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

TitleAdenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine
Authors
Keywordsadenocarcinoma in situ (AIS)
human papillomavirus (HPV)
natural history
vaccine
Issue Date2011
PublisherJohn Wiley & Sons, Inc.. The Journal's web site is located at http://www3.interscience.wiley.com/journal/29331/home
Citation
International Journal Of Cancer, 2011, v. 128 n. 6, p. 1344-1353 How to Cite?
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.
Persistent Identifierhttp://hdl.handle.net/10722/142581
ISSN
2015 Impact Factor: 5.531
2015 SCImago Journal Rankings: 2.657
ISI Accession Number ID
Funding AgencyGrant Number
Merck
Sanofi Pasteur MSD
GlaxoSmithKline
Merck and Co., Inc.
Commonwealth Serum Laboratories
GSK
Sanofi Pasteur
Funding Information:

We thank all study participants and investigators. We also thank Margaret James (Merck and Co., Inc.) for statistical assistance and Karyn Davis (Merck and Co., Inc.) for publication assistance. Merck Research Laboratories, a Division of Merck & Company, Inc., funded these studies.

References

 

DC FieldValueLanguage
dc.contributor.authorAult, KAen_HK
dc.contributor.authorJoura, EAen_HK
dc.contributor.authorKjaer, SKen_HK
dc.contributor.authorIversen, OEen_HK
dc.contributor.authorWheeler, CMen_HK
dc.contributor.authorPerez, Gen_HK
dc.contributor.authorBrown, DRen_HK
dc.contributor.authorKoutsky, LAen_HK
dc.contributor.authorGarland, SMen_HK
dc.contributor.authorOlsson, SEen_HK
dc.contributor.authorTang, GWKen_HK
dc.contributor.authorFerris, DGen_HK
dc.contributor.authorPaavonen, Jen_HK
dc.contributor.authorSteben, Men_HK
dc.contributor.authorBosch, FXen_HK
dc.contributor.authorMajewski, Sen_HK
dc.contributor.authorMuñoz, Nen_HK
dc.contributor.authorSings, HLen_HK
dc.contributor.authorHarkins, Ken_HK
dc.contributor.authorRutkowski, MAen_HK
dc.contributor.authorHaupt, RMen_HK
dc.contributor.authorGarner, EIOen_HK
dc.date.accessioned2011-10-28T02:51:58Z-
dc.date.available2011-10-28T02:51:58Z-
dc.date.issued2011en_HK
dc.identifier.citationInternational Journal Of Cancer, 2011, v. 128 n. 6, p. 1344-1353en_HK
dc.identifier.issn0020-7136en_HK
dc.identifier.urihttp://hdl.handle.net/10722/142581-
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.en_HK
dc.languageengen_US
dc.publisherJohn Wiley & Sons, Inc.. The Journal's web site is located at http://www3.interscience.wiley.com/journal/29331/homeen_HK
dc.relation.ispartofInternational Journal of Canceren_HK
dc.rightsInternational Journal of Cancer. Copyright © John Wiley & Sons, Inc..-
dc.subjectadenocarcinoma in situ (AIS)en_HK
dc.subjecthuman papillomavirus (HPV)en_HK
dc.subjectnatural historyen_HK
dc.subjectvaccineen_HK
dc.subject.meshAdenocarcinoma - pathology - prevention and control - virology-
dc.subject.meshCervical Intraepithelial Neoplasia - pathology - prevention and control - virology-
dc.subject.meshPapillomaviridae - isolation and purification-
dc.subject.meshPapillomavirus Infections - pathology - prevention and control - virology-
dc.subject.meshUterine Cervical Neoplasms - pathology - prevention and control - virology-
dc.titleAdenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccineen_HK
dc.typeArticleen_HK
dc.identifier.emailTang, GWK:gwktang@hkucc.hku.hken_HK
dc.identifier.authorityTang, GWK=rp00328en_HK
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1002/ijc.25723en_HK
dc.identifier.pmid20949623-
dc.identifier.scopuseid_2-s2.0-79551497662en_HK
dc.identifier.hkuros184241en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-79551497662&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume128en_HK
dc.identifier.issue6en_HK
dc.identifier.spage1344en_HK
dc.identifier.epage1353en_HK
dc.identifier.isiWOS:000287158700010-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridAult, KA=7005241226en_HK
dc.identifier.scopusauthoridJoura, EA=7004817276en_HK
dc.identifier.scopusauthoridKjaer, SK=7004418213en_HK
dc.identifier.scopusauthoridIversen, OE=7102966661en_HK
dc.identifier.scopusauthoridWheeler, CM=7202505711en_HK
dc.identifier.scopusauthoridPerez, G=16307983600en_HK
dc.identifier.scopusauthoridBrown, DR=7407095050en_HK
dc.identifier.scopusauthoridKoutsky, LA=7006120337en_HK
dc.identifier.scopusauthoridGarland, SM=7102220459en_HK
dc.identifier.scopusauthoridOlsson, SE=7202623557en_HK
dc.identifier.scopusauthoridTang, GWK=7401633864en_HK
dc.identifier.scopusauthoridFerris, DG=17634377600en_HK
dc.identifier.scopusauthoridPaavonen, J=7102724434en_HK
dc.identifier.scopusauthoridSteben, M=6602790643en_HK
dc.identifier.scopusauthoridBosch, FX=7201833375en_HK
dc.identifier.scopusauthoridMajewski, S=7103224726en_HK
dc.identifier.scopusauthoridMuñoz, N=7102360543en_HK
dc.identifier.scopusauthoridSings, HL=8401383500en_HK
dc.identifier.scopusauthoridHarkins, K=8912446300en_HK
dc.identifier.scopusauthoridRutkowski, MA=7007098941en_HK
dc.identifier.scopusauthoridHaupt, RM=11940557600en_HK
dc.identifier.scopusauthoridGarner, EIO=7005698484en_HK
dc.identifier.citeulike8056592-

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