medwireNews: Primary screening for human papillomavirus (HPV) detects cervical neoplasia earlier and more accurately than cytology, results of the HPV FOCAL trial suggest.
The findings prospectively validate previous studies, which showed that the benefit of HPV and cytology co-testing over cytology alone was primarily due to the contribution of HPV, Gina Suzanne Ogilvie (Women’s Hospital and Health Centre, Vancouver, British Columbia, Canada) and co-authors remark.
For the HPV FOCAL trial, 19,009 women aged 25–65 years were randomly assigned to receive primary HPV testing alone (n=9552) or liquid-based cytology (LBC; n=9457) within the Canadian Cervical Cancer Screening Program.
Women with an initial negative HPV result returned at 48 months for HPV and LBC co-testing, while those with an initial negative LBC result returned at 24 months for LBC and then at 48 months for HPV and LBC co-testing if the 24-month result was also negative.
The HPV FOCAL team previously reported that, following the first round of screening, a significant 61% more cases of cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) were detected with HPV testing than with LBC.
In the current analysis, they showed that the incidence of CIN3+ was a significant 58% lower at 48 months with HPV testing than with LBC, at 2.3 versus 5.5 cases per 1000 tests.
In addition, there was a significant 53% reduction in cases of CIN2+ 48 months among those who received HPV versus LBC testing, at 5.0 versus 10.6 cases per 1000 tests.
The researchers also found that women who were HPV-negative at baseline were a significant 75% less likely to have CIN3+ and 44% less likely to have CIN2+ at 48 months compared with women who were cytology-negative at baseline.
Writing in JAMA, Ogilvie et al conclude: “Further analyses modeling the cost-effectiveness of HPV primary screening using parameters from this study will be carried out to assess the potential economic effect of moving to HPV-based screening.”
In an accompanying comment, L Stewart Massad (Washington University School of Medicine, St Louis, Missouri, USA) pointed out that organizations that develop cancer screening guidelines are currently deciding whether to recommend replacing co-testing with primary HPV testing as the optimal screening strategy.
He said: “A draft recommendation on cervical screening from the US Preventive Services Task Force recommended either cytology testing at 3-year intervals or primary HPV testing at 5-year intervals for women 30 to 65 years of age, but the final recommendation statement has not yet been released.”
Massad concluded: “Fortunately for women, both modalities are so effective for cancer screening that an adequately powered comparative effectiveness trial is likely impossible.”
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group