Every year there are approximately 16,000 new cases of cervical cancer in Brazil. New screening technologies may lead to a reduction of this number by expanding the population coverage but also by improving the detection rate of precursor lesions.
Women participating in a routine CC primary screening program were invited to enroll in this study. An LBC sample is collected in SurePath medium and transported to Fundação Oncocentro where BD Totalys™ System prepares, in parallel, slides for cytology and an aliquot for the BD Onclarity™ HPV Assay. A positive high-risk HPV test and/or cytology class > ASC-US refers the patient to colcoscopic examination and biopsy, if found necessary by the clinican.
In between Dec., 2014 and Jan. 2016 12,084 women joined this study. Hr-HPV DNA prevalence was 15.2% while cytological abnormalities were verified in 8.9%. Per protocol, 2,058 were referred, but so far only 859 were evaluated by colposcopy. Two-hundred and sixteen were biopsied and 47 CIN2+ cases diagnosed, 46 Hr-HPV DNA+ (98%) and 11 cytology negative (76%). HPV testing identified two squamous carcinomas and an adenocarcinoma which was missed by cytology. 88% of the HSILs were positive for HPV. Hr-HPV DNA frequency among women ≥ 30 yo was 10% and the overall HPV16/18 prevalence was 4.2%. Among the 11 CIN3+ cases HPV 16 was found in 4 and HPV 52 in 3, while HPV 18, 31, 45 and HPV33_58 were identified in one CIN3+
Hr-HPV DNA detected a significant number of patients with premalignant lesions missed by cytology. In another fraction, cytology provided a classification that would, according to the current Brazilian algorithm, delay the CIN2+ detection due to a loop of repeating cytology in 6 mo - 1 year. Screening in Brazil is still mostly opportunistic demanding a “one-stop” final diagnosis. If HPV-DNA screening is adopted, to avoid an increase in the need for colposcopic examinations, it will be very important to add to HPV-DNA+ samples , one marker of high positive predictive value, before referral , preferably from the same primary cervical smear. In addition, the European age cut-off of 30 yo for HPV based-screening is probably not ideal in Brazil, where is not uncommon to observe young women with CIN2+.