title: Estimation of the overall burden of cancers, precancerous lesions, and genital warts attributable to 9-valent HPV vaccine types in women and men in Europe.
abstract: BACKGROUND
  In addition to cervical cancer, human papillomavirus (HPV) is responsible for a significant proportion of cancers and precancerous lesions of the vulva, vagina, anus, penis, head and neck, as well as genital warts. We estimated the annual number of new cases of these diseases attributable to 9-valent HPV vaccine types in women and men in Europe.
  
  
  METHODS
  The annual number of new cancers of the cervix, vulva, vagina, anus, penis, and selected head and neck sites in the population of the European Medicines Agency territory was estimated based on age-specific incidence rates extracted from Cancer Incidence in 5 Continents, Volume X and Eurostat population data for 2015. The annual number of new cancers attributable to 9-valent HPV vaccine types was estimated by applying the HPV attributable fraction from reference publications based on a large European multicenter study. For non-cervical cancers, HPV attributable fractions were based on oncogenically-active HPV infections only (i.e., detection of HPV DNA and either mRNA and/or p16 positivity). For precancerous lesions of the cervix, vulva, vagina, and anus, and for genital warts, previously published estimations were updated for the 2015 population.
  
  
  RESULTS
  The annual number of new cancers attributable to 9-valent HPV vaccine types was estimated at 47,992 (95% bound: 39,785-58,511). Cervical cancer showed the highest burden (31,130 cases), followed by head and neck cancer (6,786 cases), anal cancer (6,137 cases), vulvar cancer (1,466 cases), vaginal cancer (1,360 cases), and penile cancer (1,113 cases). About 81% were estimated to occur in women and 19% in men. The annual number of new precancerous lesions (CIN2+, VIN2/3, VaIN2/3, and AIN2/3) and genital warts attributable to 9-valent HPV vaccine types was estimated at 232,103 to 442,347 and 680,344 to 844,391, respectively.
  
  
  CONCLUSIONS
  The burden of cancers associated with 9-valent HPV vaccine types in Europe is substantial in both sexes. Head and neck cancers constitute a heavy burden, particularly in men. Overall, about 90% of HPV-related cancers, 80% of precancerous lesions, and 90% of genital warts are expected to be attributable to 9-valent HPV vaccine types each year, demonstrating the important preventive potential of the 9-valent HPV vaccine in Europe.
authors.affiliation: Department of Epidemiology, Sanofi Pasteur MSD, 162 avenue Jean Jaurès, Lyon, France.
authors.forename: Susanne
authors.identifier: 0000-0002-7879-0052
authors.initials: S
authors.lastname: Hartwig
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Tenon Hospital - Assistance Publique-Hopitaux de Paris (AP-HP) and Sorbonne University-Paris 6, Pierre-et-Marie Curie University Cancerology Institute, 4 rue de la Chine, 75020 Paris, France.
authors.forename: Jean Lacau
authors.initials: JL
authors.lastname: St Guily
authors.affiliation: Department of Epidemiology, Sanofi Pasteur MSD, 162 avenue Jean Jaurès, Lyon, France.
authors.forename: Géraldine
authors.initials: G
authors.lastname: Dominiak-Felden
authors.affiliation: Cancer Epidemiology Research Program, Institut Català d'Oncologia (ICO)-IDIBELL, L'Hospitalet de Llobregat, Catalonia Spain.
authors.forename: Laia
authors.initials: L
authors.lastname: Alemany
authors.affiliation: Cancer Epidemiology Research Program, Institut Català d'Oncologia (ICO)-IDIBELL, L'Hospitalet de Llobregat, Catalonia Spain.|CIBER Epidemiologia y Salud Pública, Barcelona, Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: de Sanjosé
keywords: Burden of disease; Cancer; Genital warts; Head and neck; Human papillomavirus; Precancerous lesions