Study aims to develop anal cancer prevention strategies for high-risk women with HPV
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The National Cancer Institute has awarded more than $4 million to a collaboration between three research institutions to evaluate anal cancer screenings in high-risk women previously diagnosed with HPV.
The large-scale study will involve the Mount Sinai Anal Dysplasia Screening Program at the Icahn School of Medicine, the University of Texas MD Anderson Cancer Center and the University of Texas Health Science Center at Houston (UTHealth).
The Journal of the National Cancer Institute has noted that anal cancer is one of the fastest rising cancers in incidence and death rates in the United States, with the most significant increases occurring among women ages 50 years and older.
Annual rates of new cases of anal cancer among these women also have grown 5% each year over the past 20 years, added the researchers, who expect the number of new anal cancer diagnoses to overtake those of cervical cancer in older women in the next decade.
“Given there are currently no evidence-based guidelines for screening this high-risk group, our study will lay the groundwork for more effective evaluations of women who have been diagnosed with other conditions that may increase the risk for anal cancer,” investigator Keith Sigel, MD, PhD, MPH, associate professor of medicine (general medicine and infectious diseases) at Mount Sinai, said in a press release.
“We think that early detection and aggressive treatment of precancers may stop the progression to cancer, but there has been very little research on this disease process in this high-risk group of women,” Sigel continued. “With the trend in rising cases among older women, effective prevention methods are urgently needed.”
During the 5-year trial, the researchers will evaluate anal cancer screening effectiveness for women not infected with HIV who have a history of HPV-related precancers in the lower genital sites including the cervix, vagina and vulva.
Previous studies have associated evidence of HPV infection at one genital site with HPV infection in the anus and with risk for precancers in the anus. Approximately 90% of anal cancers are associated with HPV infection, the researchers said.
The researchers said their study will target the population with the largest group of anal cancers in the United States, as well as one that has been understudied, by focusing on women who do not have HIV.
“This important study builds upon our prior NCI-funded work, which focused on determining optimal anal cancer screening strategies in women and men living with HIV,” said investigator Elizabeth Yu Chiao, MD, MPH, professor of epidemiology and general oncology at MD Anderson.
“It will provide the necessary data to develop evidence-based anal cancer prevention strategies for high-risk, HIV-negative women,” Chiao said.
The study aims to screen 300 women to determine how effectively existing tests perform and to estimate the prevalence and incidence of high-risk anal precancers among this population.
Machine learning and mathematical modeling approaches will be used to determine how the findings would impact at-risk women at the population level, providing estimates of the benefits, harms, impact on quality of life and cost-effectiveness of early testing.
The Mount Sinai Health System in New York and the MD Anderson Oncology Program at Harris Health Lyndon B. Johnson Hospital in Houston will host the screenings.
Women with a history of HPV-associated cancers represent a growing number of vulnerable and understudied individuals at elevated anal cancer risk, Ashish A. Deshmukh, PhD, MPH, assistant professor of management, policy and community health at the UTHealth School of Public Health in Houston, said in the release.
“This study is the first of its kind to perform a comprehensive screening evaluation to improve survivorship and quality of life of these women and inform national cancer prevention policy,” said Deshmukh.