EXECUTIVE SUMMARY

The U.S. Preventive Services Task Force has released draft guidance on cervical cancer screening, with a major proposed change stating that for average-risk women ages 30-65 years, testing may be done with either cervical cytology alone every three years or with high-risk human papillomavirus testing alone every five years. Co-testing no longer is required.

  • Women who are older than 65 years of age who have had adequate prior screening and are not otherwise at high risk for cervical cancer do not require screening.
  • Women younger than 21 years of age should not be screened for cervical cancer, the guidance states. This recommendation does not apply to women living with HIV or who otherwise have a compromised immune system.

The U.S. Preventive Services Task Force (USPSTF) has just released draft guidance on cervical cancer screening, with a major proposed change stating that for average-risk women ages 30-65, testing may be done with either cervical cytology alone every three years or with high-risk human papillomavirus (hrHPV) testing every five years. Co-testing no longer is required.1

Guidance highlights are as follows:

  • The USPSTF recommends screening for cervical cancer in women 21-29 years of age every three years with cervical cytology alone. For women 30-65 years of age, the task force recommends either screening with cervical cytology alone every three years or screening with hrHPV testing alone every five years.
  • The task force recommends against screening for cervical cancer in women older than 65 years of age who have had adequate prior screening and are not otherwise at high risk for cervical cancer.
  • The task force recommends against screening for cervical cancer in women younger than 21 years of age. This recommendation does not apply to women living with HIV or who otherwise have a compromised immune system.
  • The USPSTF recommends against screening for cervical cancer in women who have had a hysterectomy with removal of the cervix and who do not have a history of a high-grade precancerous lesion (cervical intraepithelial neoplasia grade 2 or 3) or cervical cancer.
  • The guidance does not apply to women who are already at high risk for the disease, such as those who have been diagnosed with a high-grade precancerous cervical lesion or those who have a weakened immune system.

“The task force looked at the evidence on the effectiveness of different screening tests and intervals based on age, and found that after age 30, the Pap test and hrHPV tests are both effective for cervical cancer screening,” stated task force member Maureen Phipps, MD, MPH, department chair and Chace-Joukowsky professor of obstetrics and gynecology and assistant dean for teaching and research on women’s health at the Warren Alpert Medical School of Brown University in Providence, RI, in a release accompanying the proposed guidance. “Women ages 30 to 65, therefore, have a choice between the Pap test every three years or hrHPV test every five years.”

Understand Screening Options

Reproductive health clinicians are familiar with the traditional Pap test, used to identify abnormal cervical cells such as ASC-US (atypical squamous cells of undetermined significance) and LSIL (low-grade squamous intraepithelial lesion) immediately after collection. Clinicians now can choose from five different hrHPV tests, approved by the Food and Drug Administration (FDA): the Hybrid Capture 2 and the Cobas hrHPV, Aptima hrHPV Assay, and the Cervista hrHPV 16/18 and Cervista high-risk hrHPV. These hrHPV tests have been approved for screening patients with abnormal cytology results to determine the need for colposcopy referral and for use in women 30 years of age and older in conjunction with cytology to determine possible high-risk hrHPV type. In 2014, the FDA approved the Cobas hrHPV test as a primary cervical cancer screening test for women 25 years of age or older.

Regular screening for women 21-65 years of age greatly reduces the rate of cervical cancer and the number of deaths resulting from cervical cancer.2 The most effective screening test depends on a woman’s age, according to the USPSTF evidence search. For women ages 21-29, many HPV infections will resolve on their own, so the Pap test is most effective.3 For women from age 30 to 65, HPV infections are more likely to lead to cancer, so either Pap tests or hrHPV tests are effective for screening, the evidence review noted.1

“Cervical cancer screening can lead to follow-up testing and treatment procedures that can cause harms such as vaginal bleeding, pain, infection, and complications during future pregnancies,” reads the draft guidance. “However, because screening for cervical cancer saves lives and identifies cervical cancer early, when it is treatable, the Task Force concludes that the benefits of screening outweigh any possible harms for women ages 21 to 65,” the document says.

Organizations Weigh In

Haywood Brown, MD, president of the American College of Obstetricians and Gynecologists (ACOG), and Anna-Barbara Moscicki, MD, president of The American Society for Colposcopy and Cervical Pathology (ASCCP), issued a joint statement on the proposed guidance.

“At this time, ACOG continues to affirm the clinical guidance included in Practice Bulletin No. 168, ‘Cervical Cancer Screening and Prevention,’ which recommends that for women aged 30-65 years, co-testing with cytology and high-risk HPV testing every five years is preferred, and screening with cytology alone every three years is acceptable,” the statement reads.

The task force’s draft recommen-dations for routine cervical cancer screening in women younger than 21 years of age, for women ages 21-29, and for women older than 65 years of age who have been adequately screened previously have not changed and remain the same as ACOG’s current guidance, the joint statement notes.

Self-collection on Horizon?

Not all women have easy access to cervical cancer screening because of geography or socioeconomic status. Recent research indicates that self-collected swabs are effective, and may lead to increased access to testing.4-5

The FDA will hold a public workshop, “Self-Collection Devices for Pap Test,” in January 2018 to obtain feedback about the feasibility, benefits, risks, impact on current standard of care, and validation approaches for self-collection devices for cervical cancer screening by Pap testing.

The task force notes that hrHPV testing samples offer the potential to be collected by the patient and mailed to health programs for analysis. While self-collection may be one strategy for increasing screening rates among at-risk populations, comparative studies are needed to verify their use and to identify effective strategies for implementation.

Many patients and clinicians traditionally have used the cervical cancer screening visit as an oppor-tunity to discuss other health problems and preventive measures.

“The potential for self-screening for hrHPV is exciting, but also is the source of much concern for providers who use this screening as a reason for interacting with their patients periodically,” notes Anita Nelson, MD, professor and chair of the obstetrics and gynecology department at Western University of Health Sciences in Pomona, CA. 

REFERENCES

  1. U.S. Preventive Services Task Force. Draft Recommendation Statement: Cervical Cancer: Screening. September 2017. Available at: http://bit.ly/2h73xLJ. Accessed Oct. 16, 2017.
  2. Safaeian M, Solomon D, Castle PE. Cervical cancer prevention — cervical screening: Science in evolution. Obstet Gynecol Clin North Am 2007;34:739-760.
  3. Kotaniemi-Talonen L, Anttila A, Malila N, et al. Screening with a primary human papillomavirus test does not increase detection of cervical cancer and intraepithelial neoplasia 3. Eur J Cancer 2008;44:565-571.
  4. Catarino R, Vassilakos P, Bilancioni A, et al. Accuracy of self-collected vaginal dry swabs using the Xpert human papillomavirus assay. PLoS One 2017;12:e0181905.
  5. Porras C, Hildesheim A, González P, et al; CVT Vaccine Group. Performance of self-collected cervical samples in screening for future precancer using human papillomavirus DNA testing. J Natl Cancer Inst 2014;107:400.