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Cancer Epidemiology, Biomarkers & Prevention
Cancer Epidemiology, Biomarkers & Prevention
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Assessing 10-Year Safety of a Single Negative HPV Test for Cervical Cancer Screening: Evidence from FOCAL-DECADE Cohort

Anna Gottschlich, Dirk van Niekerk, Laurie W. Smith, Lovedeep Gondara, Joy Melnikow, Darrel A. Cook, Marette Lee, Gavin Stuart, Ruth E. Martin, Stuart Peacock, Eduardo L. Franco, Andrew Coldman, Mel Krajden and Gina Ogilvie
Anna Gottschlich
1Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada.
2Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
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  • ORCID record for Anna Gottschlich
  • For correspondence: anna.gottschlich@cw.bc.ca
Dirk van Niekerk
3Lower Mainland Laboratories, Vancouver, British Columbia, Canada.
4Cervical Cancer Screening Program, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
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Laurie W. Smith
1Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada.
4Cervical Cancer Screening Program, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
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Lovedeep Gondara
4Cervical Cancer Screening Program, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
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Joy Melnikow
5Center for Healthcare Policy and Research, University of California Davis, Sacramento, California.
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Darrel A. Cook
4Cervical Cancer Screening Program, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
6British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada.
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Marette Lee
4Cervical Cancer Screening Program, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
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  • ORCID record for Marette Lee
Gavin Stuart
2Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
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Ruth E. Martin
2Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
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Stuart Peacock
7Cancer Control Research, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
8Canadian Centre for Applied Research in Cancer Control (ARCC), Vancouver, British Columbia, Canada.
9Faculty of Health Sciences, Simon Fraser University, Vancouver, British Columbia, Canada.
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Eduardo L. Franco
10Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.
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Andrew Coldman
4Cervical Cancer Screening Program, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.
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Mel Krajden
2Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
6British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada.
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Gina Ogilvie
1Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada.
2Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
6British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada.
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DOI: 10.1158/1055-9965.EPI-20-1177 Published January 2021
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Abstract

Background: Long-term safety of a single negative human papillomavirus (HPV) test for cervical cancer screening is unclear. The HPV FOr cerviCAL Cancer Trial (FOCAL) was a randomized trial comparing HPV testing with cytology. The FOCAL-DECADE cohort tracked women who received one HPV test during FOCAL, and were HPV negative, for up to 10 years to identify cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) detected through a provincial screening program.

Methods: FOCAL participants who received one HPV test, were negative, and had at least one post-FOCAL cervix screen were included (N = 5,537). We constructed cumulative incidence curves of CIN2+/CIN3+ detection, analyzed cumulative risk of detection at intervals post-HPV test, calculated average incidence rates for detection, and compared hazard across ages.

Results: Ten years after one negative HPV test, the probability of CIN2+ detection was lower than 1%, with most lesions detected 7 years or later. Average incidence rates of CIN2+/CIN3+ lesions over follow-up were 0.50 [95% confidence interval (CI), 0.31–0.78] and 0.18 (95% CI, 0.07–0.36) per 1,000 person-years, respectively. Hazards were higher for younger ages (nonsignificant trend).

Conclusions: Among women with a single negative HPV test, long-term risk of CIN2+ detection was low, particularly through 7 years of follow-up; thus, one negative HPV test appears to confer long-term protection from precancerous lesions. Even 10-year risk is sufficiently low to support extended testing intervals in average-risk populations.

Impact: Our findings support the safety of screening policies using HPV testing alone at 5-year or longer intervals.

Footnotes

  • Cancer Epidemiol Biomarkers Prev 2021;30:22–9

  • Received August 6, 2020.
  • Revision received September 25, 2020.
  • Accepted October 13, 2020.
  • Published first October 20, 2020.
  • ©2020 American Association for Cancer Research.
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Cancer Epidemiology Biomarkers & Prevention: 30 (1)
January 2021
Volume 30, Issue 1
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Assessing 10-Year Safety of a Single Negative HPV Test for Cervical Cancer Screening: Evidence from FOCAL-DECADE Cohort
Anna Gottschlich, Dirk van Niekerk, Laurie W. Smith, Lovedeep Gondara, Joy Melnikow, Darrel A. Cook, Marette Lee, Gavin Stuart, Ruth E. Martin, Stuart Peacock, Eduardo L. Franco, Andrew Coldman, Mel Krajden and Gina Ogilvie
Cancer Epidemiol Biomarkers Prev January 1 2021 (30) (1) 22-29; DOI: 10.1158/1055-9965.EPI-20-1177

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Assessing 10-Year Safety of a Single Negative HPV Test for Cervical Cancer Screening: Evidence from FOCAL-DECADE Cohort
Anna Gottschlich, Dirk van Niekerk, Laurie W. Smith, Lovedeep Gondara, Joy Melnikow, Darrel A. Cook, Marette Lee, Gavin Stuart, Ruth E. Martin, Stuart Peacock, Eduardo L. Franco, Andrew Coldman, Mel Krajden and Gina Ogilvie
Cancer Epidemiol Biomarkers Prev January 1 2021 (30) (1) 22-29; DOI: 10.1158/1055-9965.EPI-20-1177
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