Primary HPV testing may detect cervical neoplasms earlier and more accurately than cytology
1. In this Canadian, randomized controlled trial, the use of primary HPV testing compared with cytology resulted in a significantly lower likelihood of CIN3+ at 48 months.
2. There was also significantly fewer CIN2+ cases in women screened with HPV testing compared with women who were screened with cytology alone at baseline.
Evidence Rating: 1 (Excellent)
Study Rundown: For the past two decades, meta-analyses have suggested that HPV testing increases detection of pre-cancerous cervical lesions when compared to cytology. Despite this evidence, there have not been sufficient clinical trials that have directly tested whether HPV testing alone can increase prevention of pre-cancerous lesions compared to cytology as indicated through repeated screening. In this Canadian, randomized controlled trial, the use of primary HPV testing compared with cytology resulted in a significantly lower likelihood of CIN3+ at 48 months, with those being HPV-negative at baseline having a lower risk of being CIN3+ upon 48-month follow-up than those that were cytology-negative at baseline. In addition, CIN2+ lesions were also less likely in the HPV-testing group. Congruently, the number of women referred for colposcopy after baseline screening were increased in the HPV-testing group compared to the cytology-only group.
This study did support the claim that primary HPV testing detects cervical neoplasia earlier and more accurately than cytology. However, there were a few limitations. First, women in both groups received HPV and cytology co-testing at 48 months, therefore the exit intervention was not the same as the baseline intervention. Second, although women from this trial are participants in the population-based screening program, there is the potential for selection bias as this cohort was highly educated and primarily from 2 geographic regions in the province. These results may underestimate the effect of the trial findings by underrepresentation of under-screened women who may face the high risk of cancer.
Relevant Reading: Primary HPV testing in the US-Is it time?
In-Depth [randomized controlled trial]: Between January 2008 and December 2010, 19 009 women were randomly assigned to 1 of 3 cohorts (6204 to intervention, 6104 to control, and 6214 to safety cohort). Inclusion criteria were women in British Columbia with a personal health number, aged 25 to 65, who had not had a Papanicolaou test in the previous 12 months, were not pregnant, were not HIV+ or receiving immunosuppressive therapy, and without a history of CIN2+ in the past 5 years. In the first round of screening, significantly more CIN3+ cases were detected in the intervention (HPV tested) cohort compared with the control (cytology only) group (RR 1.61; CI95 1.09 to 2.37). By 48 months, fewer CIN3+ cases were detected overall and across all age groups in the intervention compared with the control group (RR 0.42; CI95 0.25 to 0.69). Further, there were fewer CIN2+ lesions detected in the intervention group compared to the control group (RR 0.47; CI95 0.34 to 0.67).
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