Experimental Vaccine Shows Promise In Treating Precancerous Vulvar Growths, Study Says

Main Category: Women's Health / Gynecology
Also Included In: Clinical Trials / Drug Trials;  Immune System / Vaccines;  Cervical Cancer / HPV Vaccine
Article Date: 06 Nov 2009 - 5:00 PST

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An experimental vaccine to treat precancerous vulvar growths eliminated the growths in nine of 20 women participating in a small trial, according to a study published in the New England Journal of Medicine, Reuters reports. The vaccine is intended to treat vulvar growths -- known as vulvar intraepithelial neoplasia -- that are caused by the human papillomavirus and can lead to vulvar cancer. More than 75% of the growths are caused by HPV type 16. In the U.S., the growths progress into cancerous lesions in about 3,200 women each year, and roughly 800 women die of vulvar cancer annually. Topical chemotherapy, laser treatments and surgery are often unsuccessful at treating the growths. Unlike Merck's Gardasil and GlaxoSmithKline's Cervarix -- which prevent infection with certain HPV strains, including type 16 -- the experimental vaccine targets precancerous growths that have already formed.

Of the 20 study participants, nine women saw their growths disappear, including one woman who had had lesions for more than 10 years. Six women saw their lesions shrink by half after one year, and one woman died of sudden heart failure before her one-year evaluation. "All the patients with a complete response were still free of disease at 24 months of follow-up," according to the researchers, who were led by Gemma Kenter of Leiden University in the Netherlands. After three-and-one-half years, two patients developed cancer and one of the women who showed initial improvements relapsed (Emery, Reuters, 11/5).

The primary side effect of the vaccine was bumps at the site of injection, some of which remained for two years. The research team hopes to conduct a larger test of the vaccine and is working to create vaccines that are more effective and target other strains of HPV (Maugh, "Booster Shots," Los Angeles Times, 11/4). Kenter said, "We're very happy with the results. We don't think we are there yet, but this is a big step forward." The team's future research will examine how to minimize side effects and obtain a stronger effect with a lower dose of the vaccine (Reuters, 11/5). In the study, the women were injected three or four times ("Booster Shots," Los Angeles Times, 11/4).

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