First Federal Guidelines for Anal Cancer Screening Based Partly on Sylvester Data
Article Summary
- U.S. health officials recently released guidelines for anal cancer screening for people with HIV, a high-risk group.
- The guidelines were made possible with data from the multisite ANCHOR study, showing that it’s better to treat potentially precancerous anal lesions than wait and watch.
- Researchers at Sylvester Comprehensive Cancer Center contributed to the study.
The U.S. Centers for Disease Control and Prevention (CDC) has released the first federal guidelines for anal cancer screening in people with HIV, a population at elevated risk for this type of cancer.
The guidelines are based on results from a landmark study conducted partly at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, and Jackson Memorial Hospital, a tertiary care center.
“The study had already affected clinical practice and now has been turned into policy,” said Isabella Rosa-Cunha, M.D., an associate professor in the Division of Infectious Diseases at the Miller School and the initiator of the anal cancer prevention program at Sylvester and Jackson Memorial. “This really validates what we have been doing and changes the landscape for anal cancer prevention.”
The ANCHOR Study
Dr. Rosa-Cunha is the Miller School’s principal investigator for the multisite study led by the University of California, San Francisco. The study addresses a longstanding question in the field: whether treating anal high-grade squamous intraepithelial lesions (HSIL) or anal pre-cancer lesions prevents anal cancer.
Key findings from the study, dubbed ANCHOR (Anal Cancer/HSIL Outcomes Research), were reported in 2022 in the New England Journal of Medicine. Treatment reduced the risk of developing anal cancer by about 60% over actively monitoring people older than 35 with HIV.
The study reinforced the value of screening and treatment for anal HSIL in this high-risk population. In people with HIV, the risk of anal cancer can be 37-fold higher than in the general population.
The study’s findings and other data supported the new guidelines. They were released July 10 by a panel of experts in HIV care, a working group of the NIH Office of AIDS Research Advisory Council, in collaboration with the CDC, the HIV Medicine Association and the Infectious Diseases Society of America.
“I grew up with the field and to see this happen is really special,” said Dr. Rosa-Cunha, who started the anal cancer prevention program at University of Miami in 2011.
Catching Anal Cancer Before It Strikes
Anal HSIL arises from the skin tissue lining the anus and is caused by human papillomavirus (HPV). People with anal HSIL have an elevated risk of developing anal cancer in their lifetimes. However, symptoms often don’t arise until later in the disease, when it is harder to treat.
Catching anal cancer before it develops has the potential to reduce lifelong side effects from cancer treatment (chemotherapy and radiation therapy) and deaths from the disease. Anal cancer kills about 2,190 people annually in the U.S. and claimed the life of actress Farah Fawcett.
The new guidelines recommend a stepwise screening process tailored to different patient HIV-positive groups with varying levels of risk. The recommendations have parallels to screening guidelines for cervical cancer, which is also caused by HPV and can be stopped with early treatment of pre-cancerous lesions detected by a pap smear.
Key provisions in the new guidelines include:
• All adults with HIV should be assessed at least yearly for anal abnormalities like pain and burning and undergo a digital anorectal examination.
• People younger than 35 who are symptomatic or show signs of anal cancer during the examination should undergo standard anoscopy, which involves shining a light through the anus using a small tube.
• Older people living with HIV should undergo lab-based screening if they are men who have sex with men or transgender women 35 and older. Other groups should undergo such screening if they are 45 or older. Lab-based screening includes collection of anorectal specimens as part of an anal “pap smear.”
• For these older groups, people with abnormalities in the lab-based screen or during the anorectal examination should be referred to high-resolution anoscopy (HRA), which uses magnification to assess for abnormal cells.
“The study was meant for HIV and the CDC guidelines target the HIV population, but we think other high-risk groups can benefit from screening,” said Dr. Rosa-Cunha, including people who have received an organ transplant and women with a history of HPV-related cervical or vulvar dysplasia and/or cancer.
A wider variety of patient groups are covered in recent guidelines from the International Anal Neoplasia Society (IANS), to which Dr. Rosa-Cunha contributed.
Increased Screening, Decreased Risk
The new CDC guidelines could lead to an increase in people getting screened for anal cancer and encourage coverage by insurance companies.
“Our next challenge is implementation,” said Dr. Rosa-Cunha, co-chair of the implementation task force of the IANS and part of its educational committee. Clinicians have been coming to the University of Miami for training in HRA, which can be challenging to master, said Dr. Rosa-Cunha.
The ANCHOR study was led by researchers at the University of California, San Francisco, and enrolled 4,459 HIV-positive individuals older than 35 with HSIL, out of 10,723 screened nationwide. A high proportion of the study’s HIV-positive individuals in the study were enrolled through the Miami site, including many women.
“Patients from different ethnic and social backgrounds had the opportunity to participate in a very important clinical trial, and I think that’s extraordinary,” said JoNell Efantis Potter, Ph.D., APRN, FAAN. Dr. Potter is chief of the Women’s HIV Service and vice chair of reproductive sciences at the Miller School. She is a co-investigator on the ANCHOR study, which is still yielding data.
Both Dr. Rosa-Cunha and Dr. Potter are grateful to the patients who contributed to the study.
“Watch and wait is no longer a thing,” said Dr. Rosa-Cunha. “Our patients trusted our program. They are the ones who made it possible.”
Tags: anal cancer, ANCHOR study, cancer screening, Dr. Isabella Rosa-Cunha, JoNell Potter, Sylvester Comprehensive Cancer Center