B����� C�����    D��������� A���������                 for Primary Care Providers        xCBE & H                         ...
B����� C�����D��������� A���������   for Primary Care Providers     California Department of Health Services,             ...
Table of ContentsBackground and Acknowledgments .............................................................................
Background and Acknowledgments                                                                                            ...
Intended Audience                                                                                                         ...
How to Read and Use the Algorithms                                                                                        ...
Background Information Applicable to All Algorithms                                                                       ...
PAGE 5evaluation will commonly include a diagnostic mammogram and breast ultrasound,           Mammograms should only be p...
PAGE 6The following legend displays the graphic designations and abbreviations used in the algorithms:Graphic Designations...
PAGE 7California Department of Health Services, 2005
ALGORITHM 1:                                                                                                              ...
PAGE 9                                                                                               breast cancer diagnos...
PAGE 10                                                                     FLOWCHART NOTESNOTE 1A: Gail Model Risk Calcul...
ALGORITHM 1                                                                             PAGE 11���������������������������...
PAGE 12California Department of Health Services, 2005
ALGORITHM 2:                                                                                                              ...
PAGE 14                                                                       FLOWCHART NOTESNOTE 2A: Upon detection of a ...
ALGORITHM 2                                                                             PAGE 15���������������������������...
PAGE 16California Department of Health Services, 2005
ALGORITHM 3:                                                                                                              ...
PAGE 18                                                                      FLOWCHART NOTESNOTE 3A: Screening mammogram r...
ALGORITHM 3                                                                              PAGE 19 �������������������������...
ALGORITHM 4:                                                                                                              ...
ALGORITHM 4                                                           PAGE 21���������������������������������������������...
PAGE 22California Department of Health Services, 2005
ALGORITHM 5:                                                                                                              ...
PAGE 24Despite some of these clinical differences, it is important to consider Paget’s       Diagnostic imaging is the firs...
ALGORITHM 5                                                                        PAGE 25��������������������������������...
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
Cds algorithms 2005a
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Cds algorithms 2005a

  1. 1. B����� C����� D��������� A��������� for Primary Care Providers xCBE & H Refer tost rete Speciali New DiscMass Palpable Yes aging Dia gnostic Im * Mass n Evaluatio BE Persists? Repeat C ays d 1 w/in 30 Negative 2 Benign California Department of Health Services Cancer Detection Section Probably 3 Breast Expert Workgroup Benign s 4 Suspiciou Highly of 5 us Suspicioancy Mali gn Third Edition, June, 2005 Online at: www.qap.sdsu.edu
  2. 2. B����� C�����D��������� A��������� for Primary Care Providers California Department of Health Services, Cancer Detection Section Breast Expert Workgroup Third Edition, June, 2005 Online at: www.qap.sdsu.edu
  3. 3. Table of ContentsBackground and Acknowledgments ..................................................................................................................................................................1Intended Audience .............................................................................................................................................................................................2How to Read and Use the Algorithms................................................................................................................................................................3Background Information Applicable to All Algorithms.....................................................................................................................................4Assessment of Risk ............................................................................................................................................................................................8 Algorithm 1 ...............................................................................................................................................................................................11New Palpable Mass .........................................................................................................................................................................................13 Algorithm 2 ...............................................................................................................................................................................................15Abnormal Screening Mammogram with Normal CBE ..................................................................................................................................17 Algorithm 3 ...............................................................................................................................................................................................19Spontaneous Unilateral Nipple Discharge .......................................................................................................................................................20 Algorithm 4 ...............................................................................................................................................................................................21Work-up of Breast Skin Changes/Nipple Retraction .......................................................................................................................................23 Algorithm 5 ...............................................................................................................................................................................................25Breast Pain in a Non-Lactating Woman ...........................................................................................................................................................27 Algorithm 6 ...............................................................................................................................................................................................29Management of Breast Biopsy Results ...........................................................................................................................................................31 Algorithm 7 ...............................................................................................................................................................................................33Appendix A-1: Breast Cancer History And Risk Assessment ........................................................................................................................34Appendix A-2: Risk Assessment Table ............................................................................................................................................................37Appendix A-3: Core Compentancies of Clinical Breast Examination.............................................................................................................38Appendix A-4: CBE Results Documentation Form ........................................................................................................................................39Appendix A-5: Glossary Of Terms ..................................................................................................................................................................40Appendix A-6: Bibliography............................................................................................................................................................................46Appendix A-7: Previous Edition Acknowledgements .....................................................................................................................................52California Department of Health Services, 2005
  4. 4. Background and Acknowledgments PAGE 1Breast Cancer Diagnostic Algorithms for Primary Care Providers (Algorithms)  Michael Lagios, MD, Pathologist, St. Mary’s Health Center, San Francisco,is the product of the California Department of Health Services Cancer Detection CASection (CDS). The Breast Expert Workgroup, a volunteer panel of California  Debbie Lawler, FNP, MSN, Santa Ana, CAclinicians, provides leadership and consultation to CDS. These algorithms provide  Britt-Marie Ljung, MD, Professor of Pathology, University of California, Sanguidelines and are based on an informal consensus development process. Francisco, San Francisco, CA  Julie Ohnemus, MD, Family Physician, Arcata, CACDS administers the state and federally funded Cancer Detection Programs: Every  Linda Olson, MD, Professor of Radiology, University of California, SanWoman Counts! The program provides free breast and cervical cancer screening Diego, San Diego, CAand diagnostic services to eligible underserved, low-income women in California.  Maren Scheuner, MD, MPH, FACMG, Visiting Associate Professor, UniversityAdditionally, CDS provides community outreach and education, quality assurance, of California, LA, School of Public Health, Los Angeles, CA and ATPMprofessional education and evaluation and research services. Fellow, Office of Genomics and Disease Prevention, CDC, Atlanta, GA  Amy Shaw, MD, Family Physician, Santa Rosa, CAThe algorithms were originally published in 1997. This third edition incorporatesupdates on guidelines, research and technologies, especially the use of ultrasound, CDS acknowledges and appreciates the voluntary contributions of these Workgroupassessment of risk, and interpretation of pathology. The algorithms, along with members and the many other California-based clinicians who participated in theother professional education information, is posted to the Internet at www.qap. review phase and/or field-testing of this document.sdsu.edu Project StaffBreast Expert Workgroup Members California Department of Health Services, Cancer Detection Section Lawrence D. Wagman, MD, Chairman, Division of Surgery, and Director,  Marcus Doane, MD, MPH Department of General Oncologic Surgery, City of Hope National Medical  Cathy Hare Center, Duarte, CA (Workgroup Chairman)  Joan Hurlock, RN, MS, EdD Lawrence Bassett, MD, Iris Cantor Professor of Breast Imaging, Iris Cantor  Kathleen Mintert, LCSW Center, Los Angeles, CA  Candace Moorman, MPH (Project Lead) Ernie Bodai, MD, Director, Breast Surgical Services, The Breast Health Center  Caroline Peck, MD, MPH, FACOG Kaiser Permanente, Sacramento, CA R. James Brenner, MD, Director of Breast Imaging, Eisenberg Keefer Breast San Diego State University Graduate School of Public Health Center, St. Johns Hospital, Santa Monica, CA  Suzanne Lindsay, PhD, MSW, MPH Barbara Florentine, MD, Medical Director, Department of Pathology, Henry  Sherry Patheal, MPH Mayo Hospital, Valencia, CA  Marie Falcon, RN, BSN, PHN Ian Grady, MD, North Valley Breast Center, Redding, CA Patty Hansen, MD, Medical Doctors Imaging, Redding, CA Project Consultant Lydia Howell, MD, Associate Dean, Professor of Pathology, University of California, Davis, Davis Medical Center, CA Pro-Health Inc. George Khoury, MD, Stockton Diagnostic Radiology and Ultrasound,  Nancy Dunn, RN, MS Stockton, CA CDS also acknowledges Liana Lianov, MD, former CDS Chief, for spearheading the development of the 1st and 2nd editions and for serving as a reviewer for this 3rd edition.California Department of Health Services, 2005
  5. 5. Intended Audience PAGE 2These algorithms were developed for Primary Care Providers (PCPs) who provide sound reasons for alternative approaches that may not be described inbreast cancer screening services. These clinicians are the critical providers to ensure this document. Use of algorithms or practice guidelines, and carefulthat women receive timely and appropriate screening and diagnostic services, documentation, are important for continuity of care, risk managementincluding the highest quality initial screening, appropriate referral of abnormal and reimbursement.findings, and follow-up with other breast specialists. PCPs are encouraged to use  This document may be copied with full acknowledgment of the source.these algorithms to aid clinical decision-making. As with all medical protocols  Please cite: Breast Cancer Diagnostic Algorithms for Primary Careand algorithms, they are intended to serve as an adjunct, not as a replacement Providers. Cancer Detection Section, California Department of Healthfor clinical judgment applied to individual cases. Excellent communication must Services, 2005.always be maintained among PCPs and radiologists, surgeons, pathologists, and  Users of the algorithms are requested to direct any written comments orother breast specialists. inquiries about updates to: Chief, Professional Education UnitClarifications and Disclaimer Regarding Practice Standards Cancer Detection Section  Recommendations in these algorithms are for informational purposes California Department of Health Services only. They do not represent the only medically or legally acceptable MS 7203 approach to breast cancer screening and follow-up, but rather are P.O. Box 997413 presented with the recognition that there are alternate and acceptable Sacramento, CA 95899-7413 approaches. Deviations do not necessarily represent a breach of a medical FAX (916) 449-5312 standard of care. New knowledge, new technologies, clinical or research E-mail: algos@dhs.ca.gov data, individual patient needs, and clinical experiences may provideCalifornia Department of Health Services, 2005
  6. 6. How to Read and Use the Algorithms PAGE 3These algorithms graphically describe a logical progression of services designed Notes for each algorithm provide additional information on the assessment andto facilitate the work-up of a patient presenting with breast symptoms or abnormal decision-making guiding principles, including selected terminology, rationales,breast screening. The graphics provide a visual presentation of decision points alternative approaches, and controversies. The Appendices contain additionalthroughout the process as well as recommendations or indications for the timing content related to assessment of risk, clinical, radiologic and pathologicof a referral to a breast specialist for definitive risk assessment, diagnosis, staging examinations and diagnostic tests. They also provide sample forms for documentingand/or treatment. For the purpose of this document, the term “breast specialist” is health history and exam findings. A bibliography is included for PCPs who wantdefined as someone who has special education and/or experience in breast cancer. additional information.It is used as a general term because the actual medical discipline of this specialistmay vary by community. Thus, a breast specialist may be a risk assessment When the algorithm recommends “routine screening” the patient can resumecounselor, radiologist, surgeon, PCP trained in breast disease, etc. PCPs using routine (usually annual) breast screening if the most recent examination is normalthese algorithms are encouraged to adapt them for each particular patient situation. and there are no new symptoms or complaints. However, if new symptoms orThe special cases or nuances that breast specialists manage are not presented in concerns arise in the time interval prior to the next routine screening, it is appropriatethis document. to undertake a new diagnostic work-up to address these.The term “concordance” is used to describe agreement between multiple tests orprocedures. Concordance implies that a lesion assessed by two or more independentmeans (i.e., clinical breast examination (CBE) and mammogram), was identified atthe same general location in the same breast, and was found to be similar in natureor in degree of suspicion by all assessment techniques. Generally speaking, in thesituation of discordance, additional diagnostic work-up is necessary.The following algorithms are included in this document:Algorithm #1 – Assessment of RiskAlgorithm #2 – New Palpable MassAlgorithm #3 – Abnormal Screening Mammogram with Normal CBEAlgorithm #4 – Spontaneous Unilateral Nipple DischargeAlgorithm #5 – Breast Skin Changes / Nipple RetractionAlgorithm #6 – Breast Pain in a Non-Lactating WomanAlgorithm #7 – Management of Breast Tissue Biopsy ResultsCalifornia Department of Health Services, 2005
  7. 7. Background Information Applicable to All Algorithms PAGE 4The American Cancer Society (ACS) 2004 guidelines for early breast cancer  Physical Examinationdetection consist of a clinical breast examination (CBE) every three years in As part of the complete physical examination, the CBE needs to be thoroughwomen between the ages of 20 and 39 years, and annually for women aged 40 and and should preferably be performed on days 5-10 of the menstrual cycle.older. Women at average risk should begin regular mammography at age 40 years. CBE and mammographic imaging of the breasts of young premenopausalAnnual breast cancer screening for women 40 and older consists of a clinical breast women can be less diagnostic due to breast nodularity (from the increasedexamination and mammographic imaging of both breasts. Women at increased glandular-to-fat ratio) when compared to the more homogeneous breastsrisk for breast cancer may benefit from earlier initiation of screening, screening of postmenopausal women. The Core Competencies of Clinical Breastat shorter intervals, and screening with additional methods such as ultrasound or Examination are included in Appendix A-3.magnetic resonance imaging (Smith, 2004). The US Preventative Services TaskForce (USPTF) 2002 guidelines recommend screening mammography, with or  Documentation of the Visitwithout clinical breast examination every 1-2 years for women aged 40 and older. Upon completion of the woman’s CBE, thorough and standardizedCDS requires a CBE prior to a mammogram for women being served in the Cancer documentation will assure appropriate continuity of care, enhanceDetection Programs: Every Woman Counts. communication between providers, and will serve as a practical risk management strategy. In order to maintain continuity of care, the PCPThe management of any patient will vary according to age, clinical history and must coordinate service delivery across settings, multiple providers andclinical findings. Health history and assessment of risk, physical examination of the time. Breakdowns in the coordination of primary and specialty care havebreast, mammographic imaging and documentation should be performed routinely the potential for missed or delayed diagnoses (Institute for Healthcarefor all patients and are defined as follows: Improvement, 2000). A sample CBE Results Documentation Form is included in Appendix A-4.  Health History and Assessment of Risk  Screening Mammography vs. Diagnostic Imaging Evaluation Significant factors to be elicited in the woman’s health history include Screening mammography is specifically designed for asymptomatic current symptoms of nipple discharge, breast mass, axillary mass, skin women, and consists of two standard views of each breast, the craniocaudal dimpling, ulceration, inflammation and/or non-cyclical pain. Other (CC) projection and the mediolateral oblique (MLO) projection. factors include current medications (including hormonal therapy), a Women who have had breast augmentation can still receive screening history of previous breast cancer; any prior breast biopsies; history of mammography (Kopans, 1997). The implants can be manipulated to breast implants or breast reduction; age at menarche and menopause; remove them from the imaging fields, but additional views may still be pregnancy and lactation history; age at first live birth; exposure to needed to provide a complete picture of the breast tissue. Women who are radiation; a history of breast trauma; and a family history (maternal breast-feeding should wait at least 3 months post-lactation before having and/or paternal) of breast, ovarian or other associated cancers including a mammogram (in order to reduce the amount of swelling and achieve a age at diagnosis. For more specific information on risk assessment, see better image), unless a suspicious abnormality is present. For all women, Algorithm #1. The history should also include the date and results of prior mammograms should be used for comparison whenever possible. the last clinical breast examination, screening mammogram, ultrasound or other diagnostic procedures, and any significant abnormal finding. A Diagnostic imaging evaluation is used for women presenting with a breast finding sample Breast Cancer History and Risk Assessment form is included (usually a palpable mass or a mammographically detected abnormality found in Appendix A-1. Examples of relative risk categories are included in on a screening mammogram) or a history of breast cancer. A diagnostic imaging Appendix A-2.California Department of Health Services, 2005
  8. 8. PAGE 5evaluation will commonly include a diagnostic mammogram and breast ultrasound, Mammograms should only be performed in facilities certified under thebut can also include additional ancillary procedures at the Radiologist’s discretion. Mammography Quality Standards Act (MQSA) with FDA accreditation. As anThe radiologist correlates the results of all of these diagnostic procedures into a MQSA certified facility, all mammographic imaging results are required to bediagnostic imaging evaluation or final imaging result. The diagnostic mammogram reported using the Breast Imaging Reporting and Data System (BI-RADS®). Thiscomponent will include the standard screening views (if not already done) plus is a standardized system for reporting categories of imaging results. The Americanadditional views. Spot compression views evaluate asymmetrical densities or better College of Radiology (ACR) has developed BI-RADS® for Ultrasound and MRIdefine areas of clinical concern. Magnification views determine the morphology of reporting as well (First Editions-2003). The standardized BI-RADS® categories forcalcifications or improve visibility of masses. A mammogram is not considered mammography results are as follows:diagnostic unless a radiologist reviews all associated images. American College of Radiology BI-RADS® Assessment Categories Category 0 Need Additional Imaging Evaluation and/or Mammograms for Comparison. Category 0 is a screening mammogram result indicating that additional imaging evaluation is needed. The additional imaging may include spot compression, magnification, special mammographic views and/or ultrasound. Category 0 may be assigned in situations where the current films need to be compared with prior films, however it should only be used for old film comparisons when such comparison is required to make a final assessment. PCPs should follow-up with radiology facilities for the final diagnostic imaging evaluation result if they receive a report describing a Bi-RADS® 0 result. Category 1 Negative. There is nothing to comment on. The breasts are symmetric and no masses, architectural distortion or suspicious calcifications are present. Category 2 Benign Finding(s). Like “negative” this is a “normal” assessment, but the interpreter chooses to describe a benign finding in the report. Category 3 Probably Benign Finding—Initial Short-Interval Follow-up Suggested. A complete diagnostic imaging evaluation should be made before assigning a Category 3 result, thus it cannot be issued as the result of a screening mammogram alone. The vast majority of patients with Category 3 results are referred for an initial short-term follow-up (6 months) followed by additional clinical and radiographic examinations until longer- term (2 years or longer) stability is demonstrated. A finding placed in this category should have less than a 2% risk of malignancy. Category 4 Suspicious Abnormality—Biopsy Should Be Considered. This category is reserved for findings that do not have the classic appearance of malignancy but have a probability of malignancy that is greater than those in Category 3. Category 5 Highly Suggestive of Malignancy—Appropriate Action Should Be Taken. These lesions have a high probability (>95%) of being cancer. This category contains lesions for which one-stage surgical treatment could be considered without preliminary biopsy. However, current oncologic management may require percutaneous tissue sampling as, for example, when sentinal node imaging is included in surgical treatment or when neoadjuvant chemotherapy is administered at the outset. Category 6 Known Biopsy / Proven Malignancy—Appropriate Action Should Be Taken. This category is reserved for lesions identified on the imaging study with biopsy proof of malignancy prior to definitive therapy. This category has been added for breast findings already known to be malignant by biopsy but prior to definitive therapies such as surgical excision, radiation therapy, chemotherapy or mastectomy. Radiologists use this for giving second opinions on outside films with known cancers or following tumor response in neoadjuvant chemotherapy settings. Note: Particularly for categories 0, 3, 4, and 6: Refer to the ACR-Guidance Chapter noted in the Bibliography Appendix.California Department of Health Services, 2005
  9. 9. PAGE 6The following legend displays the graphic designations and abbreviations used in the algorithms:Graphic Designations Abbreviations Starting point for algorithm ADH = Atypical Ductal Hyperplasia ALH = Atypical Lobular Hyperplasia Decision point BI-RADS® = Breast Imaging Reporting and Data Systems CBE = Clinical Breast Examination Process or procedure DCIS = Ductal Carcinoma In Situ DX = Diagnosis Endpoint—decision finished for that algorithm FNA = Fine Needle Aspiration F/U = Follow-up Direction for further work-up or HX = Patient History connector to another algorithm LCIS = Lobular Carcinoma In Situ Flowchart note marker NCI = National Cancer Institute US = UltrasoundCalifornia Department of Health Services, 2005
  10. 10. PAGE 7California Department of Health Services, 2005
  11. 11. ALGORITHM 1: PAGE 8Assessment of RiskRisk assessment for breast cancer effectively engages the PCP and the patient in a absolute risk for combinations of risk factors. Rather, the algorithm provides adiscussion about breast cancer prevention, educates a woman about her specific risk qualitative assessment of risk based on personal history, family history, medical/factors, and helps guide a personalized plan for risk reduction and early detection. pathological/genetic factors, with the outcome of either normal or increased riskFor the woman with high risk determined by a risk assessment algorithm, a referral for breast cancer.to a risk assessment counselor can be helpful in further defining the risk, identifyingpossible genetic risks, and recommending appropriate risk reduction strategies. Pathological factors: A personal history of breast cancer increases the general risk of a second primaryRisk is the probability or likelihood that an event will occur. Risk can be expressed breast cancer either in the contralateral breast or the ipsilateral breast if there isin several ways, the most common being relative risk and lifetime risk. Relative remaining tissue. For most women, this risk is estimated to be 0.7% to 1.0% perrisk is the ratio of the risk of disease (in this case breast cancer) among those year for the first 10 years with a 20-year cumulative risk of 4%-20%. However,exposed to a risk factor to the risk of disease among those not exposed to the risk the personal risk of another primary breast cancer depends to a great extent on thefactor. For breast cancer, important risk factors include age, gender, family history, presence of risk factors. For example, a BRCA1 or BRCA2 mutation is associatedage at menarche, other reproductive factors, use of hormone replacement therapy, with a 10-year cumulative risk of 43% and 34% respectively (Metcalfe et al.,radiation exposure, alcohol use, and previous breast biopsies – especially those 2004).with abnormal findings. See Appendix A-2 for details on relative risk estimatesassociated with certain risk factors. Absolute risk describes the risk of disease in Ductal carcinoma in situ (DCIS) confers a risk similar to invasive breast cancerthe context of time, such as the lifetime risk for a disease or risk by a certain age. (Yen, 2003). Other pathological features that increase breast cancer risk include:The Gail Model estimates the absolute risk of breast cancer for a woman over the lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH), atypicalnext five years and over her lifetime based on certain risk factors for the disease. lobular hyperplasia (ALH), fibroadenoma with complex features, moderate orIt is an excellent breast cancer risk assessment tool for most women. However, florid hyperplasia and solitary papillomas without coexistent hyperplasia.it may underestimate risk for women with a family history of cancer. The ClausTables provide a better estimate of absolute risk for women with a family history Genetic and family history risk factors:of cancer. These tables estimate breast cancer risk based on the family history of Inherited mutations in breast cancer susceptibility genes are associated with a verybreast cancer and/or ovarian cancer taking into account the age of onset of the high risk of the occurrence of breast cancer. The breast cancer susceptibility genesdisease. identified to date include:  BRCA1/BRCA2, associated with the diagnoses of hereditary breast-Algorithm #1 is intended to assist PCPs with the identification of women at ovarian cancer and hereditary site-specific breast cancer.increased risk for developing breast cancer. Breast cancer risk assessment should  PTEN, associated with the diagnosis of Cowden syndrome.be performed as part of routine screening, and it should be repeated annually since  STK11, associated with the diagnosis of Peutz-Jeghers syndrome.risk factors for breast cancer change over time. Certain breast cancer risk factors  MLH1/MSH2/MSH6, associated with hereditary non-polyposis, colorectalare more significant than others, and generally, there are interactions between these carcinoma and breast cancer in certain families.major risk factors. The interactions make true risk assessment difficult to calculate.  ATM, associated with a 4-fold increase in risk among heterozygotes.This algorithm attempts to incorporate the risk factors that have epidemiologic  CHK2, associated with a 2-fold increase in risk among heterozygotes.evidence of significant risk; it does not include all possible risk factors or assess  TP53, 50% risk of breast cancer by age 50.California Department of Health Services, 2005
  12. 12. PAGE 9 breast cancer diagnosed among men in the United States. (Male breastA family history of breast cancer significantly increases the risk of breast cancer cancer is a red flag for a possible genetic susceptibility.)for the individual if the cancer occurs in first and/or second-degree biological  Age – breast cancer risk increases with age; 96% of breast cancers occur inrelative(s) – parents, siblings, children, grandparents, aunts, uncles, nieces and women age 40 and older (ACS, 2003-2004). Most women face a lifetimenephews. Red flags suggestive of genetic susceptibility to breast cancer include: risk of 12-13%.  One or more first- or second-degree relatives with breast cancer at an early  Race – Caucasian women have a greater risk of breast cancer than other age (less than 40-50 years of age). racial groups.  Breast cancer and a second primary cancer in a close relative, especially  Prolonged exposure to endogenous estrogen and progestins (U.S. Preventive ovarian cancer. (Other cancers that may be associated with an increased Services Task Force, 2005). genetic risk include: thyroid, colorectal, prostate, endometrial, pancreatic,  Exposure to exogenous combined estrogen and progestin therapy in adrenocortical carcinoma, melanoma, childhood sarcoma, leukemia/ hormone replacement therapy for postmenopausal women has been shown lymphoma, and brain tumors.) to slightly increase the risk for breast cancer. It is controversial whether  Male breast cancer in a close relative. or not exogenous estrogen alone in estrogen replacement therapy for  Two or more relatives with breast cancer at any age. postmenopausal women affects the risk for breast cancer. (U.S. Preventive  If of Ashkenazi Jewish descent, a biological relative with breast cancer Services Task Force, 2005.) diagnosed before age 50 or ovarian cancer at any age.  Alcohol use – greater than 27 drinks per week. (Gronbaek, 2004.)  Obesity – obese women with BMI >30 had estrogen concentrationsPersonal factors: between 60% and 219% higher then thin women and the risk of breast  Gender is the most obvious and important risk factor for breast cancer. cancer increased as BMI increased at an average rate of about 18% per 5- Females have a 100-fold increase in risk as compared to males. However, point increase in BMI. (Journal of National Cancer Institute, 2003.) the ACS estimates that in 2005 there will be 1,690 new cases of invasive  Radiation exposure to the upper torso (e.g. treatment of Hodgkin’s lymphoma). (Preston, 2002.)The table below reveals changes in breast cancer risk across a woman’s lifetime, according to age group. Age-Specific Probabilities of Developing Breast Cancer* Probability of developing breast If current age is… cancer in the next 10 years is:** Or 1 in: * Among those free of cancer at beginning of age interval. 20 0.05% 2,152 Based on cases diagnosed 1988-2000. Percentages and “1 in” numbers may not be numerically equivalent due to rounding. 30 0.40% 251 40 1.45% 69 ** Probability derived using NCE DEVCAN software. 50 2.78% 36 American Cancer Society, Surveillance Research, 2003 60 3.81% 26 70 4.31% 23California Department of Health Services, 2005
  13. 13. PAGE 10 FLOWCHART NOTESNOTE 1A: Gail Model Risk Calculation  Instead of continuing with age and others, calculate risk using the National Cancer Institute (NCI) Risk Assessment Tool if possible: http://bcra.nci.nih.gov/brc/ (Gail Model)  A five-year risk of 1.7% or greater may be considered Increased Risk  After ruling out the presence of Personal Risk Factors and Family History Risk Factors listed in Algorithm #1, assessment of Age and Other Risk Factors will identify most women at increased risk for breast cancer, but may over-estimate risk for some women.NOTE 1B: Age and Breast Cancer Risk  A Caucasian woman aged 65 with average risk factors has a 2% risk of developing breast cancer within the next 5 years according to the Gail Model. Therefore, women 65yrs or older should have their personal risk evaluated on an individual basis using the Gail Model if possible.  Women with a 5-year risk of >1.7 % meet FDA criteria for receipt of approved chemoprevention (e.g., Tamoxifen). However, the potential benefit of treatment must be weighed against the associated risk of serious side effects for the individual woman.California Department of Health Services, 2005
  14. 14. ALGORITHM 1 PAGE 11������������������������������� ������� ��������������� ��������������������� �������������������� �� ������������ ������������ ������������ ������������������� ����������������������������� ��������������������� �� ���������������� ������������������ ����������������� �������������������� ��������� ��� ������������������� �������������� ����� ����������������������� ��������� ��� ��������� ������� ���������������� ����� ����� ����������������������������� ������������������������ ���������� ������������������ ������� ������� ���������� �������������������� ���������� �������������� ��������� ���� �������������������� ���������������������� ���������� ��� ����� ������� �������������������� �� ����������������� ������ ������� ����� ��������� �������������� ��������������� ��� ���������� �������������� ������ ������������ ���������������������� ������������������������ ������������������������ ������������������������ ���� ����������������������� ������������ ����������������� ������� ������������������ ����� �������������� �������������������� ����������� ��������������� �������������������������������� ����������� �������������� ������������� ������������������������������ ����������������� ����������� ���������������������� ����������������� ���������������������������������������������� �������������������������������������������� ������������������������������ ������������������ ����������������������������������������������������������������������������������� ����������������������� ����������������������������������������������������������������������������������������������������������������������������������������California Department of Health Services, 2005
  15. 15. PAGE 12California Department of Health Services, 2005
  16. 16. ALGORITHM 2: PAGE 13New Palpable MassManagement of the patient with a breast mass varies according to age, history and 2002). Physical exam alone is approximately 70% accurate; mammographyclinical findings. Detection of a breast mass often creates anxiety for the woman alone is approximately 85% accurate; minimally invasive tissue diagnosisand her family, requiring sensitive provider/patient communication. Important alone is approximately 95% accurate. While physical exam and mammogramquestions to consider when assessing the index of suspicion of a breast mass alone can detect many cancers, no single test by itself allows for detection of(lesion) detected on physical examination include: all breast cancers. The best clinical approach to the diagnosis and management of patients with a palpable mass is the combination of all three tests – physical  What is the location and depth (i.e., superficial, medium, deep) exam, radiographic imaging and pathology (biopsy or fine needle aspiration). This  Is it an asymmetrical finding in both breasts? diagnostic triad is known as the “triple test.” The diagnostic accuracy of these three tests taken together approaches 100% (Morris, 2002; Vetto, 2003). Clinicians  Is it a three dimensional discrete palpable mass? should select the “triple test” method as it helps make an evidence-based decision  Is it mobile or fixed? about clinical management. If one of the “triple test” components is discordant, the  What is the size and shape? entire diagnosis is uncertain and each of the “triple test” findings will need to be  What is the consistency? reviewed before proceeding.  Is it tender or non-tender? Pre-menopausal WomenNormal glandular tissue is generally mirrored in the contralateral breast. A discrete In patients younger than 30 years of age, or patients who are pregnant, ultrasoundpalpable mass is three-dimensional, different from surrounding tissues and usually may be the first or sole breast imaging modality performed (Mehta, 2003 andasymmetric. Clinical signs that are suggestive of benignity, but are not diagnostic, Baker, 2000). For patients 30-49 years of age with a new palpable mass, a cystinclude a mass that is soft, rubbery and mobile. Features suggestive of malignancy is the most likely diagnosis and can be confirmed or ruled-out by fine needleinclude a mass that feels firm or hard, is fixed, has an irregular shape, is solitary, and aspiration (FNA) or ultrasound (a diagnostic imaging modality). If the degree offeels much different from the surrounding breast tissue (Barton, 1999; Goodson, suspicion is very low (the palpable mass is a “ridge” and is two-dimensional, rather1996). than three-dimensional), it is acceptable to repeat the screening CBE at a more optimal time of the menstrual cycle. Any palpable mass that persists and has notCBE is a screening method, not a diagnostic test. Regardless of age, every clinically been proven to be a simple cyst, must receive additional diagnostic work-up untilsuspicious lesion requires further evaluation. CBE finds 4% to 7% of cancers that a final diagnostic status is determined.are normal or benign on mammography (Green 2003, Bobo 2000, Beyer 2003,Georgian-Smith 2000). Thus, an abnormal CBE in the presence of a negative Postmenopausal Womenmammogram requires further follow-up. The leading cause of physician delay Since the risk of breast cancer increases with age, clinicians need to be morein the diagnosis of breast cancer continues to be inappropriate judgment that a suspicious of a dominant mass or asymmetric thickening in the breasts ofmass is benign without performing a biopsy. Reducing delay in diagnosis requires postmenopausal women. Cystic findings decrease after menopause, although cysts,less reliance on CBE to determine the benignity of a mass as well as less reliance pain, and discharge can be found in women taking hormone replacement therapy.on benign mammographic reports in deciding not to biopsy a mass (Goodson, Diagnostic imaging evaluation is usually the first-line investigation of a palpable breast mass in postmenopausal women.California Department of Health Services, 2005
  17. 17. PAGE 14 FLOWCHART NOTESNOTE 2A: Upon detection of a palpable breast mass, the PCP may suspect a simple cyst. This diagnosis must be confirmed with ultrasound or FNA/biopsy. A breastmass that completely resolves by needle aspiration of non-bloody fluid can be considered insignificant if there are no signs of recurrence four to six weeks post-aspiration(Pruthi, 2001). Ultrasonography depicts the fluid within cysts and can diagnose cysts with a diameter as small as 2-3 mm in small breasts. Ultrasound is less sensitive inlarge breasts due to the fatty breast tissue. Although multiple cysts commonly occur, a woman with breast cysts needs to be advised to seek medical advice whenever anew mass arises. Neither the clinician nor the woman can automatically assume that a new mass is “just another cyst.” Non-palpable cysts detected by mammographyand confirmed by ultrasound do not need to be aspirated unless they are symptomatic and cause pain. A cyst that recurs more than two times within four to six weeks,contains bloody fluid, or leaves a residual palpable mass post-aspiration demands a diagnostic imaging evaluation. In this situation, the radiologist should be informed thatan aspiration was undertaken prior to the imaging procedure. Cysts with internal debris or thick material require further follow-up.NOTE 2B: Clinician confidence level in performing cyst aspiration may vary. Proceed with diagnostic imaging evaluation (e.g., ultrasound) if routine aspiration is notoffered in your practice.NOTE 2C: A clinically suspicious mass may have one or more features consistent with cancer, such as firmness, irregularity, or solitary. Sometimes such masses are fixedand associated with skin retraction. Any asymmetrical finding should be cause for concern (Barton, 1999; Goodson, 1996). Patients with suspicious findings should bereferred to a breast surgeon immediately.NOTE 2D: Patients with a new palpable mass and Negative (BI-RADS® category 1) diagnostic imaging evaluation result should at minimum have a repeat CBE withinthirty days. The negative imaging result indicates that there were no radiographically identified lesions, but does not preclude existence of a non-radiographically evidentlesion. The follow-up CBE will allow the PCP to determine whether the palpable mass is persistent. If the mass is not persistent, there should be another repeat CBE in3-6 months. If this confirms that the mass is no longer present, the patient can then return to routine screening intervals. Patients with negative imaging, in whom the masspersists at a follow-up CBE, should be referred to a breast specialist for decisions regarding follow-up interval or need for biopsy.NOTE 2E: Patients with a Benign finding (BI-RADS® category 2) on mammogram should have a repeat CBE within thirty days. This allows the practitioner to correlatethe physical findings with the diagnostic imaging evaluation and assure that the finding is concordant. The imaging finding identifies the anticipatory physical findingas benign; if there is no correlation between the imaged mass and the palpable mass, the patient should be referred to a breast specialist for decisions regarding intervalfollow-up or tissue biopsy. Mammography should be performed using a radio-opaque marker on the skin over a palpable lesion to assist in determining if the palpablemass corresponds to the mammographically identified lesion. A discordant mammographic finding may represent a separate lesion, which may need further evaluation inaddition to a work-up for the original palpable mass. Careful correlation of the physical exam and the diagnostic imaging evaluation is critical to assure appropriate andtimely follow-up. If the imaging findings show a simple cyst, it can be aspirated during a follow-up CBE if required to alleviate discomfort.NOTE 2F: The American College of Radiology does not recommend the assignment of a Probably Benign (BIRADS category 3) result as the final diagnostic imagingevaluation for a patient with a palpable mass. This may occur if the radiologist is unaware of the CBE findings. If the results of your CBE screening indicate a palpablemass and you receive a BIRADS category 3 final diagnostic imaging evaluation, contact the radiologist for further consultation.California Department of Health Services, 2005
  18. 18. ALGORITHM 2 PAGE 15������������������������������ �������� �������������������������� ������� �� ���� ��������� ��� ����������� ������� ��������� ������ �� ��������������� �� ���� ��� ���� �������� ���������� ��� ����������� ���������������������� ���������� �� ���� �� ������������ ������������������ ����������������� ��� ��� ����������� �� �� ���������� ���� ������� �������� � �� �������������� ��������� ������� ���������� ��������� ���������� ������ � ������ �������� ���������� ���� ����������������� ��� ������������������ ��������� �� ������� �������� � ����������� ������ �� �� ����������� ������� ��������� ���������� � �������������������� ������ ��� ��������� ���������� ������ ������ ������������� � ��������������� ���������� �������� ���������� ������� ��������� �������������������������������������������������������������������������������������������������������������������������������������������� ������������������������������������������������������������������������������������������������������������������������������������������������� ��������������������������������������������������������������������������������������������������������������������������������������������������� �����������������������������������������������������������������������������������������������������������������������������������������������California Department of Health Services, 2005
  19. 19. PAGE 16California Department of Health Services, 2005
  20. 20. ALGORITHM 3: PAGE 17Abnormal Screening Mammogram with Normal CBEWith improved imaging techniques, screening mammograms are enabling a lesion is benign. There have been reports of microcalcifications, which aredetection of earlier breast cancers. If an abnormality is suspected with screening stable on radiologic exam, yet are later found to be malignant in 8-63 monthsmammography, the radiologist performs additional mammographic views and/or (Michell, 2003). Some lesions classified mammographically as probably benignultrasound. After the imaging work-up is complete, the radiologist assigns a BI- may be biopsied depending on the recommendations of the breast specialist andRADS® category 1-6 as the final imaging result. the preferences of the patient.Final Imaging Results – Negative or Benign (BI-RADS® Categories 1 or 2) Final Imaging Results – Suspicious Abnormality or Highly Suggestive ofRoutine clinical follow-up is appropriate for Negative and Benign (BI-RADS® Malignancy (BI-RADS® Categories 4 or 5)category 1 and 2) mammographic imaging results. All mammograms showing a Suspicious Abnormality or a lesion that is Highly Suggestive of Malignancy (BI-RADS® category 4 or 5) should result in biopsy.Final Imaging Result – Probably Benign (BI-RADS® Category 3)A Probably Benign, BI-RADS® category 3 lesion generally will require a repeat Categories 3, 4, and 5 always require further evaluation despite the normal clinicalCBE in 3-6 months and repeat mammography in six months to ensure concordance breast exam. A reasonable percentage (50-90%) of category 4 and 5 lesions willbetween the CBE findings and the radiographic lesion. If the woman is at increased be shown to be cancerous (ACR, 2003). In fact, it is the detection of these smallrisk for breast cancer, immediate follow-up is recommended with a breast or pre-invasive cancers by mammography that significantly contributes to thespecialist. Women with average risk may be referred for repeat CBE and imaging reduction in breast cancer mortality.in six months (short-term follow-up). If the initial six-month short-term follow-up (unilateral mammogram) is stable, another bilateral mammogram in 6 months The false-negative rate for screening mammography is 8% to 10% (Shaw demay be recommended by the radiologist (ACR, 2003 and Kerlikowske, 2003). If Paredes, 2000). Breast density can compromise the ability of a mammogram tothere is still no change, the patient should be rescreened at one-year intervals for detect a mass, and lesions located near the sternum can be difficult to visualizetwo years. While a lesion’s radiographic stability over time suggests benignity, (Mandelson, 2000). Over a 10 year period approximately 24% of women gettinga lack of change in features cannot completely reassure the PCP and patient that an annual mammogram will have at least one false positive mammogram.California Department of Health Services, 2005
  21. 21. PAGE 18 FLOWCHART NOTESNOTE 3A: Screening mammogram results of Negative (BI-RADS® category 1) and Benign (BI-RADS® category 2) prompt routine rescreening for women with normalCBE exams.NOTE 3B: Lesions identified with a screening mammogram require a diagnostic “work-up” (additional views and/or ultrasound) before a final imaging result can beassigned (ACR, 2003). Prior to assigning the final imaging result, a BI-RADS® category 0 may be temporarily assigned to indicate that additional views or tests areneeded, or that previous mammographic results need to be reviewed.NOTE 3C: The American College of Radiology does not recommend the assignment of a BI-RADS® 3 result to a screening mammogram. If you should receive ascreening mammogram report with this result, refer the woman for additional diagnostic imaging. If a diagnostic evaluation has already been completed, continue work-upbased on that diagnostic imaging result.NOTE 3D: A patient with a final imaging result of BI-RADS® category 3 who is at increased risk for breast cancer (See Algorithm #1) should be immediately referred to abreast specialist. Referral to a breast specialist can be offered to women who are concerned about their results and do not want to wait six months for further follow-up.NOTE 3E: For BI-RADS® category 3, the vast majority of findings will be managed with an initial short-term follow-up examination in 3-6 months, followed byadditional examinations until stability is demonstrated (2 years or longer). There may be occasions when a biopsy is done (i.e. patient request or clinical concerns).Evidence from all the published studies indicates the need for biopsy if the lesion increases in size or undergoes morphologic change (ACR, 2003).NOTE 3F: A BI-RADS® category 4 lesion should lead to biopsy, and a BI-RADS® category 5 lesion requires biopsy (ACR, 2003). If the lesion is definitively diagnosedas benign after core biopsy and is consistent (concordant) with the radiological findings, excisional biopsy is not required (See Algorithm #7). The methods of biopsyinclude stereotactic or ultrasound-guided core biopsy for definitive diagnosis or needle localization followed by excisional biopsy with intraoperative confirmation ofnegative margins.California Department of Health Services, 2005
  22. 22. ALGORITHM 3 PAGE 19 ��������������������������������������������������������� �������� ����������� ��������� �� ��������� �� ���������� ������������������ � ���������� ����������� ������� ��������� �� ������ �������� �������� � � ��������� ������ ������ �������������������� ����������� ���������� � ������ � �� ������ �� �� ������������� ������������� � �������� � ��������� �� �������� ���������� ������ ����� ������������������ ��������� ���������� � ������ ��� �������� �������� ��� ������ ���������� ������� ������������� � �� ���������� �� ��������� ������ ������� ������ ������� ����������������������������������������������������������������������������������������������������������������������������������� ����������������������������������������������������������������������������������������������������������������������������������� ��������������������������������������������������������������������������������������������������������������������������������California Department of Health Services, 2005
  23. 23. ALGORITHM 4: PAGE 20Spontaneous Unilateral Nipple DischargeNipple discharge is a common breast problem that has been reported in 10-15% Bilateral nipple discharge usually has a physiological cause, such asof women with benign breast disease and in 2.5-3% of women with breast cancer hyperprolactinemia leading to galactorrhea. It can also occur in breast disease that(Morrow, 2000). A nipple discharge should be of concern when a woman reports is bilateral, such as mammary duct ectasia. This is a benign condition occurring init as unilateral and spontaneous (not in response to stimulation) and staining her postmenopausal women, characterized by dilation of the ducts, nipple secretionsbra, bed sheet, or sleeping garment. Directly squeezing the nipple to express fluid and periductal inflammation.promotes discharge and is not a routine part of the screening CBE in asymptomaticwomen. Using an aspiration pump will elicit a discharge from 50 to 80% of women Every woman with a unilateral, spontaneous, clear, watery, serous, or bloodywithout breast disease. Women should be advised to avoid checking themselves discharge should be referred for diagnostic imaging evaluation. Most mammogramsfor discharge since benign discharge may resolve when the nipple is left alone in such instances are normal and should NOT deter surgical referral. Any discharge(Morrow, 2000). from a single duct is of concern. Multiple duct discharges are rarely caused by cancer (Florio, 2003). Any mammographic abnormality should correspondA number of conditions result in nipple discharge. Endocrine causes of galactorrhea with the quadrant of the breast from which the discharge originates for it to beinclude pregnancy, hypothyroidism and amenorrehic syndromes. Medications such considered relevant to the cause of the discharge. Cytology in the assessment ofas antihypertensives, oral contraceptives, phenothiazines, and tranquilizers may nipple discharge is controversial and is generally not recommended as a first linealso cause nipple discharge. Milky discharge could be due to medications and the investigation due to the high number of false negative results.provider may want to consider ruling out this etiology prior to referral to a breastspecialist. FLOWCHART NOTESNOTE 4A: A non-spontaneous discharge is not usually significant. It is more clinically relevant if a history of a spontaneous discharge is elicited. The patient should beasked whether she has noticed staining of her clothing. A true nipple discharge originates in one or more duct(s) (Apantaku, 2000). Inverted nipples, eczema, infection,etc can cause pseudo-nipple discharges.NOTE 4B: It is important to determine if the nipple discharge is associated with a palpable mass. Any mass noted within 2 cm of the nipple is considered correlative(Sheen-Chen, 2001). Immediate referral for diagnostic imaging followed by surgical consultation is appropriate.NOTE 4C: The diagnostic imaging abnormality should correspond with the quadrant from which the discharge originates (i.e. a radiographic abnormality that does notcorrelate to the discharge quadrant may represent a separate lesion). It is important to realize that a mammographic abnormality that corresponds to a palpable lesion maybe a separate lesion that is not associated with the discharge. It may need a separate work-up and referral to a breast specialist.NOTE 4D: Clinical re-evaluation of a woman with a BI-RADS® category 1 or 2 is recommended at 3 months and is intended to assure that the nipple discharge hasresolved.California Department of Health Services, 2005
  24. 24. ALGORITHM 4 PAGE 21���������������������������������������������������� �������� �� ���������������������� ���������������� �� ������� �������� ��� ��������� ����� �� �� ��������� ������� ������������������ ��������� ���������� ��� ����� ����������� �� �� �� �������� � ���������� ��������� �������������� ���� ��������� ��������������������� ������ � ��� ��������������� �������� ��� � ���������� ������ �� �������� ���������� �������� ���������� � �� ���������� ������� ������ ��������� ������������� � ���������� �������������������������������������������������������������������������������������������������������������������������������������������� ������������������������������������������������������������������������������������������������������������������������������������������������ �������������������������������������������������������������������������������������������������������������������������������������������������� �����������������������������������������������������������������������������������������������������������������������������������������������California Department of Health Services, 2005
  25. 25. PAGE 22California Department of Health Services, 2005
  26. 26. ALGORITHM 5: PAGE 23Work-up of Breast Skin Changes/Nipple RetractionA thorough history and CBE are important in the assessment of the patient who Signs of inflammation can be treated with a 10-day course of antibiotics that coverpresents with skin changes (e.g. inflammation, scaling) or skin/nipple retraction. aerobic and anerobic skin bacteria (typical of those in the mouth and vagina), but ifImportant questions to consider include: not completely (100%) resolved, inflammatory carcinoma must be suspected and diagnostic imaging is required. A possible treatment regimen could be cephalexin  How long has the change been present? plus metronidazole. Nipple retraction can be managed in the case of suspected  Is there an associated palpable mass or mammographic abnormality? periductal mastitis or deep tissue infections. A lack of a complete (100%) response  Is it a unilateral finding? requires further diagnostic imaging work-up.Timing of onset of nipple retraction is of paramount importance; congenital There are many dermatologic causes of red, oozing and crusted nipples, includingnipple inversion is insignificant, whereas recent nipple retraction has more serious psoriasis, seborrheic dermatitis, contact dermatitis, neurodermatitis and atopicimplications. Unilateral nipple retraction, even slight, is also more suspicious than dermatitis. Eczema can be localized or can involve the complete nipple-areolarbilateral nipple inversion. complex and must be distinguished from the non-eczematous conditions of Paget’s disease of the nipple. Because Paget’s disease is a very serious but commonlySkin changes that may signify carcinoma include skin erythema, retraction, missed diagnosis, a thorough history and physical examination are important fordimpling, nipple excoriation or crustiness. Asymmetry of the breasts that indicate every patient who presents with skin and/or nipple changes of the breast. Paget’sa recent change should be noted along with other findings, particularly any masses. disease comprises 1-3% of all primary breast cancers (Marcus, 2004). Paget’sInflammatory breast cancer (IBC) symptoms include diffuse erythema, edema disease is manifested by progressive eczematoid changes of the areola withinvolving more than two-thirds of the breast, peau d’orange, tenderness, induration, persistent soreness or itching (Lev-Schelouch, 2003). A mass is often associatedwarmth, enlargement of the breast, and diffuseness (or absence) of a tumor on with Paget’s disease (NCI, 2002) and those patients with a palpable mass have apalpation (Cristofamilli, 2004). worse survival rate than do patients with a nonpalpable mass (Fu, 2001). Eczema Paget’s Disease of the Nipple Usually bilateral Unilateral Intermittent history with rapid evolution Continuous history with slow progression Moist Moist or dry Indefinite edge Irregular but definite edge Nipple may be spared Nipple always involved and disappears in advanced cases Itching common Itching commonFrom Hughes LE et al. Benign Disorders and Diseases of the Breast: Concepts and Clinical Management. London, Ballière Tindell, 1989.California Department of Health Services, 2005
  27. 27. PAGE 24Despite some of these clinical differences, it is important to consider Paget’s Diagnostic imaging is the first line investigation when there are skin or nippledisease until proven otherwise. Nipple scaling may respond to a short course of changes, even if no mass is palpable on CBE. However, a negative diagnostictopical steroids, but a follow-up appointment is critical to assess responsiveness. imaging work-up for a clinical abnormality of the breast must not precludeSometimes Paget’s will transiently respond to steroid cream, so if used, a follow- referral to a breast specialist. Patients with any nipple complaint require furtherup exam is required. Paget’s disease with a palpable breast mass is likely to be evaluation.accompanied by an invasive ductal carcinoma and has a poor prognosis (Sun Q,2003). FLOWCHART NOTESNOTE 5A: There is some controversy over the use of a topical steroid cream for nipple symptoms indicative of Paget’s disease. Some surgeons now advocate referral forexamination and possible biopsy prior to any use of steroid cream.California Department of Health Services, 2005
  28. 28. ALGORITHM 5 PAGE 25�������������������������������������������������� �������� �������������������������� ���������������￀

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