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

Garland, Suzanne M; Paavonen, Jorma; Jaisamrarn, Unnop; Naud, Paulo; Salmerón, Jorge; Chow, Song-Nan; Apter, Dan; Castellsagué, Xavier; Teixeira, Júlio C; Skinner, S Rachel; Hedrick, James; Limson, Genara; Schwarz, Tino F; Poppe, Willy; 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

doi:10.1002/ijc.30391

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

Author:

Garland, Suzanne M

Paavonen, Jorma ; Jaisamrarn, Unnop ; Naud, Paulo ; Salmerón, Jorge ; Chow, Song-Nan ; Apter, Dan ; Castellsagué, Xavier ; Teixeira, Júlio C ; Skinner, S Rachel ; Hedrick, James ; Limson, Genara ; Schwarz, Tino F ; Poppe, Willy ; 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

Keywords:

Science & Technology, Life Sciences & Biomedicine, Oncology, human papillomavirus vaccine, cervical intraepithelial neoplasia, treatment, clinical trial, OF-STUDY ANALYSIS, LONG-TERM RISK, DOUBLE-BLIND, FOLLOW-UP, QUADRIVALENT VACCINE, PARTICLE VACCINE, YOUNG-WOMEN, EFFICACY, CANCER, INFECTION, Adjuvants, Immunologic, Adolescent, Adult, Female, Human papillomavirus 16, Human papillomavirus 18, Humans, Neoplasm Grading, Neoplasm Recurrence, Local, Outcome Assessment, Health Care, Papillomavirus Infections, Papillomavirus Vaccines, Randomized Controlled Trials as Topic, Risk Factors, Vaccination, Young Adult, Uterine Cervical Dysplasia, HPV PATRICIA Study Group, 1112 Oncology and Carcinogenesis, Oncology & Carcinogenesis, 3211 Oncology and carcinogenesis

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+.