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Managing Breast Abnormalities in the Primary Care Practice. Benjamin D. Li, MD, FACS Charles Knight Sr. Professor and Vice Chairman Department of Surgery Chief, Surgical Oncology LSUHSC-Shreveport and the Feist-Weiller Cancer Center. Outline - 1. Clinical presentations of breast disease

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Managing Breast Abnormalities in the Primary Care Practice


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    1. Managing Breast Abnormalities in the Primary Care Practice Benjamin D. Li, MD, FACS Charles Knight Sr. Professor and Vice Chairman Department of Surgery Chief, Surgical Oncology LSUHSC-Shreveport and the Feist-Weiller Cancer Center

    2. Outline - 1 • Clinical presentations of breast disease • Nipple discharge • Mastalgia • Breast mass • diagnostic imaging • who to biopsy • how to biopsy

    3. Outline – 2 • Treatment of breast cancer • Local-regional control of breast cancer • Surgery • Modified Radical Mastectomy (MRM) • Breast Conservation Therapy (BCT) • Addressing nodal disease • Axillary Lymph Node Dissection (ALND) • Sentinel Lymph Node Biopsy (SLNB) • Radiation therapy • Postmastectomy Radiotherapy (PMRT) • Whole breast irradiation versus Accelerated Partial Breast Irradiation (APBI)

    4. Outline - 3 • Systemic adjuvant therapy • Advances in chemotherapy • Taxanes • Dose dense regimens • Evolving paradigms in hormonal manipulation • Estrogen receptor inhibition • Aromatase inhibitors

    5. Outline - 4 • Breast cancer screening • Guidelines for screening • Risk Factors for breast cancer • Family history • Low relative risk • High relative risk • BRCA genes • Who should be tested • Breast cancer risk reduction • Prophylatic surgery • Chemoprevention

    6. Clinical Presentation • 3 most common breast complaints: • Mastalgia • NIPPLE DISCHARGE • MASS • >50% of patients presenting to surgeon with a breast condition will have benign disease Marchant, Surg Oncol Clinics of North America, 1998

    7. Caution! • Applying the correct diagnostic and/or therapeutic algorithm is critical • Treat patient thoughtfully – • Look for a mass • Image area as appropriate • Ultrasound • Mammogram • Balance the need for diagnostic workup and avoid unnecessary procedure(s)

    8. Breast Pain (Mastalgia) • Almost all women will have experienced varying degree of breast pain in her lifetime ranging • mild discomfort • severe pain • cyclical • estrogen overstimulation • methylxanthines

    9. Mastalgia • Mastalgia is a poor predictor for cancer risk • <5% of breast cancer are associated with pain • >95% of patients with some breast pain • Beware! • Though the association of breast pain and breast cancer is NOT strong, the fear is very REAL

    10. Management of Mastalgia • The most important questions: • Is there a dominant mass? • Physical examination for dominant mass • Follow the workup of a breast mass • Is there associated nipple discharge? • If there is bloody or serous discharge, follow nipple discharge workup • Does patient have recent breast imaging • Mammogram • Ultrasound • If abnormal, follow workup of a breast mass

    11. Management of Mastalgia • If the breast examination and mammograms are negative: • Discontinue caffeinated products • Discontinue nicotine use • Nonsteroidal anti-inflammatory agents (NSAIDs) • Hormonal manipulation • Danazol • 6 month trial of 100 to 400mg daily • Side effects • Tamoxifen • Vitamins • A and E • Repeat examination in 4 to 6 months

    12. Nipple Discharge • Less than 5% chance of cancer Leis, World J Surgery, 1999 • Differentiate between high versus low risk by history Higher risk Lower risk Spontaneous versus provoked Unilateral versus bilateral Bloody/serous versus cloudy and/or multicolored Post- versus pre-menopasual

    13. Nipple Discharge • Physical examination • Is there a subareolar mass? • Types of imaging • Mammogram • Ultrasound • Duct ectasia • Ductogram • Intraductal defect

    14. Nipple Discharge • Determine the need for histologic diagnosis based on the following • History • Examination • Imaging • Causes of nipple discharge • Most common cause for spontaneous nipple discharge is intraductal papiloma • BUT intraductal (DCIS) and invasive ductal carcinoma can cause nipple discharge (5%)

    15. Management of a Breast Mass • Questions that need to be addressed • Is it dominant? • What is the age of patient? • How long has it been? • Has it change in size? • Any associated symptoms? • discharge • skin changes • pain • What is the relative risk for cancer? • previous biopsy • family history

    16. Management of a Breast Mass • Determine the type of imaging • Diagnostic mammogram • Reserved for older than 30 years of age • Pleomorphic microcalcification • Architectural distortion • Ultrasound • Diagnostic imaging • Cystic versus solid • NOT a screening test – nonspecific • MRI • Dense breast tissue • Post radiation therapy • PET scan • In house protocol for recurrent disease

    17. Management of a Breast Mass • Determine if histologic confirmation is necessary • Cystic lesion • Simple versus complex • Is there any intra-cystic defect? • Does it need drainage? • Solid lesion • Mammographic criteria • BiRads • Suspicious ultrasound characteristics • Solid lesion with • Low level internal echo • Irregular margin • Taller than in it is wide

    18. Management of a Breast Mass • 2 categories of biopsy • Excisional • Removes the whole lesion • Incisional • Removes part of the lesion

    19. Excisional Biopsy • Often used for palpable lesion • Nonpalpable, mammographically detected lesion • Needle localization • Blue dye injection • Benefits • Removes lesion completely • Reduces risk for sampling error • If tumor-free margin is achieved • Lumpectomy with curative intent

    20. Incisional Biopsy • By definition, samples the lesion • Fine needle aspiration (FNA) • Cytology • Open wedge biopsy • Tru-cut or core biopsy • Image guided or by palpation • Mammogram • Stereotatic core biopsy (SCB) • Mammotomy • Ultrasound

    21. Treatment for Breast Cancer

    22. Breast Cancer Outcome • Incidence 211,240 • Death 40,410 • 5 yr survival 1975 75% 1986 78% 2000 88% Jemal, et al., CA Cancer J Clin 55(1);10, 2005 • Improvement in breast cancer outcome • Early detection • Multimodal therapy • Locoregional control • Systemic adjuvant therapy

    23. Breast Cancer Therapy • Local-regional control • Surgery • Radiation therapy (XRT) • Systemic control • Chemotherapy • Hormonal manipulation

    24. Surgical Therapy for Breast Cancer“The Gold Standard” • Modified Radical Mastectomy (MRM) • Total mastectomy • Removal of all gross breast tissue • including the nipple areolar complex • Level I and II axillary node dissection (ALND) • Breast Conservation Therapy (BCT) • Excision of cancer with tumor-free margin • lumpectomy • ALND • XRT

    25. Systemic Therapy • Adjuvant therapy based weighing • Risk of recurrence • Sequelae of therapy • Chemotherapy • Node-positive patients • Tumors >1 cm • Age/Menopausal status • Overall health of patient • Endocrine therapy • Receptor status (ER and PR) • Anti-estrogen • Aromatase inhibitors (AIs)

    26. Breast Conservation Therapy • Removal of breast cancer • Lumpectomy • Quadrantectomy • Partial mastectomy • Segmentectomy • Must achieve tumor-free margins • Axillary node dissection • Breast irradiation • 4500 to 5000 cGy • 5 to 6weeks • Whole breast irradiation

    27. What to do with the lymph nodes?

    28. Management of Axillary Lymph Nodes • Infitrating ductal cell carcinoma (IDCA) • Invasion of tumor cells beyond the basement membrane • Nodal basin needs evaluation • Gold Standard • Complete ALND • Sentinel Node Biopsy (SLNB) • Early breast cancer

    29. Axillary Node Dissection • Staging: • Single best predictor for risk of systemic disease and cancer recurrence • Therapeutic decisions • Systemic therapy • Radiation therapy • May improve survival and cuure

    30. NSABP B-06 20 Year Update • Randomized trial initiated in 1976 • 3 arms (all patients underwent ALND) • Total mastectomy (MRM) • Lumpectomy • Lumpectomy and XRT (BCT) • Accrued 2,163 patients with tumors • < 4 cm • Included node- positive and negative patients • Establishes the efficacy and safety for BCT Fisher, NEJM Oct., 2002

    31. Breast Conservation Versus Mastectomy • For most women, breast conservation therapy is as good as mastectomy • Contraindications remain • Multicentric disease • Inability to obtain negative margins • Breast lesion and breast size • Contraindication to radiation therapy • Patients’ preference • Compliance

    32. Evolving Treatment Paradigms:The Sentinel Node

    33. Sentinel Lymph Node Biopsy (SLNB) • Definition • “gate-keeper” or first echelon node to drain a tumor, i.e. primary breast cancer • Focuses on • Identify node-negative patients • avoid unnecessary node dissection • Identify node-positive patients • Complete node dissection • Systemic therapy • XRT

    34. Identifying the Sentinel Node • Injection material • Technetium-99m sulfur colloid • Isosulfan blue • Site of injection • Intra-tumoral • Intra-parenchymal • Intra-dermal/peri-areolar • Embryological: axilla • May miss internal mammary nodes

    35. Potential Benefits • Risk reduction for lymphedema • Group 1: 117 patients SLNB and node dissection • Group 2: 303 patients SLNB without node dissection • Lymphedema 17.1% versus 3% (p<0.0001) Sener, Cancer, 2001 • Higher degree of scrutiny of SLN by pathologists • Cursory examination of 10 to 25 nodes • Extensive evaluation of a few nodes • Application of molecular techniques

    36. Potential Risks • Risk of not finding the sentinel node: 5% • In clinical trials after training • Higher in early part of learning curve • FALSE negative rate (FNS): 5 to 10% • Technical error • Injection site • Type of contrast used • Learning curve • Alternate lymphatic drainage

    37. Risks of False Negative SLN • Implications for the patients • Leaving behind nodal disease • Local-regional recurrence • Systemic implications • Understaging of disease will lead to under-treatment • Small tumor, node-negative disease • Impacts choice of adjuvant • Chemo regimen • Postoperative axillary XRT

    38. False Negative SLN • To reduce the number of missed node-positive patients: • Select patients with less likelihood of node-positive disease • Practical application based on 1,000 patients • FNR = 5% • Applied to a 10% node-positive risk group • You will miss 5 node-positive patients • Applied to a 40% node-positive risk group • You will miss 20 node-positive patients

    39. Critical Issues with SLN Biopsy • Technical competence • Learning curve • Mapping accuracy • Blue dye plus Tc-sulfur colloid • Maintain quality control • False negative rate must be 5% or less • Validated by performing completion ALND in the initial experience • Surveillance of patients for cancer recurrence

    40. Critical Issues with SLN Biopsy • NO SURVIVAL DATA • NSABP trial • ACOSOG Z00010 and Z00011 • Await cancer cooperative groups results • Importance of Informed Consent

    41. Is SLNB Safe? • Prospective, randomized trial in Milan • Over 250 patients in each arm • SLNB with completion ALND versus SLNB alone (if SLNB is negative) • In the SLNB followed by ALND • Accuracy = 96.9% • False negative rate = 8.8% • SLNB alone group (median follow-up = 46 months) • No overt axillary metastasis • No difference in rate of cancer events • 16.4 per 1,000 per year in ALND • 10.1 per 1,000 per year in SLNB Veronesi, et al., NEJM, 2003.

    42. Take Home Message • ALND remains the gold standard • Quality control • Careful patient selection for SLNB alone • T1 and small T2 lesion • Unicentric lesion • Avoid patients with excisional breast biopsy > 6 cm • Avoid patients treated with neoadjuvant therapy • Avoid patients with previous axilla surgery • Avoid patients with gross nodal disease Anderson, JNCCN, 2003.

    43. Evolving Treatment Paradigms: Adjuvant Radiation Therapy • Accelerated Partial Breast Irradiation (APBI) • Postmastectomy radiotherapy (PMRT)

    44. Postoperative XRT after BCT • External Beam Radiation Therapy (EBRT) • Whole breast therapy • Daily treatment for 5 to 6 weeks • Total dosage: 5000 cGy • Compliance issue • Non-compliance: 50% • Local failure: 50% Li, Ann Surg, 1999

    45. Accelerated Partial Breast Irradiation (APBI) • Limit the volume of breast to be treated • Within 2 cm border of lumpectomy • XRT completed in 4 to 5 days after lumpectomy • Multicatheter interstitial brachytherapy • Balloon catheter brachytherapy (MammoSite) • 3-D conformal external beam radiotherapy • Intraoperative radiotherapy

    46. Summary of APBI Results • Multicatheter interstitial brachytherapy • Longest follow-up (median FU 27 to 91 months) • 5 yr local recurrence (LR) rate: 5% (0% to 37%) • Balloon catheter brachytherapy (MammoSite) • LR rate: 0% (F/U11 to 29 months) • Infection rate 16% • 3-D conformal external beam radiotherapy • LR rate: 0 to 25% Arthur, et al., J Clin Oncol 23:1726, 2005.

    47. Clinical Trial – NSABP B39 • Partial breast irradiation trial • Tumor size < 3 cm • Unifocal tumor • After lumpectomy, randomized to • External beam radiation (EBRT) • Partial breast irradiation (PBI) • MammoSite • Intracavitary catheters • 3-D conformal EBRT

    48. Take Home Message • The role of APBI is evolving • This is NOT the standard of care • Must be considered in the context of • Clinical trial • Careful patient selection • Informed consent

    49. Radiotherapy After Mastectomy • Pre-1997: NOT indicated except for • Positive margins • High risk for local failure • Locally advance breast cancer • Inflammatory breast cancer • Post-1997 • Overgaard, et al., NEJM 337:949, 1997. • Danish Breast Cancer Cooperative Group • Ragaz, et al., NEJM 337:956, 1997. • British Columbia • Postmastectomy radiotherapy became relevant

    50. Postmastectomy Radiotherapy (PMRT) • ASCO Expert Panel • Reviewed data from 18 randomized clinical trials (RCTs) • Reduction in risk for local failure (LF) • By two thirds to three quarters, proportionally • In practical terms: • Reduction of LF from 8 per 100 patients • To 2-3 per 100 patients Recht, et al., J Clin Oncol19(5):1539, 2001