cervical cytology vs hpv testing

26 de janeiro de 2021, às 3:11

Human papillomavirus vaccine coverage among female Australian adolescents: success of the school-based approach. Louvanto Long-term protective effect of high-risk human papillomavirus testing in population-based cervical screening. This evaluation has supported Australia's decision to transition to primary HPV screening, which will take place on May 1, 2017. In the intervention group, cumulative incidence was higher earlier in the trial at 18 and 42 months compared with the control group. HPV vaccine impact in Australian women: ready for an HPV-based screening program.  I, The primary outcome was the cumulative incidence of CIN3+ 48 months following randomization. Design, Setting, and Participants  The primary endpoint was the cumulative incidence of CIN grade 3 or worse (CIN3+) 48 months after randomisation, and the cumulative incidence of CIN grade 2 or worse (CIN2+) at 48 months was a secondary outcome. Therefore, the exit intervention was not the same as the baseline intervention. American Society of Clinical Oncology. Cumulative disease incidence was plotted using 1 minus Kaplan-Meier estimates of disease-free probability. Other secondary end points not included in this analysis are histologically confirmed CIN2+detected at 2 years in both the control and safety groups; clearance of HPV infection in women who were baseline HPV positive measured at 24 and 48 months; detection of histologically confirmed CIN3+ in HPV-positive women who received 12-month retesting measured at 24 months in the safety group; and total estimated cost per woman screened and total estimated cost per quality-adjusted life-year gained for each technology measured at 48 months. If a participant had an event (histopathology-confirmed CIN2+), the time to incidence was calculated as the difference between the date of disease detection and the randomization date. Dr Krajden also reported receiving grants from Siemens.  et al; International HPV screening working group. At 12 months, if women were either HPV or LBC positive (≥atypical squamous cells of undetermined significance [ASCUS]), they were referred for colposcopy.  J, Castle Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Finally, we looked at whether an HPV test was offered specifically as an exit test at the end of the recommended screening age (exit HPV test), in which case a more aggressive management for this last test was assumed, in that all HPV-positive women would be referred to colposcopy (and HPV-negative women were assumed to be discharged from screening). Detailed trial methods and results have been previously described.11-14 As outlined in Figure 1, round 1 refers to the baseline screen and any 12-month follow-up results in both the intervention and control groups. The primary outcome was the cumulative incidence of CIN3+ 48 months following randomization. Ogilvie  LW, First, to provide a complete census of events at 48 months, women in both groups received HPV and cytology co-testing. Consensus in US cervical cancer screening guidelines currently state that Pap plus human papillomavirus (HPV) testing for women aged 30 to 65 years is recommended; cytology alone is recommended for women aged 21 to 29. Funding for the adjunct studies was not applied to the operation of the main HPV FOCAL trial results presented here. J-BL, KTS, MAS, MH, XMX, MC, and KC contributed to model design and/or construction. After the switch from current screening practice to the renewed National Cervical Screening Program, there will be a transitional period (three or more screening cycles) during which fluctuations in resource utilisation will occur because of the transition to the longer screening interval. Second, we aim to present the updated evaluation of outcomes and cost-effectiveness of the selected screening approach recommended by MSAC in 2014, after incorporating new clinical management guidelines based on HPV screening with partial genotyping. In contrast, by adding HPV testing to the control group, HPV testing detected 25 CIN2+ lesions that would not have been detected by cytology alone. As previously reported,14 in the first round of screening, significantly more CIN2+ cases were detected in the intervention group (HPV tested) compared with the control group. Drafting of the manuscript: Ogilvie, van Niekerk, Krajden, Smith, Gondara. Colposcopy procedures were standardized for all participants.  JM, Jacobs The baseline colposcopy referral rate reflects what happens when HPV-based screening is first implemented, when both prevalent and incident infections will be detected. Walboomers Interventions  The known: In December 2017, the National Cervical Screening Program shifted from cytology‐based screening to primary human papillomavirus (HPV)‐based screening. Evidence from randomised controlled trials. For loss to follow-up, demographics of women who were lost to follow-up were compared between the study groups and no significant differences were found. Groups are artificially divided at 48 months to show the incidence in the same participants if they were to be tested using liquid-based cytology alone. The absolute difference in the incidence rate for CIN2+ was −5.60/1000 (95% CI, −8.21 to −3.13).  M, Birembaut LBC slides were prepared using the ThinPrep 2000 (Hologic) processor and smears were screened manually by program cytotechnologists. The CIN3+ incidence rate was 2.3/1000 (95% CI, 1.5-3.5) in the intervention group and 5.5/1000 (95% CI, 4.2-7.2) in the control group. Between January 2008, and December 31, 2010, 19 009 women were randomly assigned (1:1) to cervical HPV testing (n=9552) or liquid based cytology testing (n=9457). The CIN2+ risk ratio for the intervention compared with the control group was 0.36 (95% CI, 0.24-0.54). Primary HPV testing was followed by reflex LBC in women with positive HPV test results, and they received the same management as the intervention group. It was assumed that at least 80% of those randomized would be eligible and return for screening at 48 months. Multiple imputation was based on logistic regression with the total number of imputations set to 25. Results  Sociodemographic and Lifestyle Characteristics of the Intervention and Control Participants, Table 2.  P, Carozzi The Cervical Cancer Screening Program has 1 centralized registry that includes the cytology, histopathology, and treatment history for every woman ever screened in British Columbia. BACKGROUND: Using primary human papillomavirus (HPV) testing for cervical screening increases detection of high-grade cervical intraepithelial neoplastic lesions and invasive cancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) compared to cytology, but no evaluation has been conducted in a population previously offered HPV vaccination.  M, Wheeler © 2017 The Author(s). Dr Quinlan reported receiving personal fees from Merck, Cook Myosite, and Allergan.  GS, Krajden Both evaluations considered both unvaccinated and vaccinated cohorts. There is limited information about the relative effectiveness of cervical cancer screening with primary human papillomavirus (HPV) testing alone compared with cytology in North American populations. At 48 months, significantly fewer CIN3+ and CIN2+ were detected in the intervention vs control group. Castle Randomization occurred at the central laboratory. In August, 2014, the Australian Health Ministers' Advisory Council endorsed the recommendation and, in March, 2015, they approved the draft policy for the renewal of the National Cervical Screening Program. Among 19 009 women who were randomized (mean age, 45 years [10th-90th percentile, 30-59]), 16 374 (8296 [86.9%] in the intervention group and 8078 [85.4%] in the control group) completed the study. KC receives salary support from NHMRC Australia (Career Development Fellowship APP1082989). J-BL, KTS, and MAS analysed or extracted data to inform model parameters. We found that the renewed Australian National Cervical Screening Program will reduce cervical cancer incidence and mortality and is cost-saving when compared with the current programme. J-BL, KTS, MAS, and KC designed the study. In Australia, the emergent evidence on HPV screening in conjunction with the introduction of HPV vaccination, and the comparatively longer screening intervals and narrower age range for screening recommended by the International Agency for Research on Cancer (IARC), As an initial evaluation of screening options, the Australian Government's Medical Services Advisory Committee (MSAC) commissioned a systematic review of the international evidence. The cumulative incidence of CIN2+ was a secondary outcome. It was assumed that this rate would be applicable to the control group and the alternate hypothesis assumed that the rate in the intervention group would be 0.5 times this rate (ie, 4.0 per 1000). Quiz Ref IDOne of the concerns for adopting HPV-based screening is the lower CIN2+ specificity of HPV testing compared with cytology, leading to higher screen positive rates and the resulting need for more colposcopies and biopsies. HSIL=high-grade squamous intraepithelial lesion as predicted by cytology. Huh Cost-effectiveness analysis on primary screening including clinical follow-up. Co-testing led to lower cumulative incidences of cervical cancer and CIN grade 3 or … Medical Services Advisory Committee recommendations. Creative Commons Attribution – NonCommercial – NoDerivs (CC BY-NC-ND 4.0), https://doi.org/10.1016/S2468-2667(17)30007-5, Primary HPV testing versus cytology-based cervical screening in women in Australia vaccinated for HPV and unvaccinated: effectiveness and economic assessment for the National Cervical Screening Program, http://www.hpvregister.org.au/research/coverage-data/HPV-Vaccination-Coverage-by-Dose-20132, http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/MSAC-recommendations, http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/E6A211A6FFC29E2CCA257CED007FB678/$File/Renewal%20Economic%20Evaluation.pdf, http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1276-public, View Large These results have demonstrated that primary HPV testing detects cervical neoplasia earlier and more accurately than cytology.  G, Giorgi-Rossi This trial has several strengths. The World Health Organization (WHO) guideline for cervical cancer screening recommends HPV testing for cervical cancer screening … In one study, more than 1 in 3 women who had CIN 2 or 3 and/or carcinoma would have been missed without the Pap cytology. The Department of Health (Australia) funded Cancer Council Australia to develop the renewed clinical management guidelines for prevention of cervical cancer; Cancer Council NSW (J-BL, KTS, MAS, MH, Y-JK, XMX, MC, LSV, and KC) was subcontracted to perform some of this work as part of the technical team, and some modelling work undertaken for this contract is included in the submitted paper. We then did additional analyses for all screening strategies to ascertain the effect of retaining an end-age of 69 years and of extending HPV testing intervals from every 5 years to every 6 years. A cost-effectiveness analysis. Dillner This Mayrand Trial exit samples were received and processed through December 2016.  N,  PE, Schiffman At 48-month exit, both groups received HPV and LBC co-testing. KC oversaw all aspects of study design and conduct. Administration of the quadrivalent vaccine (Gardasil; CSL, Parkville, VIC, Australia) commenced in April, 2007, and entailed a catch-up programme for adolescent girls and young women aged 12–26 years until the end of 2009. All intervention and control group women who did not have a CIN2+ lesion detected during the trial or otherwise became ineligible (eg, hysterectomy, moved out of province) were invited for the 48-month exit screening. The Renewal Steering Committee established preliminary clinical management algorithms for each screening approach. The objective of this study was an evaluation of the Xpert HPV Assay in a screening population using residual cervical cytology PreservCyt specimens originally obtained from women aged 20–60 years. Abnormal cytology test results were referred to a cytopathologist for final interpretation and reporting. Obtained funding: Ogilvie, van Niekerk, Krajden, Martin, Peacock, Stuart, Franco, Coldman.  M, To have an unbiased verification of the extent of disease left undiagnosed at trial exit, this trial included HPV and cytology co-testing for all participants at the 48-month screen.25,26 As a result, with ongoing future monitoring of trial participants, it is anticipated some of the cervical cancer detected in the cytology group follow-up of other trials will be reduced in this trial, due to the fact that cytology-tested participants had added HPV testing at exit, permitting detection of lesions missed earlier in the trial.  et al; New Technologies for Cervical Cancer screening (NTCC) Working Group. Exit screening for both the intervention and control groups occurred 48 months after baseline screening and consisted of HPV testing and LBC (exit co-testing). To complement the major evaluation reported here, and to provide practical information at the health services level, we previously modelled the transition in more detail to estimate the effect on volumes of women screened and resource utilisation during the initial screening rounds.  et al. Ms Smith reported receiving personal fees from Roche Molecular Systems outside the submitted work. We considered several variations for each approach. Garland Replacing the Pap Test With Screening Based on Human Papillomavirus Assays, Clarification for Reported Colposcopy Rates, Intervention and Control Group Exit Screening. Among baseline HPV or LBC-negative women, rates of CIN2+ at 48 months were significantly higher across all age groups in the control group compared with the intervention group (Table 2). By the end of trial follow-up (72 months), incidence was similar across both groups.  M, van Niekerk Cumulative CIN2+ incidence curves show no significantly different disease detection across trial groups (Figure 2B). All alternative strategies initially entailed an evaluation of screening in women aged 25–64 years, as specified in the Decision Analytic Protocol, taking into account evidence that screening in women younger than 25 years does not substantially reduce cervical cancer rates in women younger than 30 years. Human papillomavirus (HPV) DNA testing prevents more invasive cervical cancer than cytology screening alone, and should be used as the primary screening test.  SL, Havrilesky A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: extended follow up in the ARTISTIC trial. There were no significant differences between the 2 groups with respect to the distributions of sociodemographic and lifestyle characteristics. In this trial, by 48 months, among women screened for cervical cancer with HPV testing without cytology, there were significantly fewer CIN3+ and CIN2+ cases compared with women who were screened with cytology alone at baseline.  F, (A) An unvaccinated cohort, all except current practice ending screening at age 64 years. Disease detection and colposcopy referral rates at 48 months included all referrals and disease detected after round 1 screening in both groups and are reported throughout as rate per 1000. If both HPV and LBC negative at 12 months, they were recommended for exit screen at 48 months. For imputation, enrollment screen results were dichotomized to be either negative (HPV or cytology negative) or positive (HPV or cytology positive [≥ASCUS]). Trial randomization was conducted at the laboratory on receipt of the enrollment specimen. In our initial evaluation, we found that primary HPV testing strategies are more effective than cytology-based screening. Published by Elsevier Ltd. These design factors reduced bias and limited variation in clinical procedures within trial groups.14. Dr Franco reported receiving grants, personal fees, and/or nonfinancial support from Merck, GlaxoSmithKline, and Roche outside the submitted work. Transitioning from cytology-based screening to HPV-based screening intervals: implications for resource use. The CIN3+ incidence rate was 2.3/1000 (95% CI, 1.5-3.5) in the intervention group and 5.5/1000 (95% CI, 4.2-7.2) in the control group. (C) An unvaccinated cohort, ending screening at age 69 years. Women in the control group received liquid-based cytology (LBC) testing; those whose results were negative returned at 24 months for LBC. In total, 25 223 women were enrolled (9457 to the control, 6214 to the safety, and 9552 to the intervention groups). 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