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Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine

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dc.creatorAult K.A.spa
dc.creatorJoura E.A.spa
dc.creatorKjaer S.K.spa
dc.creatorIversen O.-E.spa
dc.creatorWheeler C.M.spa
dc.creatorPerez, Gonzalospa
dc.creatorBrown D.R.spa
dc.creatorKoutsky L.A.spa
dc.creatorGarland S.M.spa
dc.creatorOlsson S.-E.spa
dc.creatorTang G.W.K.spa
dc.creatorFerris D.G.spa
dc.creatorPaavonen J.spa
dc.creatorSteben M.spa
dc.creatorBosch F.X.spa
dc.creatorMajewski S.spa
dc.creatorMuñoz N.spa
dc.creatorSings H.L.spa
dc.creatorHarkins K.spa
dc.creatorRutkowski M.A.spa
dc.creatorHaupt R.M.spa
dc.creatorGarner E.I.O.spa
dc.date.accessioned2020-05-26T00:11:51Z
dc.date.available2020-05-26T00:11:51Z
dc.date.created2011spa
dc.description.abstractThe primary objective of this report is to describe the detection of adenocarcinoma in situ (AIS) and associated human papillomavirus (HPV) type distribution that was observed in the context of two phase 3 clinical trials of a quadrivalent HPV6/11/16/18 vaccine. In this intention-to-treat analysis, we include all women who had at least one follow-up visit postenrollment. Healthy women (17,622) aged 15-26 with no history of HPV disease and a lifetime number of less than five sex partners (average follow-up of 3.6 years) were randomized (1:1) to receive vaccine or placebo at day 1, months 2, and 6. Women underwent colposcopy and biopsy according to a Papanicolaou triage algorithm. All tissue specimens were tested for 14 HPV types and were adjudicated by a pathology panel. During the trials, 22 women were diagnosed with AIS (six vaccine and 16 placebo). There were 25 AIS lesions in total, with HPV16/18 present in 96% (24 of 25 with 15 of 25 as single infections). Only two of 22 women had concomitant cytology results suggesting glandular abnormality. Colposcopic impressions (25 total) were either negative or indicated squamous lesions only. Of women with AIS, all six in the vaccine cohort and seven of 16 in the placebo cohort were infected at baseline with the same HPV type that was detected in the AIS lesion. Concurrent squamous lesions were detected in 20 of these 22 women. In summary, our findings show that AIS evades colposcopic and cervical cytologic detection. As most AIS lesions were HPV16/18-related, prophylactic HPV vaccination should reduce the incidence of invasive adenocarcinoma. Copyright © 2011 UICC.eng
dc.format.mimetypeapplication/pdf
dc.identifier.doihttps://doi.org/10.1002/ijc.25723
dc.identifier.issn00207136
dc.identifier.issn10970215
dc.identifier.urihttps://repository.urosario.edu.co/handle/10336/24337
dc.language.isoengspa
dc.relation.citationEndPage1353
dc.relation.citationIssueNo. 6
dc.relation.citationStartPage1344
dc.relation.citationTitleInternational Journal of Cancer
dc.relation.citationVolumeVol. 128
dc.relation.ispartofInternational Journal of Cancer, ISSN:00207136, 10970215, Vol.128, No.6 (2011); pp. 1344-1353spa
dc.relation.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-79551497662&doi=10.1002%2fijc.25723&partnerID=40&md5=cda1124ff75e102873fb86c4bd053503spa
dc.rights.accesRightsinfo:eu-repo/semantics/openAccess
dc.rights.accesoAbierto (Texto Completo)spa
dc.source.instnameinstname:Universidad del Rosariospa
dc.source.reponamereponame:Repositorio Institucional EdocURspa
dc.subject.keywordPlacebospa
dc.subject.keywordWart virus vaccinespa
dc.subject.keywordviraleng
dc.subject.keywordAdenocarcinoma in situspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordArticlespa
dc.subject.keywordCarcinoma in situspa
dc.subject.keywordColposcopyspa
dc.subject.keywordCytologyspa
dc.subject.keywordDisease associationspa
dc.subject.keywordDouble blind procedurespa
dc.subject.keywordDrug efficacyspa
dc.subject.keywordDrug safetyspa
dc.subject.keywordEthnicityspa
dc.subject.keywordFemalespa
dc.subject.keywordHumanspa
dc.subject.keywordHuman papillomavirus type 11spa
dc.subject.keywordHuman papillomavirus type 16spa
dc.subject.keywordHuman papillomavirus type 18spa
dc.subject.keywordHuman papillomavirus type 6spa
dc.subject.keywordHuman tissuespa
dc.subject.keywordMajor clinical studyspa
dc.subject.keywordMulticenter studyspa
dc.subject.keywordNonhumanspa
dc.subject.keywordPapillomavirus infectionspa
dc.subject.keywordPhase 3 clinical trialspa
dc.subject.keywordPolymerase chain reactionspa
dc.subject.keywordPriority journalspa
dc.subject.keywordRandomized controlled trialspa
dc.subject.keywordUterine cervix biopsyspa
dc.subject.keywordUterine cervix carcinoma in situspa
dc.subject.keywordAdenocarcinomaspa
dc.subject.keywordAdolescentspa
dc.subject.keywordAdultspa
dc.subject.keywordCervical intraepithelial neoplasiaspa
dc.subject.keywordColposcopyspa
dc.subject.keywordDnaeng
dc.subject.keywordDouble-blind methodspa
dc.subject.keywordFemalespa
dc.subject.keywordFollow-up studiesspa
dc.subject.keywordHumansspa
dc.subject.keywordPapillomaviridaespa
dc.subject.keywordPapillomavirus infectionsspa
dc.subject.keywordPapillomavirus vaccinesspa
dc.subject.keywordPrognosisspa
dc.subject.keywordUterine cervical neoplasmsspa
dc.subject.keywordVaginal smearsspa
dc.subject.keywordYoung adultspa
dc.subject.keywordAdenocarcinoma in situ (ais)spa
dc.subject.keywordHuman papillomavirus (hpv)spa
dc.subject.keywordNatural historyspa
dc.subject.keywordVaccinespa
dc.titleAdenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccinespa
dc.typearticleeng
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersion
dc.type.spaArtículospa
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