UK study supports extending HPV testing interval
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Recent findings suggest that with HPV tests, intervals between cervical screenings can be extended to 5 years after a negative result in women aged 25 to 49 years and even longer for women aged older than 50 years.
Previously, data from randomized controlled trials have shown that HPV testing may be able to replace Pap smear testing, Matejka Rebolj, PhD, a senior epidemiologist at Kings College London, told Healio.
“But then comes the question of, ‘We know it works in randomized controlled trials, but would it work when you actually employ it for the general public?’” Rebolj said.
Rebolj and colleagues assessed data from a pilot study of six cervical screening laboratories in England that had partially switched their primary screening method from cytology to HPV testing. They conducted the first screening round from May 2013 to December 2016. Women who tested positive for HPV were referred to colposcopy if:
- they had a borderline abnormal cytology test;
- they remained HPV positive at 12 months and had a borderline abnormal cytology test; or
- they were still HPV positive at 24 months regardless of cytology results.
Women screened with cytology were referred to colposcopy if they had high grade abnormalities or low grade or borderline abnormalities combined with a positive HPV test.
Women aged 24 to 29 years and women aged 50 to 59 years who screened negative for HPV were invited for a second round of screening in 3 and 5 years, respectively.
The researchers monitored screening follow-up and diagnoses for women aged 24 to 64 years until the end of December 2019.
First screening round
Among 1,341,584 women screened during the first round, 300,677 and 706,820 women aged 24 to 59 years were screened with HPV testing and cytology, respectively. Cervical intraepithelial neoplasia grade 3 or higher (CIN3+) was identified in 5,313 women who had HPV testing and in 8,232 women screened by cytology (17.67 vs. 11.65 per 1,000 women screened; adjusted OR = 1.55; 95% CI, 1.5-1.61). Cervical cancer was identified in 259 women who underwent HPV testing and 441 women who underwent cytological testing (0.86 vs. 0.62 per 1,000 women screened; aOR = 1.38; 95% CI, 1.18-1.61).
Between the first and second rounds of screening, 11 cancers were diagnosed in 837,960 woman-years in women who had a negative HPV test and 62 were diagnosed in 2,135,315 woman-years in women who had a negative cytological test (1.31 vs. 2.9 per 100,000 woman-years; adjusted HR = 0.44; 95% CI, 0.23-0.84).
Second screening round
In the second round of screening, CIN3+ was detected in 227 of 188,318 women who had screened negative for HPV in the first round, compared with 1,177 of 260,266 women who had previously screened negative with cytology (1.21 vs. 4.52 per 1,000 women screened; aOR = 0.26; 95% CI, 0.23-0.3).
Cervical cancer was also detected less frequently during the second round in women who had previously tested negative for HPV compared with those who had previously had negative cytological tests (0.01 vs. 0.21 per 1,000 women screened; aOR = 0.02; 95% CI, 0-0.17).
Among 12,709 women who screened positive for HPV and negative with cytology during the first round and screened negative for HPV before their second scheduled screening, 5,380 were screened in the second round. Of these, 29 had CIN3+ lesions (5.29 per 1,000 women screened) and none had cancer. The CIN3+ detection rate was higher in this group compared with women who initially had a negative HPV result (1.21 per 1,000 women screened; aOR = 3.27; 95% CI, 2.21-4.84).
Of note, CIN3+ detection was similar during the second round of screening with clinically validated mRNA and DNA HPV tests (1.32 vs. 1.14 per 1,000 women screened; aOR = 1.05; 95% CI, 0.73-1.5).
“The clinical implications are ... if you [do] not determine that a woman is infected with the virus, that means that her risk in the subsequent 3 to 5 years is really low, and that the relatively frequent screening that was necessary with smear tests might not be necessary anymore with HPV tests,” Rebolj said. “That takes some of the burden off of women because they don’t need to be screened as often.”
Moving forward, Rebolj suggested that more research needs to be done to “optimize” screening intervals for women with prior HPV infection and women who are vaccinated against the virus.
Perspective
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This study is another example of the evolving science in the field of cervical cancer screening demonstrating the effectiveness of primary HPV screening. Multitudes of studies have continued to show the role persistent HPV infections play in the development of cervical pre-cancers as well as cancers, and that these cervical pre-cancers can be detected earlier with highly sensitive HPV tests. This in turn reduces cervical cancer incidence. As of 2020, the American Cancer Society recommends primary HPV screening as the preferred screening strategy over co-testing and cytology alone.
It is encouraging to see that extended screening intervals for all women of screening age after a negative HPV test continue to be demonstrated to be safe. The data show that clinicians should feel confident that the recommended 5-year screening interval with primary HPV testing predicts the presence of cervical pre-cancers better than cytology-based screening at a 3-year screening interval. The findings from this study further support the shift toward primary HPV screening as the preferred strategy, setting the stage for the introduction of self-collected samples pending FDA approval.
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