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HPV testing recommended as primary screening option for cervical cancer
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The HPV test should be considered the primary option for cervical cancer screening, according to an interim guidance report released today by two medical organizations.
Following up on an FDA approval of the cobas HPV test (Roche) as a front-line screening option, the Society of Gynecologic Oncology (SGO) and the American Society for Colposcopy and Cervical Pathology (ASCCP) issued guidance suggesting the HPV test alone should become the standard in place of cytology (Pap test) alone or co-testing with cytology and HPV.
Warner K. Huh, MD
The HPV test detects DNA from 14 high-risk HPV types, including types 16 and 18, which are responsible for 70% of all cervical cancers.
“Our review of the data indicates that primary HPV testing misses less pre-cancer and cancer than cytology alone,” Warner K. Huh, MD, division director and professor in the division of gynecologic oncology at the University of Alabama, Birmingham, and one of the authors of the interim guidance, said in a press release.
Recommendations in the guidance suggest:
- Primary HPV testing can be considered for woman starting at age 25 years.
- Women younger than 25 years should continue to follow current guidelines that recommend cytology alone beginning at age 21.
- Women with a negative primary HPV test result should not be retested again for 3 years, the same screening interval recommended for normal cytology test results.
- An HPV test positive for HPV 16 and 18 — two types associated with a higher risk of future disease — should be followed with colposcopy, a test that allows the doctor to examine the cervix under illumination and magnification.
- A test that is positive for HPV types other than 16 and 18 should be followed by reflex cytology testing.
Representatives from the SGO, ASCCP, American College of Obstetricians and Gynecologists, American Cancer Society, American Society of Cytopathology, College of American Pathologists and the American Society for Clinical Pathology — as well as observers from the CDC and the FDA — considered several European studies, as well as an ATHENA trial provided by Roche Diagnostics before issuing the guidance.
With more than 176,000 women followed, data indicated that after extended follow-up (median, 6.5 years) the incidence of invasive cervical cancer was significantly lower in women initially screened with high-risk HPV-based testing compared with those screened with cytology alone (RR=0.45; 95% CI, 0.25-0.81). There also was a more pronounced benefit for HPV-based testing for detection of adenocarcinoma compared with squamous cell carcinoma, with a pooled rate ratio of 0.31 (95% CI, 0.14-0.69) and 0.78 (95% CI, 0.49-1.25), respectively.
In the ATHENA trial, there was a substantially lower 3-year cumulative incidence rate of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) and cancer in women aged at least 25 years who were high-risk HPV-negative at enrollment (0.34%; 95% CI, 0.1-0.65) compared with women who were cytology-negative at enrollment (0.78%; 95% CI, 0.53-1.09).
“The introduction of cervical cytology screening was truly one of the greatest breakthroughs in medicine and has saved countless lives,” Herschel Lawson, MD, ASCCP chief medical officer, said in a press release. “We are lucky that we have so many tools available now to improve cervical cancer prevention efforts and afford patients options depending on their individual situations. We’ll continue to work to find the best way to combine screening tools with other prevention efforts like HPV vaccines, for the early detection of cervical cancer.”
Disclosure: The researchers report consultant/advisory roles with, grant funding from and employment relationships with Becton-Dickinson, Bristol-Myers Squibb, Cepheid, Eli Lilly, Endocyte, Fujiboro, Gen Probe, GlaxoSmithKline, Hologic, Inovio, Merck, Photocure, PDS Biotechnologies and Roche. See the draft guidance for a full list of disclosures.
Perspective
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Maurie Markman, MD
This important consensus statement — from a panel of experts representing a number of national organizations — presents rational guidance for gynecologists and primary care physicians regarding the utility associated with primary high-risk HPV testing as the sole strategy for initial screening for cervix cancer. The evidence presented is solid and represents the impressive cumulative controlled-trial experience involving a large number of women (more than 1.2 million) managed in a variety of settings in various parts of the world. Compared with standard cytology testing, a baseline finding of a “negative test for high-risk HPV” was associated with a lower risk for discovering cervical intraepithelial neoplasia grade 3 (CIN3) at 3 years and 5 years follow-up. The recommendation from this group to proceed immediately to colposcopy in the presence of HPV 16 and 18 — and to perform standard cytology if one of 12 other HPV genotypes is discovered — appears quite reasonable and supported by the available clinical data. However, it is important to recognize that although this strategy will find more CIN3 than associated with standard cytology testing, there will also be an overall increased number of negative colposcopies performed. Finally, the recommendation for testing every 3 to 5 years, and for such testing to not be initiated before 25 years of age, also appears to be appropriate.
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