The combined treatment showed effectiveness in a substantial proportion of patients with AEH and EC. Close follow-up during and after treatment is crucial.

A causal link between human papillomavirus (HPV) infection and cervical cancer has been well established (2,12,14,23). A large number of HPV genotypes have been identified, and the mucosal HPV strains are divided into "high-risk" (HR) and "low-risk" (LR) categories on the basis of their association with cervical lesions. The HR types are more frequently found in premalignant or malignant lesions, LR types are found in benign lesions such as condylomata acuminata (18). Infection by HR HPV types has been demonstrated in almost 100% of cervical carcinoma (29), and it has been recently shown that persistent infection with the same genotype strongly increases the risk of developing high-grade preinvasive disease (11).The detection of HR HPV in cervical samples has been proposed to improve the efficacy of cervical carcinoma screening programs and to triage women with ambiguous or borderline cervical smears (1). Women with persistent HR HPV positivity have a clearly enhanced risk of developing a premalignant lesion and, hence, may be more closely monitored (3,15). Moreover, HR HPV testing may be associated with Pap smear to monitor women who have been treated for high-grade cervical intraepithelial neoplasia (CIN) (16,30). Several studies have revealed that HPV testing yields a high negative predictive value, approaching 100%, for high-grade CIN lesions and cervical carcinomas (lesions Ն CIN3) (21,22,31).Testing for HPV relies on the detection of viral DNA. The only test currently approved by the U.S. Food and Drug Administration for the detection of HPV DNA is the Hybrid Capture 2 (HC2) system (Digene Corporation, Gaithersburg, Md.). The HC2 assay is a ready-to-use test for routine diagnostics and uses a liquid hybridization format followed by signal amplification to detect 13 HR HPV types (i.e., genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) by means of an RNA cocktail probe; the test does not distinguish individual HPV types. The sensitivity is approximately 4,700 viral copies/ml of cervical sample suspension. The evaluation of its laboratory performance has shown that HC2 is a reliable and reproducible test (4,6,8); both characteristics are fundamental for a test with potential widespread use. Different laboratories have also used many PCR-based methods. PCR methods are considered the "gold standard" for analytical sensitivity to detect infectious organisms, including HPV. However, PCRs for HPV detection are currently performed as "home brew" methods, lack standardization, show different sensitivity and specificity, are time-consuming, and require a demanding job for the laboratory. In the last years, some studies have compared the performance of HC2 and PCR, showing a good level of agreement between the two methods (19, 28).

Background:We performed a multicentre randomised controlled trial to evaluate the effect on participation in organised screening programmes of a self-sampling device mailed home or picked up at a pharmacy compared with the standard recall letter.Methods:Women aged 30–64 non-responding to screening invitation were eligible. Response rate to first invitation ranged from 30% to 60% between centres. The control was the standard reminder letter to undergo the test used by the programme (Pap test in three centres and HPV DNA test in three other centres). Home mailing of the self-sampler was preceded by a letter with a leaflet about HPV. The analysis was intention-to-treat.Results:In all, 14 041 women were randomised and recruited: 5012 in the control arm, 4516 to receive the self-sampler at home, and 4513 to pick up the self-sampler at a pharmacy. Participation was 11.9% in the control, 21.6% (relative participation: 1.75; 95% CI 1.60–1.93) in home, and 12.0% (relative participation: 0.96; 95% CI 0.86–1.07) in the pharmacy arms, respectively. The heterogeneity between centres was high (excess heterogeneity of that expected due to chance, i.e., I2, 94.9% and 94.1% for home and pharmacy arm, respectively). The estimated impact on the overall coverage was +4.3% for home mail self-sampling compared with +2.2% for standard reminder.Conclusions:Home mailing of self-sampler proved to be an effective way to increase participation in screening programmes, even in those with HPV as primary testing. Picking up at pharmacies showed effects varying from centre to centre.

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