Management of the Axilla in Early-Stage Breast Cancer
Management
I. Staging
For patients ≥70 years of age with clinically node-negative (T1N0) early-stage invasive breast cancer that is hormone receptor positive and HER2 negative, sentinel lymph node bioposy (SLNB) is NOT required.
( IC , Ins , B , M )This is supported by the Choosing Wisely statement released on July 12, 2016, and updated on June 20, 2019 by the Society of Surgical Oncology (SSO) available at: http://www.choosingwisely.org/clinician-lists/sso-sentinel-node-biopsy-in-node-negative-women-70-and-over/ that stated: “Don’t routinely use sentinel node biopsy in clinically node negative women ≥70 years of age with early stage hormone receptor positive, HER2 negative invasive breast cancer” if they will be treated with hormonal therapy. If omission of SLNB is considered, a consultation with a medical oncologist can be considered before surgery to discuss hormonal therapy.
For patients <70 years of age without significant competing comorbidities, SLNB should be considered for axillary staging of early-stage breast cancer.
( EB , , B , S )for staging by axillary lymph node dissection (ALND) versus no ALND; Ins for staging by SLNB versus no staging)
II. Further Axillary Treatment: SLN(-)
Clinicians should NOT recommend ALND for women with early-stage breast cancer who do not have nodal metastases.*
( EB , I , B , S )* Endorsed from Lyman GH, et al. J Clin Oncol. 2017;5:561-4, Recommendation 1.
In some selected patients (e.g., patients with medially or centrally located tumors or with high-risk features), and using a patient-centered approach, it is reasonable to offer the option of loco-regional nodal irradiation (LRNI) to include at least the supraclavicular and ipsilateral internal mammary lymph nodes in addition to the breast and/or chest wall (see Qualifying Statements).
For the majority of patients (i.e., node-negative patients whose tumors are not medial or central in location and who do not have other high-risk features), we cannot recommend LRNI. A risk-benefit discussion should be undertaken on a case-by-case basis for these patients (see Qualifying Statements).
III. Further Axillary Treatment: SLN(+)
A) No Further Axillary Surgery Beyond SLNB Compared with ALND
for those who received breast conserving surgery.
( EB , H , B , S )for patients who had mastectomy as well as for those excluded from the trials.
( EB , Ins , B , W )B) Radiotherapy of the Axilla (LRNI) Compared with No LRNI
It is reasonable to offer the option of treating the axilla with radiotherapy in addition to breast or chest wall irradiation following surgery, particularly in patients with medial or central tumors, and in patients with high-risk features. Discussion of pros and cons with patients needs to occur, and the decision should be made on a case-by-case basis.
(, , , )C) Radiotherapy to the Axilla Compared with Further Surgery (ALND)
We recommend radiotherapy of the axilla in lieu of ALND in patients who are clinically node-negative and pathologically sentinel lymph node-positive with tumors of up to 5 cm and unifocal or multifocal disease restricted to one quadrant.
( IC , L , , W )In patients who receive breast-conserving surgery, we recommend no ALND if one or two sentinel lymph nodes are positive. LRNI is a reasonable option, especially when there are high-risk features as in (B).
ALND and LRNI to the axilla is recommended if ≥3 sentinel lymph nodes are positive. In patients who receive mastectomy and have one to two positive nodes, post-mastectomy radiation (PMRT) to the chest wall and axilla is recommended and ALND can be safely omitted. In patients declining PMRT (i.e., patients with immediate reconstruction), either radiation to the axilla without the chest wall or completion ALND can be offered.
In patients who receive mastectomy and have ≥3 positive nodes, ALND followed by LRNI can be considered.
D) Radiotherapy Compared with No Treatment
In patients with unilateral invasive cancer of small size (i.e., T1a), favorable tumor features (e.g., ER+ undergoing hormonal therapy), clear margins, and one to three positive nodes, treated with chemotherapy or hormonal therapy, clinicians might offer the option of omitting LRNI.
( EB , I , B , W )
IV. When NAC is Used
A) Initially Node-negative Patients
Patients who are initially clinically node-negative on physical examination, and those who had clinically suspicious nodes on physical examination but deemed to be pathologically negative at fine needle aspiration/core needle biopsy, and were treated with NAC, should receive SLNB at the time of surgery as their axillary staging procedure.
( IC , Ins , B , S )B) Initially Node-positive Patients
For patients who were initially clinically and biopsy-proven node-positive, and who remained clinically node-positive after NAC, we recommend ALND.
(, , , )For patients who were initially clinically and biopsy-proven node-positive, and became node-negative after NAC, we recommend SLNB to restage the axilla. Restaging can be achieved by placing a biopsy clip into the biopsied positive node at diagnosis and localizing it at surgery along with sentinel node biopsy, or, in institutions where the use of biopsy clips for nodes is not available, by performing sentinel node biopsy with dual tracer and excising at least three sentinel nodes in order to minimize the false negative rate and optimize accuracy of the procedure. At this time, we also recommend LRNI for these patients, regardless of pathologic status of sentinel lymph nodes.
(, , , )Post-mastectomy patients who are node-positive on surgical pathology after NAC can be offered PMRT after a completion ALND.
(, , , )We recommend LRNI for the post-mastectomy node-positive cohort after NAC while awaiting data from ongoing trials (i.e., the MAC19 study).
(, , , )We recommend LRNI after ALND for patients clinically and biopsy proven node-positive at breast-conserving surgery who remain pathologically node-positive after NAC.
(, , , )Shared decision-making processes should be put in place while we await mature clinical trial data, to enable patient value-based decision making.
( EB , L , B , W )C) SLNB Timing: Before or After NAC
We recommend against performing lymph node sampling twice, before and after NAC. We recommend to time the SLNB after NAC and not before in clinically node-negative patients who will receive NAC.
( IC , L , B , S )
V. Identifying Sentinel Nodes
A) Single versus Dual Tracer
For patients having primary surgery, we recommend using a sentinel node tracer (e.g., it is not necessary to add blue dye on a regular basis for SLNB if the radiocolloid signal successfully identifies the sentinel node(s) in the axilla). In cases of non-identification, blue dye can be added.
- Screening for radiocolloid signal prior to incision is recommended, and blue dye can be added prior to making the incision.
- In patients who receive NAC, we recommend either placing a biopsy clip into the positive node at diagnosis and localizing it at the time of surgery or using dual tracer (radiocolloid plus blue dye).
B) US-guided Staging versus Standard Guided (Dye/Isotope) Staging
In clinically node-negative patients with early-stage breast cancer where the sentinel lymph node is likely to be negative (i.e., T1 and T2), preoperative axillary ultrasound (US) staging is NOT recommended.
(, , , )In patients with clinically palpable (i.e., clinically positive) lymph nodes it is recommended to conduct US-guided core biopsy of the axillary node to prove pathological positivity. If patients are pathologically negative on image-guided lymph node biopsy, see Recommendation II. Further Axillary Treatment: SLN(-). If they are pathologically positive on image-guided lymph node biopsy, see Recommendation III. Further Axillary Treatment: SLN(+).
( EB , L , B , S )C) US-guided Staging versus Surgical Staging
We recommend that diagnostic staging by US only (i.e., not confirmed by a biopsy) should NOT be used instead of traditional SLNB staging.
( EB , I , B , S )Recommendation Grading
Overview
Title
Management of the Axilla in Early-Stage Breast Cancer
Authoring Organizations
American Society of Clinical Oncology
Cancer Care Ontario
Publication Month/Year
July 18, 2021
Last Updated Month/Year
October 1, 2024
Supplemental Implementation Tools
Document Type
Guideline
Country of Publication
US
Document Objectives
To provide recommendations on the best strategies for the management and on the best timing and treatment (surgical and radiotherapeutic) of the axilla for patients with early-stage breast cancer.
Target Patient Population
Patients with early-stage breast cancer (ie, stages I, IIA, and IIB; prognostic groups T1, T2, N0, N1mi, N1, and M0; and primary tumor size ≤ 5 cm)
Target Provider Population
Surgeons, radiation oncologists, medical oncologists, and other clinicians (eg, pathologists, radiologists, oncology nurses, and genetic counselors)
Inclusion Criteria
Male, Female, Adult, Older adult
Health Care Settings
Ambulatory, Outpatient, Radiology services, Operating and recovery room
Intended Users
Nurse, nurse practitioner, physician, physician assistant
Scope
Treatment, Management
Diseases/Conditions (MeSH)
D001943 - Breast Neoplasms, D001365 - Axilla
Keywords
breast cancer, axilla management, axilla
Source Citation
Brackstone M, Baldassarre FG, Perera FE, Cil T, Chavez Mac Gregor M, Dayes IS, Engel J, Horton JK, King TA, Kornecki A, George R, SenGupta SK, Spears PA, Eisen AF. Management of the Axilla in Early-Stage Breast Cancer: Ontario Health (Cancer Care Ontario) and ASCO Guideline. J Clin Oncol. 2021 Sep 20;39(27):3056-3082. doi: 10.1200/JCO.21.00934. Epub 2021 Jul 19. PMID: 34279999.