Treating precursor lesions was found to significantly reduce the risk of progression to anal cancer, with the study finding highlighted in the New England Journal of Medicine
ROCKVILLE, MD., June 16, 2022 /PRNewswire/ — Emmes, a full-service global clinical research organization (CRO) dedicated to advancing public health and biopharmaceutical innovation, announced today that a team of its researchers has completed a successful study of AIDS Malignancy Consortium (AMC) contributed. The results of the study, which showed that treating and removing precursor lesions to anal cancer reduced the risk of cancer in HIV-infected men and women, were published in New England Journal of Medicine. Phase 3 study results included 4,446 participants at 21 clinical sites in the US and Puerto Rico.
The study enrolled people 35 years of age and older with HIV who had at least one precursor lesion to anal cancer, known as high-grade squamous intraepithelial lesions (HSIL). Participants were randomized into two groups: those who received treatment for the lesion(s) and those who were actively monitored but not receiving treatment. Participants were reassessed every three to six months. Rates of progression to anal cancer were compared between the two groups. The results showed that treating HSIL in people living with HIV resulted in a nearly 60 percent reduction in the progression of anal cancer.
Emmes’ role was to coordinate the research, which included protocol development, electronic data collection, site monitoring and regulatory compliance, and general study management for the research team.
The National Cancer Institute Office of HIV and AIDS Malignancy sponsored the current study through the AMC, which was led by Joel PalafskyMD, the University of California, San Francisco (UCSF).
Don VenaVice President and Head of Emmes’ Oncology Therapeutic Research Unit, said: “Dr. Palefsky facilitated collaboration between various stakeholders – government, industry, laboratories, clinical sites and our team – to build the research infrastructure needed to conduct a landmark study in the evolving field of anal cancer prevention. Emmes is proud to have made a contribution and proud of our 18-year relationship with the AMC.”
dr Palefsky, who founded the world’s first anal cancer prevention clinic at USCF in 1991, reported that data from the ANal Cancer/HSIL Outcomes Research (ANCHOR) study show for the first time that anal cancer occurs in high-risk groups, such as people living with HIV. He shared that the findings are likely relevant to other groups at high risk of anal cancer, such as HIV.
He presented the study highlights February 15 at the Conference on Retroviruses and Opportunistic Infections, a prestigious HIV/AIDS research event that draws scientists and infectious disease professionals from around the world. He found that in-office electrocautery not only resulted in a reduction in the incidence of anal cancer, but that the treatment was well tolerated.
according to dr Palefsky, “Anal cancer is the fourth most common type of cancer in people living with HIV. Primary prevention of this disease, long-term for those with little or no history of sexual activity, can be done through the use of human papillomavirus (HPV) vaccine. Unfortunately, many people have already been exposed to HPV, are past the vaccination age, or do not have access to it of vaccination. For these individuals, the ANCHOR study shows for the first time that secondary prevention of anal cancer is possible through treatment of anal HSIL. We expect that the results of the ANCHOR study will lead to screening and treatment of anal HSIL in people living with HIV being established as a standard of care.”
dr Palefsky added, “Emmes’ team played a key role in the success of the study through their careful monitoring and execution of the many components of such a complex study.”
DR Christine DingivanEmmes Chief Executive Officer, commented, “We are very pleased that the ANCHOR study demonstrated that HSIL treatment is effective in reducing the risk of anal cancer and will ultimately have a profound impact on patients’ quality of life. This project reflects how our client tenure and close collaboration can make a huge public health difference – for people living with HIV or at highest risk of anal cancer and for others in the future.”
About the research
This project was funded with federal funding from the Office of HIV and AIDS Malignancy of the National Cancer Institute under grant no. Funded #UM1CA121947.
Founded in 1977, Emmes is a full-service global CRO dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The Company’s customers include numerous federal agencies and agencies, as well as a wide range of biotechnology, pharmaceutical and medical device companies around the world. To learn more about how our research positively impacts human health, visit the Emmes website at www.emmes.com.