Primary cervical cancer screening with a test for human papillomavirus (HPV) DNA represents a reasonable and effective alternative to cytology or co-testing with cytology and the HPV assay, according to cooperative interim guidance recommendations.
Primary HPV testing should begin at age 25 and continue at 3-year intervals so long as a patient remains HPV negative. Any patient who tests positive for HPV 16 or 18, the strains associated with most cervical cancers, should undergo colposcopy. A positive test for other HPV strains should be followed by reflex cytology.
Starting at age 21, women should have annual cytologic assessment, as currently recommended in existing clinical guidelines.
The guidance report reflects overwhelming evidence favoring HPV DNA testing over cervical cytology (Pap test), said report co-author Warner Huh, MD, of the University of Alabama at Birmingham.
“The report revolves around the use of HPV testing alone as a screening test,” Huh told MedPage Today. “That’s new but we’ve used HPV testing with Pap smears in the past. That’s something that’s been around for 10 years.”
Strong support for HPV testing as the primary screen for cervical cancer hinged on three key factors, beginning with overwhelming evidence that HPV testing is more reproducible than Pap testing and detects far more precancerous lesions.
“Every single study worldwide that has looked at this issue shows the same result: HPV testing outperforms Pap testing,” said Huh.
The third key factor is the miniscule likelihood of a false-negative result with HPV testing.
“When a woman has a negative HPV test, she has a very tiny risk of developing cervical cancer over a 3- to 5-year window,” said Huh. “It really provides a substantial amount of reassurance to the individual woman that her chance of getting cervical cancer with a negative test is very slim.”
Developed with input from multiple medical professional organizations, the interim guidance report was published simultaneously in Gynecologic Oncology, Journal of Lower Genital Tract Disease, and Obstetrics and Gynecology. The authors emphasized that the report does not constitute a clinical guideline but is designed to help clinicians determine how they can integrate primary HPV testing into their practices until medical societies with existing guidelines update recommendations to reflect the availability of the HPV assay as a primary test.
In April 2014, the Food and Drug Administration approved Roche Diagnostics’ cobas HPV test as a primary screening test for cervical cancer. The action followed unanimous support from an FDA advisory committee.
The approval effectively replaced the Pap test as the standard of care for primary cervical cancer screening. The assay can detect 14 different HPV genotypes, including HPV 16 and 18, which account for 70% of all cervical cancers in the U.S.
The interim guidance report incorporates data and other information from 11 recent clinical studies. The most comprehensive dataset came from the ATHENA trial that compared results with the HPV assay and Pap test in 47,000 women who spanned the spectrum of HPV.
The review led the working group to conclude that the HPV DNA test misses fewer precancers and cancers as compared with cytology alone, making the test a potential option for primary screening.
The HPV assay “achieves a reasonable balance of disease detection with the number of screening tests and colposcopies required to achieve that detection,” the authors concluded. “It is expected that more data on triage options will be available soon that could lead to updated triage recommendations.
“Primary … screening at 25 to 29 years of age may lead to increased cervical intraepithelial neoplasia (CIN)3 detection, but the impact of increased number of colposcopies, integration with screening before age 25, and actual impact on cancer prevention needs further investigation.”
Participants in the review and guidance development process included representatives of the Society of Gynecologic Oncology, American Society for Colposcopy and Cervical Pathology, American College of Obstetricians and Gynecologists, American Cancer Society, American Society of Cytopathology, College of American Pathologists, and American Society for Clinical Pathology.
Huh disclosed a relevant relationship with Merck. One or more co-authors disclosed relevant relationships with Merck, Hologic, Roche, Gen Probe, Ventana Medical, GlaxoSmithKline, Bristol-Myers Squibb, Photocure, Cepheid, PDS Biotechnologies, Inovio, Endocyte, Fujiboro, Eli Lilly, and Becton-Dickinson.
Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner.
Courtesy of MedPage Today