The new Anal Cancer/HSIL Outcomes Research Study (ANCHOR) is about to open enrollment at UCSF and other cities. The rates of anal cancer are increasing in general, and are about 150 times greater among HIV positive gay men and 26 times higher in HIV positive women. The rates are also higher in people who have had organ transplants and are on steroid therapies for conditions like lupus, arthritis, and Crohn’s disease.
The purpose of the ANCHOR study is to determine if it is possible to prevent anal cancer by screening and treating lesions that might progress to cancer. These are called high-grade lesions or, officially, HSIL. The acronym stands for high-grade squamous intraepithelial lesion.
For the study, 17,000 people will be screened with Pap smears (in the “tush” it’s called a cytology test) and examined for HSIL. Among these individuals, the study organizers estimate that at least 30% will have the lesions. Ultimately, 5,058 HIV positive individuals will be enrolled across 15 sites in the United States. Participants will be randomized to treatment or screening alone for 5 years. The study hypothesizes that the treated group will have fewer anal cancers develop compared to the untreated group.
At first glance, the study seems shocking. How could this be ethical? Screening to prevent cervical cancer in women began in the 1950s without any proof whatsoever that Pap smears would help prevent cancer—it did—but that is not today’s health care environment. We’ve been stuck in a catch-22 situation.
We know that the precursor lesion HSIL exists. We know its treatment prevents cervical cancer, but health care systems want proof that this is also true for anal cancer. Providers, health care officials and insurers have been skeptical that the measures advocated for anal cancer prevention work, are medically necessary, and are demanding evidence. This study is designed to provide this evidence and to establish the standards of care to prevent anal cancer.
Twenty-three years ago, an innovative study got underway at UCSF to find out if the anus, like the cervix, had a cancer precursor lesion. The study determined that this health issue was a bigger problem for HIV positive versus HIV negative gay men. It has been decades since we established that the problem exists. Now it is time to do something about it. And here we are: ANCHORS away! Would you like to volunteer, or do you have additional questions? If so, please call 844-448-2888.
Dr. Naomi Jay is a nurse practitioner in the department of Infectious Disease at UCSF.
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