Human papillomavirus testing and liquid-based cytology in primary screening of women younger than 35 years: results at recruitment for a randomised controlled trial

Ronco, Guglielmo; Rossi, Paolo Giorgi; Carozzi, Francesca; Palma, Paolo Dalla; Mistro, Annarosa Del; Marco, Laura De; Lillo, Margherita De; Naldoni, Carlo; Pierotti, Paola; Rizzolo, Raffaella; Segnan, Nereo; Schincaglia, Patrizia; Zorzi, Manuel; Confortini, Massimo; Cuzick, Jack

doi:10.1016/s1470-2045(06)70731-8

Cited by 207 publications

(212 citation statements)

References 22 publications

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“…Women aged 25–60 years who were not pregnant, had never underwent hysterectomy, had not been treated for CIN in the last 5 years and who were attending for a new routine cervical screening episode were randomly assigned, between February 2002 and December 2004, to conventional cytology (classified according to the Bethesda 1991 system and managed according to the standard protocol of each centre) or to HPV‐based screening, either in combination with liquid‐based cytology (phase 1)14, 15 or alone (phase 2) 16. Details on randomization and masking have been reported previously 14, 15, 16, 17…”

Section: Methodsmentioning

confidence: 99%

Human papilloma virus genotyping for the cross‐sectional and longitudinal probability of developing cervical intraepithelial neoplasia grade 2 or more

Mistro

Adcock

Carozzi

et al. 2018

Intl Journal of Cancer

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Human papilloma virus (HPV) testing is more sensitive but less specific than cytology. We evaluated stand‐alone genotyping as a possible triage method. During a multicentre randomised controlled trial comparing HPV testing to conventional cytology, HPV‐positive women were referred to colposcopy and followed up if no high‐grade lesion was detected. HPV‐positive samples were genotyped by GP5+/GP6+ primed polymerase chain reaction followed by reverse line blot. Genotypes were hierarchically ordered by positive predictive value (PPV) for CIN grade 2 or more (CIN2+), and grouped by cluster analysis into three groups (A, B and C in decreasing order). Receiver operating characteristic curves were computed. Among 2,255 HPV‐positive women with genotyping, 239 CIN2+ (including 113 CIN3+) were detected at baseline or during a 3‐year follow‐up. HPV33 had the highest PPV with CIN2+ and CIN3+ as the endpoint and when considering lesions detected at baseline or also during follow‐up. HPV16 and HPV35 were the second and third, respectively. Cross‐sectional sensitivity for CIN2+ at baseline was 67.3% (95% CI 59.7–74.2), 91.8% (95% CI 86.6–95.5) and 94.7% (95% CI 90.2–97.6), respectively, when considering as “positive” any of the HPV types in group A (33, 16 and 35), A or B (31, 52, 18, 59 and 58) and A or B or C (39, 51, 56, 45 and 68). The corresponding cross‐sectional PPVs for CIN2+ were 15.8% 95% (CI 13.2–18.7), 12.0% (95% CI 10.3–13.9) and 9.6% (95% CI 8.2–11.1), respectively. HPV33, 16 and 35 confer a high probability of CIN2+ but this rapidly decreases when adding other genotypes.

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Section: Methodsmentioning

confidence: 99%

Human papilloma virus genotyping for the cross‐sectional and longitudinal probability of developing cervical intraepithelial neoplasia grade 2 or more

Mistro

Adcock

Carozzi

et al. 2018

Intl Journal of Cancer

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“…24 The relative DR of HPV was derived from the NTCC study results. 3,9 The main outcome of the analysis was the cost (i.e. resource consumption) per lesion detected by different screening strategies.…”

Section: Outcomes Assessmentmentioning

confidence: 99%

“…These women present quite a high risk and it is crucial to follow them in order to realize the advantages of HPV strategy. 3,9,10,14 On the other hand, it is also important that a conservative approach be taken, since the risk of over-treatment, particularly in younger women, could be very high if they received immediate colposcopy. 11 Therefore, it is important that they trust the screening recommendations without obtaining a colposcopy outside the programme.…”

Section: Screening and Health Outcomesmentioning

confidence: 99%

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

Confortini

Rossi²,

Barbarino

et al. 2010

J Med Screen

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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.

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“…However its specificity is lower, especially for younger women. [3][4][5] The high sensitivity of HPV testing suggests that it can safely be done less frequently than cytology. If so, the savings associated with longer screening intervals are likely to more than compensate for the higher test costs and the greater positivity rates per screen.…”

mentioning

confidence: 99%

Long‐term follow‐up of cervical abnormalities among women screened by HPV testing and cytology—Results from the Hammersmith study

Cuzick

Szarewski

Mesher

et al. 2008

Intl Journal of Cancer

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Several studies have shown that HPV testing is substantially more sensitive than cytology for primary cervical screening. However, less data exist concerning the duration of protection afforded by a negative HPV test compared to a normal cytological outcome. Here we report the long-term findings from the Hammersmith study in women aged 35 or more. HPV testing by Hybrid Capture II was performed on all available samples from the baseline screening visit. Passive surveillance of subsequent cytology screening results for the 2,982 women in the study was undertaken using a national registry. Histological outcomes were sought for all women with abnormal smears. The primary outcome was duration of protection against histologically confirmed CIN21 afforded by a negative HPV test compared to normal cytology. 2,516 women had at least one further smear at least 1 year after entry and 20 new cases of CIN21 were identified during a median follow-up of 6.4 years. Including disease identified at baseline, the risk of developing CIN21 at 1, 5 and 9 years after a normal cytology was 0.33%, 0.83% and 2.20% respectively whereas it was 0.19%, 0.42% and 1.88% after a negative HPV test. HPV testing offered excellent protection from CIN21 for at least 6 years after a negative test, whereas the protection from cytology began to wane after about 3 years. Substantially more CIN21 lesions were found in the followup period in those initially HPV positive compared to those HPV negative (HR 5 6.52, p 5 0.001), whereas there was little difference according to initial cytology (HR 5 1.64, p 5 0.51). ' 2008 Wiley-Liss, Inc.Key words: HPV testing; cytology; duration of protection; cervical screening High risk types of the human papillomavirus (HPV) have been shown to be the primary causal factor for invasive cervical cancer. 1,2 Several studies have clearly demonstrated that HPV testing has a much higher sensitivity for CIN than cytology. However its specificity is lower, especially for younger women. [3][4][5] The high sensitivity of HPV testing suggests that it can safely be done less frequently than cytology. If so, the savings associated with longer screening intervals are likely to more than compensate for the higher test costs and the greater positivity rates per screen. 6 Five other studies 7-11 have reported on aspects of this issue, but they have focussed on the protection provided by being doubly negative for cytology and HPV versus being cytology negative but HPV positive. Thus these studies have sought to evaluate the role of HPV testing as an adjuvant to cytology. The strengths and weaknesses of these studies are reviewed in the Discussion section. Here we investigate the duration of protection associated with a negative HPV test and compare it directly to that achieved after a negative cytology based on long-term follow-up of a study using HPV and cytology for screening which commenced in April 1994 at the Hammersmith Hospital. 12 Material and methods Patients and clinical procedures at baselineWomen from 40 general practitioner (G...

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Human papillomavirus testing and liquid-based cytology in primary screening of women younger than 35 years: results at recruitment for a randomised controlled trial

Cited by 207 publications

References 22 publications

Human papilloma virus genotyping for the cross‐sectional and longitudinal probability of developing cervical intraepithelial neoplasia grade 2 or more

Human papilloma virus genotyping for the cross‐sectional and longitudinal probability of developing cervical intraepithelial neoplasia grade 2 or more

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

Long‐term follow‐up of cervical abnormalities among women screened by HPV testing and cytology—Results from the Hammersmith study

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