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
Journal
International journal of cancer
Journal Volume
139
Journal Issue
12
Pages
2812
Date Issued
2016-12-15
Author(s)
Garland, Suzanne M
Paavonen, Jorma
Jaisamrarn, Unnop
Naud, Paulo
Salmerón, Jorge
Apter, Dan
Castellsagué, Xavier
Teixeira, Júlio C
Skinner, S Rachel
Hedrick, James
Limson, Genara
Schwarz, Tino F
Poppe, Willy A J
Bosch, F Xavier
de Carvalho, Newton S
Germar, Maria Julieta V
Peters, Klaus
Del Rosario-Raymundo, M Rowena
Catteau, Grégory
Descamps, Dominique
Struyf, Frank
Lehtinen, Matti
Dubin, Gary
Abstract
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+.
Subjects
cervical intraepithelial neoplasia; clinical trial; human papillomavirus vaccine; treatment
Publisher
WILEY
Type
journal article