risk of malignancy (3). Randomized trials have ern countries, using different screening modalities such as reported that screening using FOBT and sigmoidoscopy the guaiac-based fecal occult blood test (FOBT), the im- may reduce CRC mortality by 15% to 17% (4, 5) and 31% munologic FOBT (FIT), sigmoidoscopy, and colonoscopy (6), respectively. Test performance of the semiquantitative (1). Apart from the early diagnosis of asymptomatic CRC, FIT appears to be superior to that of the guaiac-based detection of advanced adenomas (i.e., adenomas 10 mm FOBTs (7, 8), but so far, results of randomized controlled trials on the effects of FIT on CRC mortality are lacking. Although many studies assessed the individual perfor- Authors' Affiliations: 1Division of Gastroenterology-Hepatology, Depart- mance of FIT or sigmoidoscopy in various populations, ment of Internal Medicine, 2Department of Pathology, NUTRIM-School for only a few were conducted comparing both methods with Nutrition, Toxicology, and Metabolism, 3Department of Pathology, GROW-School for Oncology and Developmental Biology, Maastricht colonoscopy as a reference standard in screening popula- University Medical Center, Maastricht; 4Department of Pathology, VU tions (9, 10). In addition, the impact of age, gender, and 5 University Medical Center, Amsterdam; and Department of Gastroenter- location of adenomas on performance of the most com- ology-Hepatology, Elkerliek Ziekenhuis, Helmond, the Netherlands monly used screening tests has not been extensively stud- Corresponding Author: Ad A.M. Masclee, Division of Gastroenterology- Hepatology, Department of Internal Medicine, Maastricht University Med- ied. Studies, applying colonoscopy only for FIT-positive ical Center, PO Box 5800, 6202 AZ Maastricht, the Netherlands. Phone: individuals, have reported lower positivity rates and stool 31-433-875-021; Fax: 31-433-875-006; E-mail: [email protected] hemoglobin (Hb) in women, in younger age groups, and doi: 10.1158/1940-6207.CAPR-11-0076 subjects with proximal lesions (7, 11). As in these studies, Ó2011 American Association for Cancer Research. colonoscopy data were not available from participants with www.aacrjournals.org 1563 Downloaded from cancerpreventionresearch.aacrjournals.org on October 2, 2021. © 2011 American Association for Cancer Research. Published OnlineFirst July 12, 2011; DOI: 10.1158/1940-6207.CAPR-11-0076 Khalid-de Bakker et al. a negative FIT, it remains unclear whether this discrepancy cided to use a cutoff value of 50 ng/mL to determine reflects a lower adenoma rate or possibly a lower sensitivity positivity. of FIT in these subgroups. Primary colonoscopy screening of all FIT positives as well as negatives is needed to obtain Colonoscopic procedure and sigmoidoscopy findings this information on sensitivity in subgroups but the num- Bowel cleansing consisted of 4 L hypertonic polyethylene ber of such studies is limited. Only one screening study glycol solution (Klean-Prep, Norgine Europe B.V.). Four comparing FIT positives and negatives with colonoscopy experienced endoscopists carried out all the procedures and findings did report on gender differences (12), and a recorded endoscopic findings, including quality indicators second study did report on colonic location in relation (19) in a standardized registration form. Conscious seda- to test performance (13). Up to now, an overview of the tion was administered using midazolam and pethidine variables gender, age, and location on screening test sen- intravenously. A 4-point scale was used to rate bowel sitivity within the same study population is lacking. preparation (i.e., "excellent," "good," "fair," or "poor-in- In view of the recent adoption of large-scale, nationwide adequate"). After cecal intubation, a 20-mg bolus of butyl screening programs using FIT in several Western countries, bromide was administered intravenously for optimal visu- it is essential to determine potential factors which may alization of the colon during retraction. Polyp size and affect the performance of these tests and possibly offer the location were registered. The proximal colon was defined as opportunity for developing tailored, more efficient screen- cecum, ascending colon, hepatic flexure, transverse colon, ing strategies in the future. and splenic flexure, and the distal colon was defined as In this prospective, single-center study, we compared the descending colon, sigmoid, and rectum. Finally, colorectal test performance concerning the detection of advanced polyps were removed by cold biopsy, snare polypectomy, adenomas of FIT and sigmoidoscopy with colonoscopy or endoscopic mucosal resection. as reference standard in an average risk screening popula- One experienced gastrointestinal pathologist revised all tion. In addition, we explored whether demographic fea- lesions. Adenomas with a size 10 mm or greater, any villous tures (i.e., age and gender), as well as the anatomic location component, and/or high-grade dysplasia were classified as of adenomas may impact on mean Hb values in stool and advanced adenomas (3). on the sensitivity of the FIT. In case of incomplete colonoscopy, participants were offered additional CT-colonography to visualize the entire Methods colon. For the purpose of this study, we separately registered Study population sigmoidoscopy findings (i.e., pseudosigmoidoscopy), Employees of the Maastricht University Medical Center, which were deducted from the colonoscopy reports and aged 50 to 65 years, were invited to participate in a CRC defined as an endoscopic examination of the distal colon screening trial using primary colonoscopy. Exclusion cri- (rectum, sigmoid, and descending colon). Sigmoidoscopy teria were severe comorbidity, colonoscopy within the screening was regarded as a positive examination, in case of previous 5 years, surveillance after polypectomy or CRC, 1 or more adenoma(s) in the distal colon. According to and development of lower gastrointestinal symptoms in current guidelines, subjects with at least 1 adenoma the 3 months prior to colonoscopy. Written informed detected by sigmoidoscopy screening should undergo a consent was obtained from all participants. The study colonoscopy. Subjects with lesions in the proximal colon, protocol was approved by the Dutch Health Council having at least 1 advanced and/or nonadvanced adenoma and by the Institutional Medical Ethics Committee in the distal colon were therefore defined as detected by (METC-04088). sigmoidoscopy. Immunologic FOBT Data analysis A single FIT was offered to all participants in this colo- Sample size calculation was conducted on the basis of noscopy screening trial. The automated semiquantitative previously reported prevalence rates for advanced adeno- OC-sensor test (Eiken Chemical Co.) was used for the mas in average risk groups
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