Prior human papillomavirus-16/18 AS04-adjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: Post-hoc analysis from a randomized controlled trial.

Autor: Garland SM; Microbiology and Infectious Diseases Department, Royal Women's Hospital and Department of Obstetrics and Gynaecology, University of Melbourne, VIC, Australia. suzanne.garland@thewomens.org.au., Paavonen J; Department of Obstetrics and Gynaecology, University of Helsinki, Finland., Jaisamrarn U; Department of Obstetrics and Gynaecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand., Naud P; University Federal of Rio Grande do Sul, Hospital de Clínica de Porto Alegre, Brazil., Salmerón J; Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, Mexico., Chow SN; Department of Obstetrics and Gynecology, College of Medicine and the Hospital, National Taiwan University, Taipei, Taiwan., Apter D; Family Federation of Finland, Sexual Health Clinic, Helsinki, Finland to VL-Medi Research Center, Helsinki, Finland., Castellsagué X; Institut Català d'Oncologia, L'Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain., Teixeira JC; Department of Gynecology, Oncology Division-CAISM, State University of Campinas, Campinas, Brazil., Skinner SR; Vaccine Trials Group, Telethon Institute for Child Health Research, Sydney, NSW, Australia.; Sydney University Discipline of Paediatrics and Child Health, Children's Hospital at Westmead, Sydney, NSW, Australia., Hedrick J; Kentucky Pediatric and Adult Research, Bardstown, KY, USA., Limson G; Makati Medical Centre, University of the Philippines, College of Medicine, Philippine General Hospital, Makati City, Philippines., Schwarz TF; Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Academic Teaching Hospital of the University of Wuerzburg, Germany., Poppe WA; Department of Gynaecology, University Hospital KU Leuven Gasthuisberg, Leuven, Belgium., Bosch FX; Institut Català d'Oncologia, L'Hospitalet de Llobregat, IDIBELL, CIBER-ESP, Catalonia, Spain., de Carvalho NS; Department of Gynecology and Obstetrics, Federal University of Paraná, Infectious Diseases in Gynecology and Obstetrics Sector, Curitiba, Paraná, Brazil., Germar MJ; University of the Philippines College of Medicine, Philippine General Hospital, Manila, Philippines., Peters K; Facharzt für Frauenheilkunde und Geburtshilfe, Hamburg, Germany., Del Rosario-Raymundo MR; San Pablo Colleges Medical Center, San Pablo City, Laguna, Philippines., Catteau G; GSK Vaccines, Belgium., Descamps D; GSK Vaccines, Belgium., Struyf F; GSK Vaccines, Belgium., Lehtinen M; School of Public Health, University of Tampere, Finland., Dubin G; GlaxoSmithKline, King of Prussia, PA, USA.
Jazyk: angličtina
Zdroj: International journal of cancer [Int J Cancer] 2016 Dec 15; Vol. 139 (12), pp. 2812-2826. Date of Electronic Publication: 2016 Sep 09.
DOI: 10.1002/ijc.30391
Abstrakt: We evaluated the efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in preventing HPV-related disease after surgery for cervical lesions in a post-hoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15-25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPV-16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present post-hoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPV-related cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more post-surgery. Other outcomes included the incidence of HPV-related CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more post-surgery. Of the total vaccinated cohort of 18,644 women (vaccine = 9,319; control = 9,325), 454 (vaccine = 190, control = 264) underwent an excisional procedure during the trial. Efficacy 60 days or more post-surgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (-21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more post-surgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPV-16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+.
(© 2016 UICC.)
Databáze: MEDLINE
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