Spotlight on Cervical Cancer Screening Maximizing Benefits and Minimizing Harms

Faculty/Presenter Disclosure 2 Faculty: [Your Name Here] MD and RPCL with CCO “Spotlight on Breast, Cervical and Colorectal Cancer Screening: Maximizing Benefits and Minimizing Harms” Relationship with Commercial Interests: Not applicable

Disclosure of Commercial Support 3 Relationship with Commercial Interests: The delivery of this Cancer Screening program is governed by an agreement with Cancer Care Ontario. No affiliation (financial or otherwise) with a pharmaceutical, medical device or communications organization

Mitigating Potential Bias 4 Not applicable

Learning Objectives To better understand the benefits and harms of cancer screening To identify the goals and key features of Ontario’s population-based cancer screening programs (breast, cervical and colorectal) To explore and understand current evidence on cancer screening To apply the evidence-based guidelines to relevant cancer screening case studies 5

Agenda Outline 1.Provincial Goals for Cancer Screening 2.Role of Primary Care 3.Benefits and Harms of Screening 4.Spotlight on Screening Programs Screening rate targets: challenges/opportunities Latest evidence-based guidelines Current program performance Relevant case studies 6

Cancer Care Ontario Vision and Mission 2012 – Our New Vision Working together to create the best health systems in the world Our New Mission Together, we will improve the performance of our health systems by driving quality, accountability, innovation, and value

Cancer Care Ontario (CCO) Provincial government agency Supports and enables provincial strategies Directs and oversees > $800 million Three lines of business: Cancer – CCO’s core mandate since 1943 to improve prevention, treatment and care Chronic Kidney Disease – Ontario Renal Network launched June 2009 Access to Care – Building on Ontario’s Wait Times Strategy; provides information solutions that enable improvements to access 8

CCO’s Screening Goal VISION Working together create the best cancer system in the world VISION Working together create the best cancer system in the world GOAL Increase screening rates for breast, cervical and colorectal cancers, and integrate into primary care Increase patient participation in screening Increase primary care provider performance in screening Establish a high- quality, integrated screening program 9

10 CS Strategic Framework GOAL Accelerate reduction in cancer mortality by implementing a coordinated, organized cancer screening program across Ontario GOAL Accelerate reduction in cancer mortality by implementing a coordinated, organized cancer screening program across Ontario STRATEGIC DIRECTIONS Enhance coordination and collaboration Improve quality Maximize resources and build capacity Maximize resources and build capacity Promote innovation and flexibility Advance clinical engagement Deliver patient- centred care

What is Screening? The application of a test, examination or other procedure to asymptomatic target population to distinguish between: Those who may have the disease and Those who probably do not 11

Types of Screening Population-Based Screening Offered systematically to all individuals in defined target group within a framework of agreed policy, protocols, quality management, monitoring and evaluation Opportunistic Case-Finding Offered to an individual without symptoms of the disease when he/she presents to a healthcare provider for reasons unrelated to that disease 12

Current State of Programs 3 cancer screening programs:  ColonCancerCheck (CCC)  Ontario Breast Screening Program (OBSP)  Ontario Cervical Screening Program (OCSP) Different stages of development Different information systems 13

Ontario Cancer Statistics Cancer Type# New Cases# Deaths Breast9,300 (F)1,950 (F) Cervical 610 (F) 150 (F) Colorectal4,800 (M) 3,900 (F) 1,850 (M) 1,500(F)

CCO and Primary Care RPCL LHIN 1 RPCL LHIN 2 RPCL LHIN 3 RPCL LHIN 4 RPCL LHIN 5 RPCL LHIN 6 RPCL LHIN 7 RPCL LHIN 8 RPCL LHIN 9 RPCL LHIN 10 RPCL LHIN 11 RPCL LHIN 12 RPCL LHIN 13 RPCL LHIN 14 Primary Care Program Provincial Lead 15

Cancer Journey and Primary Care 16 PRIMARY CARE

Primary Care and Cancer Screening The essential role family physicians play in screening intervention is widely recognized:  Identify screen-eligible populations and recommend appropriate screening based on guidelines and patient’s history  Manage follow-up of abnormal screen test results 17

SAR Dashboard 18

Screening Activity Report (SAR) PurposeApproach Motivation: Enhance physician motivation to improve screening rates Dashboard displays a comparison of a physician’s screening rates relative to peers in LHIN and province Administration: Provide support to foster improved screening rates Provides detailed lists of all eligible and enrolled patients displaying their screening- related history; clinic staff can be appointed as delegates Failsafe: Identify participants who require further action Patients with abnormal results with no known follow-up are clearly highlighted on the reports Performance: Improve physician adherence to guidelines and program recommendations Methodology based on the program’s clinical guidelines and recommendations for best practice 19

Potential Benefits of Screening 20 Reduced mortality and morbidity from the disease, and in some cases reduced incidence More treatment options when cancer diagnosed early or at a pre-malignant stage Improved quality of life Peace of mind

Possible Harms of Screening 21 Anxiety about the test False-positive results  Psychological harm  Labeling due to negative association with disease  Unnecessary follow-up tests False-negative results  Delayed treatment Over-diagnosis and over-treatment

Sensitivity and Specificity 22 Cancer Site TestSensitivitySpecificity BreastMammography77% to 95% Less sensitive in younger women and those with dense breasts 94% to 97% BreastMRI71% to 100% Studies conducted in populations of women at high risk for breast cancer 81% to 97% Studies conducted in populations of women at high risk for breast cancer ColorectalgFOBT (repeat testing) 51% to 73%90% to 100% CervicalPap test44% to 78%91% to 96% CervicalHPV test88% to 93% * * Sensitivityfor CIN II 86% to 93%

Effectiveness of Screening 23 Cancer SiteEffectiveness of ScreeningType of Studies BreastWith mammography: 21% reduction in mortality with regular screening in 50 to 69-year- olds Randomized controlled trials CervicalWith Pap testing: Incidence and mortality reduced by up to about 80% with regular screening Observational studies and Global incidence data ColorectalWith FOBT: 15% reduction in mortality with biennial screening Randomized controlled trials

Spotlight on Cervical Cancer Screening 24

Burden of Disease in Ontario Estimated 610 women will be diagnosed and 150 will die of cervical cancer in 2013 Up to 80,000 abnormal Pap tests require assessment each year 4 th most common cancer among women under age 50 25

Pre-cancer lesions/ Pap abnormalities: 80,000 Cervical Abnormalities Cancer (0.015%) Atypical Glandular Cells (0.1%) Atypical Squamous Cells: HSIL Cannot be Excluded (0.1%) High-Grade Squamous Intraepithelial Lesion (HSIL) (0.3%) Low-Grade Squamous Intraepithelial Lesion (2.1%) Atypical Squamous Cells of Undetermined Significance (2.3%) Negative for Intraepithelial Lesion or Malignancy (95.0%) Women (aged 20 – 69) Eligible for Cervical Cancer Screening 26

Ontario Screening Data 65% of women aged 20 to 69 screened (2009 to 2011) Ontario Cancer Plan provincial target is 85% participation for cervical screening Of the 454 women diagnosed with invasive cervical cancer in 2008, 60% were under- /never-screened and 40% were screened 27

28 Cervical Cancer Causes Persistent infection with high risk (oncogenic) types of HPV (human papillomavirus) HPV is commonly found in sexually active men and women and transmitted through any skin to skin sexual contact Most HPV infections are transient; about 90% will clear within 2 years Pap tests detect cervical cell changes that are a result of HPV infections Some abnormal Pap tests are also a reflection of premalignant change Other co-factors (like smoking), that are not well-understood, are also involved in oncogenesis

Cervical Cancer Natural History 29

30 HPV Vaccine Two vaccines — bivalent (Cervarix ® ) and quadrivalent (Gardasil ® )—prevent 2 high risk HPV types that cause 70% of cervical cancers Injected in 3 doses over 6 months Provides best protection if received prior to HPV exposure Natural infection does not reliably result in immunity Does not replace regular cervical cancer screening

31 Ontario HPV Vaccination Program Publicly funded school-based immunization program for grade 8 girls New catch-up program since September 2012 for girls in grades % uptake in grade 8 girls (2009/2010) More vaccine program information at

Current Guidelines Clear evidence for primary HPV screening with cytology triage, starting at age 30, every 5 years Must implement within organized program Must be publicly funded Follow cytology-based guidelines during transition to funded HPV screening 32

Comparison of 2005 and 2011Guidelines Question2005 Guidelines2011 Guidelines Initiation Within 3 years of first vaginal sexual activity with cytology (Pap test) Age 21 Interval after Negative Test Annual until 3 consecutive negative cytology tests, then every 2 to 3 years Every 3 years Cessation Age 70 if adequate and negative screening history in previous 10 years (≥ 3 negative tests) No change Management guidelines for follow-up of abnormal cytology did not change Guidelines summary: 33

Screening Initiation Start at age 21 in sexually active women  Cervical cancer rare < 25 years and extremely rare < 21 years  10 to 15 years to develop cervical cancer Aligns with other jurisdictions 34

Harms of Screening Adolescents 90% will clear infection within 2 years High rates of low-grade mostly transient and clinically inconsequential abnormalities Unnecessary anxiety from detection, biopsies and treatment Treatment linked to possibility of adverse future pregnancy outcomes No protective effect with screening 35

Screening Interval Cytology screening every 3 years unless immunocompromised or previously treated for dysplasia No incremental benefit of screening more frequently than every 3 years Aligns with other jurisdictions 36

Screening Cessation Stop screening at age 70 if adequate and negative screening history  Low incidence of cancer in women who have been adequately screened  Potential discomfort of procedure  Difficulties visualizing squamocolumnar junction Aligns with other jurisdictions 37

Follow-Up of Abnormal Cytology Management based on current screening result and screening history Refer to the Ontario Cervical Screening Cytology Guidelines Summary

39 Cervical Screening Participation Rate Ontario Cancer Plan target 2010: 85%

40 Cervical Screening Participation Rate, by Age Ontario Cancer Plan target 2010: 85%

41 Cervical Screening Participation Rate, by LHIN Ontario Cancer Plan target 2010: 85%

Colposcopy Rate Following a High- Grade Abnormal Pap Test at 6 Months 42

Challenges Cervical cancer screening often linked to periodic health exam, hormonal contraception and bimanual exam Longer screening interval does not align with physician/provider incentives Difficult for physicians/providers to track 3-year screening interval Roll-out of program correspondence in 2013 (phased approach) 43

CCO Initiatives Underway Phased correspondence to women starting in August 2013  Privacy notification  Result (normal, abnormal, unsatisfactory) letters  Followed by recalls and invitations 44

Opportunities Updated guidelines reflect new evidence Increase awareness of balance between benefits and potential harms of screening Reduce interventions in young women whose abnormal Pap tests are due to transient and inconsequential HPV infections Increase screening rates for under-/never- screened groups 45

Opportunities Improve appropriate follow-up after abnormal Pap test result Continue to encourage primary prevention through HPV immunization CCO and Public Health Ontario evaluating impact of primary and secondary prevention of HPV-related disease 46

Screening: Future State Clear evidence for primary HPV screening Must be implemented within an organized program HPV test must be publicly funded Updated cytology guidelines to bridge transition 47

Future Considerations CCO working with ministry regarding implementation of primary HPV screening  Public funding of HPV test  Family physician/primary care provider education/information  Laboratories  Organization of colposcopy services 48

Clinical Case Study 1 A 17-year-old old female sees you to initiate birth control pill She started having unprotected intercourse 2 months ago Do you screen her for cervical cancer? 49

Clinical Case Study 2 A 69-year-old female had a normal Pap test when she was 59 years old, an abnormal test when she was 63 years old and a normal Pap test most recently when she was 66 At what age can she safely stop screening? 50

Clinical Case Study 3 A 35-year-old woman had an ASCUS result on her recent Pap test What is the appropriate next step? 51

OCSP Resources For more information: 52

New: Ontario Cervical Screening Mobile App! Guidelines and recommendations for follow-up of abnormal cytology available for free iPhone: search “Ontario cancer screening” in Apple App Store Blackberry, Android or Windows 7, visit

Call to Action! Screen Your Patients 54 ScreenedNot Screened Breast 61%39% Cervical 65%35% Colorectal 30%47%