Sentinel Lymph Node Biopsy for Patients With Early-Stage Breast Cancer
Publication Date: December 12, 2016
Last Updated: October 30, 2024
Key Points
Clinicians should NOT recommend axillary lymph node dissection (ALND) for women with early-stage breast cancer:
Who do not have nodal metastases.
( EB , H , B , S )3336
Who have one or two sentinel lymph node metastases and will receive breast-conserving surgery (BCS) with conventionally fractionated whole-breast radiotherapya.
( EB , H , B , S )a Clinicians should consider this recommendation with caution in patients with clinically enlarged axillary lymph nodes, those with large primary tumors (>5 cm), those with large or bulky metastatic axillary sentinel lymph nodes, and/or those with gross extranodal extension of the tumor.
3336
Clinicians may offer ALND for women with early-stage breast cancer with nodal metastases found on sentinel lymph node (SNB) who will receive mastectomy.
( EB , L , B , W )3336
Clinicians may offer SNB for women who have operable breast cancer who have the following circumstances:
Multicentric tumors. ( EB , I , B , M )
3336
Ductal carcinoma in situ (DCIS) when mastectomy is performed.
( IC , Ins , B , W )3336
Prior breast and/or axillary surgery.
( EB , I , B , S )3336
Preoperative/neoadjuvant systemic therapyb.
( EB , I , B , M )b SNB may be offered before or after neoadjuvant chemotherapy (NACT), but the false negative rate is higher afterward, and therefore, the procedure seems less accurate after NACT and may be unacceptably high with known metastatic nodes.
3336
There are insufficient data to change the 2005 recommendation that clinicians should NOT perform SNB for women who have early-stage breast cancer and are in the following circumstances:
Large or locally advanced invasive breast cancers (tumor size T3/T4). ( IC , Ins , , W )
3336
Inflammatory breast cancer.
( IC , Ins , , W )3336
DCIS when breast-conserving surgery is planned.
( IC , Ins , , S )3336
Pregnancy.
( IC , Ins , , W )3336
Recommendation Grading
Disclaimer
The information in this patient summary should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.
Overview
Title
Sentinel Lymph Node Biopsy for Patients With Early-Stage Breast Cancer
Authoring Organization
American Society of Clinical Oncology
Publication Month/Year
December 12, 2016
Last Updated Month/Year
November 7, 2024
Supplemental Implementation Tools
Document Type
Guideline
External Publication Status
Published
Country of Publication
US
Document Objectives
To provide current recommendations on the use of sentinel node biopsy (SNB) for patients with early-stage breast cancer.
Target Patient Population
Patients with early stage breast cancer undergoing sentinel node biopsy (SNB)
Target Provider Population
Medical oncologists, radiation oncologists, pathologists, surgeons, oncology nurses, patients/caregivers, and guideline implementers.
PICO Questions
How should the results of sentinel node biopsy (SNB) be used in clinical practice?
What is the role of SNB in special circumstances in clinical practice?
What are the potential benefits and harms associated with SNB?
Inclusion Criteria
Female, Adult, Older adult
Health Care Settings
Ambulatory, Hospital, Outpatient, Operating and recovery room
Intended Users
Nurse, nurse practitioner, physician, physician assistant
Scope
Management
Keywords
sentinel node biopsy, SNB
Source Citation
DOI: 10.1200/JCO.2016.71.0947 Journal of Clinical Oncology 35, no. 5 (February 10, 2017) 561-564.
Supplemental Methodology Resources
Methodology
Number of Source Documents
8
Literature Search Start Date
January 1, 2013
Literature Search End Date
January 6, 2016
Description of External Review Process
ASCO has a rigorous review process for guidelines. After the draft has been approved by the Expert Panel, the guideline is independently reviewed and approved by the Clinical Practice Guideline Oversight Committee (CPGC). Select members of the CPGC are asked to critically review the guideline prior to the next scheduled CPGC meeting. The CPGC members then present the results of their reviews to the full committee, discuss the review with the full committee, and the CPGC votes on whether to approve the guideline (with recusals from members who have relationships with affected companies). Approved ASCO Guidelines are then submitted to the Society’s journal for consideration of publication.
Description of Public Comment Process
ASCO Guidelines are available for open comment for a 2 to 3‐week period. Guideline recommendations available for open comment are posted on asco.org/open‐comment‐guidelines. Prospective reviewers must contact ASCO to request to review the draft guideline recommendations and are required to sign a non‐disclosure and confidentiality agreement before receiving the draft guideline recommendations. Reviewers must identify themselves by name and affiliation; anonymous comments will not be accepted. Guidelines staff review and summarize comments and bring relevant comments to the Expert Panel Co‐ chairs, and to the entire panel if necessary. Any changes made from the open comment process will be reviewed by the entire panel prior to CPGC approval. Comments are advisory only and ASCO is not bound to make any changes based on feedback from open comment. ASCO does not respond to reviewers or post responses to comments; however, major edits to the draft will be reflected in the open comment discussion.
Specialties Involved
Oncology, Pathology, Clinical Pathology, Medical Oncology, Surgical Oncology, Radiation Oncology, Pathology, Oncology, Oncology, Oncology
Description of Systematic Review
The Protocol specifies the purpose of the guideline product, target patient population, clinical outcomes of interest, key features of the systematic literature review, and a proposed timeline for completion. ASCO staff, the Expert Panel Co‐Chairs, and possibly other panel members selected by the Co‐Chairs (the Expert Panel Steering Committee), will typically draft the protocol for full panel review. A standard protocol worksheet is used for consistency.
Once the Co‐Chairs have approved a first draft of the Protocol, the Protocol will be shared with the full Expert Panel. At the discretion of the Guidelines Director, the CPGC leadership and/or the CPGC Methodology Subcommittee may review the Protocol to make suggestions for revision intended to clarify aspects of the plan for developing the guideline. These suggestions are sent to the Expert Panel Co‐Chairs. Work on the systematic literature review can proceed upon the sign‐off of the Protocol by the Expert Panel.
List of Questions
See full text.
Description of Study Criteria
See supplement.
Description of Search Strategy
Upon approval of the Protocol, a systematic review of the medical literature is conducted. ASCO staff use the information entered into the Protocol, including the clinical questions, inclusion/exclusion criteria for qualified studies, search terms/phrases, and range of study dates, to perform the systematic review. Literature searches of selected databases, including The Cochrane Library and Medline (via PubMed) are performed. Working with the Expert Panel, ASCO staff complete screening of the abstracts and full text articles to determine
eligibility for inclusion in the systematic review of the evidence.
Unpublished data from meeting abstracts are not generally used as part of normal ASCO guideline development (“Meeting Data”). However, abstract data from reputable scientific meetings and congresses may be included on a case‐by‐case basis after review by the CPGC leadership. Expert Panels should present a rationale to support integration of abstract data into a guideline. The CPGC leadership will consider the following inclusion criteria for the unpublished scientific meeting data: 1) whether the data were independently peer reviewed in connection with a reputable scientific meeting or congress; 2) the potential clinical impact of the unpublished data; 3) the methodological quality and validity of the associated study; 3) the potential harms of not including the data; and 4) the availability of other published data to inform the guideline recommendations.
Description of Study Selection
Literature search results were reviewed and deemed appropriate for full text review by two ASCO staff reviewers in consultation with the Expert Panel Co-Chairs. Data were extracted by two staff reviewers and subsequently checked for accuracy through an audit of the data by another ASCO staff member. Disagreements were resolved through discussion and consultation with the Co-Chairs if necessary. Evidence tables are provided in the manuscript and/or in Data Supplement.
Description of Evidence Analysis Methods
ASCO guideline recommendations are crafted, in part, using the GuideLines Into DEcision Support (GLIDES) methodology. ASCO adopted a five‐step approach to carry out quality appraisal, strength of evidence ratings and strength of recommendations ratings. The ASCO approach was primarily adapted from those developed by the AHRQ,, USPSTF, and GRADE, however with the validation of the GRADE methodology, the sole use of GRADE is being evaluated by the Clinical Practice Guidelines Committee.
Description of Evidence Grading
High: High confidence that the available evidence reflects the true magnitude and direction of the net effect (i.e., balance of benefits v harms) and that further research is very unlikely to change either the magnitude or direction of this net effect.
Intermediate: Moderate confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research is unlikely to alter the direction of the net effect; however, it might alter the magnitude of the net effect.
Low: Low confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research may change either the magnitude and/or direction this net effect.
Insufficient: Evidence is insufficient to discern the true magnitude and direction of the net effect. Further research may better inform the topic. The use of the consensus opinion of experts is reasonable to inform outcomes related to the topic.
Description of Recommendation Grading
ASCO uses a formal consensus methodology based on the modified Delphi technique in clinically important areas where there is limited evidence or a lack of high‐quality evidence to inform clinical guidance recommendations.
Evidence Based: There was sufficient evidence from published studies to inform a recommendation to guide clinical practice.
Formal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. Therefore, the Expert Panel used a formal consensus process to reach this recommendation, which is considered the best current guidance for practice. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak"). The results of the formal consensus process are summarized in the guideline and reported in the Data Supplement (see the Supporting Documents" field).
Informal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. The recommendation is considered the best current guidance for practice, based on informal consensus of the Expert Panel. The Panel agreed that a formal consensus process was not necessary for reasons described in the literature review and discussion. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak").
No recommendation: There is insufficient evidence, confidence, or agreement to provide a recommendation to guide clinical practice at this time. The Panel deemed the available evidence as insufficient and concluded it was unlikely that a formal consensus process would achieve the level of agreement needed for a recommendation.
Description of Funding Source
ASCO provides funding for Guideline Development.
Company/Author Disclosures
ASCO Conflict of Interest Policy complies with the CMSS Code for Interactions with Companies. ASCO requires disclosure by individuals involved in drafting, reviewing, and approving guideline recommendations.
Percentage of Authors Reporting COI
100