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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