Cervical Cancer Screenings: Pap and HPV Co-Testing Saves Lives



Dear Colleague: USPSTF RELEASED DRAFT RECOMMENDATIONS FOR CERVICAL CANCER SCREENING – PLEASE HELP PROTECT PATIENT CAREBelow please find a response to draft USPSTF recommendations that you can use during the open comment period (between now and October 9, 2017 at 8 p.m.ET). The draft recommendations represent a significant change from current clinical practice and are a clear step back in protecting women from cervical cancer. For many years, the Pap test has been trusted by women and physicians and is an important part of cervical cancer screening. Many healthcare providers follow current American Congress of Obstetricians and Gynecologists (ACOG) guidelines by using PAP+HPV, or co-testing, as the “preferred” screening strategy for women ages 30 to 65. Please join us in urging USPSTF to include an A grade for co-testing in its final recommendations. I’m very concerned that the USPSTF draft recommendations do not include co-testing as a cervical cancer screening strategy. I firmly believe in the clinical effectiveness and power of co-testing and it is the strategy I routinely use for patients who are in the 30-65 age range. This screening strategy is supported by numerous global studies and is the preferred cervical cancer screening strategy of ACOG, of which I am a member.7 In addition, recent HRSA recommendations also include co-testing for women age 30 to 65 as the preferred screening strategy for cervical cancer.8Many studies in the United States (U.S.) indicate that screening with co-testing identifies more cervical pre-cancer and cancer than either test used alone, and most of these studies were not taken into consideration in the analysis.1,2,3,4,5,6 Counter-intuitively, the USPSTF analysis showed far greater performance for HPV alone than co-testing (Pap+HPV). This seems improbable when co-testing is simply the addition of HPV screening to cytology and therefore should be at least as good as HPV by itself. I have additional concerns regarding the model design. The model seemingly disadvantaged co-testing in numerous ways. The first is that co-testing scenarios did not include genotyping, reducing the immediate detection of disease. Secondly, the model did not account for HPV negative cervical cancers. Studies have shown up to 31% of cervical cancers were missed with HPV alone screening. Finally, the model discounts contributions of cytology. As a result, the overall performance of co-testing is undervalued. My concern is that these findings fail to adequately account for U.S. clinical practices, patient screening habits or demographics and have limited, if any, relevance to the screening of women in the U.S. Because USPSTF recommendations serve as the basis for insurance coverage with no cost-sharing for patients, if these recommendations are finalized in their current form they could have a serious adverse effect on the lives of many women. Accordingly, I urge USPSTF to restore an A grade for co-testing in the final recommendations.References:Zhou, H., Mody, R. R., Luna, E., Armylagos, D., Xu, J., Schwartz, M. R., Mody, D. R. and Ge, Y. (2016), Clinical performance of the Food and Drug Administration–Approved high-risk HPV test for the detection of high-grade cervicovaginal lesions. Cancer Cytopathology. doi:?10.1002/cncy.21687 [Study included cobas HPV test, SurePath, ThinPrep]Blatt, A. J., Kennedy, R., Luff, R. D., Austin, R. M. and Rabin, D. S. (2015), Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices. Cancer Cytopathology, 123: 282–288. doi: 10.1002/cncy.21544 [Study included ThinPrep, SurePath, Hybrid Capture 2 assay].Katki HA, Kinney WK, Fetterman B, et al. Cervical cancer risk for women undergoing concurrent testing for human papillomavirus and cervical cytology: a population-based study in routine clinical practice. Lancet Oncol. 2011;12(7):663-72. PMID: 21684207. (11)70145-0. Gage JC, Hunt WC, Schiffman M, et al. Similar risk patters after cervical screening in two large U.S. populations. Cervical Dysplasia. 2016;128(6):1248-57. Gage JC, Schiffman M, Katki HA, et al. Reassurance against future risk of precancer and cancer conferred by a negative human papillomavirus test. J Natl Cancer Inst. 2014;106(8). PMID: 25038467. . Accessed September 13, 2017.Katki HA, Schiffman M, Castle PE, et al. Five-year risks of CIN 3+ and cervical cancer among women who test Pap-negative but are HPV-positive. J Low Genit Tract Dis. 2013;17(5 Suppl 1):S56-63.The American Congress of Obstetricians and Gynecologists. Practice Bulletin Number 168: Cervical cancer Screening and Prevention. Obstet Gynecol. 2016; 128(4): e111-e130.Women’s Preventative Services Initiative. Recommendations for preventive services for women: final report to the U.S. Department of Health and Human Services. Health Resources & Services Administration, Washington, DC. The American Congress of Obstetricians and Gynecologists: 2016. ................
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