Clinically validated HPV assays offer comparable long-term safety in primary cervical cancer screening : a 9-year follow-up of a population-based screening cohort

Oštrbenk Valenčak, Anja (avtor), Kroon, Kelsi R. (avtor), Fabjan, Danijela (avtor), Mlakar, Jana (avtor), Seme, Katja (avtor), Berkhof, Johannes (avtor), Poljak, Mario (avtor)

Molecular testing for human papillomaviruses (HPV) is gradually replacing cytology in cervical cancer screening. In this longitudinal population-based cohort study, 4140 women 20 to 64 years old attending organized screening were tested at baseline by five different screening methods and followed for 9 years. To assess long-term safety, the cumulative risks of CIN2+/CIN3+ were estimated after a negative baseline result obtained by conventional cytology and four clinically validated HPV assays: Hybrid Capture 2 (hc2), RealTime High Risk HPV assay (RealTime), cobas 4800 HPV Test (cobas_4800), and Alinity m HR HPV (Alinity). HPV-negative women at baseline had a substantially lower risk for CIN2+ compared to those with normal baseline cytology: 0.84% (95% CI, 0.46–1.22), 0.90% (95% CI, 0.51–1.29), 0.78% (95% CI, 0.42–1.15), and 0.75% (95% CI, 0.39–1.11) for hc2, RealTime, cobas_4800, and Alinity, respectively, compared to 2.46% (95% CI, 1.88–3.03) for cytology. No differences were observed between HPV assays in longitudinal sensitivity (range: 86.21%–90.36%) and negative predictive values (range: 99.54%–99.70%) for CIN2+ in women ≥30 years, but were significantly different from cytology (p < .05). The 9-year cumulative risk of CIN2+ differed significantly between HPV genotypes, reaching 32.1% (95% CI, 14.5–46.1) for HPV16, 24.9% (95% CI, 4.7–40.8) for HPV18/45, 27.2% (95% CI, 14.6–37.8) for HPV31/33/35/52/58, and 8.1% (95% CI, 0.0–16.7) for HPV39/51/56/59. Four clinically validated HPV assays showed comparable safety and better assurance against precancerous lesions than cytology, but some important differences were identified in the performance characteristics of HPV assays impacting the referral rate. Information about the HPV genotype is valuable for guiding further clinical action in HPV-based screening programs.

• Jezik: Angleški jezik
• Ključne besede: HPV testing, cervical cancer, cervical screening, cytology
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: MF - Medicinska fakulteta
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2025
• Št. strani: Str. 788-801
• Številčenje: Vol. 156, iss. 4
• PID: 20.500.12556/RUL-166442
• UDK: 618.1-006
• ISSN pri članku: 0020-7136
• DOI: 10.1002/ijc.35200
• COBISS.SI-ID: 221889795
• Datum objave v RUL: 13.01.2025

Gradivo je del revije

• Naslov: International journal of cancer
• Skrajšan naslov: Int. j. cancer
• Založnik: Wiley, Union for International Cancer Control
• ISSN: 0020-7136
• COBISS.SI-ID: 25638656

Licence

• Licenca: CC BY-NC-ND 4.0, Creative Commons Priznanje avtorstva-Nekomercialno-Brez predelav 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by-nc-nd/4.0/deed.sl
• Opis: Najbolj omejujoča licenca Creative Commons. Uporabniki lahko prenesejo in delijo delo v nekomercialne namene in ga ne smejo uporabiti za nobene druge namene.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: testiranje na HPV, rak materničnega vratu, pregled materničnega vratu, citologija

Projekti

• Financer: ARRS - Agencija za raziskovalno dejavnost Republike Slovenije
• Številka projekta: P3-0083
• Naslov: Odnosi parazitskega obstajanja

• Financer: EC - European Commission
• Program financ.: H2020
• Številka projekta: 847845
• Naslov: Risk-based screening for cervical cancer
• Akronim: RISCC