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Abstract
Background:
The PATER study assessed the frequency of high-risk (HR) and low-risk (LR) human papillomavirus (HPV) in HPV-induced lesions in patients with borderline cytology.
Methods:
This retrospective observational cohort study was designed to evaluate ASCUS patients detected through a local cervical cancer screening programme and referred to the Department of Gynaecology and Obstetrics at the S. Orsola-Malpighi University Hospital in Bologna, in the period between January 2000 and December 2007.
Results:
In 1047 patients aged 38.4 ± 9.6 years (range 23–65 years), 34.8% (n = 364) was positive for HR- or LR-HPV DNA. The mean age of women with HPV infection was significantly lower compared with the negative group (36.8 ± 9.4 versus 39.3 ± 9.6 years; p < 0.001). Overall, 357 (34.1%) women had cervical lesions: 279 (26.6%) had CIN1, 18 (1.7%) CIN2, and 60 (5.7%) CIN3+. HR-HPV genotype was detected in 83.3%, and 91.5% of patients with CIN2 and CIN3+ respectively. Among the 124 CIN1 HPV-positive women, 8.9% harboured LR-HPV genotypes, 80.6% HR-HPV and 10.5% a combination of HR- and LR-HPV. HPV-6 and 11 accounted for 19.4% of all HPV-positive CIN1 lesions.
Conclusion:
Our study suggest that: in ASCUS patients over 40 years there is a low risk of positivity for HPV infection; the HPV DNA testing in patients with CIN3+ and a mean age close to 40 years is highly sensitive (98.3%) and acceptably specific (75.5%); the frequency of LR-HPV (alone or in combination with HR) in ASCUS cytology is not negligible. A tetravalent-based HPV vaccination alongside the screening programme would provide considerable clinical, organizational, and economic benefits.
Transparency
Declaration of funding
The study was supported with unrestricted funding from Sanofi Pasteur MSD, Italy.
Declaration of financial/other relationships
S.C., S.V., F.S.M., A.M., M.P., E.L., A.F., E.M., M.C., D.S., M.Z. and G.P. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.
The CMRO peer reviewers have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.
Acknowledgements
The authors wish to acknowledge the support of the Organized Screening Programme Service of Bologna Health Unit which provided screening data for carrying out the assessment.
These date were previously presented as a poster at the 16th International meeting of the European Society of Gynecological Oncology (ESGO) Belgrade, Serbia, October 11–14, 2009. Costa S., Marcellusi A., Mennini FS., Venturoli S. ‘Population-based frequency Assessment of HPV infections in borderline Pap Tests in the Emilia-Romagna Region – the PATER study’.