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: | F. Xavier Bosch, Dan Apter, Jorge Salmerón, Frank Struyf, Julio Cesar Teixeira, S. Rachel Skinner, Newton Sérgio de Carvalho, Dominique Descamps, Maria Julieta V Germar, Willy Poppe, Suzanne M. Garland, Paulo Naud, Grégory Catteau, Matti Lehtinen, Klaus Peters, M. Rowena Del Rosario-Raymundo, Unnop Jaisamrarn, Xavier Castellsagué, Gary Dubin, Genara Limson, James Hedrick, Jorma Paavonen, Song-Nan Chow, Tino F. Schwarz |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty Adolescent human papillomavirus vaccine cervical intraepithelial neoplasia Cervical intraepithelial neoplasia law.invention 03 medical and health sciences Young Adult 0302 clinical medicine Randomized controlled trial Adjuvants Immunologic law Risk Factors Internal medicine Outcome Assessment Health Care medicine Humans 030212 general & internal medicine Papillomavirus Vaccines Cancer Therapy and Prevention Randomized Controlled Trials as Topic Colposcopy Gynecology Human papillomavirus 16 Vaginal intraepithelial neoplasia medicine.diagnostic_test Human papillomavirus 18 treatment business.industry Papillomavirus Infections Vaccination HPV infection clinical trial medicine.disease Uterine Cervical Dysplasia female genital diseases and pregnancy complications 3. Good health Clinical trial Oncology 030220 oncology & carcinogenesis High Grade Cervical Intraepithelial Neoplasia Female Neoplasm Grading Neoplasm Recurrence Local business |
| Zdroj: | International Journal of Cancer |
| Popis: | 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+. What's new? Persistent infection with oncogenic human papillomavirus (HPV) is a pre‐requisite for cervical cancer, with women who have already undergone treatment for related cervical lesions representing a high‐risk group for the subsequent development of cervical cancer. To date, HPV vaccination is not thought to alter the course of disease in women with prevalent type‐specific infections or pre‐existing lesions at the time of vaccination. This post‐hoc analysis of a randomized controlled trial however shows that women who undergo surgery for cervical lesions after receiving the HPV‐16/18 AS04‐adjuvanted vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent high‐grade cervical disease. |
| Databáze: | OpenAIRE |
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