Montefiore Einstein Cancer Center was a key contributor to new research that shows the incidence of anal cancer can be significantly reduced by treating precursor lesions. The findings were published June 16 in the New England Journal of Medicine (NEJM) article, “Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer.” The phase 3 clinical trial, known as the Anal Cancer/HSIL Outcomes Research (ANCHOR) study, funded by the National Cancer Institute, produced such dramatic results that the study was halted early.
The ANCHOR study evaluated treatment outcomes in people with human immunodeficiency virus (HIV). Those living with HIV are at substantially greater risk of anal cancer than the general population. The study demonstrates, for the first time, a new standard of care for the prevention of anal cancer in people with HIV. The results suggest secondary anal cancer prevention could be similarly possible in other groups at high risk.
Rebecca A. Levine, MD, Colorectal Surgeon, Surgical Oncologist, Department of Surgery and Assistant Professor of Surgery, Montefiore Einstein, was the ANCHOR study site principal investigator. Renee Huang, MD, Colon and Rectal Surgery, Department of Surgery, and Assistant Professor, Montefiore Einstein served as co-investigator.
The study was conducted across 25 U.S. sites and evaluated nearly 4,500 people living with HIV who were 35 years of age or older. All had biopsy-proven anal HSIL. They were randomly assigned to receive either HSIL treatment or active monitoring without treatment. Montefiore Einstein enrolled more than 300 patients, one of the highest recruitment rates among the 25 research sites. The research is especially important to the Bronx because the community has the largest density of HIV-positive people in the country.
Participants in the treatment group were treated until HSIL was completely resolved. Prior to the study, there was no evidence that treatment of lesions would reduce the incidences of anal cancer. During the study, at least every six months, all patients underwent high-resolution anoscopy, a diagnostic procedure that requires special training and is regularly performed at Montefiore Einstein. Biopsies were performed annually in the active-monitoring group and whenever researchers suspected ongoing HSIL in the treatment group. Biopsies also were performed for anyone in either group who was suspected of having anal cancer.
When the study was halted, those patients who had been in the treatment group were 57% less likely to have developed anal cancer than those in the active-monitoring group. The study has transitioned to the next phase of continued treatment and follow-up care for two years. All patients in the active-monitoring group were offered the opportunity to have their lesions treated.