A CME workshop presented by

Workshop Learning Objectives1. Assess breast cancer risk for individual

women patients.2. Identify patients for whom breast cancer risk

reduction is feasible and should be considered.

3. Describe the reduction in breast cancer risk in older women being treated for osteoporosis with Selective Estrogen Receptor Modulators (SERMs)

4. Analyze the risks and benefits of SERMs in breast cancer prevention.

Epidemiology of Breast CancerMost common cancer in women.Second only to lung cancer as cause of

cancer-related deaths in women.One women diagnosed every 3 minutes

and one women dies of disease every 13 minutes.

In 2006, over 200,000 women were diagnosed with invasive breast cancer.

A woman’s lifetime risk for developing breast cancer is 12.5% (1 in 8).

Risk Factor for Breast CancerEthnic and FamilialHormonal and

ReproductiveDietary/Lifestyle Risk Factor

Assessment

Ethnic Variations in Breast Cancer RiskRate of breast cancer stratified by race/ethnicity

Race/Ethnicity Rate of breast cancer occurrence

Caucasian 141 per 100,000African American 119 per 100,000Asian American/Pacific Islander

97 per 100,000

Hispanic/Latina 90 per 100,000American Indian/Alaska natives

55 per 100,000

Familial Risk Factors

Risk for all women compared to those with a family history% of

population% of all breast cancer

Average lifetime risk of breast cancer %

General population 90 80-85 11-12Family history of breast cancer

5-10 15-20 20-25

Positive for BRCA1 or BRCA2 mutations

0.1 5-6 65-85

Two- to three-fold increased risk for women whose first-degree relative was diagnosed with breast cancer.

The risk declines significantly if only second-degree relatives are affected.

Reproductive/Hormonal Risk Factors

NulliparityEarly menses (< age 12)Late menopause (> age 55)First full-term pregnancy after age 35Use of oral contraceptives

Before first full-term pregnancyUse for longer duration in BRCA mutation

carriersUse of hormone replacement therapy

Dietary/Lifestyle Risk FactorsIn post-menopausal women:

Higher weightHigher body mass index

(BMI)Alcohol use (<2 drinks per day)Regular exercise associated

with a decreased risk, but lack of exercise not associated with an increased risk

Exposure to ionizing radiationBefore 40 years of ageExposure between 10 and 14

years of age most critical.

Risk Factor AssessmentImportant for healthcare professionals to

identify high risk factors:Previous medical history of breast cancer.History of lobular carcinoma in situ or ductal

carcinoma in situ.Family history of breast cancer.Presence of BRCA 1 and 2 mutations.

In the absence of personal or family history, the presence of multiple risk factors can result in an elevated risk

The Gail ModelInternet-based tool Projects a women’s estimated risk of breast

cancer over a 5-year period and over her lifetime.Includes assessment of:

Age and raceFirst-degree relative historyHormonal factors

Does not take into account:Personal history of cancer, Second degree relative history of breast cancerFamily history of breast cancer before age 50Family history of bilateral disease and ovarian cancerBRCA1/2 mutations

The Gail Model ExamplePatient background: Lucy is a 34 year-old female whose mother had breast cancer.

Age at Menarche 12

Age at first live birth Nulliparous

# of biopsies 0

atypical hyperplasia

First degree relatives 1

Race Caucasian

5-year Risk 0.4% (Average risk 0.2%)

Lifetime Risk 17.2% (Average risk 12.6%)

The Gail Model is available at: http://www.cancer.gov/bcrisktool

Pedigree Assessment ToolUseful in identifying those individuals most at

risk for hereditary breast cancer.More information available at:

https://myosfhealth.osfhealthcare.org/sites/OSF/BCRA/default.aspx

Pedigree Assessment Scoring System

Diagnosis Points assigned

Breast cancer at age 50 or higher

3

Breast cancer prior to age 50

4

Ovarian cancer at any age 5Male breast cancer at any age

8

Ashkenazi Jewish heritage 4

PreventionPrimary prevention

Modifiable risk factors

ChemopreventionGenetic screening

Secondary preventionSelf breast examClinical breast examMammography

Tertiary prevention

Primary Prevention: Modifiable Risk Factors

Modifiable risk factors Non-modifiable risk factors

Use of hormone replacement therapy

ObesityPhysical activityAlcohol use BreastfeedingPregnancy (number, age,

etc)

AgeGenderRace/ethnicityAge of

menarche/menopausePersonal history of

breast cancerFamilial historyGenetic mutations

Primary Prevention: ChemopreventionSelective estrogen receptor modulators

(SERMS).Tamoxifen

FDA approved for risk reduction of breast cancer in high-risk women.

RaloxifeneThe FDA Advisory Committee recently

recommended approval of Raloxifene for breast cancer risk reduction (July 2007).

Only recommended for high risk women, not those with low or average risk.

Chemoprevention: TamoxifenThe Breast Cancer Prevention Trial (BCPT)

50% reduction in the incidence of breast cancer after receiving tamoxifen for 5 years.

Other studies Statistically significant reductions in the incidence of

contralateral breast cancer in those treated with tamoxifen.

Side effects:Increased risk of endometrial cancer and thrombosisHot flashes.

Chemoprevention: RaloxifeneMultiple Outcomes of Raloxifene Evaluation

(MORE)76% reduction in invasive breast cancer compared to placebo

when treatment continued for a median of 40 months.

Side effects:ThrombosisHot flashes

STAR TrialRaloxifene as effective as tamoxifen in reducing risk of invasive

breast cancer.Raloxifene had a lower risk of thromboembolic events and

cataracts, but a nonstatistically significant higher risk of noninvasive breast cancer compared to tamoxifen.

Primary Prevention: Genetic ScreeningFamily history patterns associated with increased risk for

inherited BRCA mutations in non-Ashkenazi Jewish women:1st degree relative with a known BRCA mutationTwo 1st degree relatives with breast cancer, one who received

the diagnosis at age 50 or youngerThree or more 1st or 2nd degree relatives with breast cancer

regardless of age at diagnosisCombination of both breast and ovarian cancers among 1st

and 2nd degree relatives1st degree relative with bilateral breast cancerCombination of two or more 1st or 2nd degree relatives with

ovarian cancer1st or 2nd degree relative with both breast and ovarian cancersBreast cancer in a male relative

Primary Prevention: Genetic ScreeningOptions for women who test positive BRCA

mutations:Prophylactic mastectomy and oophorectomy.Increased surveillance, including:

Clinical breast exams 2-4 times per year.Monthly self breast exams.Annual mammograms starting at age 25.Twice yearly ovarian cancer screening with ultrasound

beginning at age 35.

Chemoprevention with SERMs.

Secondary Prevention: Self Breast Exam (SBE)Noninvasive screening test.Clinical evidence does not show clear benefit.Patient and healthcare professional should

discuss.Women should be told to report any changes

or abnormalities.

Secondary Prevention: Clinical Breast Exam (CBE)Approximately 5% of

breast cancers identified by CBE alone.54% Sensitivity94% Specificity

No clinical trial exist comparing CBE alone to no screening. Bobo JK, et al. J Natl Cancer Inst. 2000;92(12):971-976.

Secondary Prevention: Screening Mammography

Recommendations for mammography screening

Age to start screening (yrs.)

Interval of screening (yrs.)

Organization

40 1

National Comprehensive Cancer Network American College of Radiology American Medical Association American Cancer Society

40 1-2 American College of Obstetricians and Gynecologistsa

National Cancer Institute US Preventative Services Task Force American Academy of Family Physicians

50b 1-2 American College of Preventive Medicine*

a: 1-2 years for women 40-49 years, 1 year for women >50 years; b: age 40 for high risk women; * the ACPM policy is currently under review.

Secondary Prevention: Other Modalities

UltrasoundMRI

Recommended as annual screening tool for women who: Have a BRCA 1 or 2 mutation. Have a first-degree relative with a BRCA 1 or 2 mutation

and are untested. Have a lifetime risk of breast cancer of 20-25 percent or

more using standard risk assessment models. Received radiation treatment to the chest between ages

10 and 30, such as for Hodgkin Disease. PET

Tertiary PreventionCancer treatment-related complications

Early complications Wound infection Shoulder immobility and neuropraxia Skin desquamation Acute toxicities of chemotherapy Febrile neutopenia Early lymphedema

Late Complications (rare) Tissue fibrosis Chemotherapy-induced heart disease Myelodysplasias Late-onset lymphedema Psychological and possible intellectual effects

Endocrine therapy TamoxifenEndometrial cancerVaginal bleedingThromboembolic eventsAromatase inhibitorsDecreased bone densityMyalgias and arthralgias

Tertiary PreventionContinue preventive screening.

No long-term survival benefit seen with intensive follow-up vs. routine mammograms and physical exams.

Continue ongoing primary care and screenings for other cancers (i.e.. Colon cancer).

Provide psychosocial support, education, and resource materials.

Encourage exercise and weight loss (if applicable).

Special Issues for Rural Providers Compared to urban counterparts, the

rural population: Is generally older, poorer, and

less educated.Has fewer physicians and

hospitals per capita.This disparity results in:

Lower level of patient-reported health status.

Less confidence in being able to obtain needed care.

Fewer physician visits.The need to travel farther to

obtain care.

Poverty in Rural Regions

Percentage of population living in poverty stratified by geographic location

Geographic location % of population living in poverty*

Urban population 13.8%

Rural adjacent population 15.8 %

Rural non-adjacent population 22.5%*Poverty is defined as household income below the 100% of the 1997 federal poverty level; specific numbers can be found at http://aspe.os.dhhs.gov/poverty/97poverty.htm.

Ormond B, et al. A Rural/Urban Differences in Health Care Are Not Uniform Across States. New Federalism: National Survey of America's Families [Number B-11 http://www.urban.org/publications/309533.html.

Barriers Facing Rural Providers Negative patient attitudes about

mammography.Fear of pain, discomfort, and anxiety.

Cultural/racial norms and attitudes about disease processes.Screening rates lower in women with no high

school diploma or GED.African-American and Hispanic women have

fewer baseline and routine mammograms.

Barriers: Health InsurancePercentage of patients uninsured:

14.3 percent of urban residents17.5 percent of residents in rural adjacent

counties21.9 percent in rural non-adjacent counties

Significantly more women with insurance received regular mammograms than did those without insurance (60% vs. 33%, respectively).

The National Breast Cancer and Cervical Cancer Early Detection Program

Ormond B, et al. New Federalism: National Survey of America's Families [Number B-11 http://www.urban.org/publications/309533.html; Smith RA, et al. 2006. CA Cancer J Clin. Jan-Feb 2006;56(1):11-25.

Barriers: Screening Site Issues Shortage of breast imaging specialists;

however, new technologies may help:Increase the accuracy of breast cancer

detection.Improve access to mammography.Broaden the pool of medical personnel who can

interpret mammograms.Shortage of new visiting specialists

Rural Health Care programs help fund necessary telecommunications.

Barriers: Access Issues Components of an office system for annual preventive care prompts and reminders Determine the target women for breast cancer

screening/preventive services Computerized prompts through an electronic

medical record (EMR) system Flow sheets Mailed or telephone reminders Newsletters or educational materials Brief telephone counseling for women who have

not received a mammogram in the preceding 15 months.

Improving CommunicationsLearn about your community. If you

are new to the community, learn about the demographics of your population.

With your staff, decide on a realistic target and set a goal. For example, develop a plan to increase the mammogram screening of your target population by 20% in the next year.

Visit the women in your community at adult education classes, coffee shops, and other places where women are gathering. Put together a “Grab Bag” with handouts and important date reminders.

Improving CommunicationsUse the office staff to teach and help with

follow-up. Ask them for ideas on how to reach out into your community.

Create a “reward” for repeat positive behavior or change in behavior. For instance, create a “Bring a friend to your mammogram” program.

Use the Pink Ribbon symbol to remind women how important screening is. Contact the Susan G. Komen Foundation and others who offer free Pink Ribbons.

Be visible. Health care providers are viewed as the experts, and when you speak, others listen and will know the message is important.

ConclusionsRural healthcare providers face challenges in

addressing patient needs. Acute issues vs. preventive measures. Patient barriers

Assess individual risk factorsDiscuss chemoprevention in applicable

patientsEncourage regular screenings for all eligible

patients.