HPV Testing Versus Cytology for Cervical Cancer Screening Among Women 50 Years and Older: Evidence From the HPV FOCAL Randomized Controlled Trial
Menée à partir des données de l'essai clinique "HPV FOCAL" portant sur 6 471 femmes âgées de 50 ans, cette étude évalue l'efficacité, du point de vue du taux d'incidence de lésions CIN2+ et CIN3+ 48 mois après la première session de dépistage, d'un premier test HPV seul par rapport à une première analyse cytologique seule
Evidence on the comparative effectiveness of HPV testing versus cytology specifically in women aged ≥ 50 years who are approaching screening cessation remains limited. This analysis included 6471 women aged ≥ 50 at baseline screening in the HPV FOCAL randomized clinical trial. Women were randomly allocated to receive cytology (Control Group, n = 3248, 50.19%) or HPV testing (Intervention Group, n = 3223, 49.81%) at baseline, with co-testing at 48-month exit. We calculated incidence rates and risk ratios for CIN2+ detection over follow-up and compared missed lesions at exit by screening method. At the 48-month exit, CIN2+ detection was lower among HPV baseline-negative women than among those in the cytology group (1.61/1000 [95% CI, 0.52–3.76] vs. 3.15/1000 [95% CI, 1.51–5.78]; risk ratio, 0.51 [95% CI, 0.11–0.91]), reflecting higher baseline detection with HPV testing and fewer prevalent lesions at exit. Even with cytology re-screening at 2 years, 50% of CIN2+ cases were missed compared to 30% with HPV testing. After adjusting for age, education, smoking status, and lifetime sexual partners, the hazard ratio for CIN2+ comparing HPV to cytology was 0.44 (95% CI, 0.22–0.88). Among women aged ≥ 50 years, HPV primary screening was more effective than cytology at detecting CIN2+ lesions and was associated with a continued lower subsequent risk following a negative HPV test, supporting its use in cervical cancer screening programs in this age cohort.
International Journal of Cancer , article en libre accès, 2026