Detection rates of precancerous and cancerous cervical lesions within one screening round of primary human papillomavirus DNA testing: prospective randomised trial in Finland

Abstract

Objective To compare the detection rates of precancerous and cancerous cervical lesions by human papillomavirus (HPV) DNA testing and by conventional cytology screening.Design Prospective randomised trial. Two cohorts were followed over one screening round of five years, screened initially by primary HPV DNA testing or by primary Pap test.Setting Population based programme for cervical cancer screening in Finland.Participants Women aged 25-65 years invited for screening in 2003-07 (101 678 in HPV arm; 101 747 in conventional cytology arm).Intervention Women were randomly allocated (1:1) to primary HPV DNA screening followed by cytology triage if they had positive results, or to primary cytology screening. Screening method was disclosed at the screening visit. Trial personnel involved were aware of all test results. Main outcome measuresCumulative detection rates of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), and invasive cervical cancer before the second screening (after five years) or before 31 December 2008. Lesions detected at screening and during the five year interval were included.Results 1010 and 701 precancerous or cancerous lesions were detected during an average follow-up of 3.6 years in the HPV and cytology arms, respectively. Among invited women, the hazard ratio was 1.53 (95% confidence interval l.28 to 1.84) for CIN grade 1, 1.54 (1.33 to 1.78) for CIN 2, 1.32 (1.09 to 1.59) for CIN 3 or AIS, and 0.81 (0.48 to 1.37) for cervical cancer. In 25-34 year old participants, the cumulative hazard (or cumulative detection rate) was 0.0057 (0.0045 to 0.0072) for HPV screening versus 0.0046 (0.0035 to 0.0059) for conventional screening; corresponding data for women aged 35 years and older were 0.0022 (0.0019 to 0.0026) and 0.0017 (0.0014 to 0.0021), respectively.Conclusions Primary HPV DNA screening detects more cervical lesions than primary cytology within one screening round of five years. Even if the detection rate of CIN 3 or AIS increased in the HPV arm in both age groups, the absolute difference in cumulative rates in women aged 35 years or older was small. By carefully selecting age groups and screening intervals, HPV screening could increase the overall detection rate of cervical precancerous lesions only slightly. However, these findings should be interpreted in the context of the high level of opportunistic screening that occurs in Finland.Trial registration International Standard Randomised Controlled Trial ISRCTN23885553.

Divergent coverage, frequency and costs of organised and opportunistic Pap testing in Finland

“…Women are referred for colposcopy if they had Papanicolaou classes III to V or squamous intraepithelial lesions of low to more severe grades and they were invited to a repeat test after 12-24 months if they had ASC-US or Papanicolaou class II. 20 Follow-up Pap tests are taken by different health care providers but colposcopy with biopsies is performed in secondary health care. For women with abnormal Pap test result in organised screening in the Helsinki metropolitan region 2004-8, the follow-up episodes were divided into 3-month periods.…”

The clinical performance of computer‐assisted liquid‐based cytology, primary hrHPV screening, and cotesting at a Turkish Tertiary Care Hospital

“…14, [16][17][18] In 2012, Cox et al 16 conducted a study to compare 9 cervical cancer screening strategies for the detection of high-grade cervical disease.…”

Use of Fast Transfer Analysis Cartridges for Cervical Sampling and Real Time PCR Based High Risk HPV Testing in Cervical Cancer Prevention - a Feasibility Study from South India

“…Several recent studies show strengthened evidence supporting high risk human papillomavirus (HR HPV) testing as primary testing very substantially. (Gyllensten et al, 2012;Leinonen et al, 2012;Malila et al, 2012;Oglivie et al, 2012;RijKaart et al, 2012;Ronco et al, 2014).…”