ASCO: Cervical Cancer Vaccine Also Protective for Vaginal and Vulvar Lesions
10/21/2007 Atlanta, GA By Peggy Peck, Managing Editor, MedPage Today MedPageToday.com Gardasil (quadrivalent human papillomavirus [Types 6, 11, 16, 18]) appears to be 100% effective against HPV-related vaginal and vulvar lesions, researchers reported here. This vaccine has won endorsement by an FDA advisory committee for cervical cancer and was expected to win agency approval for that indication this week. Meanwhile, at the American Society of Clinical Oncology meeting here, Jorma Paavonen, M.D., of the University of Helsinki in Finland, said HPV is present in about 80% of vaginal and vulvar cancers. In a pre-specified modified intention-to-treat combined analysis of data from the three randomized, placebo-controlled Gardasil clinical trials, there were 24 cases of vulvar or vaginal intraepithelial neoplasia in the placebo arm and no cases in the active treatment arm after an average of two years of follow-up, he said. "These findings support the prophylactic efficacy of Gardasil in preventing HPV-16 and HPV-18-related vulvar and vaginal cancer," Dr. Paavonen said at an ASCO press briefing here. Dr. Paavonen said the data he reported here were made available to the FDA, "but have not been previously reported or published." The analysis included data from 8,641 women ages 16 to 26 who received three doses of the vaccine and 8,667 women who received three placebo injections. The women were recruited from the U.S. as well as South America, Europe and Asia. Dr. Paavonen said that the health ministry in Finland is planning to include the HPV vaccine as a standard childhood immunization [...]