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Physician Assistant Cancer Education

CANCER

BREAST

Case-Based Series in Population-Oriented Prevention

Supported by a Grant Number 1 R25 CA10974301A2/05 from the National Cancer Institute

SCHOOL OF ALLIED HEALTH SCIENCES


PACE Project Personnel J. David Holcomb, EdD, Principal Investigator Laurel R. Spence, MS, PA-C, Co-investigator Carl E. Fasser, PA, Project Coordinator Robert McLaughlin, PhD, Consulting Psychologist Module Authorship Laurel R. Spence, MS, PA-C Carl E. Fasser, PA Julia Middleton, MS, PA-C

Funding Source This project was supported by a Grant Number 1 R25 CA109743-01A2/05 from the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute of the National Institutes of Health. Copyright Statement The following copyright information applies to the PACE project during all phases of curricula development and dissemination. Materials that remain under development, as well as curricula in the dissemination phase of the project are subject to copyright protection, as outlined below. The material in this curriculum may be used for educational purposes without restriction or permission. Electronic or print redistribu­tion for all non-profit purposes is permitted, provided this notice is attached in its entirety. Unauthorized, for-profit redistribution is prohibited. The BCM School of Allied Health Sciences requests that attribution of source be made when the material is used. Š School of Allied Health Sciences, Baylor College of Medicine, 2009.


Physician Assistant Cancer Education i

PACE Diffusion Steering Committee Frank Ambriz, PA-C, Associate Professor and Director, Physician Assistant Program, University of the Texas-Pan American, Edinburg, Texas Carl Fasser, PA, Professor and Director, Physician Assistant Program, School of Allied Health Sciences, Baylor College of Medicine, Houston, Texas Venetia Orcutt, MBA, PA-C, Associate Professor and Director, Physician Assistant Program, University of Texas Southwestern Medical Center, Dallas, Texas Henry Lemke, MMS, PA-C, Professor and Director, Physician Assistant Program, University of North Texas Health Science Center, Fort Worth, Texas Edward Maxwell, PA-C, Associate Professor and Director, Physician Assistant Program, Texas Tech University Health Science Center, Midland, Texas Richard Rahr, EdD, Professor and Director, Physician Assistant Program, University of Texas Medical Branch at Galveston, Galveston, Texas Dennis Blessing, PhD, PA-C, Professor and Director, Physician Assistant Program, University of Texas Health Science Center in San Antonio, San Antonio, Texas James Somers, PhD, PA-C, Professor and Director, Physician Assistant Program, University of Nebraska Medical Center, Omaha, Nebraska

Physician Assistant Cancer Education Project Cancer Instructional Content Committee Maria Jibaja, EdD, Associate Professor, Baylor College of Medicine, Family & Community Medicine, Houston, Texas – Chair Robert Evans, PA-C, Physician Assistant, Department of Urology at MD Anderson Cancer Center, Houston, Texas Gilad Amiel, MD, Assistant Professor, Department of Urology, Baylor College of Medicine, Houston, Texas Cathy Montoya, MLS, Director, Education Resource Center, Baylor College of Medicine, Houston, Texas Maura Polansky, MS, PA-C, Director, PA Postgraduate Program on Oncology at MD Anderson Cancer Center, Houston, Texas Lorraine Potocki, MD, Associate Professor, Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, Texas Lynn Yeoman, PhD, Professor, Department of Pharmacology, Baylor College of Medicine, Houston, Texas J. David Holcomb, EdD, Senior Vice President and Dean, School of Allied Health Sciences, Baylor College of Medicine, Houston, Texas (ex-officio)


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Table of Contents Section I: Frequently Asked Questions....................................................... 2 What is the impact of breast cancer within the United States?................................................................... 2 What are the risk factors for breast cancer?.................................................................................................... 2 How in the anatomy of the female breast significant with regard to breast cancer?............................... 2 How does breast tissue change with aging?..................................................................................................... 3 What benign lesions are common in the breast?............................................................................................ 3 What are the common symptoms of breast cancer?...................................................................................... 4 What are the types of breast cancer?................................................................................................................ 5 How is breast cancer typically managed?......................................................................................................... 6

Section II: Clinical Prevention and Epidemiologic Concepts......................... 6 Absolute risk.......................................................................................................................................................... 7 Relative risk............................................................................................................................................................ 7 Breast cancer risk factors – non modifiable.................................................................................................... 8 Breast cancer risk factors – modifiable............................................................................................................ 9 Mathematical models for risk assessment in breast cancer....................................................................... 10

Section III: Statewide Statistics................................................................. 10 Texas Cancer Plan............................................................................................................................................... 10 Texas Cancer Registry........................................................................................................................................ 10

Section IV: Breast Cancer Screening Programs......................................... 11 Why screen for breast cancer?......................................................................................................................... 11 What methods are used for breast cancer screening?................................................................................. 11 Who issues breast cancer screening guidelines?.......................................................................................... 11 What are the most current breast cancer screening guidelines?............................................................... 12

Section V: Case Studies............................................................................ 13 Case 1: Annual Well Woman Examination.................................................................................................... 13 Case 2: Post Menopausal Woman with Hysterectomy in for Annual Check.......................................... 13 Case 3: Multisystem Disease in Woman with Heavy Menstrual Bleeding.............................................. 14

Section VI: Counseling Patients Regarding Screening Outcomes............... 17 Which patients benefit from genetic counseling and testing due to breast cancer risk?..................... 17 Risk Reduction..................................................................................................................................................... 17

Section VII: Integration/Clinical Correlation............................................. 18 Section VIII: References........................................................................... 29


Physician Assistant Cancer Education 1

BREAST CANCER MODULE

Case-based Series in Population-Oriented Prevention (CPOP)

Recommended Reading: 1. American Cancer Society. Detailed guide: Breast cancer. American Cancer Society. Sept 13, 2007. [accessed 4/19/08] Available from: http://www.cancer.org/docroot/CRI/ CRI_2_3x.asp?rnav=cridg&dt=5 2. National Cancer Institute. Screening Mammograms: Questions & Answers. 9-4-2007. [accessed 11/05/07] Available from: http://www.cancer.gov/Templates/db_alpha. aspx?CdrID=44650 3. U.S. Preventive Services Task Force (USPSTF). Recommendations and Rationale: Screening for breast cancer. U.S. Preventive Services Task Force. Feb 2002. [accessed 4/19/08] Available from: http://www.ahrq.gov/clinic/3rduspstf/breastcancer/brcanrr.htm

Objectives: Knowledge Competencies 1. Discuss risk factors for breast cancer 2. Describe the incidence, prevalence and mortality rate of breast cancer 3. Discuss the role of genetic markers in screening, diagnosis and management of breast cancer 4. Describe the methods for breast cancer detection 5. Describe the relationship between early detection and survival Skill Competencies 1. Elicit risk factors for breast cancer during interview 2. Perform a clinical breast examination 3. Educate patients regarding self breast examination technique 4. Order the appropriate follow-up tests for a particular individual and refer for follow up assessment Attitudinal Competencies 1. Appreciate importance of identifying high-risk patients for appropriate preventive interventions 2. Appreciate patient education and counseling as integral components of clinical practice


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How is the anatomy of the female breast significant with regard to breast cancer?

Section I: Frequently Asked Questions What is the impact of breast cancer within the United States? The National Institutes of Health (NIH) reports that breast cancer accounts for 20 to 25 percent of the total cost for all cancers combined within the United States (U.S.), which translates to a societal burden of some $40 to $50 billion annually.1,2 Breast cancer is the most commonly diagnosed cancer among women, other than skin cancer. The mortality rate of breast cancer is second only to that of lung cancer.1,3,4 The American Cancer Society (ACS) projected 182,460 new diagnoses of invasive breast cancer and 40,938 deaths to occur due to breast cancer in the United States (U.S.) during the year 2008.1 Despite these estimates, breast cancer mortality continues to decline, especially in women younger than age 50.2,3 Furthermore, diagnoses of breast cancer in situ have become more common in recent years, with 58,490 cases estimated by ACS for 2008.1,5 Cancer in situ is a precancerous condition in which abnormal cells replicate within a single location or tissue prior to crossing the basement membrane and invading other tissue. In situ cancer of the breast is either confined to breast ducts [ductal carcinoma in situ (DCIS)] or breast lobules [lobular carcinoma in situ (LCIS)]. Such improved outcomes are attributed to better breast cancer awareness among the public, increased screening, early detection, and more effective treatment options in recent years.3,4

What are the risk factors for breast cancer? General categories of breast cancer risk factors include the following (details in next section): 1,3-6 1. Female gender 2. Advancing age 3. Family history 4. Genetic mutations 5. Race/ethnicity 6. Proliferative breast disease 7. Personal history of prior malignancy 8. Therapeutic radiation to the breast region 9. Carcinogenic environmental factors 10. Dietary and lifestyle factors 11. Hormonal factors

An understanding of female breast anatomy is important, as it allows one to better conceptualize the potential for the various types of benign and malignant processes that may occur within the breast. Several different tissue types are found within the breast, including lobular (glandular), ductal, adipose, and connective tissues. 6-8 (Figures 1 and 2)

Ribs

Pectoralis major muscle

Fat

Suspensory ligaments of Cooper Glandular tissue Lactiferous ducts

Cross section - lateral view FIGURE 1. Thin bands of fascia (Cooper’s ligaments) connect

the skin to the underlying fascia and glandular tissue providing support to the breast. The upper-outer quadrant of the breast, the Tail of Spence, extends into the axilla and contains a disproportionate amount of glandular tissue and is a difficult area to image; therefore, a thorough clinical breast exam (CBE) that includes the axillary region is a vital part of breast cancer screening.6-8 Twelve to twenty pyramidal-shaped lobes are arranged in radial fashion converging toward the nipple of each breast. The lobes are divided into smaller segments, called lobules, which contain glandular tissue and multiple clusters of alveoli. These clusters are secretory epithelial cells surrounded by connective tissue and contractile myoepithelial cells that drain into a network of excretory milk ducts. This collecting duct system arising from each lobe traverses the breast and ultimately empties into a few terminal milk ducts that lead to the nipple for the purpose breast milk ejection when stimulated by oxytocin.6-8 From Reference6.


Physician Assistant Cancer Education 3

Levels:

I

II

Consequently, increased breast density may result in reduced sensitivity and specificity of breast screening studies, as such images may be more difficult to interpret definitively.6

III

What benign lesions are common in the breast?

3

1 2

FIGURE 2. A complex blood supply and lymphatic system weave throughout the breast. Blood Supply - The arterial blood supply of the breast is derived from three main sources: 1) The third, fourth, and fifth intercostals supply the lateral portion of the breast; 2) The internal mammary sends perforators to the medial aspect of the breast; and, 3) Branches of the thoracoachromial trunk descend along the lower border of the pectoralis minor muscle and enter the breast from below.6-8 Lymphatics - Lymphatic drainage is the route of local and distant metastasis for cancerous cells of the breast.6-8 The lymphatic system includes the superficial and deep nodal chains in the trunk, neck, axilla, those deep to the pectoralis muscles, and those caudal to the diaphragm. The axillary lymph nodes drain approximately 60% of the lymph. These lymph nodes are conventionally grouped in three levels: Level I is lateral to the lateral border of the pectoralis minor; Level II is behind the pectoralis minor; and, Level III is medial to the medial border of the pectoralis minor (Halsted Node). 6-8 From Reference7.

How does breast tissue change with aging?

Both benign and malignant processes occur within the breast. Providers must be familiar with the characteristics of benign and malignant lesions of the breast in order to better differentiate between these processes. Characteristics com­ mon to benign breast disease include bilateral involvement, a diffuse nodularity, fluctuation with the menstrual cycle, and a relative mobilility with a rubber-like consistency; in contrast, malignant lesions are typically unilateral, may be partially or completely fixed to the chest wall, are more likely firm in nature and may be accompanied by nipple discharge and/or skin changes/retractions.4-8 Common benign processes include: 4-8 1. Fibrocystic changes – [also known as “fibrocystic breast disease”] the most common benign breast disorder, present in 30 to 50 percent of reproductive-aged women (uncommon finding in menopausal women); histologic changes: stromal proliferation (particularly in the upper outer quadrants) with tissue adenosis leading to cyst formation; bilateral, multiple, small, non-dominant masses with diffuse nodularity, cyclic mastalgia (may radiate to shoulders and upper arms) and engorgement most noticeable just prior to menses; breast tissue may appear indurated upon inspection and may be tender, lumpy, bumpy breasts to palpation; management is typically minimal and focused upon dietary restrictions [limit caffeine, salt, foods with methlyxanthines (chocolate)], supplemental vitamin E and a diuretic as needed; with cysts suspicious for malignancy and/or larger cystic formations—may perform fine needle aspiration or an open biopsy. 4-8

Breast density varies with age, such that younger women’s 2. Fibroadenoma - the second most common benign breasts are denser and consist of more glandular tissue breast disorder, affects reproductive-aged women than those of older women. During menopause, the (peak incidence between ages 20 to 30 years), glandular tissues of the breasts are largely replaced larger in size than fibrocysts, firm, painless, wellby fat. Density and conformation differences between circumscribed, freely mobile “rubbery” nodules, younger and older women are palpable on clinical breast unaffected by menses, typically unilateral/solitary exam (CBE) and visible with breast mammography.


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3. 4.

5.

6.

7.

lesions, 15 to 20 percent develop multiple nodules throughout lifetime; management includes mammographic spot compression and ultrasound, biopsy or excision.4-8 Lipoma – painless, ill-defined tumor; skin and nipple discharge may suggest cancer; management requires biopsy or excision.4-8 Fat necrosis – uncommon; associated with trauma; solitary, tender, ill-defined mass; if suspicious for malignancy following imaging, management requires biopsy or excision.4-8 Intraductal papillomas – polypoid epithelial tumors arising from ductal tissue; typically nonpalpable (range in size from two to five millimeters in size); may present with spontaneous nipple discharge (bloody, serous, or cloudy), management requires excisional biopsy.4-8 Mammary duct ectasia – most common in the fifth decade; arises from intraductal and periductal inflammation secondary to ductal dilation; mastalgia and tenderness, thick black or gray nipple discharge, and nipple retraction commonly; management requires biopsy.4-8 Galactocele – secondary to ductal obstruction or inflammation in breast feeding patient; cystic dilation of ducts containing milky secretions, may progress to acute mastitis and abscess (if left untreated), management requires fine needle aspiration and decompression.4-8

A thorough CBE, imaging studies, fine needle aspira­ tion and/or referral to a surgeon for breast biopsy may be required for complete evaluation of breast lesion(s), as benign disease may be difficult to distinguish from malignant processes. Furthermore, any patient complaint of a new breast mass and/or new or rapidly changing breast masses palpated by a provider must be evaluated further. Complete and proper docu­mentation are vital parts of the CBE. A useful diagram for documentation of the breast exam follows. Notice the division of the breast into quadrants, which includes the axillary tail. Also note the projection of the face of a clock onto the outline of the breast; this is another standard and useful way to conceptualize, document and communicate with other providers regarding the position, shape, size, consistency and mobility of a breast mass.4-8 (Figure 3) In addition to careful documentation of CBE findings, close follow-up of any patient with suspicious findings for malignancy is warranted. As multiple sources have reported that the “[f ]ailure to be impressed by physical findings and [the] subsequent failure to diagnose breast

12

12

Tail UOQ

UIQ

9

UIQ 3

LOQ

LIQ 6

Right Breast

Tail UOQ

9

3

LIQ

LOQ 6

Left Breast

FIGURE 3. Documenting Clinical Breast Exam Findings KEY: Tail – Axillary Tail of Spence; UOQ – Upper Outer Quadrant; UIQ – Upper Inner Quadrant; LOQ – Lower Outer Quadrant; LIQ – Lower Inner Quadrant3,6,7,9,12

cancer [have been] cited as the most common reasons for a delayed diagnosis of breast cancer and the most common reasons for litigation against physicians.” 9

What are the common symptoms of breast cancer? Due to the broadened usage of routine screening tests, many breast cancers are detected prior to the emergence of signs or symptoms of disease.4 Nevertheless, the most frequent complaint for those with symptoms is a palpable breast mass.4,6 A thorough breast exam is essential, as a CBE allows the provider to assess the characteristics of the mass. A unilateral/solitary lesion that is distinct from the surrounding breast tissue with a three-dimensional structure is characteristic of a dominant breast mass. Dominant masses may be benign or malignant; every new or rapidly growing dominant mass mandates close follow-up.5,7 Characteristics of the mass and the provider’s impression guide the next steps for assessment and management of the mass. Patients with breast complaints require a diagnostic mammogram and ultrasound to radiologically assess the area of concern. This type of imaging differs from the routine screening mammograms, which are ordered for asymptomatic patients to look for radiologic evidence of disease. As shown in the figure below, the average breast lesion doubles in size every one hundred days. Thus, the majority of breast cancers develop for a number of years prior to detection by imaging. Furthermore, radiologic signs of breast cancer, such as microcalcifications and/or presence of a visible lesion by mammography, typically appear several years prior to the emergence of a palpable breast mass. 1,6,7,10 (Figure 4)


1014 1013 1012 1011 1010 109 108 107 106 105 104 103 102 101 100

1 cm lesion

1 mm lesion Visible on mammography

Palpable lesion

Visible lesion Microcalc

Number of Cells

Physician Assistant Cancer Education 5

Unable to detect

0

1

2

3

4

5

6 7 Time (Years)*

8

9

10

11

12

FIGURE 4. Breast Cancer Symptoms. Based upon average doubling of 100 days. Modified from7

Breast ultrasound is helpful for distinguishing solid from cystic masses. Fluid aspirated from a cystic mass is sent to pathology for confirmation of a benign lesion. Patients with cyst aspiration should be examined two weeks later and then periodically to assess for recurrence, which would necessitate a biopsy of the area. Solid masses also require biopsy to distinguish benign from malignant masses. It is recommended that patients presenting with diffuse breast tenderness without a palpable dominant breast mass return for a subsequent CBE at a different time during the menstrual cycle. Diffuse tenderness of the breasts that fluctuates in a cyclical manner may be attributable to benign fibrocystic changes of the breast.6,7,10 Malignant masses may feel somewhat mobile in the early stages of development. In later stages, malignant masses become fixed to the surrounding ligamentous tissue and fascia, resulting in visible changes in the shape or contour of the breast and/or retraction of the nipple.4,6,7,11 A painless, hard, fixed mass with irregular or indistinct borders raises suspicion for malignancy.4,6,7,11 Additional signs of malignancy include: nipple discharge/pain, skin changes (irritation, erythema or flaking), generalized edema, peau d’orange, axillary edema or nodules, and/or lympadenopathy.1,3-7,11

What are the types of breast cancer? Carcinoma in situ is the earliest stage of cancer, classified as a precancerous lesion. Cellular atypia is present in carcinoma in situ lesions, but cellular invasion through the basement membrane has not yet occurred.5-7,11 Therefore, in situ lesions are considered a form of non-invasive breast cancer. Dependent upon the tissue of origin, such lesions are classified as either ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS). 5-7,11 DCIS is the more common than LCIS; nevertheless, women with both DCIS and LCIS are at increased risk for developing invasive breast cancer. 5-7,11 LCIS tends to be an “incidental� finding on imaging studies, as it typically occurs without any notable signs or symptoms on CBE. Furthermore, LCIS requires close surveillance, as it commonly reoccurs in either the ipsilateral or bilateral breast.5 Malignant breast processes are classified by location and histologic differences, and a single tumor may be comprised of mixed histologic cellular types. Cancers originating from glandular tissue, are classified as adenocarcinoma. Invasive breast cancers have spread through the basement membrane of the tissue of origin (typically either ductal or lobar) to infiltrate surrounding tissues.4-7


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The most common form of invasive breast cancer is called invasive ductal carcinoma. This type of tumor, accounting for between 70% to 80% of all breast cancers, originates within the ductal tissues of the breast.4,6 The second invasive type of breast cancer originates within the lobules of the breast, and is known as invasive lobular carcinoma. Invasive lobular carcinoma may be more difficult to detect with a routine screening mammogram. This is particularly true for patients with dense breast tissue and for lobular cancers that invade the upper outer quadrant and/or axillary tail of the breast (as this region is typically more difficult to image and more dense than the surrounding breast tissue).4,6 Inflammatory breast cancer is an aggressive form of breast cancer that accounts for just one to three percent of all breast cancers.11 Rather than being associated with a distinct mass, this form of breast cancer is often associated with skin changes, such as erythema, thickening, and dimpling.4,6 It is often mistaken for cellulitis or dermatitis in its earliest stages, leading to a delay in diagnosis. However, at later stages the breast may increase in size, become firmer, tender, or pruritic.4,6,8 This type of cancer has a higher propensity for metastasis, may strike younger patients, tends to be more common in African American females and carries a bleaker prognosis than invasive ductal carcinoma.4,8 The rarest forms of breast cancer, accounting for less than 10% of all of breast cancers combined, include medullary cancer, metaplastic tumors, mucinous carci­ noma, Paget disease of the nipple, Phyllodes tumor, tubular carcinoma, and angiosarcoma.4 (Table 1)

How is breast cancer typically managed? The selection of treatment for breast cancer varies according to the type and stage of the particular cancer. The goals of therapy are to control local disease and malignant metastasis to other organs and tissues through radiation, chemotherapy, hormonal therapy (tamoxifen for a maximum of five years in premenopausal and menopausal patients and raloxifene for menopausal patients), and surgical management as necessary. Another goal of treatment for any type of malignancy is to improve the patient’s quality of life by controlling pain and other symptoms associated with the disease and to avoid or alleviate unpleasant side effects of treatment regimens. Breast cancer patients are at higher risk for developing a new malignancy on the contralateral breast and are at risk for distant metastasis. As mentioned previously, breast cancer spreads via the lymphatic system. Metastatic disease is more difficult to treat and must be followed closely.5,7

Section II: Clinical Prevention and Epidemiologic Concepts This section will review the absolute and relative risk in order to gain a better understanding of these terms and how they are derived. An understanding of these terms is essential to interpreting epidemiologic data and the scientific literature. More on this topic can be found at the following website: http://www.cytyc.com/women/ women_breast_cancer_risk_types.shtml

TABLE 1. Histologic Classification of Breast Cancer7,12 Ductal • Intraductal (in situ) • Invasive/Infiltrating, with predominant intraductal component • Invasive, NOS • Comedo • Inflammatory • Medullary with lymphocytic infiltrate • Mucinous (colloid) • Tubular • Other

Lobular • In situ • Invasive/Infiltrating, with predominant in situ component • Invasive, NOS

Nipple

Other (atypical)

• Paget disease, NOS

• Phyllodes tumor

• Paget disease, with intraductal carcinoma

• Angiosarcoma

• Paget disease, with invasive ductal carcinoma

• Primary lymphoma


Physician Assistant Cancer Education 7

Next, the list of breast cancer risk factors listed previously will be further examined to provide greater detail for improved comprehension regarding nonmodifiable and modifiable risk factors for an individual patient.1, 3-6, 13 Absolute risk is the chance that an individual will develop a particular disease over a specified amount of time. This type of risk typically examines a group of similar individuals, stratifying them by one or two non-modifiable common risk factors applicable to a group (such as age or gender) without consideration of additional individual risk factors. Such estimates are derived by observing a large group and estimating the chance that someone with similar characteristics to the group will develop “X” disease, based upon the number of individuals from the large group that develop “X” disease over a specified time period. For example, the absolute risk for female patients within a certain age group to develop breast cancer is calculated by statistically analyzing public health data collected from a large group of female patients within the same age group that develop breast cancer over the specified time frame. The table below shows the most current absolute risk estimates for female patients in specified age groups.13 (Table 2) TABLE 2. Advancing Age as Risk Factor for Invasive Breast Cancer5 Age

Absolute Risk

≤ 39 Years

1 : 235

40 - 59 Years

1 : 25

60 - 79 Years

1 : 15

80 - 90 Years

1:8

Absolute risk estimates are reported in a variety of different ways depending upon the preference of the group reporting the data. This is often confusing to the public, as well as to providers. The estimate reported in the table above that one out of every 25 women aged 40-59 years develop breast cancer can be restated in a variety of ways. This same estimate can be stated as: a one in 25 risk, a risk of four out of every 100 women, a 4% risk, a 0.04 risk, or 1:25 (as given above). Thus, absolute risk must be considered in the context of the characteristics of the group and the similarity of the individual being compared to the group.5,13

The lifetime risk of similar individuals for a particular disease is often reported. According to sources from ACS and the National Cancer Institute (NCI), breast cancer will affect one in eight women during their lifetime.2,5,11 This statistic applies to non-Hispanic, Caucasian women and is a lifetime risk, or cumulative risk, estimate. In this case, cumulative risk is a subset of absolute risk, as the duration of time referenced is cumulative across the lifespan of women who are of non-Hispanic, Caucasian race/ethnicity. “As a result, this number will overestimate risk for women with no known risk factors and underestimate risk for those with identified risk factors.” 5,13 Thus, it is necessary to consider the timeframe from which absolute risk is defined and the characteristics of the group (age, gender, race/ethnicity) from which the data was derived for the estimated risk. Relative risk compares a group of affected/exposed individuals with the overall group that has not been affected by nor has been exposed to a particular risk factor. This type of risk comparison seeks to determine the difference in risk for the affected/exposed group in relation to the risk inherent in the average population (not known to be affected/exposed). In other words, relative risk compares two groups with differing characteristics. The chance that an individual with a specified risk factor has an increased risk of developing breast cancer is estimated by comparing a group of women with the risk factor (presence of a germline mutation) to a group of women without the same risk factor (absence of a germline mutation). The observed cases of breast cancer among each group are compared to determine the relative risk of breast cancer among the affected group as compared with the unaffected group.13 (Table 3) TABLE 3. Family History: Relative Risk5 Premenopausal

Postmenopausal

Unilateral

1.5 x Risk

3.1 x Risk

Bilateral

4.0 x Risk

8.8 x Risk

Modified from5

Relative risk may be reported as a risk ratio or as a percentage increase for those with a particular risk factor as compared with the general population. According to Table 3, the risk that an individual with a family history of bilateral premenopausal breast cancer will develop breast cancer herself is 4.0 times the risk of the general population (risk ratio). This may be


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restated as a relative risk of 400% (percentage increase), or may be expressed as a four-fold increase in risk for breast cancer. When considering relative risk, it is also important to possess an awareness of the risk level of the general population. This is especially relevant for rare diseases, conditions, exposures and/or risk factors. For example, a 400% increase for a rare condition that occurs just 0.5% of the time in the general population translates to an overall risk of 2%. In contrast, when considering the absolute risk of breast cancer for a female aged 40-59 years is 1:25, or 4%, a 400% increase for a female aged 40-59 years with a family history of premenopausal bilateral breast cancer translates to a 16% risk. 5,13

Breast cancer risk factors Non-modifiable risk factors include: • Female gender • Advancing age • Family history • Germline mutations • Race/ethnicity • Proliferative breast disease • Personal history of prior malignancy • Therapeutic radiation to the breast The most influential non-modifiable risk factors are female gender and advancing age. In fact, two-thirds of women diagnosed with breast cancer have no identifiable risk factors aside from female gender and advancing age.1,3-6 Almost 80% of invasive breast cancer is diagnosed in women after age 50 years, versus the 17% of women who are diagnosed during their forties.4 • Family history - Although the majority of invasive breast cancers occur sporadically, or by chance, it is important to identify those at higher than average risk for breast cancer by examining each patient’s family history of cancer. Patients with a positive family history of breast cancer (including documented germline mutations, hereditary and/ or familial patterns) require close surveillance for breast and related cancers due to increased risk for such disease states. Therefore, documentation of a thorough family history of cancer with a pedigree analysis is vital for individual patients encountered in the clinical setting.1,4,5,14 Additional information regarding the family pedigree is available from: https://familyhistory.hhs.gov/fhh-web/home.action A positive family history is defined as presence of a first degree relative (parent, sibling, child) with

breast cancer.4 A family history of breast cancer in two or more second degree relatives, family members with history of related endothelial cancers (prostate, ovarian), relatives with both breast and ovarian cancers, family members with bilateral breast cancer, breast cancer in male relatives, breast cancer diagnosis prior to age 50, and/or familial ancestry (e.g. Ashkenazi Jewish and Dutch Icelander populations) confer increased breast cancer risk for an individual.3-5 Families with a familial pattern of breast cancer have a greater number of breast cancer cases than expected for the general population. Furthermore, familial breast cancer does not always follow a clear pattern of inheritance, as other factors, such as environmental exposures and/or the influence of modifier genes may play a role in familial breast cancer.5,14 • Hereditary breast cancer – Germline mutations are associated with a small percentage of invasive breast cancer cases, on the order of five to ten percent. Cancer-predisposing mutations identified in the BRCA1 and BRCA2 genes follow an autosomal dominant pattern of inheritance. Although these genes have been referred to as the “breast cancer susceptibility genes,” BRCA1 and BRCA2 mutations also increase an individual’s risk for ovarian, prostate and other cancers.4,14 Alterations in tumor suppressor genes lead to many different types of cancers. Cowden’s Syndrome is associated with breast cancer and a defect in the PTEN tumor suppressor gene. The PTEN gene is responsible for aspects of cellular regulation, including apoptosis. “Mutations in the PTEN gene are documented in cancers of the breast, prostate, endometrium, ovary, colon, melanoma, glioblastoma and lymphoma.” 14,15 Li-Fraumeni Syndrome is an autosomal dominant condition associated with an increased risk of development for multiple types of cancers by the age of 50. This syndrome is also linked with alteration in a tumor suppressor gene, a mutation in the p53 allele.1,4,5,14 • Race/ethnicity – Non-Hispanic Caucasian American women are more likely than other racial/ ethnic groups within the U.S. to be diagnosed with breast cancer; yet breast cancer mortality rates for Asian American, Hispanic American, Native American and African American women are significantly higher than those for Non-Hispanic Caucasian American women. 1,4,10,16,17 Recent studies


Physician Assistant Cancer Education 9

have reported a higher frequency of aggressive, difficult-to-treat breast tumors in African American women, which may account for a portion of the discrepancy in mortality data between African American women and those of other racial/ethnic origin.16 In addition, a disproportionate number of members of racial/ethnic groups with higher mortality rates for breast cancer report substantial barriers to adequate healthcare. Reasons for limited access to quality healthcare/preventive services include: lack of affordable health insurance, inadequate insurance coverage for preventive healthcare, suboptimal adherence to screening guidelines, low literacy rates, lower household income, and a lower level of perceived vulnerability to developing cancer. Such barriers to healthcare translate into a higher incidence of preventable diseases and later-staged malignancies among affected populations. 1,6,11 • Proliferative breast disease - Breast changes resulting in increased density of the breast tissue, hyperplasia or proliferative disease with atypia, and/ or a history of a prior abnormal breast biopsy is associated with an increased risk of breast cancer.5-7 (Table 4) • Personal history of prior malignancy - A per­sonal history of breast cancer increases the likeli­hood of developing cancer in the remaining breast tissue by three to four times. This risk differs from the risk of recurrence of the primary cancer. 3-5 • Therapeutic radiation to the breast region Patients who have undergone radiation therapy to the chest or trunk have up to 12 times the normal

risk of developing breast cancer, and age at time of exposure influences the degree to which risk increases, with exposure during adolescence leading to the highest risk-increases as that is the time during which the breasts develop.4 Modifiable risk factors include: • Dietary and lifestyle • Carcinogenic environmental • Hormonal • Dietary and lifestyle factors - By limiting exposure to harmful factors, a patient’s relative risk for developing breast cancer is theoretically lowered.4 Alcohol use is a well-established cause of increased • as little as breast cancer risk, a risk that begins with one drink per day and increases as does the amount of alcohol consumed.3,4 The role of tobacco use on breast cancer risk is controversial, as many studies show a correlation between the two, whereas other studies do not confirm such increased risk.4 • Carcinogenic environmental factors - Also at increased risk are women who were exposed to diethylstilbestrol (DES) in utero, a drug commonly used in pregnant women between the 1940s and 1970s, to prevent spontaneous abortion.1,3,4 • Hormonal factors - Prolonged estrogen exposure is partially a modifiable and a non-modifiable risk factor for breast cancer. Factors contributing to estrogen exposure include: menarche prior to age 12 or menopause after age 55, nulliparity or first live birth after age 30, and obesity.3,4,6 Obesity raises breast cancer risk since adipose tissue produces a weak form of estrogen known as estrone.6

TABLE 4. Benign Breast Disease and Risk Assessment: Correlation with Breast Biopsy Pathology Results5 Risk Category

Benign Breast Disease Category

No Increased Risk

Adenosis, Apocrine change, Duct ectasia, Mild epithelial hyperplasia

Slightly Increased Risk (1.5 – 2.0 x Risk)

Moderate or florid epithelial hyperplasia, Papilloma without atypia, Sclerosing adenosis

Moderately Increased Risk (4.0 – 5.0 x Risk)

Atypical ductal (or lobular) hyperplasia, Micropapilloma with atypical hyperplasia

High Risk (8.0 – 10.0 x Risk)

Lobular carcinoma in situ (LCIS), Ductal carcinoma in situ (DCIS), Large papilloma with atypical hyperplasia

Modified from5


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Conversely, pregnancy prior to age 30 and breast feeding may decrease breast cancer risk due to the interruption in the menstrual cycle.4,6 The use of supplemental estrogen or combination estrogen and progesterone for relief of menopausal symptoms, hormone replacement therapy (HRT), has likewise been linked to increased rates of breast cancer.1,3,4,6,8 Patients and providers alike must understand that a woman is still at risk for breast cancer even after stopping HRT, and must continue routine screening.10

Mathematical models of risk assessment for breast cancer Several models exist to estimate individual risk for breast cancer. The Gail Model and the Breast Cancer Risk Assessment Tool utilize the past medical history of an individual to determine the five-year and lifetime risk of an individual for developing invasive breast cancer. This model does not apply to individuals with evidence of a genetic mutation, LCIS, DCIS, or history of a prior breast cancer. Furthermore, the Gail Model has only been validated for Caucasian women. Research is currently underway to develop statistical prediction models with potential for broader application.5,18

SECTION III: Statewide Statistics Texas Cancer Plan Established in 1985, the Texas Cancer Council is charged with the responsibility for developing and implementing the Texas Cancer Plan.19 This “statewide blueprint for cancer prevention and control in Texas… provides a planned, evidence-based approach to reducing the impact of cancer on Texans.” The Texas Cancer Plan outlines five comprehensive goals which, when accomplished, will yield a significant decrease in the effects of cancer upon the state of Texas and its citizens.19 The first objective listed under the “Goal II: Early Detection and Treatment” emphasizes the need to “increase appropriate utilization of effective cancer screening services.” Originating from this need, the statewide Breast and Cervical Cancer Control Program (BCCCP) was created with funds from the state of Texas and the Center for Disease Control (CDC). The BCCCP, operated by the Department of State Health Services (DSHS), serves women in Texas who possess limited resources (living 200% below the federal

poverty level) and have limited access to preventive healthcare services.19 As one of the largest statewide cancer screening programs in the nation, the BCCCP provides breast and/or cervical cancer education, screening, and diagnostic services to approximately 20,000 women on an annual basis through more than 300 clinical sites. Nonetheless, the DSHS estimates that the program reaches just a fraction (less than 3%) of those eligible to receive such preventive services within Texas.19,20 The 2003 Action Plan on Breast and Cervical Cancers for Texas noted a significant increase in the percentage of women receiving Pap tests within the previous three years, as compared with similar figures from the previous decade.20

Texas Cancer Registry The Texas Cancer Registry (TCR) is a database of statewide statistics collected and maintained by a branch of the Texas Department of State Health Services, whose mission is “to contribute significantly to the knowledge of cancer for use in reducing the cancer burden in Texas.” 21 According to TCR’s 2004 Cancer Facts & Figures report, breast cancer is the most common cancer among female Texans across all race and ethnicity groups. The vast majority of breast cancer occurs in women over the age of 50 years in Texas, as throughout the nation. The 2004 report states that over 11,000 cases of invasive breast cancer are diagnosed annually and that approximately 2,500 women die of breast cancer each year in Texas. Approximately six of every ten cases of female breast cancer in Texas are detected at early stage (in situ and localized).21 A racial/ethnic disparity is evident when pooling incidence and mortality figures related to breast cancer in Texas. The vast majority of breast cancer cases occur in non-Hispanic white female Texans. Between the reporting years 1997-2001, some 50,000 cases of breast cancer were reported in this group during the five year timeframe. By comparison, fewer than 10,000 cases of breast cancer reportedly occurred during the same five years in Hispanic females, and just over 6,000 cases were reported in female Texans that identified themselves as African American. Astonishingly, approximately 40 percent of the deaths attributed to breast cancer in Texas occurred in African Americans, while non-Hispanic white females and Hispanic females accounted for 26 percent and 20 percent of the breast cancer deaths, respectively. Such incidence and mortality patterns are reflective of those reported


Physician Assistant Cancer Education 11

throughout the country between racial/ethnic groups. According to the TCR report, such findings “may suggest major differences in early diagnosis, treatment, and other risk factors influencing this disease.” African American and Hispanic females in Texas are significantly more likely to be diagnosed with a latestaged breast cancer as compared with non-Hispanic white females, who are “more likely to be diagnosed when the disease is at its earliest stage.” 21 The cancer incidence data above was provided by the Texas Cancer Registry (TCR), Cancer Epidemiology and Surveillance Branch, Texas Department of State Health Services, 1100 W. 49th Street, Austin, Texas, 78756,://httpwww. dshs.state.tx.us/tcr/default.shtm

SECTION IV: Breast Cancer Screening Programs Why screen for breast cancer? The average breast tumor is present and slowly growing for up to nine years prior to reaching a palpable size of one centimeter, yet earlier changes such as microcalcifications and smaller lesions are visible on mammography up to three years sooner.1,3-7 Early detection, through routine screening, has a tremendous impact upon a patient’s long-term prognosis, treatment, and management.1,4 It enables healthcare providers to detect cancer at an earlier, asymptomatic stage, when treatments have been proven more successful, as there is less time for metastasis to occur.1,4,6,8 Several screening modalities are available to detect cancerous changes of the breast.

What methods are utilized for breast cancer screening? Several screening modalities are available to detect cancerous changes of the breast. Breast self exam (BSE) is performed by the patient, preferably on a monthly basis following menses; whereas, the CBE is performed by a healthcare professional and generally occurs on an annual basis. The CBE consists of thorough inspection and palpation of breast tissue, including the axilla, and lymph nodes.3,4,6,8 The gold standard modality for breast cancer screening is mammography.3,4,11 A screening mammogram requires taking several x-rays of the breast which can detect microcalcifications, benign breast disease, and invasive carcinoma.3 Digital mammography is becoming more widely available and is similar

to conventional mammography, except the images captured are stored electronically, allowing the radiologist to manipulate and enhance the images to increase the accuracy of interpretation.3,4,11 The use of magnetic resonance imaging (MRI) in breast cancer screening and diagnosis is relatively new and continues to expand. MRI is able to display breast tissue in greater detail than mammography and as such, can detect cancers that might otherwise be missed. Because MRI has a low specificity, there are a high number of false positives, leading to an increased number of biopsies and other invasive testing, as well as undue anxiety.4,22,23 Alternatively, diagnostic imaging is indicated when either the patient or healthcare provider detects a breast lump, nipple discharge, or other finding suspicious for cancer.3,4,6,8 Ultrasound is particularly useful in determining whether the composition of a mass is cystic or solid, and simple or complex and is commonly ordered for further definition of suspicious areas following an abnormal or inconclusive screening mammogram.3 Diagnostic mammography incorporates additional radiologic views for a more thorough evaluation of the breast, as compared with a screening mammogram.3,4,6,8

Who issues breast cancer screening guidelines? In an effort to have the greatest effect while making the best use of available resources in the public health arena, various organizations have issued evidencebased, consensus guidelines for breast cancer screening. These guidelines contain recommendations for the most appropriate screening modality, optimal age to initiate screening, and the most favorable frequencies at which to screen both average-risk and high-risk patients for breast cancer and its precursor lesions.4,11,23,24 The breast cancer screening guidelines in Table 5 include those published by the following agencies/organizations: The United States Preventive Services Task Force (USPSTF), sponsored by the Agency for Healthcare Research and Quality (AHRQ), is an “independent panel of private-sector experts in prevention and primary care…” that reviews and evaluates epidemiologic data and guidelines from other agencies and organizations within the U.S. to reach a consensus regarding the “preventive services [that] should be incorporated routinely into primary medical care.” The panel uses a population-based model as the basis for its prevention recommendations.23


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The American Cancer Society (ACS) is “a nationwide, community-based voluntary health organization dedicated to eliminating cancer as a major health problem by preventing cancer, saving lives, and diminishing suffering from cancer, through research, education, advocacy, and service…In addition to cancer prevention, the Society focuses on a variety of early detection programs and encourages regular medical checkups and recommended cancer screenings.” 4

The American College of Obstetricians and Gynecologists (ACOG) is a professional organization of approximately 50,000 physicians who provide healthcare to women in the U.S. ACOG is committed to the areas of education, research, practice and advocacy for women’s health issues.24

What are the most current breast cancer screening guidelines? TABLE 5. Breast Cancer Screening Recommendations

USPSTF (23)

Age 40 yrs Age to Initiate Screening

Preferred Screening Modality

Screening Mammography with or without CBE

ACS (4) Average-Risk: Age 40 yrs High-Risk: Age 30 yrs -OR10 yrs prior to earliest breast cancer in family (whichever is earliest)

Age 40 yrs

Screening Mammography with CBE

Screening Mammography with CBE

Every 1 to 2 yrs Annually Screening Frequency

Insufficient evidence to recommend for or against routine CBE alone as screening

Ages 20 – 39 yrs: Recommend CBE every 3 years

May be used as adjunct to mammography every 1-2 yrs. over age 40

Age 40 yrs and above: Annually with screening mammography

CBE Recommendation

Insufficient evidence to Recommended beginning recommend for or against at age 20 years teaching/performing SBE

SBE Recommendation

Other (MRI)

ACOG (24)

Ages 40-49 yrs: Every 1 to 2 yrs Age 50 yrs and above: Annually with screening mammography Recommended annually for ALL women

Recommended monthly for ALL women (despite a lack of definitive data for or against SBE, it has the potential to detect palpable breast cancer)

No official recommendation Consider adding MRI No official recommendation issued regarding use of MRI as an adjunct to mammog- issued regarding use of MRI for breast cancer screening raphy on an annual basis for breast cancer screening


Physician Assistant Cancer Education 13

SECTION V: Case Studies

TS, a 37-year-old, Caucasian, G4P3013 woman with a past medical history of hypertension and obesity (BMI 30.5), presents to the office for an annual well CASE #1 woman examination complaining of “constant exhaustion.” Current medications include a multivitamin, hydrochlorothiazide 25mg, and an oral contraceptive. Menarche was at age 13, menses occur at regular 28-day intervals without intermenstrual spotting, heavy bleeding, clotting, or pelvic pain on oral contraceptives for “past few years.” She denies history of abnormal Pap smears or sexually transmitted infections. Her children are ages 13, 9, and 7—all vaginal deliveries without complications. She had one spontaneous abortion 4 years ago at 8 weeks gestation. She denies family history of breast, colorectal, endometrial, prostate, or ovarian cancers. She performs monthly breast self-exams, has yearly clinical breast and pelvic exams, and has never had a mammogram. Ms. Smith has been married for the past 15 years, is a graduate of technical school, has worked as a full-time secretary for 9 years, and is in the middle class socioeconomic group. She does not exercise at all and her diet is low in fiber, high in fat, and lacks the recommended amount of fruits and vegetables. She sleeps 5 to 6 hours nightly. She denies ever using tobacco products, illicit drugs, and prescription drug abuse. She admits to “occasional” consumption of alcohol­—averaging 5 servings monthly, with no more than 2 servings daily. Select the letter corresponding to your answer for the following multiple-choice questions based upon your current risk assessment practice standards and understanding of current cancer screening guidelines. 1. How do you classify this patient’s risk for breast cancer? A. Average risk B. High risk C. Insufficient information 2. Which variables below influenced your classification of this patient’s risk for breast cancer? (select all that apply) A. Adherence to screening guidelines B. Age at menarche

C. Age at menopause D. Age of first live birth of child E. Alcohol and tobacco use history F. Benign breast disease G. Body mass index H. Diet/exercise habits I. Education level J. Ethnicity/race K. Family history L. Gender M. Patient age N. Prior breast biopsies O. Religious beliefs P. Socioeconomic status Q. Use of artificial hormones (oral contraceptives, hormone therapy) 3. Which screening test(s), if any, would you recommend for this patient? (select all that apply) A. Diagnostic mammography plus ultrasound B. Mammography only C. Mammography plus MRI of the breast D. None indicated at this time 4. Which of the following genetic test(s), if any, would you refer this patient for at this time? (select all that apply) A. BRCA-1 B. BRCA-2 C. Hereditary non-polyposis colorectal cancer (HNPCC) D. None of the above LB, a 58-year-old, African American, postmenopausal, G4P4004 woman with past medical history of diabetes mellitus—type II, obesity (BMI 33.6), CASE #2 hypertension, dyslipidemia and atypical endometrial hyperplasia (status post total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH/BSO) 5 years ago), presents to the office today for an annual well woman examination without current complaints. Current medications include metformin 500 mg three times daily, NPH insulin 30 units in the morning and 20 units in the evening, metoprolol 100 mg twice daily, lisinopril 40 mg daily, and Crestor 10 mg daily. Menarche was at age 14


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years, menopause was confirmed at age 52 years. She denies history of abnormal Pap smears and sexually transmitted infections. Her children are ages 41, 38, 36, and 33 years—all vaginal deliveries without complications. She has a positive family history of two maternal aunts with breast cancer (postmenopausal), mother with colorectal cancer at age 60, and father with prostate cancer at age 62; she denies family history of ovarian cancer or endometrial cancer. She does not perform monthly self breast exams, although does report annual clinical breast and pelvic exams, with mammograms every 2 years since age 43. She was married for 25 years, divorced for the past 15 years, did not graduate high school, has been employed as a custodian, is currently unemployed. She exercises by walking 2 to 3 times weekly with neighbors and began following the diabetic diet once diagnosed with diabetes 4 years ago. She sleeps 7 to 8 hours nightly. She admits to smoking tobacco cigarettes for 22 years, and quit smoking 18 years ago. She denies ever using illicit drugs, alcohol and prescription drug abuse. She enjoys spending time with family, neighbors and friends from her local church. Select the letter corresponding to your answer for the following multiple-choice questions based upon your current risk assessment practice standards and understanding of current cancer screening guidelines. 1. How do you classify this patient’s risk for breast cancer? A. Average risk B. High risk C. Insufficient information 2. Which variables below influenced your classi­ fication of this patient’s risk for breast cancer? (select all that apply) A. Adherence to screening guidelines B. Age at menarche C. Age at menopause D. Age of first live birth of child E. Alcohol and tobacco use history F. Benign breast disease G. Body mass index H. Diet/exercise habits I. Education level J. Ethnicity/race K. Family history

L. Gender M. Patient age N. Prior breast biopsies O. Religious beliefs P. Socioeconomic status Q. Use of artificial hormones (oral contraceptives, hormone therapy) 3. Which screening test(s), if any, would you recommend for this patient? (select all that apply) A. Diagnostic mammography plus Ultrasound B. Mammography only C. Mammography plus MRI of the breast D. None indicated at this time 4. Which of the following genetic test(s), if any, would you refer this patient for at this time? (select all that apply) A. BRCA-1 B. BRCA-2 C. Hereditary non-polyposis colorectal cancer (HNPCC) D. None of the above SM, a 46-year-old, Latin American, G3P2012 woman with past medical history of allergic rhinitis, eczema, migraine headaches, fibrocystic CASE #3 breast changes and uterine fibroids, presents to the office today for an annual well woman examination complaining of increased heavy menstrual bleeding. Current medications include fenofexadine and a “nasal spray” daily, with Imitrex and ibuprofen taken as needed (prn). Menarche at age 11 years, menses occur at 28 to 32-day intervals with quarter to lemon-sized clots and heavy menses for 5 to 7 days during past 6 months. She denies abnormal Pap smears and sexually transmitted infections. She has never taken oral contraceptives and relies upon “natural family planning” for contraception. Her children are ages 14 and 11 years —both delivered by caesarean section; she reports one voluntary termination of pregnancy. Family history is negative for breast, endometrial, prostate and ovarian cancers; both she and her twin sister have had multiple benign breast biopsies and reports a history of colorectal cancer in both grandfathers in “old age.” She performs monthly self breast exams, has yearly clinical breast and pelvic exams, and began annual mammograms at age 40 years. SM has been married for the past 17 years, has practiced family law for 20 years; became partner in the law firm 8


Physician Assistant Cancer Education 15

years ago, and is in the upper-middle socioeconomic class. She maintains an extensive exercise regi­ men, involving running, biking, swimming and competition in triathlon events; she also follows a strict, nutrient-rich diet and sleeps 8 hours a night. She denies ever using tobacco products, illicit drugs, and abuse of prescription drugs. She admits to “frequent” consumption of “small amounts” of alcohol—which she describes as a “glass of red wine with dinner” 4 to 5 times a week. Select the letter corresponding to your answer for the following multiple-choice questions based upon your current risk assessment practice standards and understanding of current cancer screening guidelines. 1. How do you classify this patient’s risk for breast cancer? A. Average risk B. High risk C. Insufficient information 2. Which variables below influenced your classification of this patient’s risk for breast cancer? (select all that apply) A. Adherence to screening guidelines B. Age at menarche C. Age at menopause D. Age of first live birth of child E. Alcohol and tobacco use history

F. Benign breast disease G. Body mass index H. Diet/exercise habits I. Education level J. Ethnicity/race K. Family history L. Gender M. Patient age N. Prior breast biopsies O. Religious beliefs P. Socioeconomic status Q. Use of artificial hormones (oral contraceptives, hormone therapy) 3. Which screening test(s), if any, would you recommend for this patient? (select all that apply) A. Diagnostic mammography plus Ultrasound B. Mammography only C. Mammography plus MRI of the breast D. None indicated at this time 4. Which of the following genetic test(s), if any, would you refer this patient for at this time? (select all that apply) A. BRCA-1 B. BRCA-2 C. Hereditary non-polyposis colorectal cancer (HNPCC) D. None of the above


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SECTION V: Case Studies: ANSWERS Breast Case Study 1: 1. A. Average risk 2. G. Body mass index H. Diet/exercise habits L. Gender 3. D. None indicated at this time 4. D. None of the above Breast Case Study 2: 1. A. Average risk 2. G. Body mass index J. Ethnicity K. Family history L. Gender M. Patient age 3. C. Mammography only 4. D. None of the above

Breast Case Study 3: 1. B. High risk 2. B. Age at menarche D. Age of first live birth of child F. Benign breast disease N. Prior breast biopsies 3. C. Mammography plus MRI of the breast 4. D. None of the above


Physician Assistant Cancer Education 17

SECTION VI: Counseling Patients Regarding Screening Outcomes Which patients benefit from genetic counseling and testing due to breast cancer risk? Genetic counseling is essential prior to genetic testing. In addition to taking a thorough family history and constructing a detailed family pedigree, genetic counselors review probability statistics for genetic mutation, positive and negative aspects associated with genetic testing, and current management options for patients found to have a genetic mutation. The most common tests ordered for those with a suspected germline mutation due to significant family history of breast and related cancers are the “breast cancer susceptibility genes,” BRCA-1 and BRCA-2.5 Multiple groups have published guidelines to assist primary care providers in determining which patients warrant referral for genetic counseling and testing. Consensus guidelines do not currently exist for this purpose.25 Patients at The University of Texas M. D. Anderson Cancer Center with the following criteria are referred for genetic counseling and testing: 1) More than two relatives with breast or ovarian cancer diagnosis prior to age 50; 2) One relative with breast and ovarian cancer; 3) One relative with bilateral breast cancer prior to age 50; 4) One male relative with breast cancer; 5) Ashkenazi Jewish ancestry with breast or ovarian cancer in the family.5 Various checklists have also been devised to determine a risk threshold for genetic counseling referral. A computer program called “Risk Assessment in Genetics” estimates individual risk based upon family history of breast and ovarian cancer and generates a pedigree. This computer program was designed for primary care populations and has been validated for use in the U.S. and among general practitioners in the United Kingdom.25,26 According to the USPSTF, “…the evidence base for genetic risk assessment and BRCA mutation testing for breast and ovarian cancer

susceptibility as a screening strategy is limited by lack of studies demonstrating effectiveness, biases inherent in studies conducted in highly selected populations, and incomplete information on adverse effects.” 23,25

Risk Reduction The Selective Estrogen Receptor Modulator (SERM) medications tamoxifen and raloxifene are utilized as chemoprevention for patients with BRCA1 and/ or BRCA2 mutations. Tamoxifen was approved by the FDA as chemoprevention for premenopausal and postmenopausal patients; the drug is typically taken for up to five years for those taking it for chemoprevention. Research has shown a fifty percent decrease in invasive breast cancer cases in those taking tamoxifen for up to a five year time span. Tamoxifen is also used to treat DCIS and for estrogen receptor positive invasive breast cancers. Another SERM, raloxifene, has been FDA approved for osteoporosis prevention and treatment, for fracture prevention, and for risk reduction for invasive breast cancer in postmenopausal breast cancer.5 Prophylactic surgical procedures, such as mastectomy [removal of breast tissue] and oophorectomy [removal of ovaries] are quite effective at risk reduction. Bilateral prophylactic mastectomy is 90% effective at reducing breast cancer risk for those with genetic mutations and/or LCIS. Ten percent of those who undergo prophylactic mastectomy develop breast cancer in the residual breast tissue that remains in the chest wall, skin or axillary region.5 Prophylactic bilateral oophorectomy performed by age 35 years reduces breast cancer risk by 50% to 70%.5 Extensive patient counseling is mandatory prior to prophylactic procedures. The consequences associated with prophylactic procedures are considerable: prophylactic mastectomy is linked with an altered body image and prophylactic oophorectomy leads to early surgical menopause. 5


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SECTION VII: Integration/Clinical Correlation

THE OFFICE VISIT This simulated office visit is designed to take you through the process of the steps that are necessary to implement breast cancer screening, to make recommendations for your individual patient based upon the evidence-based guidelines, to counsel your patient appropriately according to risk factors, test results and suggest appropriate follow-up evaluation, which may include a referral to another healthcare provider.

Patient Intake Process Chief Complaint (CC): BY is a 50-year-old Caucasian woman presenting to your family practice as a new patient “to check on her blood pressure, cholesterol, and thyroid.� Next Steps: BY fills out the standard intake forms. She is then escorted to the examination room by the medical assistant who confirms the reason for the patient visit, takes vital signs and prepares BY to been seen by the provider.


Physician Assistant Cancer Education 19

PATIENT INTERVIEW 1.

What specific elements of the past medical history are pertinent? (select all that apply) A. Childhood illnesses B. Adult illnesses C. Obstetric/gynecologic D. Accidents/injuries E. Surgeries/hospitalizations F. Medications/allergies

2.

What specific elements of the family history are pertinent? (select all that apply) A. Parental illnesses B. Sibling illnesses C. Children illnesses D. Cause/age of death-1st degree relatives E. Cancer-related history F. Psychiatric history

3.

What specific elements of the prevention history are pertinent? (select all that apply) A. Diet and exercise B. Tobacco, alcohol and illicit drug use C. Sexual history D. Sunscreen usage E. Environmental exposures F. Screening tests G. Immunization

4.

Which components of the review of systems are pertinent? (select all that apply) A. General B. Skin, Hair, Nails C. Head, Eyes, Ears, Nose/Sinuses, Mouth/Throat D. Neck E. Breast F. Cardiovascular G. Respiratory H. Gastrointestinal I. Genitourinary J. Musculoskeletal K. Neurological L. Psychiatric M. Endocrine


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Additional Historical Information HPI: BY is a 50-year-old Caucasian woman with past medical history of hypertension, hyper­cholestero­ lemia and hypothyroidism who presents to your family practice today as a new patient “to check on her blood pressure, cholesterol and thyroid.” She has not seen a medical provider for the past two years and reports that she has generally been in “good health” since her last medical visit, after which she began a “low salt/low fat diet” and began walking “occasionally” for exercise due to the doctor’s recommendation in an attempt to control her blood pressure and cholesterol levels. She also ran out of her thyroid medication “sometime last year” and did not follow-up sooner due to her recent divorce and busy teaching schedule. She admits general fatigue at unspecified times and shortness of breath when walking “in the heat,” which she avoids to prevent symptom. She denies shortness of breath at rest, at night, and while lying flat. She sleeps six to eight hours nightly on one pillow without difficulty. She also reports a 15 pound weight gain during the past year, which she attributes to an increased appetite, difficulty “staying on her diet,” and discontinuation of her thyroid medication. She denies chest pain, fainting, edema, cough, wheezing, fever, chills, sweats, weakness and malaise. PMH: Adult illnesses 1. Hypertension – since 1999 – no medications – “controlled with diet and exercise” 2. Hypercholesterolemia – since 2005 – no current medications, though previously taken 3. Hypothyroidism – since 1989 – began during pregnancy – has taken levothyroxine intermittently since then – none for past year – dosage unknown Obstetric G2P1011 - two pregnancies, one miscarriage, one living child (age 19) 1989 - vaginal delivery without complications Gynecologic Menarche age 14; last menstrual period three months ago, reports irregular menses intermittently for past year, duration of flow 5 to 7 days ranging from heavy to light “depending on how long it has been since the last period” Hospitalizations 1990 - Childbirth – vaginal without complications Medications No prescription medications taken currently, over-the-counter (OTC) medications include a multivitamin and baby aspirin –daily, ibuprofen and “Tums” – as needed Allergies Sulfa – rash Family history: Father – deceased, age 62, massive myocardial infarction; also history of hypertension, hypercholesterolemia and substance abuse


Physician Assistant Cancer Education 21

Additional Historical Information (continued) Mother – deceased, age 64, metastatic breast cancer; also history of hypertension, hypercholestero­ lemia, anxiety and depression Two brothers – ages 58, 56 – both living, with history of hypertension and hypercholesterolemia One sister – age 54 – living, with ovarian cancer – currently under treatment Prevention: Screening tests Last Pap test and mammogram were two years ago – denies any abnormal screening tests in past. ROS: Gen - Fatigue (see HPI) Breast – Denies nipple discharge, mastalgia, does not perform breast self examinations. CV - Shortness of breath while walking (see HPI) Resp - Shortness of breath (see HPI) GI - Occasional gas/bloating and indigestion/heartburn – relieved with “Tums.” Denies nausea, vomiting, diarrhea, constipation, change in bowel habits, abdominal pain, pain with swallowing. GU - Occasional nocturia. Menstrual irregularity during past year (see GYN history). Denies dysuria, incontinence, hematuria, urinary frequency, vaginal discharge, genital lesions, decreased libido. Musculoskeletal - Reports stiffness, back and joint pain “at times.” Denies joint swelling, muscle cramps or weakness. Neurological - Occasional headache – relieved with ibuprofen and rest. Denies history of migraine, tremors, vertigo, numbness, seizures, weakness. Psychiatric - Reports increased anxiety since divorce six months ago. Denies depression, memory loss, suicidal or homicidal ideation, delusions, hallucinations. Endocrine - Admits increased appetite, heat and cold intolerance (see HPI and PMH). Denies polydipsia or polyuria.


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Physical Examination 5. Which 9 of the physical examination components and/or body systems below will you focus upon during the physical examination? A. General H. Thorax/Lungs B. Vital Signs I. Abdominal C. Skin/Hair/Nails J. Pelvic D. Head/Eyes/Ears/Nose/Throat K. Rectovaginal E. Neck L. Musculoskeletal F. Breast M. Neurological G. Cardiovascular (CV)


Physician Assistant Cancer Education 23

Physical Examination Findings GEN: Obese female, no acute distress, appears stated age VS:

BP – 158/98, RR – 18, P – 82 Weight – 226 lbs./height – 5’5”

Neck: Thyroid not enlarged, no masses, nontender; no palpable lymph nodes Breast: Fibrocystic changes bilaterally without discrete palpable masses, nontender bilaterally, no asymmetry, no nipple discharge, no skin changes, no dimpling, no palpable lymph nodes CV: Regular rate and rhythm without murmurs, rubs, gallops TL: Clear to auscultation bilaterally, no adventitious sounds, nonpalpable lymph nodes ABD: Skin-colored stria present lower abdominal quadrants, nondistended, normal bowel sounds in all four quadrants, nontender to light and deep palpation, without masses or organomegaly Pelvic:

Vulva – Slightly atrophic in appearance, without lesions or palpable masses, no color changes Vagina – Redundant tissue without lesions, slight mucous-like discharge Cervix - Parous, without lesions, no cervical motion tenderness Uterus - Retroverted, retroflexed, not enlarged, nontender, no palpable masses Adnexa - Nontender without palpable masses

NEURO: Mini-mental status exam (MMSE) 30/30, CN I-XII intact bilaterally, sensation intact throughout, finger-to-nose and rapid-alternating-movements accomplished with adequate precision, steady gait, negative Romberg, Babinski not present, reflexes intact.


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Breast Cancer Risk Assessment & Stratification Select the letter corresponding to your answer for the following multiple-choice questions, based upon your current risk assessment practice standards and understanding of current cancer screening guidelines. 6. How do you classify this patient’s risk for breast cancer? A. Average risk B. High risk C. Insufficient information 7. Which variables below influenced your classification of this patient’s risk for breast cancer? (select all that apply) A. Adherence to screening guidelines B. Age at menarche C. Age at menopause D. Age of first live birth of child E. Alcohol and tobacco use history F. Benign breast disease G. Body mass index H. Diet/exercise habits I. Education level J. Ethnicity/race K. Family history L. Gender M. Patient age N. Prior breast biopsies O. Religious beliefs P. Socioeconomic status Q. Use of artificial hormones (oral contraceptives, hormone therapy) 8. Which screening test(s), if any, would you recommend for this patient? (select all that apply) A. Diagnostic mammography plus ultrasound B. Mammography only C. Mammography plus MRI of the breast D. None indicated at this time 9. Would you refer this patient for genetic counseling and testing? A. Yes B. No C. Unsure


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Breast Cancer Screening Results Radiologic Interpretation Patient: BY Patient ID: XXXX Birthdate: 06/12/1958 Exam Description MAMMO SCREENING BILAT

Ordering Physician: XX Radiologist/Transcript.: XX/xx Reason for Exam: Routine Screening Exam Date

Exam Time

Order #

Exam Code

12/05/20xx

1300

XXXX

21525

Clinical History: 50-year-old Caucasian woman with fibrocystic breast changes bilaterally for routine screening. CC and MLO views of each breast were obtained. Prior studies not available for comparison. Breast parenchyma is dense radiographically. No underlying mass, architectural distortion, or suspicious calcifications seen in either breast by mammography. IMPRESSION: 1. NO EVIDENCE OF MALIGNANCY BILATERALLY. 2. RECOMMEND ROUTINE FOLLOW-UP MAMMOGRAM BILATERALLY IN ONE (1) YEAR. BIRADS-2, BENIGN. Electronically signed by/on: XX

12/05/20XX

Ordered: XX Completed: 12/05/20xx 1300 Dictated by: XX Transcribed by/on: xx 12/05/20xx Report Status: Final THIS REPORT IS VERIFIED AND FINALIZED ONLY IF SIGNED BY A RADIOLOGIST.


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Breast Cancer Screening Follow-Up BY returns to your office two weeks after the screening mammogram for a blood pressure check and to discuss laboratory and mammography results. After discussing cholesterol and thyroid laboratory results and medication changes, you discuss mammography results with BY. You discuss the following with BY: 1.) Mammogram does not show evidence of malignancy; 2.) Mammogram is consistent with the bilateral fibrocystic breast changes that were palpated by CBE and were discussed last visit; 3.) Increased density of breast parenchyma decreases the sensitivity of the mammogram; 4.) Re-emphasize the importance of SBE, prompt reporting of emergence of dominant breast mass, increased or persistent mastalgia, skin changes or dimpling and commitment to well-woman care and routine screening. During the visit, BY reports that her sister was diagnosed with breast cancer last week and that she is quite concerned about her risk for developing breast or ovarian cancer. You review BY’s family history and note that BY’s sister is also currently undergoing treatment for ovarian cancer. You probe further into the death of BY’s mother from “metastatic breast cancer” at age 64 years and discover that the breast cancer was bilateral. You reassess BY’s risk and discuss your follow-up recommendations with her. Application Activity: Utilize the National Cancer Institute’s online Breast Cancer Risk Assessment Tool18 to determine BY’s 5-year and lifetime breast cancer risk. Available from: http://www.cancer.gov/bcrisktool/ Questions: 10. What is BY’s 5-year breast cancer risk is in which of the following ranges according to the Breast Cancer Risk Assessment Tool?18 A. 0.5 – 0.8% D. 1.7 – 2.0% B. 0.9 – 1.2% E. 2.1 – 2.4% C. 1.3 – 1.6% 11. What is BY’s lifetime breast cancer risk is in which of the following ranges according to the Breast Cancer Risk Assessment Tool?18 A. 10.5 – 11.8% D. 15.7 – 17.0% B. 11.9 – 13.2% E. 17.1 – 20.4% C. 13.3 – 15.6% 12. How do you classify this patient’s risk for breast cancer according to results from the Breast Cancer Risk Assessment Tool?18? A. Average risk B. High risk C. Insufficient information 13. Does this risk classification differ from your previous risk assessment? A. Yes – it’s different B. No – it’s the same 14. Would you refer this patient for genetic counseling and testing? A. Yes B. No C. Unsure


Physician Assistant Cancer Education 27

Breast Cancer Genetic Counseling You refer BY to genetic counseling to review: • Family history • Probability statistics for cancer-susceptibility mutation • Pros and cons associated with genetic testing • Current management options for those with cancer-susceptibility mutation Following genetic counseling, BY chooses to undergo testing for the breast cancer susceptibility genes, BRCA1 and BRCA2. BY tests positive for BRCA2. 15. Which of the following would be an appropriate next step for BY? (select all that apply) A. Bilateral Breast Biopsy B. Magnetic Resonance Imaging (MRI) C. Referral to Breast Surgeon and/or Oncologist D. Continue yearly screening


28 BCM School of Allied Health Sciences - Physician Assistant Program

SECTION VII: Integration/Clinical Correlation: Answers 1. B. Adult Illnesses C. Obstetric/Gynecologic E. Surgeries/Hospitalizations F. Medications/Allergies 2. A. Parental illnesses B. Sibling illnesses D. Cause/age of death-1st degree relatives E. Cancer-related history 3. F. Screening tests 4. A. General E. Breast F. Cardiovascular G. Respiratory H. Gastrointestinal I. Genitourinary J. Musculoskeletal K. Neurological L. Psychiatric M. Endocrine 5. A. General B. Vital Signs E. Neck F. Breast

G. Cardiovascular (CV) H. Thorax/Lungs I. Abdominal J. Pelvic M. Neurological 6. A. Average risk 7. A. Adherence to screening guidelines B. Age at menarche D. Age of first live birth of child K. Family history L. Gender M. Patient age 8. B. Mammography only 9. B. No 10. D. 1.7 – 2.0% 11. D. 15.7 – 17.0% 12. B. High Risk 13. A. Yes – it’s different 14. B. Yes 15. B. Magnetic Resonance Imaging (MRI) AND/OR C. Referral to Breast Surgeon and/or Oncologist


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SECTION VIII: References 1. American Cancer Society. Cancer Facts & Figures 2008. American Cancer Society. Atlanta, GA. 2. Radice D, Redaelli A. Breast cancer management: quality-of-life and cost considerations. Pharmacoeconomics 2003; 21(6):383-396. 3. Apantaku LM. Breast cancer diagnosis and screening. Am Fam Physician 2000; 62(3):596. 4. American Cancer Society. Detailed guide: Breast cancer. American Cancer Society. Sept 13, 2007. [accessed 4/19/08] Available from: http://www.cancer.org/docroot/CRI/CRI_2_3x. asp?rnav=cridg&dt=5 5. Hunt Lecture. Breast Cancer Prevention Lecture. American Academy of Physician Assistants Annual Convention. San Antonio, TX. May 2008. 6. Beckmann CR, Ling FW, Smith RP, et al. Obstetrics and Gynecology. 5th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005. 7. Miller H. Breast Exam and Disorders Lecture. Baylor College of Medicine, School of Allied Health Sciences, Physician Assistant Program, Women’s Health Course. Houston, TX. May 2007. 8. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA 2002; 288(3):321-333. 9. Pruthi S. Detection and Evaluation of a Palpable Breast Mass. Mayo Clin Proc. 2001;76:641-648. 10. Ravdin PM, Cronin KA, Howlader N, Berg CD, Chlebowski RT, Feuer EJ et al. The decrease in breast-cancer incidence in 2003 in the United States. N Engl J Med 2007; 356(16):1670-1674. 11. National Cancer Institute. Screening Mammograms: Questions & Answers. 9-42007. [accessed 11/05/07] Available from: http://www.cancer.gov/Templates/db_alpha. aspx?CdrID=44650 12. National Cancer Institute. Breast Cancer Treatment: Cellular Classification of Breast Cancer. 7-25-2008. [accessed 8/05/08] Available from: http://www.cancer.gov/cancertopics/pdq/ treatment/breast/healthprofessional/page3

13. Cytyc, A Hologic Company. Breast Cancer Risk Assessment: Types of Risk. 2008. [accessed 8/05/08] Available from: http://www.cytyc.com/ women/women_breast_cancer_risk_types.shtml 14. Cancer Genetics Web. 4/29/2003. [accessed 8/05/08] Available from: http://www.cancerindex. org/geneweb/ 15. Kovich O and Cohen D. Cowden’s syndrome. Dermatology Online Journal, 10(3):3, 2004. [accessed 8/05/08] Available from: http:// dermatology.cdlib.org/103/NYU/case_ presentations/102103n3.html 16. Dawood S BKHGGS. Trends In Survival of Stage IV Breast Cancer Among Caucasian and African American Breast Cancer Patients. 2008. 8-14-2007. 17. Susan G. Komen for the Cure. Breast Cancer Mortality Report: Closing the Gap in Eight Communities. 4-2-0007. 18. National Cancer Institute. Breast Cancer Risk Assessment Tool. [accessed 6/30/08] Available from: http://www.cancer.gov/bcrisktool/ 19. Texas Cancer Council. Texas Cancer Plan 2005: A statewide blueprint for cancer prevention and control in Texas. 2005 [accessed 7/24/07]; 4th ed. Available from: http://www.tcc.state.tx.us/pdfs/ texascancerplan2005.pdf 20. Texas Medical Association. Physician Oncology Education Program. Action plan on breast and cervical cancers. August 2003. [accessed 7/24/07] Available from: www.dshs.state.tx.us/bcccs/ actionplan.pdf 21. Texas Department of State Health Services: Texas Cancer Registry. Texas cancer facts & figures 2004 [accessed 4/19/08] Available from: httpwww.dshs. state.tx.us/tcr/default.shtm 22. Saslow D, Boetes C, Burke W, Harms S, Leach MO, Lehman CD et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin 2007; 57(2):75-89. 23. U.S. Preventive Services Task Force (USPSTF). Recommendations and Rationale: Screening for breast cancer. U.S. Preventive Services Task Force. Feb 2002. [accessed 4/19/08] Available from: http://www.ahrq.gov/clinic/3rduspstf/ breastcancer/brcanrr.htm


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24. American College of Obstetricians and Gyne足 cologists (ACOG). Breast cancer screening. Washington (DC): American College of Obstetri足 cians and Gynecologists; 2003 Apr. 12. (ACOG practice bulletin; no. 42). [accessed 4/19/08] Available from: http://www.guideline.gov/ summary/pdf.aspx?doc_id=3990&stat=1&string= 25. U.S. Preventive Services Task Force (USPSTF). Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility: Evidence Synthesis, No. 37. September 2005. [accessed 8/05/08] Available from: http://www.ahrq.gov/downloads/pub/ prevent/pdfser/brcagensyn.pdf

26. Emery J, Walton R, Murphy M, et al. Computer support for interpreting family histories of breast and ovarian cancer in primary care: comparative study with simulated cases. BMJ. 2000;321(7252):28-32.


Breast Cancer