HPV for cervical cancer screening (HPV FOCAL): Complete Round 1 results of a randomized trial comparing HPV-based primary screening to liquid-based cytology for cervical cancer.
Complete Round 1 data (baseline and 12-month follow-up) for HPV FOCAL, a randomized trial establishing the efficacy of HPV DNA testing with cytology triage as a primary screen for cervical cancer are presented. Women were randomized to one of three arms: Control arm - Baseline liquid-based cytology (LBC) with ASCUS results triaged with HPV testing; Intervention and Safety arms - Baseline HPV with LBC triage for HPV positives. Results are presented for 15,744 women allocated to the HPV (intervention and safety combined) and 9,408 to the control arms. For all age cohorts, the CIN3+ detection rate was higher in the HPV (7.5/1,000; 95%CI: 6.2, 8.9) compared to the control arm (4.6/1,000; 95%CI: 3.4, 6.2). The CIN2+ detection rates were also significantly higher in the HPV (16.5/1,000; 95%CI: 14.6, 18.6) vs. the control arm (10.1/1,000; 95%CI: 8.3, 12.4). In women ≥35 years, the overall detection rates for CIN2+ and CIN3+ were higher in the HPV vs. the control arm (CIN2+:10.0/1,000 vs. 5.2/1,000; CIN3+: 4.2/1,000 vs. 2.2/1,000 respectively, with a statistically significant difference for CIN2+). HPV testing detected significantly more CIN2+ in women 25-29 compared to LBC (63.7/1,000; 95%CI: 51.9, 78.0 vs. 32.4/1,000; 95%CI: 22.3, 46.8). HPV testing resulted in significantly higher colposcopy referral rates for all age cohorts (HPV: 58.9/1,000; 95%CI: 55.4, 62.7 vs.


METHODS
30.9/1,000; 95%CI: 27.6, 34.6). At completion of Round 1 HPV-based cervical cancer screening in a population-based program resulted in greater CIN2+ detection of across all age cohorts compared to LBC screening.
Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.|British Columbia Centre for Disease Control, Vancouver, BC, Canada.
Gina S
GS
Ogilvie
Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.|British Columbia Centre for Disease Control, Vancouver, BC, Canada.
Mel
M
Krajden
Lower Mainland Laboratories, Vancouver, BC, Canada.|Cervical cancer screening program, British Columbia Cancer Agency, Vancouver, BC, Canada.
Dirk
D
van Niekerk
Cervical cancer screening program, British Columbia Cancer Agency, Vancouver, BC, Canada.
Laurie W
LW
Smith
British Columbia Centre for Disease Control, Vancouver, BC, Canada.|Cervical cancer screening program, British Columbia Cancer Agency, Vancouver, BC, Canada.
Darrel
D
Cook
Cervical cancer screening program, British Columbia Cancer Agency, Vancouver, BC, Canada.
Kathy
K
Ceballos
Cervical cancer screening program, British Columbia Cancer Agency, Vancouver, BC, Canada.
Marette
M
Lee
Cervical cancer screening program, British Columbia Cancer Agency, Vancouver, BC, Canada.
Laura
L
Gentile
Cervical cancer screening program, British Columbia Cancer Agency, Vancouver, BC, Canada.
Lovedeep
L
Gondara
Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Ruth
R
Elwood-Martin
Cervical cancer screening program, British Columbia Cancer Agency, Vancouver, BC, Canada.
Stuart
S
Peacock
Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Gavin
G
Stuart
Departments of Oncology and Epidemiology & Biostatistics, McGill University, Montreal, Quebec, Canada.
Eduardo L
EL
Franco
Cervical cancer screening program, British Columbia Cancer Agency, Vancouver, BC, Canada.
Andrew J
AJ
Coldman
D000328:Adult; D000368:Aged; D003127:Colposcopy / Q000379:methods; D004279:DNA, Viral / Q000235:genetics; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology*; D012017:Referral and Consultation; D012680:Sensitivity and Specificity; D014218:Triage / Q000379:methods; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology*; D014626:Vaginal Smears / Q000379:methods
D004279:DNA, Viral
HPV; cervical cancer screening; human papillomavirus; molecular-based testing