Screening for Cervical Cancer with the Human Papillomavirus Test in an Area of Central Italy with No Previous Active Cytological Screening Programme

Abstract

Objective We report performance indicators and costs of the first round of a cervical cancer screening programme based on the human papillomavirus (HPV)-DNA test. Methods We implemented a demonstration study using HPV as the primary test in Guidonia, Italy (90,000 inhabitants). All women aged 25 -64 were invited to undergo a Hybrid Capture II highrisk HPV test. Two cervical samplings, smear and liquid, were taken. The smear was dyed and interpreted only for HPV-positive (HPVþ) women. Women with a non-negative Pap smear were referred for colposcopy, women HPVþ/cytology negative were referred to one-year follow-up with HPV. A cost-analysis indicated the price at which the HPV-based and cytological screening would cost the same per screened woman and per lesion found. Results Of 24,000 women invited, 7639 accepted and 427 (5.6%) were HPVþ; 141 (34%) of these had a non-negative Pap test, and 20 cervical intraepithelial neoplasia (CIN) 2 or higher were found ( positive predictive value 15%). Compliance to one-year follow-up was 58% (166/286); 90 (54%) were HPV-positive and five additional lesions were found ( positive predictive value 9%; overall detection rate 3.4/1000). The cost analysis showed that at a price of 8.3 euros per HPV-DNA test, the strategy using HPV as primary test followed by cytological triage would cost the same per screened woman, while at a price of 12.7 euros it would have the same cost per CIN2þ found. Conclusion The workload for management of positive women was similar to cytological screening. Low compliance to one-year follow-up was the main barrier to effectiveness. The price of HPV test should be about 9 euros to maintain the same screening budget, and can go as high as 13 euros per lesion found.

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

“…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?…”

“…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.…”

“…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.…”

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

“…However, results on primary HPV testing in cervical cancer screening outside a research context are still scarce. 4,15,16 The contribution to the overall CIN2þ detection rate of the recall of the group of HPVþ/cyto-women was substantial (15.2%), confirming the importance of this step of the protocol. It is, however, lower than expected.…”

“…Many feasibility projects are being performed in Italy within organized service programmes, in order to better define the performance of HPV testing in the routine setting, outside of a research context. [15][16] A critical aspect of an HPV-based screening programme with a cytological triage for HPVþ cases is represented by the group of HPVþ/cytology negative (cyto-) women; these women are informed of the positive HPV result and are asked to wait 12 months without any further ascertainment, after which time they are invited to repeat the test. What has not been shown is whether these women will comply with the screening algorithm, or seek reassurance by seeking other exams in the interval, outside the screening programme, nor how the repetition of the HPV test will work in routine service screening programmes.…”