Cervical cancer screening by high risk HPV testing in routine practice: results at one year recall of high risk HPV-positive and cytology-negative women

Abstract

Objective: Cervical cancer screening by human papillomavirus (HPV) testing requires the use of additional triage and follow-up analyses. We evaluated women's compliance with and the performance of this strategy in a routine setting. Setting: Five cervical service screening programmes in North-East Italy. Methods: Eligible women aged 25-64 invited for a new screening episode underwent HPV testing for high risk types (hrHPV by Hybrid Capture 2) and cytology triage. Women with positive HPV and cytology results were referred for colposcopy; women with positive HPV but negative cytology results were referred to 1-year repeat hrHPV testing. Results: Of 46,694 women screened by HPV testing up to December 2011, 3,211 (6.9%) tested hrHPV positive; 45% of these had a positive triage cytology. Those with negative cytology were invited for 1-yr repeat testing. Compliance with invitation was 61.6% at baseline and 85.3% at 1-yr repeat. Rate of persistent hrHPV positivity was 58% (830/1,435). Colposcopy performed in women with a positive hrHPV test at 1-yr repeat accounted for 36% of all colposcopies performed within the screening programmes. Cumulatively, a histological high-grade lesion was detected in 276 women (5.9% detection rate), 234 at baseline (85%), and 42 (15%) at 1-yr repeat. Conclusions: Compliance with hrHPV-based screening programmes was high both at baseline and at 1-yr repeat. Compared with the randomized trials, a higher proportion of triage cytology was read as positive, and only a small number of high-grade lesions were detected among the group of hrHPV positive cytology negative women who repeated testing 1-yr after baseline.

Cervical cancer screening with HPV testing in the Valcamonica (Italy) screening programme

“…The main difference we noted in comparison with trials results was the detection rate in women HPV-positive cytologypositive at baseline, which was substantially higher in our study than in cytology-based screening, despite the fact that no cytology-negative women were referred to colposcopy. This finding is consistent with what has been observed in other studies 15,16 that applied a real cytological triage. The cytology in most of the trials was interpreted blind to the HPV results, 5,6,[23][24][25][26] while in reality in an HPV-based screening programme, HPV positivity informs cytology.…”

“…5,27,28,29 It was consistent, however, with the 40-50% observed in other Italian pilot studies. 16,17 The finding is anomalous because persistence is higher in younger women, while the opposite was observed in all previous studies. 27 It is possible that the increase was only relevant for the first colposcopies, while colposcopies generated by the follow up after negative colposcopy and after treatment are reduced because of the introduction of HPV in the management protocols.…”

“…21,22 It is worth noting that compliance to colposcopy in those with persistent HPV after one year was substantially lower than that in women positive to cytological triage. This finding has been already observed, 16,17 and should be analysed to understand the reasons (eg. did women perceive their situation as low risk because the screening recommended waiting one year?…”

“…The protocol will also form part of the upcoming European recommendations, 12 and is similar to the other protocols adopted in Europe. 13,14 The Italian pilot studies, sponsored by the Italian Ministry of Health, implemented HPV-based screening to test organizational impact, acceptability by women and operators, performance of cytology triage, impact on midwives, laboratory, cytology, and gynaecology workload, and costs, [15][16][17] including budget impact and cost-effectiveness. 17 The aim of this study was to evaluate the performance of an HPV test-based strategy in a well consolidated screening programme in Northern Italy (the Valcamonica-Sebino Local Health Authority), relative to a complete round of screening, and to the first year of the second screening round.…”

Efficacy of self-sampling in promoting participation to cervical cancer screening also in subsequent round

“…Up to the end of April 2016, after excluding those who migrated or exited the screening target age, 2300 women were re-invited (776 B 1; 746 B2; 778 B3) for the subsequent screening round with a standard invitation letter to perform a screening test at the clinic. One of the two centres (Este) has been using hrHPV testing since April 2009 (Zorzi et al, 2013, Del Mistro et al, 2014), while for the other centre (Pieve di Soligo) in the first round the standard test was cytology, and since June 2015 the programme adopted hrHPV testing according to Italian recommendations (Ronco et al, 2012); therefore, the control arm in the second round mostly had a different test than in the first round.…”