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
AuthorGarland, SM; Paavonen, J; Jaisamrarn, U; Naud, P; Salmeron, J; Chow, S-N; Apter, D; Castellsague, X; Teixeira, JC; Skinner, SR; ...
Source TitleInternational Journal of Cancer
University of Melbourne Author/sWark, Suzanne
AffiliationObstetrics and Gynaecology
Document TypeJournal Article
CitationsGarland, S. M., Paavonen, J., Jaisamrarn, U., Naud, P., Salmeron, J., Chow, S. -N., Apter, D., Castellsague, X., Teixeira, J. C., Skinner, S. R., Hedrick, J., Limson, G., Schwarz, T. F., Poppe, W. A. J., Xavier Bosch, F., de Carvalho, N. S., Germar, M. J. V., Peters, K., Rowena Del Rosario-Raymundo, M. ,... Dubin, G. (2016). 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. INTERNATIONAL JOURNAL OF CANCER, 139 (12), pp.2812-2826. https://doi.org/10.1002/ijc.30391.
Access StatusOpen Access
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+.
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