© The Author 2006. Published by Oxford University Press.
ARTICLE |
Human Papillomavirus Testing and Liquid-Based Cytology: Results at Recruitment From the New Technologies for Cervical Cancer Randomized Controlled Trial
For the New Technologies for Cervical Cancer Working Group
Affiliations of authors: Unit of Cancer Epidemiology, Centro per la Prevenzione Oncologica, Turin, Italy (GR, NS); Agency for Public Health, Lazio Region, Rome, Italy (PGR); Centro per lo Studio e la Prevenzione Oncologica, Florence, Italy (MZ, FC, MC); Unit of Pathology, Ospedale Maggiore, AUSL Bologna, Italy (GPC); Unit of Pathology, Ospedale di Trento, Trento, Italy (PDP); Service of Immunology and Cancer Molecular Diagnostics, Azienda Ospedaliera di Padova, Padua, Italy (ADM); Unit of Pathology, Presidio Ospedaliero, AUSL Imola, Imola, Italy (SF); Unit of Cancer Epidemiology and CPO, CERMS, University of Turin, Turin, Italy (AGT); Preventive Gyneacological Oncology, Ospedale Civile Maggiore di Verona, Verona, Italy (GN); Centro di riferimento screening—Assessorato alla Sanità—Regione Emilia-Romagna, Bologna, Italy (CN); Centro Prevenzione Oncologica, AUSL Ravenna, Ravenna, Italy (PS); Venetian Tumour Registry, Azienda Ospedaliera di Padova, Padua, Italy (MZ); Queen Mary's School of Medicine and Dentistry and Cancer Research UK, London, U.K. (JC)
Correspondence to: Guglielmo Ronco, MD, PhD, Unit of Cancer Epidemiology, Centro per la Prevenzione Oncologica Piemonte, via San Francesco da Paola 31, 10123 Torino, Italy (e-mail: guglielmo.ronco{at}cpo.it).
Background: Although testing for human papillomavirus (HPV) has higher sensitivity and lower specificity than cytology alone for detecting cervical intraepithelial neoplasia (CIN), studies comparing conventional and liquid-based cytology have had conflicting results. Methods: In the first phase of a two-phase multicenter randomized controlled trial, women aged 35–60 years in the conventional arm (n = 16 658) were screened using conventional cytology, and women in the experimental arm (n = 16 706) had liquid-based cytology and were tested for high-risk HPV types using the Hybrid Capture 2 assay. Women in the conventional arm were referred to colposcopy with atypical cells of undetermined significance (ASCUS) or higher and those in the experimental arm were referred with ASCUS or higher cytology or with a positive (
1 pg/mL) HPV test. Sensitivity and positive predictive value (PPV) for detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) were calculated. Results: The screening methods and referral criterion applied in the experimental arm had higher sensitivity than that in the conventional arm (relative sensitivity = 1.47; 95% confidence interval [CI] = 1.03 to 2.09) but a lower PPV (relative PPV = 0.40; 95% CI = 0.23 to 0.66). With HPV testing alone at 1 pg/mL and at 2 pg/mL, the gain in sensitivity compared with the conventional arm remained similar (relative sensitivity = 1.43, 95% CI = 1.00 to 2.04 and relative sensitivity = 1.41, 95% CI = 0.98 to 2.01, respectively) but PPV progressively improved (relative PPV = 0.58, 95% CI = 0.33 to 0.98 and relative PPV = 0.75, 95% CI = 0.45 and 1.27, respectively). Referral based on liquid-based cytology alone did not increase sensitivity compared with conventional cytology (relative sensitivity = 1.06; 95% CI = 0.72 to 1.55) but reduced PPV (relative PPV = 0.57; 95% CI = 0.39 to 0.82). Conclusions: HPV testing alone was more sensitive than conventional cytology among women 35–60 years old. Adding liquid-based cytology improved sensitivity only marginally but increased false-positives. HPV testing using Hybrid Capture 2 with a 2 pg/mL cutoff may be more appropriate than a 1 pg/mL cutoff for primary cervical cancer screening.
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