Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial – the HPV FOCAL Study

• Published in: British journal of cancer Vol. 107; no. 12; pp. 1917 - 1924
• Main Authors: Ogilvie, G S, Krajden, M, van Niekerk, D J, Martin, R E, Ehlen, T G, Ceballos, K, Smith, L W, Kan, L, Cook, D A, Peacock, S, Stuart, G C E, Franco, E L, Coldman, A J
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 04-12-2012; Nature Publishing Group
• Subjects: 631/326/596/2560; 692/699/67/1517/1371; 692/699/67/2322; Adult; Algorithms; Alphapapillomavirus - genetics; Alphapapillomavirus - isolation & purification; Biomedical and Life Sciences; Biomedicine; Canada - epidemiology; Cancer Research; Carcinoma, Squamous Cell - diagnosis; Carcinoma, Squamous Cell - virology; Cervical cancer; Cervical Intraepithelial Neoplasia - diagnosis; Cervical Intraepithelial Neoplasia - virology; Cervix; Clinical Study; Colposcopy; Cytological Techniques - methods; Data processing; DNA; DNA, Viral - isolation & purification; Drug Resistance; Early Detection of Cancer - methods; Epidemiology; Female; Human papillomavirus; Humans; Mass Screening - methods; Middle Aged; Molecular Medicine; Neoplasia; Oncology; Papillomavirus Infections - complications; Papillomavirus Infections - diagnosis; Papillomavirus Infections - epidemiology; Sexual Partners; Squamous cells; Uterine Cervical Neoplasms - diagnosis; Uterine Cervical Neoplasms - epidemiology; Uterine Cervical Neoplasms - prevention & control; Uterine Cervical Neoplasms - virology; Vaginal Smears; Canada; screening; randomised trial; cervical cancer; North America; HPV
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/bjc.2012.489

Background:
Round 1 data of human papillomavirus (HPV) FOCAL, a three-arm, randomised trial, which aims to establish the efficacy of HPV DNA testing as a primary screen for cervical cancer, are presented.
Methods:
The three arms are: Control arm – liquid based cytology with atypical squamous cells of unknown significance (ASC-US) triage with hrHPV testing; Intervention Arm – hrHPV at entry with liquid-based cytology (LBC) triage of hrHPV positives, with exit screen at 4 years; Safety check arm – hrHPV at entry with LBC triage of hrHPV positives with exit screen at 2 years.
Results:
A total of 6154 women were randomised to the control arm and 12 494 to the HPV arms (intervention and safety check). In the HPV arm, the baseline cervical intraepithelial neoplasia (CIN)2+ and CIN3+ rate was 9.2/1000 (95%CI; 7.4, 10.9) and 4.8/1000 (95%CI; 3.6, 6.1), which increased to 16.1/1000 (95%CI 13.2, 18.9) for CIN2+ and to 8.0/1000 (95%CI; 5.9, 10.0) for CIN3+ after subsequent screening of HPV-DNA-positive/cytology-negative women. Detection rate in the control arm remained unchanged after subsequent screening of ASC-US-positive/hrHPV DNA-negative women at 11.0/1000 for CIN2+ and 5.0/1000 for CIN3+.
Conclusion:
After subsequent screening of women who were either hrHPV positive/cytology negative or ASC-US positive/HPV negative, women randomised to the HPV arms had increased CIN2+ detection compared with women randomised to the cytology arm.