Assessing 10-Year Safety of a Single Negative HPV Test for Cervical Cancer Screening: Evidence from FOCAL-DECADE...

Area of Science:

• Gynecology
• Oncology
• Infectious Diseases

Background:

• The long-term safety of a single negative human papillomavirus (HPV) test for cervical cancer screening requires further investigation.
• The HPV FOr cerviCAL Cancer Trial (FOCAL) compared HPV testing with cytology.
• The FOCAL-DECADE cohort followed HPV-negative women for up to 10 years after a single HPV test.

Purpose of the Study:

• To evaluate the long-term safety of a single negative HPV test in cervical cancer screening.
• To determine the cumulative incidence and risk of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) after a single negative HPV test.
• To assess the impact of age on the risk of CIN2+/CIN3+ detection.

Main Methods:

• Included 5,537 women with a single negative HPV test and at least one post-FOCAL cervical screen.
• Constructed cumulative incidence curves and analyzed cumulative risk of CIN2+/CIN3+ detection at various intervals.
• Calculated average incidence rates and compared hazard ratios across different age groups.

Main Results:

• The probability of CIN2+ detection 10 years after a single negative HPV test was less than 1%.
• Most CIN2+ lesions were detected 7 years or later post-test.
• Average incidence rates for CIN2+/CIN3+ were 0.50 and 0.18 per 1,000 person-years, respectively, with a nonsignificant trend for higher hazards in younger women.

Conclusions:

• A single negative HPV test demonstrates long-term safety and protection against precancerous cervical lesions, particularly up to 7 years post-test.
• The low 10-year risk supports extended screening intervals for average-risk populations.
• Findings support the safety of HPV testing alone at 5-year or longer intervals.