Sylvester Plays Pivotal Role in Practice-Changing Anal Cancer Prevention Study Published by NEJM

The New England Journal of Medicine (NEJM) has published the results of a study by Sylvester Comprehensive Cancer Center at the University of Miami Miller School and other investigators on anal cancer prevention in people living with HIV (PLHIV) that will likely establish a new standard of care.

Findings from the ANCHOR study that has screened 10,723 PLHIV and enrolled 4,446 from 25 U.S. sites, including Sylvester and Jackson Memorial Hospital, show that treating anal high-grade squamous intraepithelial lesions (HSIL), which are potentially precancerous, significantly lowers the risk of anal cancer among PLHIV compared to taking a wait-and-see approach.

The risk of anal cancer is higher among PLHIV than in the general population. And anal cancer is biologically similar to cervical cancer in the sense that both are caused by HPV and preceded by HSIL, according to Isabella Rosa-Cunha, M.D., principal investigator of the ANCHOR study sites at Sylvester and Jackson Memorial Hospital and associate professor of medicine at the Miller School.

“Looking for and treating these lesions in cervical cancer prevention has been a gamechanger for women, greatly reducing overall cervical cancer rates. This is the only prospective study to show a similar impact on anal cancer prevention,” said Dr. Rosa-Cunha.

Investigators studied PLHIV 35 years and older with biopsies showing that they had anal HSIL. Subjects were randomized to either a treatment group, in which their lesions were treated mainly with electrocauterization, or an active monitoring group, without treatment.

Lower Incidence of Cancer Among Treated Participants

During the study, nine cases of anal cancer were diagnosed among the 2,227 treated participants, compared with 21 cases of the cancer among the 2,219 participants in the active monitoring group. The incidence of anal cancer was about 60% lower in the treatment arm, which is a significant finding.

“While the treatment of precancerous anal lesions has room for improvement to further reduce or eliminate anal cancer risk in these patients, this data supports the recommendation to include screening and treating anal HSIL for anal cancer prevention in PLHIV,” Dr. Rosa-Cunha said.

This study looked specifically at PLHIV, but looking for and treating these lesions will likely improve anal cancer prevention in other high-risk groups, including HIV-negative men who have sex with men, transplant patients, and women with HPV vulvar disease, according to Dr. Rosa-Cunha.

“This paper is already having a big impact. CDC is evaluating its recommendations for anal cancer prevention in PLHIV based on the ANCHOR study,” she said.

The National Cancer Institute, which funded the study, has approved the study to continue to follow these patients until 2025.

“There is a massive amount of data that has not been analyzed yet. The Miller School was among the top enrolling sites in the U.S., and there is a large number of samples collected from participants that will likely help to answer other important questions in the natural history of anal cancer,” Dr. Rosa-Cunha said.