Clinical Trial: First Evidence that Anal Cancer is Preventable

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As described in the paper, the vaccine proved effective at reducing anal infections with HPV and precancerous lesions known as high-grade anal intraepithelial neoplasia, which are anal cancer precursors. The trial showed that the vaccine reduced the incidence of these cancer precursors by nearly 75 percent among those who had not been previously exposed to any of the HPV types in the vaccine. Among those who were previously exposed to one or more of the types in the vaccine, the vaccine reduced the incidence of the precancerous lesions by 54 percent.

"Based on these data, the vaccine works well to prevent HPV infection and precancerous anal disease, and will likely prevent anal cancer in men," said Palefsky. “The ideal time to begin vaccination would be before initiation of sexual activity, but vaccination may also be useful after initiation of sexual activity.”

An earlier study led by Palefsky’s coauthor Anna Guiliano at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, FL showed that the HPV vaccine effectively protects both heterosexual men and men who have sex with men against external genital warts. The new study adds to the body of evidence supporting routine HPV vaccination of young males, said Palefsky.

This week, a group known as the Advisory Committee on Immunization Practices (ACIP), which is convened by the Department of Health and Human Services and the Centers for Disease Control and Prevention, met in Washington, D.C. to consider how it recommends HPV vaccine for men.

On Tuesday, the ACIP group voted to change their policy on the vaccine, which they previously "recommended," which means that it was approved and available to people if they want it. Individuals could order it, but it would have been up to insurance companies if they wanted to reimburse for the vaccine or not.

After weighing the clinical evidence, including the data presented in the New England Journal of Medicine paper this week, ACIP voted to make HPV vaccinations "routine" for boys up to the age of 21 years. This means the vaccine will be placed on routine schedule of vaccines and insurance companies will be obligated to cover it.

The study was funded by Merck and Co.

The article, "HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia" by Joel M. Palefsky, Anna R. Giuliano, Stephen Goldstone, Edson D. Moreira, Jr., Carlos Aranda, Heiko Jessen, Richard Hillman, Daron Ferris, Francois Coutlee, Mark H. Stoler, J. Brooke Marshall, David Radley, Scott Vuocolo, Richard M. Haupt, Dalya Guris, and Elizabeth I.O. Garner appears in the October 27, 2011 issue of the New England Journal of Medicine.

In addition to UCSF, authors on the study are affiliated with the H. Lee Moffitt Cancer Center and Research Institute in Tampa, FL; Mount Sinai School of Medicine in New York; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; the University Medical Center, National Public Health Institute, Morelos, Mexico; J2: Private Clinic for Infectious Diseases, Berlin Germany; the University of Sydney in Australia; the Medical College of Georgia in Augusta, Georgia; the Centre de Recherche du Centre Hospitalier de l’Université de Montréal, in Montreal, Canada; the University of Virginia in Charlottesville, VA; and Merck, located in North Wales, PA.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.

UCSF Anal Cancer Information site: http://id.medicine.ucsf.edu/analcancerinfo/

Source: University of California, San Francisco (UCSF)

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