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

Autor: Laura A. Koutsky, Elmar A. Joura, Grace W.K. Tang, Daron G. Ferris, Gonzalo Perez, Susanne K. Kjaer, Cosette M. Wheeler, Elizabeth I.O. Garner, Jorma Paavonen, Nubia Muñoz, Mary Anne Rutkowski, F. Xavier Bosch, Darron R. Brown, Sven Eric Olsson, Heather L. Sings, Slawomir Majewski, Richard M. Haupt, Suzanne M. Garland, Ole Erik Iversen, Kathy Harkins, Kevin A. Ault, Marc Steben
Rok vydání: 2011
Předmět:
Papillomavirus vaccines
Cancer Research
Uterine Cervical Neoplasms
Human papillomavirus type 18
Human papillomavirus type 6
Human papillomavirus (hpv)
0302 clinical medicine
Human Papillomavirus Recombinant Vaccine Quadrivalent
Types 6
11
16
18
Phase 3 clinical trial
Human papillomavirus type 16
Uterine cervix carcinoma in situ
Ethnicity
Human papillomavirus type 11
Papillomaviridae
Drug safety
Priority journal
Colposcopy
0303 health sciences
medicine.diagnostic_test
biology
Double blind procedure
Prognosis
Multicenter study
Polymerase chain reaction
3. Good health
Oncology
Randomized controlled trial
030220 oncology & carcinogenesis
Adenocarcinoma
Female
Adenocarcinoma in situ
Human
viral
Papanicolaou Test
Adult
medicine.medical_specialty
Uterine cervical neoplasms
Uterine cervix biopsy
Double-blind method
Adolescent
Adenocarcinoma in situ (ais)
Natural history
Papanicolaou stain
Context (language use)
Major clinical study
Follow-up studies
Papillomavirus infection
Cervical intraepithelial neoplasia
Carcinoma in situ
Article
Papillomavirus infections
Young Adult
03 medical and health sciences
Disease association
Double-Blind Method
Internal medicine
medicine
Humans
Papillomavirus Vaccines
Human tissue
Placebo
030304 developmental biology
Vaginal Smears
business.industry
Papillomavirus Infections
Dna
Nonhuman
Uterine Cervical Dysplasia
medicine.disease
biology.organism_classification
Surgery
Clinical trial
Drug efficacy
Young adult
DNA
Viral
Vaginal smears
Cytology
business
Wart virus vaccine
Vaccine
Follow-Up Studies
Zdroj: Repositorio EdocUR-U. Rosario
Universidad del Rosario
instacron:Universidad del Rosario
ISSN: 0020-7136
DOI: 10.1002/ijc.25723
Popis: The 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.
Databáze: OpenAIRE
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