Clinical Review & Education

JAMA Clinical Guidelines Synopsis

Cervical Cancer Screening Anna Volerman, MD; Adam S. Cifu, MD

GUIDELINE TITLE Screening for Cervical Cancer DEVELOPER American College of Obstetricians and Gynecologists (ACOG) RELEASE DATE October 22, 2012 PRIOR VERSION November 20, 2009 FUNDING SOURCE ACOG TARGET POPULATION Women aged 21-65 years

MAJOR RECOMMENDATIONS • Screening for cervical cancer should begin at 21 years of age, regardless of sexual behaviors and risk factors. • For women 21-29 years old, cervical cytology alone should be performed every 3 years. • For women 30-65 years old, co-testing with cervical cytology and human papillomavirus (HPV) testing should be performed every 5 years; an alternative screening method is cytology alone every 3 years.

Summary of the Clinical Problem Approximately 12 000 new cases of cervical cancer are expected to occur in the United States in 2014, with 4000 deaths from the disease.1 Women younger than 50 years have the highest incidence of cervical cancer, and the disease is more prevalent in Hispanic and black women. Fifty percent of women diagnosed with cerJAMA Patient Page page 2302 vical cancer were never screened, and an additional 10% were not screened in the 5-year period before the diagnosis.1 For decades, screening has been performed via cytological examination of cells from the cervical transformation zone (Papanicolaou smear). More recently, testing for HPV, the causative agent in most cases of cervical cancer, has been added as a screening modality.

• Screening should occur more frequently in women who have established risk factors for cervical cancer (including HIV infection, immunocompromised status, exposure to diethylstilbestrol in utero, and history of cervical intraepithelial neoplasia [CIN] 2, CIN 3, or cancer). • Screening should stop at 65 years, as long as there are adequate negative results (3 consecutive negative cytology or 2 consecutive negative co-test results in prior 10 years with most recent in past 5 years) and no history of CIN 2 or higher. • Cervical cytology may be collected via liquid-based or conventional Pap smears. • Screening should not be performed with HPV testing alone. • If co-testing results show atypical squamous cells of undetermined significance (ASCUS) cytology and negative HPV, women should continue routine screening according to their age. • If co-testing results show negative cytology and positive HPV, women may repeat co-testing in 12 months or perform HPV genotype-specific testing. • Screening recommendations remain the same irrespective of whether women received the HPV vaccine.

Cancer Society/American Society for Colposcopy and Cervical Pathology/American Society for Clinical Pathology (ACS/ASCCP/ ASCP) and the US Preventive Services Task Force (USPSTF).3,4

Evidence Base A literature review conducted by ACOG identified relevant articles published between January 1990 and March 2012. Articles describing original research were prioritized; reviews, commentaries, and prior guidelines were also included. Due to limited studies, modeling performed by the Agency for Healthcare Research and Quality provided support for the age to initiate and stop screening and the

Table. Guideline Rating Standard

Rating

Characteristics of the Guidelines Source

1. Establishing transparency

Fair

The cervical cancer screening guideline was published by ACOG,2 a private, voluntary, nonprofit organization representing 55 000 physician members. Two clinical review panels of obstetricians and gynecologists were involved in the development of these guidelines, and the final version was reviewed and approved by the executive board for ACOG. Individual members of the committees were not identified and no comment was made about conflicts of interest (Table). This guideline was published within the same year as updates to the cervical cancer screening guidelines by the American

2. Management of COI in the guideline development group

Poor

3. Guideline development group composition

Poor

4. Clinical practice guideline–systematic review intersection

Good

5. Establishing evidence foundations and rating strength for each of the guideline recommendations

Good

6. Articulation of recommendations

Good

7. External review

Poor

8. Updating

Fair

9. Implementation issues

Fair

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Clinical Review & Education JAMA Clinical Guidelines Synopsis

interval of screening. Starting screening before age 21 years, continuing screening after age 65 years for those who were adequately screened, or screening more frequently than at 3- to 5-year intervals did not significantly affect outcomes.5 Two randomized trials demonstrated no difference between conventional and liquidbased methods for cervical cytology in identifying CIN2+ or CIN3+.5,6 Observational studies demonstrated HPV testing was more sensitive and less specific than cervical cytology for detecting CIN2+ and CIN3+. The recommendation to potentially begin co-testing with HPV and cytology at age 30 years was based on the risk of false-positive results with cervical cytology and the known epidemiology of cervical cancer.7 Trials also showed that co-testing had higher rates of detection for cervical adenocarcinoma vs cytology alone.8 Expert opinion guides the recommendation against changing the screening schedule based on history of HPV vaccination.

Benefits and Harms The goal of cervical cancer screening is to identify precancerous lesions and invasive cancer. Given the transient and indolent nature of HPV infection, the benefit of early identification of cancer must be balanced with the harms related to invasive procedures required to follow up on positive screening tests. Earlier initiation and increased frequency of screening are associated with more falsepositive results, which translates into additional testing and treatment, with little change in cancer risk. Abnormal screening results lead to more frequent testing, invasive procedures such as colposcopy or biopsy, or both. Adverse effects of these procedures include vaginal bleeding, pain, and infection. The psychological effect, such as anxiety and stigma, of a diagnosis of precancer or cancer as well as the cost of testing may be significant.

Discussion Updated guidelines for cervical cancer screening were released by ACOG, ACS/ASCCP/ASCP, and USPSTF in 2012. All of the organizations used epidemiologic, modeling, and original research data to identify appropriate screening methods and timing for averagerisk, asymptomatic women while balancing the benefits and harms of testing. There is significant agreement among the guidelines related to the initiation of cervical cancer screening at age 21 years and discontinuation of screening at age 65 years if there have been adARTICLE INFORMATION Author Affiliations: Department of Medicine, University of Chicago, Chicago, Illinois. Corresponding Author: Adam S. Cifu, MD, Department of Medicine, University of Chicago, 5841 S Maryland Ave, MC 3051, Chicago, IL 60637 ([email protected]). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. REFERENCES 1. Cervical cancer. American Cancer Society website. http://www.cancer.org/cancer/cervical cancer/detailedguide/. Accessed August 20, 2014. 2. Committee on Practice Bulletins—Gynecology. ACOG Practice Bulletin No. 131: Screening for cervical cancer. Obstet Gynecol. 2012;120(5):1222-1238.

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equate negative results and no history of CIN 2 or higher. Because studies show similar reduction in cancer risk and decreased invasive procedures with cytology alone every 3 years vs more frequently, the guidelines recommend against annual screening. Cotesting with cytology and HPV every 5 years has been demonstrated to have similar rates of cancer cases, procedures, and death in women aged 30 to 65 years; however, the high rate of false-positive results makes this strategy less ideal for screening women aged 21 to 29 years. Differences among the guidelines include the strength of recommendation for co-testing with cervical cytology and HPV in women aged 30 to 65 years. ACOG and ACS/ASCCP/ASCP recommend co-testing every 5 years, whereas USPSTF recommends this approach as an alternative to cytology alone every 3 years.

Areas in Need of Future Study or Ongoing Research The recommendations revise prior guidelines based on the availability of new data. HPV testing has emerged as a highly sensitive screening method that, compared with cytology, better identifies adenocarcinoma but is also associated with a higher risk of falsepositive results. As HPV testing is further incorporated into practice, research examining outcomes with various screening strategies, including those incorporating HPV testing, are needed to establish the benefits and harms and compare the effectiveness of these approaches. Preliminary studies also demonstrate high sensitivity of HPV testing performed in the absence of cytological examination; however, further data and algorithm development are necessary prior to adopting use of high-sensitivity HPV testing as a screening approach in clinical practice.10 Long-term studies about outcomes are also needed to appropriately adapt screening strategies based on risk, targeting women with the highest risk of cervical cancer and considering alternative screening approaches for those at low risk to optimize the benefits and minimize risk.

Related guidelines and other resources USPSTF Guidelines4 Comparison of related guidelines at National Guideline Clearinghouse10

3. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012;62(3):147-172. 4. Moyer VA; US Preventive Services Task Force. Screening for cervical cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;156(12):880-891. 5. Kulasingam SL, Hvrilesky L, Ghebre R, Myers ER. Screening for Cervical Cancer: A Decision Analysis for the US Preventive Services Task Force. AHRQ No. 11-05157-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2011. 6. Ronco G, Cuzick J, Pierotti P, et al. Accuracy of liquid based versus conventional cytology: overall results of new technologies for cervical cancer screening. BMJ. 2007;335(7609):28.

7. Siebers AG, Klinkhamer PJ, Grefte JM, et al. Comparison of liquid-based cytology with conventional cytology for detection of cervical cancer precursors: a randomized controlled trial. JAMA. 2009;302(16):1757-1764. 8. Whitlock EP, Vesco KK, Eder M, et al. Liquid-based cytology and human papillomavirus testing to screen for cervical cancer: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2011;155(10):687-697, W214-5. 9. Screening for cervical cancer in women at average risk. National Guideline Clearinghouse. http://www.guideline.gov/syntheses/synthesis .aspx?id=43606. Accessed November 11, 2014. 10. Katki HA, Kinney WK, Fetterman B, et al. Cervical cancer risk for women undergoing concurrent testing for human papillomavirus and cervical cytology. Lancet Oncol. 2011;12(7):663-672.

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