Targeting Surgery for Known Axillary Disease. Abigail Caudle, MD Henry Kuerer, MD PhD Dept. Surgical Oncology MD Anderson Cancer Center

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1 Targeting Surgery for Known Axillary Disease Abigail Caudle, MD Henry Kuerer, MD PhD Dept. Surgical Oncology MD Anderson Cancer Center

2 Nodal Ultrasound at Diagnosis Whole breast and draining lymphatic basin ultrasound performed on all patients with invasive cancer Axilla -Internal mammary Infra-clavicular -Supraclavicular Suspicious lymph nodes biopsied Fornage

3 Ultrasound Guided FNA Specificity: 100% Positive Predictive Value: 100% Krishnamurthy et al Cancer, 2002

4 Preoperative Systemic Therapy General approach for large primary tumor or nodal metastases at MDACC Response in the breast and nodes can be monitored during therapy Surgery in the axilla following chemotherapy Initial node negative: SLN and ALND if positive Initial node positive: ALND

5 Conversion of Axillary Metastases: Clinically Positive to Pathologic Negative Clinical Positive NCT Pathologic Negative HER2-Negative - 40% HER2-Positive (with trastuzumab) 74%

6 Sentinel Node Biopsy after Preoperative Chemotherapy for Node Positive Breast Cancer?

7 SLN after Preoperative Chemotherapy for Known Node Positive: Retrospective Studies Author Year Number of Patients Identification Rate (%) False Negative Rate (%) Mamounas et al Shen et al Classe et al Gimbergues et al Gomez et al Chintamani et al Canavese et al Alvarado et al

8 San Antonio Breast Cancer Symposium, December 4-8, 2012 The role of sentinel lymph node surgery in patients presenting with node positive breast cancer (T0-T4, N1-2) who receive neoadjuvant chemotherapy results from the ACOSOG Z1071 trial Judy Boughey, Vera Suman, Elizabeth Mittendorf, Gretchen Ahrendt, Lee Wilke, Bret Taback, Marilyn Leitch, Teresa Flippo-Morton, David Byrd, David Ollila, Tom Julian, Sarah McLaughlin, Linda McCall, Fraser Symmans, Carisa Le-Petross, Bruce Haffty, Tom Buchholz, Kelly Hunt This presentation is the intellectual property of the author/presenter. Contact for permission to reprint and/or distribute.

9 San Antonio Breast Cancer Symposium, December 4-8, 2012 ACOSOG Z1071 Hypothesis: SLN surgery is an accurate method of axillary staging after NAC in node positive patients Primary Endpoint: False negative rate of SLN surgery in clinically node positive disease after NAC ClinicalTrials.gov Identifier: NCT This presentation is the intellectual property of the author/presenter. Contact for permission to reprint and/or distribute.

10 San Antonio Breast Cancer Symposium, December 4-8, 2012 Z1071 schema T0-4, N1-2, M0 invasive breast cancer (pretreatment axillary ultrasound with FNA or core biopsy documenting axillary metastases) REGISTER* Neoadjuvant chemotherapy REGISTER* SLN and ALND This presentation is the intellectual property of the author/presenter. Contact for permission to reprint and/or distribute.

11 San Antonio Breast Cancer Symposium, December 4-8, 2012 Methods Recommended surgical standards Resection of minimum of 2 SLNs Use of dual tracer (radiocolloid and blue dye) Pathologic assessment Standard processing with H&E staining Node positive defined as tumor >0.2mm on H&E This presentation is the intellectual property of the author/presenter. Contact boughey.judy@mayo.edu for permission to reprint and/or distribute.

12 San Antonio Breast Cancer Symposium, December 4-8, 2012 SLN Identification Rate SLN(s) detected in 639 (92.7%) of 689 women Patients N SLN identified SLN identification rate (%) CI All patients cn cn This presentation is the intellectual property of the author/presenter. Contact boughey.judy@mayo.edu for permission to reprint and/or distribute.

13 San Antonio Breast Cancer Symposium, December 4-8, 2012 Node positive disease 637 pts Chemotherapy Node negative 255 pts (40%) Residual nodal disease 382 pts (60%) SLN positive 326 pts SLN negative / ALND positive 56 pts SLN correctly identified nodal status in 91.2% This presentation is the intellectual property of the author/presenter. Contact boughey.judy@mayo.edu for permission to reprint and/or distribute.

14 San Antonio Breast Cancer Symposium, December 4-8, 2012 False negative rate among pts with cn1 disease and at least 2 SLNs examined FNR = # pts SLN - / ALND + # pts SLN + or ALND patients had residual nodal disease 39 of these patients had negative SLNs FNR = 12.6% 95% probability that the FNR lies in the range of 9.4 to 16.7%. This presentation is the intellectual property of the author/presenter. Contact boughey.judy@mayo.edu for permission to reprint and/or distribute.

15 San Antonio Breast Cancer Symposium, December 4-8, 2012 Clip placement in patients with cn1 disease and 2+ SLNs examined 172 of 525 (32.8%) patients had clip placed in LN at diagnosis. Clip Clip placed and found in SLN Clip placed, not documented where located at surgery N Nodal residual disease FNR 95% CI % % % % Clip not placed % % This presentation is the intellectual property of the author/presenter. Contact boughey.judy@mayo.edu for permission to reprint and/or distribute.

16 Nodal FNA and Placement of Gel Marker Wei Yang, MD

17 Question #1: What is the fate of individual nodes with documented metastases?

18 Prospective Registry of Breast Cancer Patients with Axillary Nodal Metastases Identified During Ultrasound Staging at MD Anderson Cancer Center: Protocol Eligibility: limited axillary disease One or two abnormal axillary nodes on US documented by cytology Gel marker clip (visible on ultrasound and mammography) in node with metastases Preoperative chemotherapy Routine axillary node dissection

19 Prospective Registry of Breast Cancer Patients with Axillary Nodal Metastases Identified During Ultrasound Staging at MD Anderson Cancer Center: Protocol Routine ALND, identification of marked node, pathologic correlation (disease presence and size) with compared with other nodes

20 Question #2: Can we identify the clipped node intra-operatively?

21 Feasibility of Selective Image Guided Resection of Cytologically Documented Axillary Lymph Node Metastases Following Preoperative Chemotherapy: Protocol T0 T4 FNA documented axillary metastases One or two nodes with clip placement Preoperative Chemotherapy Repeat nodal ultrasound, FNA Excision of marked nodes Routine axillary node dissection OUTCOME Technical Success? Correlation: FNA results with Histology Clip Node with Others

22 Potential Next Clinical Protocols? Marker placed if <3 suspicious nodes Standard chemotherapy Assess response by ultrasound Biopsy clipped node after NCT- Positive ALND Negative SLND and removal of clipped node Both negative no further axillary surgery Positive - ALND

23 Using Biologic Predictors: NodeS Assay Microarray-based genomic predictor Based on tumor core or needle biopsies Based on two signatures: Nodal response pln- versus extensive disease Pathologic response pcr/rcb-i vs. RCB-2/RCB-3

24 Clinically Node Positive Clinical LN Positive N=88 Predicted Responder N=18 Predicted Non-Responder N=70 Chemotherapy pln Negative N=12 pln Negative N=27 67% (95% CI 41-87%) Symmans et al. ASCO Breast Symposium. Poster Presentation % (95% CI 27-51%)

25 What about patients who go to surgery first? Role of axillary ultrasound in the post-acosog Z0011 era?

26 ACOSOG Z0011 Trial Designed to determine if ALND impacts survival in selected SLN positive patients Enrolled patients with: Clinical T1-2 N0 breast cancer Undergoing breast conservation therapy (BCT) followed by whole breast radiotherapy Found to have 1-2 positive SLN Randomized patients to ALND versus no ALND At median 6.3 follow-up, there was no difference in survival or locoregional recurrence rates 1,2 1 Giuliano et al. JAMA Giuliano et al. Ann Surg 2010

27 Defining Nodal Disease Burden Compared patients T1-2 tumors with axillary metastasis: Cohorts: Clinically negative, metastasis found by SLN 1-2 suspicious nodes on U/S, confirmed by FNA Exclusions: >2 suspicious nodes N3 disease Patients undergoing NCT Clinical or pathologic tumor size > 5 cm

28 Burden of Nodal Disease Identified by SLN N= 518 Identified by U/S N=149 P value Mean number of + LN <0.001 Total number of + LN: Largest LN Metastasis (Mean) Extra-nodal Extension Present 290 (56%) 127 (25%) 101 (19%) 44 (30%) 38 (25%) 67 (45%) < mm mm < (24%) 75 (50%) <0.001

29 Summary Ultrasound with FNA highly sensitive and specific for identification of nodal metastases Marking of nodal metastases may allow for targeted excision of disease Improve assessment of response? Minimize axillary surgery? Biologic predictors may also allow targeted surgical therapy

30

31 San Antonio Breast Cancer Symposium, December 4-8, 2012 Future Studies ALLIANCE A11202 Schema Clinical T1-3 N1 M0 BC Neoadjuvant Chemotherapy BCT or Mastectomy Sentinel Lymph Node Surgery SLN Negative Randomization SLN Positive NSABP B-51/RTOG 1304 (NRG 9353) Schema Clinical T1-3 N1 M0 BC Axillary nodal involvement (FNA or core needle biopsy) Neoadjuvant chemo (+ Anti-HER-2 therapy for HER-2 neu pts) Definitive surgery with histologic documentation of negative axillary nodes (either by axillary dissection or by SLNB axillary dissection Stratification Type of surgery (mastectomy vs lumpectomy) ER status (+ vs -), HER-2 status (+ vs -) pcr in breast (yes vs no) ALND Breast/chest wall and nodal XRT No further axillary surgery. Breast/chest wall and nodal XRT No Regional Nodal XRT with breast XRT if BCS & No chest wall XRT if mastectomy Randomization Regional Nodal XRT with breast XRT if BCS and chest wall XRT if mastectomy This presentation is the intellectual property of the author/presenter. Contact for permission to reprint and/or distribute.

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