Clinical Review


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Guidelines have changed again, of necessity. Here is a roundup of the major alterations and new guidance.




To access 10 recent articles and audiocasts from OBG Management on cervical disease, click here.

Dr. Einstein reports that Montefiore Medical Center has received payment from Roche and Hologic for time he spent as an advisor or educational speaker. In some cases, his travel has been paid for when required for meetings. In addition, Dr. Einstein reports that Montefiore has received grant funding from Roche, Hologic, and Becton-Dickinson for research-related costs of clinical trials that he has been the overall or Montefiore principal investigator.

Dr. Cox reports that he is a consultant to OncoHealth; a member of the Scientific Advisory Boards for Roche and Hologic; a speaker for Roche; and on the Data and Safety Monitoring Board for HPV vaccines for Merck.

Cervical cancer screening is necessarily complex, and guidelines must change fairly frequently as our understanding of the natural history of HPV infection and cervical cancer continues to evolve. Up-to-date guidelines enhance our ability to detect cervical intraepithelial neoplasia and cancer early and manage them appropriately.

In April 2013, the American Society for Colposcopy and Cervical Pathology (ASCCP) updated guidelines for the management of abnormal cervical cytology and cervical cancer precursors for the first time since 2006.1 This update follows new cervical cancer screening guidelines published in 2012 by the ACS/ASCCP/ASCP,2 the USPSTF,3 and the American College of Obstetricians and Gynecologists4 (and reported in OBG Management in June 20125).

For many clinicians, all these modifications amount to a dizzying “sea change” in the way they have been screening and managing patients to prevent cervical cancer. Clinicians often express frustration with the guidelines, both for their complexity and for what seems like all-too-frequent changes. Do they really need to change … again? Do they really need to get even more complex? And what about them is really new?

This article addresses these questions by reviewing the guidelines and their updates in more depth. For a specific answer to the question of “What’s new?” see sidebar below.

What’s new?

The following features of the 2013 ASCCP update to cervical cancer screening guidelines are new:

  • The return to “routine” screening is now better defined
  • The management of women who have “unsatisfactory” cytology or a specimen lacking endocervical or transformation-zone components now includes the results of HPV testing
  • Management guidelines previously used for adolescents (<21 years) now apply to young adult women (<25 years)
  • There is now advice on the management of women aged 30 and older who have discordant cotest results, including HPV-positive/cytology-negative findings and HPV-negative/cytology-positive findings of ASC-US or more severe.

Did the guidelines really need to change … again?

Cervical cancer screening tests—be they the Pap test or a human papillomavirus (HPV) test—are not as clear-cut as other tests used to screen for sexually transmitted infections or their effects. We treat a patient whenever her gonorrhea or Chlamydia test is positive, for example. However, other than cytology classified as high-grade (ie, HSIL), which may prompt immediate treatment in women 25 years and older by “see-and-treat” loop electrosurgical excision procedure (LEEP), neither cervical cytology nor HPV testing is sufficiently specific for present disease (cervical intraepithelial neoplasia [CIN] 3 or cancer) to warrant treatment without a diagnostic work-up. That’s because the cause of cervical cancer (infection with HPV) usually does not produce CIN 3 or cancer, and the cell changes that it does produce most often (atypia and koilocytosis) are very common. And other cervical-vaginal changes associated with hormonal fluctuations, tampons, intercourse, and so on, may result in cervical cytologic changes unrelated to HPV and, therefore, do not represent a risk for cervical cancer.

How can we best sort out who needs to be evaluated without under- or overdoing it? When we find CIN, some of which is destined to progress and some not, how do we reduce the risk of overtreatment without increasing the likelihood that some will progress to cancer? If we have treated CIN or adenocarcinoma in situ (AIS), how do we make sure there is no recurrence without risking over-management and potential overtreatment?

The first thing we do is ensure that we use our best clinical judgment and also respect the informed wishes of the patient. Because the guidelines are based on the best available data, and on expert opinion when data are lacking, guidelines developed through a consensus process provide a framework for care that is optimal for most women at each phase of their lives. This knowledge can help the clinician—and often the patient—make the best-informed decisions.

Which HPV tests are recommended?14

Because only high-risk HPV types cause cervical cancer, testing should be restricted to high-risk (oncogenic) HPV types. Do not test for low-risk HPV types.

The guidelines are intended for use only with HPV tests that have been analytically and clinically validated, as documented by US Food and Drug Administration licensing and approval or by publication in peer-reviewed scientific literature. This distinction is important because management based on results of HPV tests that have not been similarly validated may not result in outcomes intended by these guidelines and may increase the potential for patient harm.


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