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Huh WK, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Gynecol Oncol. 2015;136(2):178–182.
The most recent set of consensus guidelines for managing abnormal cervical cancer screening tests and cancer precursors is the American Cancer Society/American Society for Colposcopy and Cervical Pathology (ASCCP)/American Society for Clinical Pathology 2012 guidelines,6 which recommend cotesting as the preferred strategy in women aged 30 to 65 years. However, to address increasing evidence that HPV testing alone is an effective primary screening approach and how clinicians should adopt these findings in their practice, an expert panel convened to offer interim guidance. The panel was cosponsored and funded by the Society of Gynecologic Oncology (SGO) and ASCCP and included 13 experts representing 7 societies, including SGO, ASCCP, and the American College of Obstetricians and Gynecologists. This guidance can be adopted as an alternative to the updated 2012 recommendations until the next consensus guidelines panel convenes.
The panel considered a number of questions related to primary HPV testing and overall advantages and disadvantages of this strategy for screening.
Is HPV testing (for high-risk HPV [hrHPV] types) for primary screening as safe and effective as cytology-based screening?
The panel’s answer: Yes. A negative hrHPV test provides greater reassurance of low CIN 3 or greater risk than a negative cytology result. Because of its equivalent, or even superior, effectiveness—which has been demonstrated in the ATHENA study and several European randomized controlled screening trials7,8—primary hrHPV screening can be considered as an alternative to current US cervical cancer screening methods.
A reasonable approach to managing a positive hrHPV result, advises the panel, is to triage hrHPV-positive women using a combination of genotyping for HPV 16 and 18 and reflex cytology for women positive for the 12 other hrHPV genotypes
(FIGURE 2).9
What is the optimal age to begin primary hrHPV screening?
The panel’s clinical guidance is not before age 25. This is a gray area right now, however, as there are concerns regarding the potential harm of screening at age 25 despite the increased detection of disease, particularly with regard to the number of colposcopies that could be performed in this age group due to the high incidence of HPV infection in young women. So the ideal age at which to begin hrHPV screening will need further discussion in future consensus guideline panels.
What is the optimal interval for primary hrHPV screening?
Prospective follow-up in the ATHENA study was restricted to 3 years. The panel advises that rescreening after a negative primary hrHPV screen should occur no sooner than every 3 years.
Outstanding considerations
The changeover from primary cytology to primary HPV testing represents a very different workflow for clinicians and laboratories. It also represents a different mode of screening for our patients, so patient education is essential. Many questions and concerns still need to be considered, for instance:
- There are no real comparative effectiveness data for the number of screening tests that are needed for an HPV primary screening program, including the number of colposcopies.
- There needs to be further discussion about the optimal age to begin primary HPV screening and the appropriate interval for rescreening patients who are HPV-negative.
- There are questions about the sampling from patients, such as specimen adequacy, internal controls, and the impact of other interfering substances in a large screening program.
What this EVIDENCE means for practice
A move to the HPV test for primary screening represents a paradigm shift for clinicians and patients. Such a shift likely will be slow to occur, due to changes in clinical and laboratory workflow, provider and patient education, and systems issues. Also, there are a number of questions that still need to be answered. Primary hrHPV screening at age 25 to 29 years may lead to increased CIN 3 detection, but the impact of the increased number of colposcopies, integration for those women who already have been screened prior to age 25, and actual impact on cancer prevention need further investigation, the panel points out.
However, primary HPV screening can be considered as an alternative to current US cytology-based cervical cancer screening approaches. Over time, use of primary HPV screening appears to make screening more precise and efficient as it will minimize the number of abnormal cytology results that we would consider cytomorphologic manifestations of an active HPV infection that are not clinically relevant.
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