HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial - 11/08/11
, Maribel Almonte, PhD c, Claire Thomson, BSc a, Paula Wheeler, MRes a, Alexandra Sargent, PhD a, Boyka Stoykova, MD d, Clare Gilham, MSc e, f, Helene Baysson, PhD e, Christopher Roberts, PhD b, Robin Dowie, PhD d, Mina Desai, MBchB g, Jean Mather, MIBMS g, Andrew Bailey, FIBMS h, Andrew Turner, MB ChB h, Sue Moss, PhD f, Julian Peto, ProfDSc e, fSummary |
Background |
Testing for human papillomavirus (HPV) DNA is reportedly more sensitive than cytology for the detection of high-grade cervical intraepithelial neoplasia (CIN). The effectiveness of HPV testing in primary cervical screening was assessed in the ARTISTIC trial, which was done over two screening rounds approximately 3 years apart (2001–03 and 2004–07) by comparing liquid-based cytology (LBC) combined with HPV testing against LBC alone.
Methods |
Women aged 20–64 years who were undergoing routine screening as part of the English National Health Service Cervical Screening Programme in Greater Manchester were randomly assigned (between July, 2001, and September, 2003) in a ratio of 3:1 to either combined LBC and HPV testing in which the results were revealed and acted on, or to combined LBC and HPV testing where the HPV result was concealed from the patient and investigator. The primary outcome was the detection rate of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) in the second screening round, analysed by intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number ISRCTN25417821.
Findings |
There were 24
510 eligible women at entry (18386 in the revealed group, 6124 in the concealed group). In the first round of screening 233 women (1·27%) in the revealed group had CIN3+, compared with 80 (1·31%) women in the concealed group (odds ratio [OR] 0·97, 95% CI 0·75–1·25; p>0·2). There was an unexpectedly large drop in the proportion of women with CIN3+ between the first and second rounds of screening in both groups, at 0·25% (29 of 11676) in the revealed group and 0·47% (18 of 3866 women) in the concealed group (OR 0·53, 95% CI 0·30–0·96; p=0·042). For both rounds combined, the proportion of women with CIN3+ were 1·51% (revealed) and 1·77% (concealed) (OR 0·85, 95% CI 0·67–1·08; p>0·2).
Interpretation |
LBC combined with HPV testing resulted in a significantly lower detection rate of CIN3+ in the second round of screening compared with LBC screening alone, but the effect was small. Over the two screening rounds combined, co-testing did not detect a higher rate of CIN3+ or CIN2+ than LBC alone. Potential changes in screening methodology should be assessed over at least two screening rounds.
Funding |
National Institute of Health Research Health Technology Assessment Programme.
Le texte complet de cet article est disponible en PDF.Plan
Vol 10 - N° 7
P. 672-682 - juillet 2009 Retour au numéro
Article précédent
- Predicting outcomes for children with neuroblastoma using a multigene-expression signature: a retrospective SIOPEN/COG/GPOH study
- Joëlle Vermeulen, Katleen De Preter, Arlene Naranjo, Liesbeth Vercruysse, Nadine Van Roy, Jan Hellemans, Katrien Swerts, Sophie Bravo, Paola Scaruffi, Gian Paolo Tonini, Bruno De Bernardi, Rosa Noguera, Marta Piqueras, Adela Cañete, Victoria Castel, Isabelle Janoueix-Lerosey, Olivier Delattre, Gudrun Schleiermacher, Jean Michon, Valérie Combaret, Matthias Fischer, André Oberthuer, Peter F Ambros, Klaus Beiske, Jean Bénard, Bárbara Marques, Hervé Rubie, Janice Kohler, Ulrike Pötschger, Ruth Ladenstein, Michael D Hogarty, Patrick McGrady, Wendy B London, Geneviève Laureys, Frank Speleman, Jo Vandesompele
- Resection of the embryologically defined uterovaginal (Müllerian) compartment and pelvic control in patients with cervical cancer: a prospective analysis
- Michael Höckel, Lars-Christian Horn, Norma Manthey, Ulf-Dietrich Braumann, Ulrich Wolf, Gero Teichmann, Katrin Frauenschläger, Nadja Dornhöfer, Jens Einenkel
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?