In a controversial move, the American Cancer Society (ACS) recently recommended that people with a cervix should have a primary human papillomavirus (HPV) test every five years starting from age 25 to 65 to screen for cervical cancer. The recommendations displace the Papanicolaou (Pap) test that has formed the backbone of cancer screening for decades and extend the time between tests by two years. The changes put ACS at odds with current guidelines from the American College of Obstetricians and Gynecologists (ACOG) and the U.S. Preventive Services Task Force (USPSTF).

“These streamlined recommendations can improve compliance and reduce potential harms,” said Debbie Saslow, managing director, HPV & GYN Cancers for the American Cancer Society. “They are made possible by some important developments that have allowed us to transform our approach to cervical cancer screening, primarily a new understanding of the role of HPV and the development of tools to address it.”

HPV causes nearly all cervical cancers, as well as five other cancers in men and women. In the U.S., a vaccine for HPV has been available for almost 15 years, and “more women of screening age are now vaccinated and protected from the majority of cervical cancers,” the ACS said.

“We estimate that compared with the currently recommended strategy of cytology (Pap testing) alone beginning at age 21 and switching to co-testing at age 30 years, starting with primary HPV testing at age 25 prevented 13% more cervical cancers and 7% more cervical cancer deaths,” said Saslow. “Our model showed we could do that with a 9% increase in follow-up procedures, but with 45% fewer tests required overall.”

Hologic Inc. of Marlborough, Mass., a manufacturer of both the Pap test and the HPV test, decried the changes.

“Hologic is a global champion for women’s health, and we believe all women should be free to make choices with their doctors about the best available options for monitoring and managing their health,” Kevin Thornal, president, Diagnostic Solutions at Hologic told BioWorld. “Large, real-world clinical studies have shown that co-testing for cervical cancer – using both a Pap test and an HPV test, rather than either test alone – offers women the most protection against this preventable cancer.”

Neither ACOG nor the USPSTF saw the changes as terribly out of line with the direction they’ve taken, though ACS is the first to emphasize the superiority of the HPV test and to change the age of first test.

USPSTF response

“We regularly review topics every five to eight years, sometimes earlier if there is significant new information or new studies that would influence our recommendation grade,” said Melissa Simon, member of the USPSTF, vice chair of clinical research in the department of obstetrics and gynecology, and professor of preventive medicine and medical social sciences at Northwestern University Feinberg School of Medicine. “We’re not ready yet to put out new recommendations for cervical cancer screening.”

“We try very hard to stay on top of the science, particularly when other organizations issue new recommendations. With the pandemic, though, unless something comes out that would really change practice in oncology, we would probably hold off,” she told BioWorld.

Currently, USPSTF recommends screening every three years using cervical cytology alone (the Pap test) from age 21 to 29. From age 30 to 65, the task force offers three options for screening, all with grade A ratings: every three years with cytology alone, every five years with high-risk (or primary) HPV testing alone, or every five years with high-risk HPV testing plus cytology, called co-testing.

“So, we start at age 21 and the ACS guidelines start at age 25,” Simon noted. “We will definitely consider age and HPV self-sampling when we review our recommendations in the next few years.” HPV self-sampling tests have yet to gain U.S. FDA clearance.

While the task force will not be reviewing their recommendation in the short-term, Simon said that the HPV test and Pap test have similar specificity, but the HPV test has much higher sensitivity, about 95% vs. 55%.

ACOG response

ACOG’s recommendations follow the USPSTF’s, including three options for testing.

“ACOG looks forward to comprehensively reviewing the ACS recommendations and the supporting evidence in order to determine whether a similar update to our clinical guidance document on cervical cancer screening is needed,” said Christopher Zahn, ACOG vice president of practice activities. “In the interim, ACOG affirms our current cervical cancer screening guidelines, which encompass all three cervical cancer screening strategies (high-risk human papillomavirus testing alone, cervical cytology alone, and co-testing). ACOG’s current screening guidelines reflect a balance of benefit and potential harms and support shared decision-making between patients and their clinicians.”

“The value of cervical cancer screening cannot be emphasized enough,” Zahn said. “The incidence of cervical cancer in the United States has decreased more than 50% in the past 30 years because of widespread screening. An evidence-based approach to cervical cancer screening will allow us to continue to build on this progress.”

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