Two leading medical organizations say that using a Human papillomavirus (HPV) test alone for cervical cancer screening is an effective alternative to the current recommendation for screening with either cytology (the Pap test) alone or co-testing with cytology and HPV testing.
The Society of Gynecologic Oncology (SGO) and the American Society for Colposcopy and Cervical Pathology (ASCCP) issued an Interim Guidance Report after the U.S. Food and Drug Administration (FDA) approved the cobas® HPV test as a "primary," or first, test performed for cervical cancer screening. The test detects DNA from 14 high-risk HPV types, including types 16 and 18, which are responsible for 70 percent of cervical cancers. The guidance report is being jointly published online on Jan. 8 by Gynecologic Oncology, the Journal of Lower Genital Tract Disease, and Obstetrics and Gynecology.
The Interim Guidance Report, "Use of Primary High Risk Human Papillomavirus Testing for Cervical Cancer Screening: Interim Clinical Guidance," will help doctors and other clinical providers determine how best to integrate primary HPV testing into the care of their patients until several medical societies update their evidence-based guidelines for cervical cancer screening.
Cervical cytology, frequently called the "Pap" test, can detect abnormal cells in the cervix that could be pre-cancerous; follow-up and management leads to prevention of invasive cancer. Its widespread use in the U.S. is credited with greatly reducing both the occurrence of and deaths from cervical cancer.
As investigators learned about the role HPV plays in the development of cervical cancer, tests to detect the virus were developed and used in conjunction with cytology. Many studies now show that HPV testing may be more effective than cytology alone in detecting cervical pre-cancer.
"Our review of the data indicates that primary HPV testing misses less pre-cancer and cancer than cytology alone. The guidance panel felt that primary HPV screening can be considered as an option for women being screened for cervical cancer," said Warner K. Huh, MD, Division Director and Professor in the Division of Gynecologic Oncology at the University of Alabama, Birmingham. Dr. Huh is a spokesperson for the SGO and lead author of the Interim Guidance Report.
The Interim Guidance Report recommends:
•Primary HPV testing can be considered for women starting at age 25.
•Women under age 25 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 three years. This is the same screening interval recommended under current guidelines for a normal cytology test result.
•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.
In developing the guidance report, the medical societies reviewed 11 studies, including "Primary Cervical Cancer Screening with Human Papillomavirus: End of Study Results from the ATHENA Study Using HPV as the First-Line Screening Test," also published Jan. 8 in Gynecologic Oncology. This U.S. study demonstrated that primary HPV screening is an effective screening strategy in women 25 years and older. The authors of the guidance report noted the need for additional studies to further define the role of primary HPV screening and its integration with other existing guidance on screening for cervical cancer, and managing abnormal screening tests and diagnosed cervical pre-cancer.
"The introduction of cervical cytology screening was truly one of the great breakthroughs in medicine, and has saved countless lives," said ASCCP's Chief Medical Officer Herschel Lawson, MD. "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 and treatment of cervical cancer.
"The most important message for providers and the community is that women should be screened for cervical cancer," Dr. Lawson added. "Screening saves lives."
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