Spotlight on Breast Cervical and Colorectal Cancer Screening

Spotlight on Breast, Cervical and Colorectal Cancer Screening Maximizing Benefits and Minimizing Harms

Faculty/Presenter Disclosure 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 2

Disclosure of Commercial Support 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 3

Mitigating Potential Bias Not applicable 4

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

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– 2018 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 7

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 Access to Care – Building on Ontario’s Wait Times Strategy; provides information solutions that enable improvements to access Chronic Kidney Disease – Ontario Renal Network launched June 2009 8

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

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

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 Opportunistic Case-Finding Offered systematically to all individuals in defined target group within a framework of agreed policy, protocols, quality management, monitoring and evaluation 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: ØColon. Cancer. Check (CCC) ØOntario Breast Screening Program (OBSP) ØOntario Cervical Screening Program (OCSP) • Different stages of development • Different information systems 13

Ontario Cancer Statistics 2013 Cancer Type # New Cases # Deaths Breast 9, 300 (F) 1, 950 (F) 61014 (F) 150 (F) 4, 800 (M) 3, 900 (F) 1, 850 (M) 1, 500(F) Cervical Colorectal 14

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

Cancer Journey and Primary Care PRIMARY CARE 16

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

Screening Activity Report (SAR) Purpose Approach 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 screeningrelated 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 18

SAR Dashboard 19

Potential Benefits of Screening • 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 20

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

Sensitivity and Specificity Cancer Site Breast Test Sensitivity Mammography 77% to 95% Specificity 94% to 97% Less sensitive in younger women and those with dense breasts Breast 71% to 100% 81% to 97% Studies conducted in populations of women at high risk for breast cancer 51% to 73% 90% to 100% Cervical g. FOBT (repeat testing) Pap test 44% to 78% 91% to 96% Cervical HPV test 88% to 93% * 86% to 93% Colorectal MRI * Sensitivityfor CIN II 22

Effectiveness of Screening Cancer Site Effectiveness of Screening Type of Studies Breast With mammography: Randomized 21% reduction in mortality with controlled trials regular screening in 50 to 69 -yearolds Cervical With Pap testing: Incidence and mortality reduced by up to about 80% with regular screening Observational studies and Global incidence data Colorectal With FOBT: 15% reduction in mortality with biennial screening Randomized controlled trials 23

Spotlight on Breast Cancer Screening 24

Burden of Disease • In Ontario, an estimated 9, 300 women will be diagnosed and 1, 950 will die of breast cancer in 2013 • Most frequently diagnosed cancer in women • 1 in 9 Canadian women will develop breast cancer in their lifetime • Breast cancer occurs primarily in women aged 50 to 74 (57% of cases); 8 in every 10 breast cancers are found in women aged 50+ • More deaths occur in women aged 80+ than in any other age group • Reflects benefits of screening/treatment in prolonging life for middle-aged women 25

Screening Rates • 61% of eligible Ontario women aged 50 to 74 years were screened for breast cancer in 2010– 2011 • 71% in OBSP, 29% outside of OBSP • The national target is to increase screening rates to ≥ 70% of the eligible population 26

Challenges • Screening rates have slowed; lowest in 70 to 74 year (53%) followed by 50 to 54 year age groups (58%) • Recruitment of under- and never-screened women (e. g. , marginalized groups) • Increasing awareness of and referrals to the high risk program among public and providers • Controversy around screening women at average risk in the 40 to 49 age group 27

Screening Recommendations Screening Modality Mammography Canadian Task Force on Preventive Health Care (2011) • • MRI • • Women 40 to 49: Recommend not routinely screening Women 50 to 69: Recommend routinely screening Women 70 to 74: Recommend routinely screening Women aged 50 to 74: suggest screening every 2 to 3 years Women aged 40 to 74 who are not at high risk for breast cancer: Recommend not routinely screening with MRI Women at high risk aged 30 to 69: Recommend annual screening with MRI (in addition to mammography) 28

Screening Recommendations Screening Modality Breast self examination (BSE) Canadian Task Force on Preventive Health Care (2011) Recommend not advising women to routinely practice BSE Clinical breast Recommend not routinely examination (CBE) performing CBE alone or in conjunction with mammography 29

Ontario Breast Screening Program (OBSP) • Province-wide organized breast cancer screening program • Ensures Ontario women at average risk aged 50 to 74 receive benefits of regular mammography screening • Expansion of OBSP (July 2011) extended benefits of organized screening to women at high risk aged 30 to 69 (to be screened annually with mammography and MRI) 30

OBSP Eligibility Criteria Average-risk screening: • Women aged 50 to 74 years • Asymptomatic • No personal history of breast cancer • No current breast implants 31

OBSP Eligibility Criteria High risk screening: • Women aged 30 to 69 years • Asymptomatic • May have personal history of breast cancer • May have current breast implants • Confirmed to be at high risk for breast cancer (see next slide) 32

OBSP Eligibility Criteria High risk categories: 1) Confirmed carrier of gene mutation 2) First-degree relative of mutation carrier and refused genetic testing 3) ≥ 25% personal lifetime risk (IBIS, BOADICEA tools) 4) Radiation therapy to chest more than 8 years ago and before age 30 33

OBSP Screening Intervals • Average risk: biennial recall (every 2 years) • Increased risk: annual (ongoing) recall, e. g. , • High-risk pathology lesions • Family history • Increased risk: one-year (temporary) recall, e. g. , • Breast density ≥ 75% • Radiologist, referring MD, recommendation • Client request • High risk: annual recall 34

OBSP Features • Two-view mammography • Automatic client recall • Physician and client notification of results • Quality assurance for all components • Monitoring follow-up/outcomes • Program evaluation • Comprehensive information system 35

OBSP Features For women at high risk: • Patient navigator • If appropriate, referral to genetic assessment • Screening breast MRI and mammogram • Screening breast ultrasound if MRI contraindicated 36

Mammography Accreditation Program Canadian Association of Radiologists sets standards for: • Equipment • Image quality • Radiology staff skills and qualifications 100% of OBSP-affiliated sites are accredited 37

Digital Mammography The Digital Mammographic Imaging Screening Trial (DMIST) found digital mammography more accurate in: • Women < 50 years • Women with radiographically dense breasts • Pre-menopausal and peri-menopausal women A study using OBSP data found: • Digital radiography (DR) and screen film mammography (SFM) have similar cancer detection rates • Computed radiography (CR) had lower cancer detection rates than SFM 38

ld W el li ut h So es t ng t W ir io la . C St ar nt on m nd -B Ce rn t n M tra iss l. W iss es au t ga H To al to ro n nt o Ce nt ra l Ce nt ra Ce l nt ra l. E as t So ut h Ea N or st Ch th am Si m pl co a e M in us ko ka N or th Ea st N or th W es t gr -H lo o er ltn -N m H at W ie Er O Breast Cancer Screening Participation Rate, by LHIN 100 90 80 70 National target: ≥ 70% 60 50 40 30 20 10 0 OBSP Non OBSP 39

on ilt am H 2004 -2005 2006 -2007 2008 -2009 as t So ut h Ea N or st C th ha Si m m pl co a e M in us ko ka N or th Ea st N or th W es t l. E l ra Ce nt l nt ra n to al Ce ra Ce nt to To ro n es t . . on B. l. W ra an d ga H iss au iss M nt Ce es t lin gt el m di W W ir la . C St io ar nt ut h So al o lo a. H ga r ia N er at W ie Er O Breast Cancer Screening Participation Rate, by LHIN 100 90 80 70 60 50 40 30 20 10 0 National target: ≥ 70% 2010 -2011 40

Diagnostic Interval (%) Breast Diagnostic Interval National target: ≥ 90% for both categories 100 90 80 70 60 50 40 30 20 10 0 2008 2009 2010 2011 Year Without Biopsy Within 5 Weeks With Biopsy Within 7 Weeks 41

Clinical Case Study 1 • 42 -year-old asymptomatic woman asks to be screened for breast cancer • Her grandmother was diagnosed with breast cancer at age 65 What is your response? 42

Clinical Case Study 2 • 39 -year-old asymptomatic woman asks to be screened for breast cancer • Her mother was diagnosed with breast cancer at age 37 What is your response? 43

Clinical Case Study 3 • Your 58 -year-old average risk asymptomatic patient in a small rural community asks about breast screening • She wonders if she should take the longer trip to Community A where there is a new digital mammography unit; go to Community B, which is closer and has an analogue unit; or wait for the OBSP coach (with a digital unit) to come to town What is your advice? 44

OBSP Resources For more information: www. cancercare. on. ca/obspresources 45

Spotlight on Cervical Cancer Screening 46

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 47

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%) Pre-cancer lesions/ Pap abnormalities: 80, 000 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 48

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 49

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, 50 are also involved in oncogenesis

Cervical Cancer Natural History 51

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 52

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 9 -12 • 59% uptake in grade 8 girls (2009/2010) • More vaccine program information at www. hpvontario. ca 53

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 54

Comparison of 2005 and 2011 Guidelines Question Initiation Interval after Negative Test Cessation 2005 Guidelines 2011 Guidelines Within 3 years of first vaginal sexual activity with cytology (Pap test) Age 21 Annual until 3 consecutive negative cytology tests, then every 2 to 3 years Every 3 years 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: www. cancercare. on. ca/screenforlife 55

Screening Initiation • Start at age 21 in sexually active women ØCervical cancer rare < 25 years and extremely rare < 21 years Ø 10 to 15 years to develop cervical cancer • Aligns with other jurisdictions 56

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 57

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 58

Screening Cessation • Stop screening at age 70 if adequate and negative screening history ØLow incidence of cancer in women who have been adequately screened ØPotential discomfort of procedure ØDifficulties visualizing squamocolumnar junction • Aligns with other jurisdictions 59

Follow-Up of Abnormal Cytology • Management based on current screening result and screening history • Refer to the Ontario Cervical Screening Cytology Guidelines Summary www. cancercare. on. ca/screenforlife 60 60

Cervical Screening Participation Rate 100 95 Ontario Cancer Plan target 2010: 85% 90 85 80 75 70 65 60 55 2000 -2002 2003 -2005 2006 -2008 2009 -2011 61

Cervical Screening Participation Rate, by Age 100 Ontario Cancer Plan target 2010: 85% 90 80 70 60 50 40 30 20 10 0 20 -29 30 -39 2000 -2002 40 -49 2003 -2005 2006 -2008 50 -59 60 -69 2009 -2011 62

Cervical Screening Participation Rate, by LHIN 100 Ontario Cancer Plan target 2010: 85% 90 80 70 60 50 40 30 20 10 0 t t t on ntral East lain oka East es gton Brnt rio lair es es t a l t k p C W lin W d- ral W a Ha Ce Ce tral outh ham Mus orth On St. uth n l e t o n N S ie C No So o W Hldm Cen saug ront Ce oe Er c s o i rl To im gr iss S ate n-N M th W lt or m N H 2000 -2002 2003 -2005 2006 -2008 2009 -2011 63

Colposcopy Rate Following a High. Grade Abnormal Pap Test at 6 Months 100 95 90 85 80 75 2008 2009 2010 2011 64

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) 65

CCO Initiatives Underway • Phased correspondence to women starting in August 2013 ØPrivacy notification ØResult (normal, abnormal, unsatisfactory) letters ØFollowed by recalls and invitations 66

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-/neverscreened groups 67

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 68

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 69

Future Considerations • CCO working with ministry regarding implementation of primary HPV screening ØPublic funding of HPV test ØFamily physician/primary care provider education/information ØLaboratories ØOrganization of colposcopy services 70

Clinical Case Study 1 • A 17 -year-old female sees you to initiate birth control pill • She started having unprotected intercourse 2 months ago Do you screen her for cervical cancer? 71

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? 72

Clinical Case Study 3 • A 35 -year-old woman had an ASCUS result on her recent Pap test What is the appropriate next step? 73

OCSP Resources For more information: www. cancercare. on. ca/pcresources 74

New: Ontario Cervical Screening Mobile App! • Guidelines and recommendations for follow-up of abnormal cytology available for free • i. Phone: search “Ontario cancer screening” in Apple App Store • Blackberry, Android or Windows 7, visit https: //screening. cancercare. on. ca 75

Spotlight on Colorectal Cancer Screening 76

Burden of Disease • In Ontario, an estimated 8, 700 new cases of colorectal cancer will be diagnosed and 3, 350 people will die from it in 2013 • Incidence of colorectal cancer in Canada is similar to other developed countries, and is among the highest in the world • Approximately 93% of cases are diagnosed in people aged 50 years and older • 5 -year relative survival rate for colorectal cancer has improved over the past decade in Canada 77

Adenoma-Carcinoma Sequence • Majority of colorectal cancers arise from adenomatous polyps • Progression to invasive cancer takes 10 years on average 78

Colorectal Cancer Sub Site • Cancers arising in the left vs. right side of colon have different epidemiological, histological and molecular features • Higher proportion of right-sided colon cancers diagnosed in women • Survival rates are poorer in those diagnosed with right colon cancer 79

Recommended Screening Average Risk: fecal occult blood test (FOBT) • Biennial (every 2 years), aged 50 to 74 • Follow up abnormal FOBT with colonoscopy Increased Risk: Colonoscopy • One or more first-degree relatives with a history of colorectal cancer • Begin at age 50, or 10 years earlier than age relative was diagnosed, whichever is first 80

FOBT and Colonoscopy • Average risk patients who have had a negative/normal colonoscopy should not be screened for 10 years, following which screening should resume using either FOBT or colonoscopy 81

Evidence for Screening Using FOBT A meta-analysis of 3 randomized clinical trials shows that regular screening with FOBT reduces colorectal cancer mortality by 15% 82

Colon. Cancer. Check (CCC) Program Goals • Reduce mortality through an organized screening program • Improve capacity of primary care to participate in comprehensive colorectal cancer screening 83

CCC Program Features • Colonoscopy and FOBT quality standards • Increased colonoscopy capacity across Ontario • Primary care provider awareness • Program-branded FOBT kits • Financial incentives for family physicians • Patient correspondence • Initiatives to assist with follow-up of abnormal results 84

CCC Program Features Patient correspondence includes: • FOBT result letters • Recall/reminder letters • Invitation letters to people aged 50 to 74 85

Assessing Risk Assess for colorectal cancer (CRC) signs and symptoms Symptoms (high risk of CRC) No symptoms; 1 or more 1 st degree relatives with CRC (increased risk of CRC) Age 50 to 74; no symptoms; no affected 1 st degree relatives (average risk of CRC) Refer to colonoscopy; FOBT not appropriate Refer to colonoscopy; start at 50 years of age or 10 years before age of relative’s diagnosis FOBT every 2 years 86

FOBT Screening Participation Rate, by LHIN 100 90 80 70 60 50 CCO program target 2010: 40% 40 30 20 10 0 rio ta On ie Er t t l l t t a n n st as es es ton tra ok lai lto ran E E Ea g n n k a p W W W l B e e n s i l a th th m u C a. H rth nd uth or ell tra o. C M ha ou ntr g o a t n e S N C u e n W e So N m a C o C co ldi or iss loo m a s r i T s e H i S at M rth ara W o g a N Ni n o ilt 2004 -2005 2006 -2007 2008 -2009 2010 -2011 m a lai C t. S H r 87

Overdue for CRC Screening 100 90 80 Overdue (%) 70 60 50 40 30 20 10 0 2008 2009 2010 2011 Year 88

FOBT Abnormal Rate Male Abnormal FOBT result (%) 6 Female 5 4 3 2 1 0 50– 74 50– 54 55– 59 60– 64 65– 69 70– 74 Age group 89

Colonoscopy within 6 months (%) Follow-up Colonoscopy After +FOBT 100 90 80 70 60 50 40 30 20 10 0 2008 2009 2010 2011 Year 90

Colonoscopy Wait Time Benchmarks Colon. Cancer. Check’s program colonoscopy wait time benchmarks (adapted from the Canadian Association of Gastroenterology benchmarks) are: • 8 weeks for those with a FOBT+ result • 26 weeks for those with a family history 91

Clinical Case Study 1 A 54 -year-old asymptomatic male comes in for his periodic health visit What screening test would you suggest for him? 92

Clinical Case Study 2 • A 47 -year-old woman inquires about colorectal cancer screening • Her mother was diagnosed at age 65 with colorectal cancer What would you suggest? 93

CCC Resources For more information: www. cancercare. on. ca/pcresources 94

Call to Action! Screen Your Patients Screened Not Screened Breast 61% 39% Cervical 65% 35% Colorectal 30% 47% 95