Human papillomavirus testing and liquid-based cytology in primary screening of women younger than 35 years: results at recruitment for a randomised controlled trial

被引:198
作者
Ronco, Guglielmo
Giorgi-Rossi, Paolo
Carozzi, Francesca
Dalla Palma, Paolo
Del Mistro, Annarosa
De Marco, Laura
De Lillo, Margherito
Naldoni, Carlo
Pierotti, Paola
Rizzolo, Raffaella
Segnan, Nereo
Schincaglia, Patrizia
Zorzi, Manuel
Confortini, Massimo
Cuzick, Jack
机构
[1] Centre for Cancer Prevention (CPO), Turin
[2] Agency for Public Health Lazio Region, Rome
[3] Scientific Institute for Cancer Prevention of Tuscany Region (CSPO), Florence
[4] S Chiara Hospital, Trento
[5] Veneto Oncology Institute, Padua
[6] Centre for Experimental Research and Medical Studies (CERMS), University of Turin, Turin
[7] Emilia-Romagna Region, Bologna
[8] Maggiore Hospital, AUSL Bologna
[9] Centre for Cancer Prevention, AUSL Ravenna
[10] Queen Mary's School of Medicine and Dentistry and Cancer Research UK, London
关键词
D O I
10.1016/S1470-2045(06)70731-8
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background Testing for human papillomavirus (HPV) DNA is more sensitive but less specific than cytological analysis. Loss in specificity is most relevant in women younger than 35 years because of increased HPV prevalence. We aimed to compare conventional screening with an experimental strategy in women aged 25-34 years, and investigate the effect of different criteria of referral to define the best methods of HPV screening. Methods Women were randomly assigned to the conventional procedure (standard cytology, with referral to colposcopy if cytology showed atypical squamous cells of undetermined significance or more [ASCUS+]) or an experimental procedure (liquid-based cytology and testing for high-risk HPV types, with referral to colposcopy with ASCUS+ cytology). Women positive for HPV (cutoff >= 1 pg/mL) but with normal cytology were retested after 1 year. The main endpoint was the presence of cervical intraepithelial neoplasia at grade 2 or more (CIN2+) in reviewed histology. The main analysis was by intention to screen. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN81678807. Findings We randomly assigned 5808 women aged 25-34 years to the conventional group and 6002 to the experimental group. The experimental procedure was significantly more sensitive than the conventional procedure (55 vs 33 CIN2+ lesions detected; relative sensitivity 1(.)61 [95% CI 1(.)05-2(.)48]), but had a lower positive predictive value (PPV, relative PPV 0(.)55 [0(.)37-0(.)82]). HPV testing (>= 1 pg/mL) with cytology triage was also more sensitive than conventional cytology (relative sensitivity 1(.)58 [1(.)03-2(.)44], relative PPV 0(.)78 [0(.)52-1(.)16]). Relative PPV could be improved, with minimum loss in sensitivity, by use of a 2 pg/mL cutoff for HPV testing. Compared with conventional cytology, liquid-based cytology had a relative sensitivity of 1(.)32 (0(.)84-2(.)06), relative PPV 0(.)58 [0(.)38-0(.)89]). Interpretation HPV testing alone with cytology triage could be a feasible alternative to conventional cytology for screening women younger than 35 years. Follow-up will provide data on possible overdiagnosis and on the feasibility of extended intervals.
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收藏
页码:547 / 555
页数:9
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