New Ontario Cervical Cancer Screening Guidelines

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New Ontario Cervical Cancer Screening Guidelines

• Dr. Joan Murphy
• Clinical Lead, Ont. Cervical Screening Program,
  Cancer Care Ontario
• Primary Care Symposium
• Nov 10, 2012

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Disclosure

• Dr. Joan Murphy
• NONE

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Objectives
1. review the evidence that informs best
practice in cervical cancer screening, 2. review
the new Cancer Care Ontario Cervical Screening
Program guidelines, and 3. discuss the imminent
and projected Ontario Cervical Screening Program
enhancements that will support clinicians and
women in achieving optimal screening and follow
up
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Background

• CCO 2005 guidelines due for update
• Program redevelopment required clarity for
  initiation / cessation / interval
• CCOs Program in Evidence-Based Care (PEBC)
  started work in July 2010
• Posted to CCO website Feb 2012
• Published in May 2012 issue of JOGC

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PEBC Evidence-based Advice Cycle
Evidence-based Advice Panel
Topic Selection explicit question Method
Selection adaptation, systematic review,
environmental scan, consensus

• Draft Report
• evidentiary base
• expert interpretation consensus
• draft advice

Dissemination Publication
updating

• System end-users
• Clinical Council
• MOHLTC
• Quality Indicator Cycle
• Clinical Program Heads

updated advice

• Review internal/external
• Report Approval Panel
• CCO leadership
• Peer reviewers
• Ontario stakeholders

• Final Report
• evidentiary base
• expert interpretation and consensus
• description of external review
• final advice

See also PEBC Handbook https//www.cancercare.on.
ca/common/pages/UserFile.aspx?fileId50876
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Core Methodology Systematic Review

• Clearly stated set of objectives with pre-defined
  eligibility criteria
• Explicit, reproducible methodology
• Systematic search to identify all studies that
  would meet eligibility criteria
• Assessment of validity of included studies
• Systematic presentation and synthesis
• 7 RCTs evidence for Ontario guidelines

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Evidence 7 RCTs in the prior 5 years evaluating
HPV testing

• CCCaST (Canada) Mayrand M, Duarte-Franco E, et
  al. Human papillomavirus DNA versus papanicolaou
  screening tests for cervical cancer. New Engl J
  Med. 2007357(16)1579-88.
• Sankaranarayanan (India) Sankaranarayanan R,
  Nene BM, et al. HPV screening for cervical cancer
  in rural India. N Engl J Med. 2009360(14)1385-94
  .
• POBASCAM (Netherlands) Bulkmans NW, Berkhof J,
  et al. Human papillomavirus DNA testing for the
  detection of cervical intraepithelial neoplasia
  grade 3 and cancer 5-year follow-up of a
  randomised controlled implementation trial.
  Lancet. 2007370(9601)1764-72.

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Evidence (contd) 7 RCTs in the prior 5 years
evaluating HPV testing

• 4. FPHT (Finland) Leinonen M, Nieminen P,
  Kotaniemi-Talonen L, Malila N, et al.
  Age-Specific Evaluation of Primary Human
  Papillomavirus Screening vs Conventional Cytology
  in a Randomized Setting. J Natl Cancer Inst
  200910116121623.
• 5. NTCC (Italy) Ronco G, Giorgi-Rossi P, et al.
  Efficacy of human papillomavirus testing for the
  detection of invasive cervical cancers and
  cervical intraepithelial neoplasia a randomised
  controlled trial. Lancet Oncol.
  201011(3)249-57.
• 6. ARTISTIC (UK) Kitchener HC, Almonte M, et al.
  HPV testing in combination with liquid-based
  cytology in primary cervical screening
  (ARTISTIC) a randomised controlled trial. Lancet
  Oncol. 200910(7)672-82.

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Evidence (contd) 7 RCTs in the prior 5 years
evaluating HPV testing

• 7. Swedescreen (Sweden) Naucler P, Ryd W, et al.
  Human papillomavirus and Papanicolaou tests to
  screen for cervical cancer. N Engl J Med.
  2007357(16)1589-97.
• FOCAL (BC) British Columbia is currently
  conducting a randomized controlled trial, the
  FOCAL study, which has some early first round
  data.

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Ontario Guidelines Summary
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Changes to Guidelines
Question 2005 Guidelines Updated Cytology Guidelines (2011) Primary HPV Guidelines (2011)
Initiation Within 3 yrs of 1st vaginal sexual activity with cytology (Pap test) Age 21 with cytology for sexually active women Age 30 with primary HPV screening
Interval (after negative test) Annual until 3 consecutive negative cytology tests, then every 2-3 yrs Every 3 yrs Age 30 Every 5 yrs
Cessation Age 70 if adequate negative screening history in previous 10 yrs ( 3 negative tests) No change Age 65 if adequate negative screening history and final negative HPV test at age 65
Follow-up (positive tests) ASCUS (age 30) triage with HPV test ASCUS (age lt30) repeat cytology at 6 mo. intervals over 12 mos. ASC-H, HSIL, squamous carcinoma, adenocarinoma, other malignant neoplasms refer to colposcopy AGC, atypical endocervical cells, atypical endometrial cells refer to colopscopy and/or endometrial sampling LSIL repeat cytology at 6 mo. intervals over 12 mos. or refer to colposcopy No change  Age 30 HPV ve triage with cytology HPV ve/cytology ve (ASCUS) refer to colposcopy HPV ve/cytology -ve repeat HPV test at 12 mos. refer HPV ve results to colposcopy
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1º HPV Management Algorithm
HPV testing in women age 30-65 years
Negative
Positive
Repeat HPV testing at 5 year intervals until age
65
Cytology test
Negative
Positive (ASCUS)
Repeat HPV testing at 12 months
Colposcopy
Positive
Negative
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HPV ve Triage with Cytology

• HPV less specific (61-96) than cytology (91-96)
• Cytology triage of HPV ve results
• Improve specificity of screening
• Identify clinically relevant HPV infections
• More appropriate referral to colposcopy

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Disconnect Science Reality

• Clear evidence for primary HPV screening
• HPV test not currently publicly-funded in Ontario
• Should implement primary HPV screening within
  organized program
• Updated cytology guidelines to bridge transition
  to HPV primary screening

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Updated Cytology Guidelines

• Start screening at age 21
• Screen every 3 years
• Stop screening at age 70, if adequate and
  negative screening history

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(No Transcript)
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Canada1 and United States
Organized Program? Primary screening test Initiation (age) Interval after negative test (years) Cessation (age)
Alberta Yes Cytology 21 3 (after 3X normal) 69
British Columbia Partially Cytology 21 2 (after 3X normal) 69
Manitoba Partially Cytology Within 3 years of sexual activity 2 69
Ontario Partially Cytology 21 3 70
Ontario Partially HPV test 30 5 65
Newfoundland2 Partially Cytology 20 3 (after 3X normal) 70
New Brunswick3 No Cytology 21 2-3 (after 3X normal) 69
Northwest Territories No Cytology 21 2 (after 3X normal) 69
Nova Scotia Partially Cytology 21 2 (after 3X normal) 75
Nunavut No Cytology 16 2 (after 3X normal) 70
Prince Edward Island No Cytology 20 2 69
Quebec 4 No Cytology 21 2 to 3 65
Saskatchewan Yes Cytology 21 3 (after 3X normal) 69
Yukon No Cytology 18 2 (after 3X normal) -
American Cancer Society (ACS), American Society for Colposcopy Cervical Pathology (ASCCP) and American Society for Clinical Pathology (ASCP)1 No Cytology (age 21-29) Co-testing (age 30-65) preferred Cytology alone (age 30-65) acceptable 21 3 (age 21-29) cytology 5 (age 30-65) co-testing 3 (age 30-65) cytology alone 65
United States Preventive Services Task Force (USPSTF)2 No Cytology (age 21-29) Co-testing (age 30-65) 21 3 9age 21-29) 5 (age 30-65) co-testing 65
American College of Obstetricians and Gynecologists (ACOG)3 No Cytology (age 21-29) Co-testing (age 30) 21 2 (age 21-29) 3 (age 30) 65 or 70
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Europe
Organized Program? 1 Primary screening test Initiation (age) Interval after negative test (years) Cessation (age)
Austria No Cytology 20 1 70
Belgium No2 Cytology 25 3 64
Denmark Yes Cytology 23 3 59
Finland Yes Cytology 30 5 60
Finland Yes HPV test3 35 5 65
France Regional Cytology 25 3 65
Germany No Cytology 20 1 Not specified
Hungary Yes Cytology 25 3 65
Iceland Yes Cytology 20 2-3 69
Ireland Yes Cytology 25 3 (age 25-44) 5 (age 45-60) 60
Italy Yes Cytology 25 3 64
Netherlands Yes Cytology 30 5 60
Netherlands Yes HPV test4 30 5 (age 30-40) 10 (age 40-60) 60
Norway Yes Cytology 25 3 69
Portugal Regional Cytology 25 3 64
Spain Regional2 Cytology 25 3 65
Sweden Yes Cytology 23 3 (age 23-50) 5 (age 51-60) 60
Sweden Yes HPV test5 - - -
United Kingdom England Yes Cytology 25 3 (age 25-49) 5 (age 50-64) 64
European Union N/A Cytology 25 or 30 3 or 5 60 or 65
European Union N/A HPV test 30 or 35 5 60 or 65
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Organized Program (IARC)
Features Features Ontario Cervical Screening Program
Recent Ontario/PEBC guidelines Recent Ontario/PEBC guidelines ?
Initiatives to increase screening participation Public ?
Initiatives to increase screening participation Providers ?
Routine recall Routine recall ?
Follow-up of abnormal results Follow-up of abnormal results ?
Quality Assurance Quality Assurance ?
Monitoring/evaluation Monitoring/evaluation ?
Information system Information system ?
? Yes ? Partial ? No
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Patient Correspondence

• Focus on women aged 21-69 (4.4M women)
• May 2012 Provider education tools
• Focus on updated cytology guidelines
• New patient correspondence (i.e., results)
• June 2012 Privacy notices
• July 2012 Abnormal/unsatisfactory results
• Only to those who received privacy notice and did
  not opt out of correspondence

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Implementing Primary HPV Screening Logistical
Issues
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The HPV Test

• What do we need to test for (16/18)?
• Performance characteristics of the test
• Sample stability
• Quality standards for HPV test as primary test
  and for cytology as triage test
• Immunized population reaching screening ages
• Reflex cytology

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Laboratory Impacts

• Technology - evolving
• Throughput/volumes
• Costs individual and aggregate
• Quality assurance
• Standardized operating procedures
• Standardized reporting
• Human resources
• Competencies and training

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Colposcopy Capacity

• Current volumes
• Geographic locations
• Colposcopy service not organized
• No formal training programs, minimum
  qualifications or quality processes implemented
• No comprehensive colposcopy data
• Unable to provide performance feedback to
  practitioner or system

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Economic Evaluation

• HPV test not currently publicly funded
• Economic evaluation of entire screening process
  needed
• 1º HPV screening cytology triage
• Laboratory
• Colposcopy
• Business case for primary HPV screening to
  Government

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Provider Knowledge Attitudes

• What is known about HPV and HPV tests?
• Stigma of STIs
• Cervical cancer and recommended guidelines
• Age, interval, benefits/harms
• Management of HPV ve results
• Counseling HPV ve women
• Alignment of physician incentives
• Icon of annual Pap/annual health exam

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Public Knowledge Attitudes

• What is known about HPV and HPV immunization?
• Stigma of STIs
• Cervical cancer and recommended guidelines
• Age, interval, benefits/harms
• Icon of annual Pap/myth that more screening is
  better
• Longer interval seen as cost savings

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Organizing the Program

• 1º HPV screening must be implemented only within
  an organized program
• OCSP not fully organized underway
• Prescribed registry status
• Cytology results and health claims data
• Patient correspondence starts summer 2012

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HPV as Primary Test Approach
OCSP Program Quality Standards (Screening and
Follow-up)
PEBC Cervical Screening Guidelines (2011)
Revised Program Quality Standards w/ HPV Testing
Follow-up Guidelines and Standards w/ HPV Testing
Economic Evaluation and Business Case for HPV
Testing to MOH
Test Standards
Lab Standards
Program Design with HPV Test
ICS Program Design and Implementation
Performance Management
Service Delivery
Funding Model
Screening Operations
Education Comms
Data Requirements / Data Collection Approach
IT Requirements
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1940s Technologies