DISCIPLINA DE MASTOLOGIA ESCOLA PAULISTA DE MEDICINA UNIVERSIDADE FEDERAL DE SÃO PAULO Management of the Axilla at Initial Surgery Manejo da Axila em Cirurgia Inicial Disciplina de Mastologia Prof. Dr. Afonso Celso Pinto Nazário Professor Livre-Docente e Chefe da Disciplina de Mastologia EPM-UNIFESP
Evolution of the axilla surgical treatment
Axilla Surgical Treatment - Axillary lymphadenectomy: standard treatment (independent of clinical stage) Halsted s Theory X Fisher s Theory Morbidity, Quality of life, Mortality
Cirurgia axilar Axillary lymphadenectomy X Sentinel lymph node biopsy
Axilla Surgical Treatment History - 1951: Gould first study of sentinel lymph node in parotid tumors - 1977: Cabanas Penis carcinoma SLN as the first lymph node to receive lymphatic drainage from the tumor area
Axilla Surgical Treatment History - 1992: Giuliano Breast cancer Blue vital dye technique - 1995: Krag Tc99 radioisotope-labeled technique - 1996: Albertini Combination of both techniques
Sentinel lymph node Technique was considered valid for clinical use in breast cancer T1 e T2 and negative axilla
Axillary Surgery - Clinically Negative Axilla and tumor till 5 cm = Sentinel lymph node biopsy - Clinically Positive Axilla or tumor > 5cm = Axillary lymphadenectomy
Is there a necessity for axillary dissection in patients with sentinel lymph node metastatic? 1) Positive SLN is the only positive lymph node in most cases (67%) 2) Adjuvant treatment can be based T and not necessarily N 3) Tangential radiotherapy of the breast reaches axilla leavel 1(=therapeutic) 4) Axillary metastasis is a predictive but not a determining factor of systemic disease Observation of the breast cancer patient with a tumor-positive sentinel node: implications of the ACOSOG Z0011 trial. Semin. Surg. Oncol. 2001 Apr- May;20(3):230-7.
ACOSOG Z0011 trial - Randomized study - Phase 3 - Multicenter - National Cancer Institute - May 1999 a Dec 2004 - Invasive breast cancer - T1 and T2 N0 M0-1 or 2 SLN + Ann Surg 2010 Sep;252(3):426-32; discussion 432-3
ACOSOG Z0011 trial Objective: Evaluate axillary dissection in breast cancer T1 and T2 with SLN+ Primary end point: - Overall survival Secondary end points: - Disease-free survival, Locoregional Recurrence, Surgical morbidity Ann Surg 2010 Sep;252(3):426-32; discussion 432-3
Critérios Inclusão: Critérios Inclusão: Inclusion Criteria: T1 or T2 N0 M0 1 or 2 SLN + (frozen section, touch preparation, H&E) Conservative breast surgery with negative margins Radiotherapy 45-50 Gy (1.8-2 Gy per day) Systemic treatment (Chemotherapy, Hormone therapy or both)
Introduction: Axillary lymphadenectomy is the main treatment for locoregional control in SLN + Objeticve: Evaluate local and regional recurrence in the patients of the Z0011 trial Ann Surg 2010 Sep;252(3):426-32; discussion 432-3
The outcome of the study was published on 2010 After a mean follow-up of 6.3 years, there was no statiscally significant difference: 1) Locoregional recurrence 3.6% in axillary lymphadenectomy X 1.8% SLN (p=0,45) 2) Local recurrence 0.5% in axillary lymphadenectomy X 0,9% SLN (p=0,11) Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg 2010 Sep;252(3):426-32; discussion 432-3.
CONCLUSION - Patients with invasive breast cancer T1 or T2 and low risk of axillary metastatic disease, the lymphadenectomy is not beneficial in locoregional control (conservative treatment and sistemic adjuvant treatment) - The indication of lymphadenectomy axillary is questioned Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg 2010 Sep;252(3):426-32; discussion 432-3.
Survival of the ALND group compared with SLND alone group Axillary Dissection vs No Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis. JAMA, Feb 9, 2011 vol 305-n6
CONCLUSION American College of Surgeons Oncology Group Z0011 The axillary lymphadenectomy not significantly changed the overall survival and disease-free survival in patients with breast cancer T1-T2 and metastasis in sentinel lymph node, treated with conservative surgery, sistemic therapy and radiotherapy. Axillary Dissection vs No Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis. JAMA, Feb 9, 2011 vol 305-n6
Amaros trial (After mapping of the axilla: radiotherapy or surgey) Non-inferiority phase 3 study Follow-up: 6.1 anos T1-2, N0 SLN+ Axillary RT N = 681 Lymphadenectomy N = 744 Asco, 2013
Amaros trial (After mapping of the axilla: radiotherapy or surgey) Recurrence Disease-free survival Overall survival Lymphedema Lymphadenectomy 0,54% 86,9% 93,3% 28% Axillary RT 1,03% 82,6% 92,5% 14% Asco, 2013
T1-2, N0 SLN Negative Positive ACOSOG Z0011 criteria fulfilled Positive ACOSOG Z0011 criteria not fulfilled No further additional axillary approach Lymphadenectomy
N1 PAAF or CORE Negative Positive SLN T3 N0 Lymphadenectomy