Interim guidance may not be the answer, according to Karen Smith-McCune, MD, PhD. “There will be areas of uncertainty…such as how often to do the test,” Dr. Smith-McCune, director of the cervical dysplasia clinic at the University of California, San Francisco, told Medscape Medical News. “Guidelines that leave us with areas of uncertainty are not really helpful.”
Sarah Feldman, MD, MPH, echoes that point. “I’m kind of concerned that the interim guidance may actually confuse things, rather than help things,” Dr. Feldman, who is on the faculty of Harvard Medical School and practices gynecologic oncology at Brigham and Women’s Hospital in Boston, Massachusetts, told Medscape Medical News. In a viewpoint article published online May 5 in JAMA Internal Medicine, she called for simplifying the current screening and management guidelines.
She notes that the trial that provided supportive data for the new cobas test indication was well-designed but lasted only 3 years, so it is not known whether women could wait longer than that between normal screenings. “We may find ourselves in a transition phase where it adds additional confusion,” she says of the new cervical cancer screening option.
“Pap testing has been a successful test,” Dr. Feldman continued. “I think in the future we probably will move to primary HPV testing. But we don’t have enough information yet to make that move.”
Dr. Smith-McCune, who also authored a viewpoint article published in the same issue of JAMA Internal Medicine, even questions the value of HPV testing even as a co-test. “I’m of the opinion that just because something is FDA-approved doesn’t mean it has a role in clinical practice,” she said.
In addition, Dr. Smith-McCune says she does not understand why the 2012 guidelines developed by the American Cancer Society, the American Society of Colposcopy and Cervical Pathology, and the American Society of Clinical Pathology prefer co-testing over the Pap test alone. (The preventive services task force guidelines are neutral on that issue.) “Is more [testing] better, or is more just more? Is it just more confusing? Is it going to prevent cervical cancer or not?” she questioned. “This really is an unanswered question for the co-testing strategy.”
In her viewpoint article, Dr. Smith-McCune notes that overall, 3% to 8% of women screened with co-testing have a normal Pap test with a positive HPV test, and that percentage is even higher in younger women. Although the guidelines from the cancer society, the American Society of Colposcopy and Cervical Pathology, and the American Society of Clinical Pathology prefer co-testing over the Pap test alone, they acknowledge that more research is needed into how to manage women with a normal Pap test and a positive HPV test, Dr. Smith-McCune writes.
However, for some experts, the debate over how best to screen women obscures the fact that a lack of screening, rather than the type of screening, is the main reason US women are still diagnosed with cervical cancer. “We really want to impact the total of women with cervical cancer in this country,” Dr. Chelmow said. “Half of them are women who don’t get screened.”
Dr. Huh serves as an unpaid consultant to Roche and sits on the company’s publication steering committee. Dr. Smith-McCune is the founding chair of the clinical and scientific advisory board for OncoHealth Inc, which is developing diagnostic tests for cervical cancer and other cancers associated with HPV. She also holds stock options in the company. In addition, she is a coinvestigator for 2 studies funded by the National Institutes of Health, related to cervical cancer screening. Dr. Feldman is paid to write chapters for UpToDate, a peer-reviewed online textbook.
JAMA Intern Med. Published online May 5, 2014. Feldman extract, Smith-McCune extract
