BackgroundGiven the disproportionately elevated anal cancer risk in high‐risk populations, it is important to assess the performance of commonly used anal cancer screening tools to improve the effectiveness of detection and treatment methods. This study evaluates 1) the concordance between anal cytology and histology results and 2) the performance of cytology and high‐risk human papillomavirus (HR‐HPV) genotyping as screening tools for detecting histologically confirmed anal high‐grade squamous intraepithelial lesions (HSIL).MethodsData from the Anal Neoplasia Clinic in Puerto Rico (2014–2021; n = 466) was used. The clinical performance of anal cytology and HR‐HPV genotyping to detect HSIL was compared to the gold standard: high‐resolution anoscopy‐guided biopsy. Sensitivity, specificity, positive predictive value, negative predictive value, and κ coefficients were calculated.ResultsA total of 66.95% of the patients were men, 74.0% were people living with HIV, 76.2% had anal HR‐HPV infection, and 40.34% had histologically confirmed anal HSIL. The weighted κ statistic between the tests (cytology and histology) was 0.25 (p < .001). The sensitivity and specificity of cytology alone to detect anal HSIL were 84.3% (95% confidence interval [CI], 78.3%–89.1%) and 36.0% (95% CI, 30.3%–42.0%), respectively. Anal HR‐HPV genotyping had higher sensitivity (92.2%; 95% CI, 87.4%–95.6%) and similar specificity (34.8%; 95% CI, 29.2%–40.7%) compared to cytology. The two tests combined (positive results following cytology or HR‐HPV test) improved sensitivity to detect anal HSIL (97.9%; 95% CI, 94.8%–99.4%), but specificity was compromised (19.2%; 95% CI, 14.7%–24.4%).ConclusionAlthough HR‐HPV genotyping improved the detection of anal HSIL, HR‐HPV testing had lower specificity than anal cytology alone.
Introduction: Anal cancer incidence has been rising rapidly in Puerto Rico. The ANCHOR study showed that treating high-grade squamous intraepithelial lesions (HSILs) significantly reduces anal cancer incidence. Limited research has been done to understand the validity and associated costs of screening tools used to detect anal lesions in Hispanic populations. We aimed to evaluate the clinical performance (sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) and screening test costs in the clinic-based sample. Understanding the accuracy and costs of screening tools can guide interventions in resource-limited settings to broaden the availability of effective, low-cost screening options and promote anal cancer prevention. Methods: The cross-sectionally analyzed data was collected (May 2015 - June 2021) by the Anal Neoplasia Clinic of the University of Puerto Rico Comprehensive Cancer Center. The clinic predominantly serves referred adults (≥18 years old). Patients were included in the analyses if they had complete results for anal cytology, high-resolution anoscopy (HRA) with biopsy, and anal high-risk HPV (HR-HPV) typing (n=436). Sensitivity, specificity, PPV, and NPV were estimated to evaluate the clinical performance of anal cytology alone and in combination with HR-HPV typing in the detection of histologically confirmed anal HSIL (Gold standard). Analyses were stratified by risk group (women, MSM, and heterosexual men) and HIV status. Evaluation of cost-effective alternative screening strategies is currently ongoing. Results: The mean age of our sample was 44 ± 13 years; more than half (67%) were male. HIV-infected MSM, HIV-infected women, and HIV-negative MSM comprised 45.4%, 22.2%, 13.3% of our sample, respectively. 40% of the sample had HSIL and 69% tested positive for HR-HPV. Measured against the gold standard, we found that co-testing (anal cytology and HR-HPV typing) increased the sensitivity in the groups evaluated and decreased specificity in some. Among HIV-infected MSM, the sensitivity of anal cytology alone to detect HSIL was 84.7%, whereas specificity was 30.0%. Although the sensitivity of the 2 tests combined (anal cytology and HR-HPV typing) to detect histologically confirmed HSIL increased (91.8%), the specificity decreased (22.0%). Overall, the sensitivity of cytology alone was higher in women compared to men and among PLWH compared to HIV-negative individuals. Conclusion: While higher sensitivity for HSIL detection was seen for cytology alone for women and HIV-infected populations, co-testing increased the sensitivity for HSILs detection. Understanding the accuracy and cost of screening tools can guide interventions to broaden the availability of effective, low-cost screening options and promote anal cancer prevention. Access and availability of these tools in a wide context of communities must be considered. Citation Format: Kandyce G. Keller, Celeste Leigh Pearce, Karen J. Ortiz-Ortiz, Jeslie M. Ramos-Cartagena, Humberto Guiot, Vivian Colón-López, Ashish A. Deshmukh, Maribel Tirado-Gómez, Ana Patricia Ortiz. Evaluating anal cancer screening approaches in high-risk populations in Puerto Rico [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 2241.
Introduction: Anal cancer is increasing in the general population of Puerto Rico. Anal cytology is currently the standardized method for screening among populations at higher risk for developing anal high-grade squamous intraepithelial lesions (HSIL), the precursor lesion of anal cancer. However, studies have shown that anal cytology alone underestimates the anal lesion grade compared to the gold standard test, high-resolution anoscopy (HRA). While studies with both anal histology and cytology confirmed results are limited, the validity of cytology as a screening test seems to improve with more extensive HSILs. We evaluated the validity of anal cytology in detecting HSIL overall and by anal HSIL extension in a clinic-based Hispanic population. Methods: Data from baseline visits and examination from October 2014 to April 2021 of the Anal Neoplasia Clinic at the University of Puerto Rico Comprehensive Cancer Center were analyzed. Individuals who attended the clinic were eligible if they had completed anal cytology testing, HR-HPV typing, and HRA with biopsy. During the baseline visit basic demographic and clinical characteristics were collected. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were estimated by comparing anal cytology results with biopsy results from HRA, overall and by extent of histologically confirmed HSIL, defined as number of octants in the anal canal affected by HSIL (1 vs 2+). Results: Among 431 patients, 67.5% were male and the mean age was 43.57 +/- 13.27 years. Overall, 75.2% were living with HIV and 76.8% tested positive for HR-HPV. Persons diagnosed with any type of squamous intraepithelial lesion (SIL) via anal cytology and histology were 71.46% and 84.22%, respectively. In contrast, while anal HSIL was detected in only 2.09% of individuals through anal cytology, it was detected in 40.37% through biopsy-confirmed histology samples. The overall sensitivity of anal cytology compared to histology was 83.9% (95% CI: 77.6%-89%), whereas the specificity was 37% (95% CI: 31%-43.2%). Among persons with biopsy-confirmed HSIL, when comparing anal cytology to histology by HSIL extension (1 vs. 2+ octants affected) the sensitivity remained similar for both groups (83.7% vs. 84.1%), while specificity was the same with 37%. While the PPV decreased with HSIL extension (32.2% vs. 29.9%) and the NPV increased (86.4% vs. 88.0%), these indicators act as poor predictors of disease status in both groups. Conclusion: In this Hispanic population, anal cytology underestimates biopsy-confirmed HSIL and its performance in detected anal HSIL did not improve with HSIL extension. While future studies with larger sample sizes are needed to further validate research findings, this study emphasizes the need to continue to optimize anal cancer screening methods in high-risk populations. Determining the best way to detect and treat cellular abnormalities will help prevent further disease progression and anal cancer development. AMC-NCI Grant #'s: UM1CA121947, 2U54CA096297-17, R25CA240120. Citation Format: Kandyce G. Keller, Jeslie M. Ramos-Cartagena, MS, Humberto M. Guiot, Cristina Munoz, Yolanda Rodriguez, Vivian Colon-Lopez, Ashish A. Deshmukh, Maribel Tirado-Gomez, Ana Patricia Ortiz. Assessment of the performance of anal cytology as a screening tool for anal high-grade squamous intraepithelial lesions by extent of disease in a clinic-based sample in Puerto Rico [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-254.
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