Is Complete Axillary Dissection Needed Following Mastectomy and Sentinel Node Biopsy for N1 disease?

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1 Is Complete Axillary Dissection Needed Following Mastectomy and Sentinel Node Biopsy for N1 disease? Mylin A. Torres, MD Director, Glenn Family Breast Center Louis and Rand Glenn Family Chair in Breast Cancer Research Associate Professor Department of Radiation Oncology Winship Cancer Institute Emory University 1

2 YES 2

3 Is Axillary Node Dissection Needed for Mastectomy Patients Who are Clinically Node Negative, but Pathologically Node Positive? 3

4 20-60% of patients will have additional axillary nodes positive for breast cancer if the sentinel node contains disease 4

5 ACOSOG Z11 All Breast Conserving Therapy Patients: Lumpectomy + XRT Giuliano AE, et al. JAMA. 2011;305(6):

6 ACOSOG Z11 Giuliano AE, et al. JAMA. 2011;305(6):

7 ACOSOG Z11 Disease Free Survival and Overall Survival Giuliano AE, et al. JAMA. 2011;305(6):

8 ACOSOG Z11 Complications Caudle AS, et al. Ann Surg Oncol. 2011;18(9):

9 ACOSOG Z11 Complications Caudle AS, et al. Ann Surg Oncol. 2011;18(9):

10 ACOSOG Z11 Complications Caudle AS, et al. Ann Surg Oncol. 2011;18(9):

11 ACOSOG Z11 T1 or T2 tumors Clinically Node Negative Treated with upfront breast conserving surgery, not neoadjuvant systemic therapy <3 lymph nodes involved, no ECE; 40% of patients had N1 micromets The majority received adjuvant radiation and systemic therapy that contribute to low rates of recurrence Axillary lymph node dissection was not associated with higher rates of objective measures of lymphedema (arm measurements) 11

12 NSABP B-06: Breast Conserving Therapy vs. Mastectomy 2/3 (66%) relative risk reduction of recurrence among XRT treated patients. 39.2% No XRT 14.3% XRT Significantly more patients who received XRT kept their breast because they did not develop an in-breast recurrence. No Difference in Survival Rates Based on Surgery Received Fisher et al. NEJM 2002

13 Can we apply the findings of ACOSOG Z11 to mastectomy patients who may or may not receive radiation? 13

14 Recht A, et al. J Clin Oncol. 2016;34(36):

15 Indications for Postmastectomy Radiation (PMRT) N2 or N3 disease T3 or T4 tumors Positive margins N1 disease and 3 lymph nodes or- LVSI or- Premenopausal or- High grade or- Extracapsular extension or- >20% of lymph nodes removed involved with tumor 15

16 A 68 year old with a T1N1, luminal A, low grade tumor, no LVSI, negative margins, and 1 of 9 positive lymph nodes without extracapsular extension has a low absolute risk of local regional recurrence and may not need post mastectomy radiation 16

17 When a sentinel lymph node is positive in a mastectomy patient, critical information for determining adjuvant treatment is lost if a full axillary lymph node dissection is not performed 17

18 2016 ASCO/ASTRO/SSO PMRT Guideline PMRT should be administered if there is otherwise sufficient evidence to warrant its use when ALND is omitted and the potential toxicities of PMRT, including rare but potentially fatal secondary cancers and cardiac events, are felt to be justified, and ALND should be used when totality of the evidence is not yet sufficient for administering PMRT. Recht A, et al. J Clin Oncol. 2016;34(36):

19 2016 ASCO/ASTRO/SSO PMRT Guideline PMRT should be administered if there is otherwise sufficient evidence to warrant its use when ALND is omitted and the potential toxicities of PMRT are felt to be justified, and ALND should be used when totality of the evidence is not yet sufficient for administering PMRT. Would I recommend PMRT if the patient had a full ALND and no additional disease was found in nonsentinel nodes? If the answer is NO, ALND should be performed Recht A, et al. J Clin Oncol. 2016;34(36):

20 AMAROS Trial Donker M, et al. Lancet Oncol. 2014;15(12):

21 AMAROS Trial

22 AMAROS TRIAL: Patient Characteristics ~60% postmenopausal 80% T1 tumors 75% Grade I or II 90% received systemic therapy 61% received chemotherapy 22

23 AMAROS TRIAL: Patient Characteristics ~60% postmenopausal 80% T1 tumors 75% Grade I or II 90% received systemic therapy 61% received chemotherapy Do these patients need chemo? Do they need radiation? 23

24 AMAROS Trial Donker M, et al. Lancet Oncol. 2014;15(12):

25 AMAROS-Lymphedema Donker M, et al. Lancet Oncol. 2014;15(12):

26 AMAROS TRIAL: Patient Characteristics ~60% postmenopausal 80% T1 tumors 75% Grade I or II 90% received systemic therapy 61% received chemotherapy who had one positive lymph node on sentinel node biopsy Could chemotherapy, radiation and their associated toxicities have been avoided in the SLNbx, axillary radiotherapy patients? 26

27 IBCSG % of patients received mastectomy 95% received systemic therapy: 30% chemo Galimberti V, et al. Lancet Oncol 2013; 14:

28 Favorable, low burden of disease in all studies to date of sentinel lymph node biopsy alone for pathologic N1 disease 28

29 Is XRT Enough Treatment for Significant Axillary Disease? Nodal disease greater than 2.0cm Extracapsular extension 3 or more involved lymph nodes Matted nodes 29

30 Is XRT Enough Treatment for Significant Axillary Disease? Nodal disease greater than 2.0cm Extracapsular extension 3 or more involved lymph nodes Matted nodes Probably not 30

31 NCDB Park TS, et al. J Clin Oncol. 2017;35(suppl): Abstract 554.

32 NCDB Park TS, et al. J Clin Oncol. 2017;35(suppl): Abstract 554.

33 Axillary lymph node dissection is absolutely needed in node positive patients following mastectomy Performing SLNbx alone increases the risk of overtreatment with chemo and radiation and their associated toxicities Knowing the true number of involved lymph nodes better informs decisions regarding adjuvant treatment Surgery is needed to eradicate significant burden of axillary disease Data suggests axillary lymph node dissection may help improve survival over sentinel lymph node biopsy alone in node positive breast cancer patients treated with mastectomy 33

34 Surgical Management of the Axilla in Clinically Node Positive Breast Cancer Patients who Receive Neoadjuvant Therapy 34

35 Residual Axillary Nodal Disease is found in 50-60% of Breast Cancer Patients who are cn+ before Neoadjuvant Chemotherapy 35

36 False Negative Rate of SLN Biopsy in cn1 patients following Neoadjuvant Therapy Study # of patients False Negative Rate (%) Alvarado et al Canavese et al Chintamani et al Gomez et al (I-SPY) Gimbergues et al Classe et al (Gannea-French) Shen et al Mamounas et al (NSABP B-27) FNR is 5-30% 36

37 ACOSOG Z1071 Primary Objective: Determine the FNR of SLNbx following chemotherapy in biopsy proven cn1 patients Predetermined 10% FNR was Acceptable Boughey JC, et al. JAMA. 2013;310(141):

38 FNR = 12.6%

39 ACOSOG Z1071 Boughey JC, et al. JAMA. 2013;310(141):

40 Kuehn T, et al. Lancet Oncol. 2013;14(7):

41 SENTINA Trial Results for Arm C FNR was 14.2% FNR decreased to 7.3% if >2 SLNs removed FNR decreased to 8.6% if both blue dye and radiolabeled colloid are used Kuehn T, et al. Lancet Oncol. 2013;14(7):

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43 ALLIANCE A

44 Axillary lymph node dissection is absolutely needed in node positive patients following mastectomy and neoadjuvant chemotherapy FNR is high of SLNbx alone Surgery is needed to eradicate significant burden of axillary disease Ongoing ALLIANCE A11202 Trial to determine if full axillary lymph node dissection is not needed 44

45 Lymphedema 45

46 The larger the number of lymph nodes removed, the higher the risk for lymphedema 46

47 Lymphedema Rao R, et al. JAMA. 2013;310(13):