Evolution of the Management of the Axilla with Breast Cancer Ralph L. Corsetti, MD, FACS Medical Director Lieselotte Tansey Breast Center Ochsner Health System Associate Professor of Surgery University of Queensland School of Medicine Ochsner Clinical School Background • • • The status of the axillary lymph nodes is one of the most important prognostic factors in women with early stage breast cancer. Axillary lymph node dissection (ALND) has/had traditionally been a routine component of the management of early breast cancer. The benefits of ALND include its impact on regional disease control, its prognostic value through staging, and its role in treatment selection Axillary Asessment For Lymph Nodes (LN) • • • • • • PE not very sensitive or reliable LN’s w/ mets often not palpable Negative predictive value 50 to 60 % Palpable LN’s may be reactive ones Positive predictive value 61 to 84 % Therefore, surgical staging is indicated IF it will change management Background • • • However, ALND may result in: – – – – Lymphedema Nerve Injury Shoulder Dysfunction Function and Quality of Life With clinically negative LN’s or without histologic confirmation of CA in a palpable LN, Sentinel Lymph Node Dissection) SLND allows axillary staging with less morbidity. ALND used when node clinically palpable or positive LN’s by US guided FNA. Levels of Axilla Sentinel Lymph Node Biopsy Sentinel Lymph Node Biopsy Lymphedema Axillary Ultrasound • For clinically palpable or suspicious LN(s), then US guided FNA or core biopsy may identify patients who could go to ALND ALND vs SLND • • • Traditionally ALND had been routine for staging and management of invasive breast cancer. Now SLND accepted as initial approach and standard of care for women with early stage breast cancer. The use of full ALND in clinically node negative patients with early stage disease is contraindicated. ALND Potential Benefits • Impact on disease control – Axillary recurrence – Survival • Prognastic (staging) value • Role in treatment selection ALND Impact on Survival • • • • • • DOUBTFUL NSABP B-04, clinically negative axillae Mastectomy w/ ALND, mastectomy w/ nodal radiation, or mastectomy with ALND delayed until positive LN’s developed. No difference in disease free or overall survival @ 10 years. N Engl J Med 1985; 312:674. @ 25 years. N Engl J Med 2002; 347:567. Impact on Survival • Meta-analysis of three randomized trials between 200 and 2007 comparing ALND to no ALND • No difference in survival. • WHY? – Improved targeted and more widespread use of chemotherapy – Breast radiation for breast conservation includes at least low axillary fields. Impact on Regional (Axillary Recurrence) • • • • • NSABP B-04 Axillary failure significantly higher (18%) in those without ALND 3.1% with Radiation 1.4% with ALND 18 % high – No widespread use of MMG so mean tumor size larger in early 1970’s – Improved targeted chemotherapy. – So by 1990’s axillary failure rate 8-10%. Radiation Therapy (RT) vs. ALND • • • • • • Tumors <1 cm, clincally negative axilla 381 women Breast conservation plus RT or ALND F/U 26 months One axillary recurrence in each arm Int J radiat Oncolo Biol Phys 1998; 42:250 SLND • • • • • • Identifies patients without axillary LN involvement Obviates need for more extensive surgery Decision about proceeding with ALND based on results of SLND Axillary recurrence 0.5% if SLND negative and no subsequent ALND. Many randomized controlled trials. Typically proceed with ALND if SLND is positive. Until ACoSOG Z0011 (Z11) Z11 • • • • • 891 women randomized after positive SLNB All women had breast conservation (lumpectomy) with RT and systemic therapy (96%) Half with ALND and half no ALND Local-regional recuurence – 4% for no ALND – 3% for ALND – Axillary recurrence: 0.5% w/ ALND; 1% w/o ALND. Ann Surg. 2010; 252(3): 426-32. Z11 • • • • Excluded patients with SLN metastasis only identifiable by immunohistochemistry (IHC). Could only have one or two positive SLN’s. Does not apply to mastectomy patients. No pre-op axillary ultrasound. Present • • • • • • SWOG S1007 (RxPONDER) Women w/ hormone receptor positive / HER2 negative breast CA N1 disease (1 – 3 positive LN) by SLNB or ALND Oncotype DX score assessment on primary tumor Score of 25 or less eligible Chemotherapy and endocrine therapy vs. endocrine therapy alone. ACoSOG Z1071 • • • • • • Clinically N1 received neoadjuvant chemotherapy Followed by SLND and ALND 7.1% SLN could not be identified 41% complete nodal response False negative rate of 12.6% JAMA. 2013;310(14):1455-1461. Future NSABP B-51 • • Randomized phase III trial evaluating post-mastectomy chestwall and regional nodal RT and post-lumpectomy regional nodal RT in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary lymph nodes after neoadjuvant chemotherapy. Assess recuurence free intervals. NSABP B-51 NSABP B-51 Alliance A011202 A RANDOMIZED PHASE III TRIAL EVALUATING THE ROLE OF AXILLARY LYMPH NODE DISSECTION IN BREAST CANCER PATIENTS (CT1-3 N1) WHO HAVE POSITIVE SENTINEL LYMPH NODE DISEASE AFTER NEOADJUVANT CHEMOTHERAPY Clinical stage T1-3 N1 M0 breast cancer at Dx prior to start of neoadjuvant chemotherapy Patients must have clinically negative axilla on physical examination documented at completion of neoadjuvant chemotherapy. No neoadjuvant endocrine therapy or neoadjuvant radiation therapy. No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to initiation of chemotherapy Alliance A011202 • • Schema: For positive SLNB on intra-operative or final pathology then randomize: – ALND and Nodal RT – vs – Axillary and Nodal RT Axillary Assessment for DCIS • • No role for ALND ? Role for SLNB – – – – – High grade lesions Comedo necrosis Presentation as a mass ?UOQ lesions When performing a mastectomy SLND for Prophylactic Mastectomy • Risk of incidental finding of cancer in prophylactic mastectomy – – – – – About 2 - 3 % As high as 8 % with higher risk features (lobular carcinoma) Risk of lymphedema with SLNB 1 - 2% Risk of lymphedema with ALND 15 -20 % Risk assessment ?MRI? • • • • • ?Bloodless future for axillary staging? Ultrasmall paramagnetic iron oxide (USPIO) Injected subareolar as for SLND False positive 6.3% vs. <0.5% with SLNB Sensitivity and specificity about 90% and 95% respectively MRI with USPIO Questions?
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