Clinical Practice Guidelines for Sentinel Lymph Node Biopsy in Patients with Early-Stage Breast Cancer: Chinese Society of Breast Surgery (CSBrS) Practice Guidelines 2021
Sentinel lymph node biopsy (SLNB) has become a cornerstone in the management of early-stage breast cancer, offering a less invasive alternative to conventional axillary lymph node dissection (ALND). The Chinese Society of Breast Surgery (CSBrS) has developed the 2021 Clinical Practice Guidelines for Sentinel Lymph Node Biopsy in Patients with Early-Stage Breast Cancer to standardize SLNB techniques and provide evidence-based recommendations for clinicians in China. These guidelines are based on a comprehensive review of the literature, incorporating the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system, and reflect the latest advancements in the field.
Level of Evidence and Recommendation Strength
The guidelines employ a robust system for evaluating the level of evidence and the strength of recommendations. The level of evidence is categorized into four levels (I to IV), with Category I representing the highest quality of evidence derived from high-level prospective randomized controlled trials and meta-analyses. The recommendation strength is determined by four factors: level of evidence, health economics, product equivalence, and accessibility. Recommendations are graded as A (strong recommendation), B (weak recommendation), or C (not recommended).
Indications and Contraindications for SLNB
The guidelines outline clear indications and contraindications for SLNB. Indications include early-stage invasive breast cancer with clinically negative axillary lymph nodes, ductal carcinoma in situ (DCIS) where invasive carcinoma cannot be excluded, and patients who are clinically node-negative (cN0) before and after neoadjuvant therapy. Contraindications include inflammatory breast cancer, confirmed axillary lymph node metastasis without neoadjuvant therapy, and allergy to the tracer used in SLNB.
Mapping Methods and Tracer Selection
Several mapping methods for SLNB are discussed, including the use of blue dye, radioisotopes, a combination of both, and fluorescence imaging. The combination of radioisotope and blue dye is recommended for qualified hospitals, while blue dye alone is recommended for broader use due to its accessibility in China. Specific tracers such as methylene blue, carbon nanoparticles, and indocyanine green are highlighted for their efficacy and safety. The guidelines also provide detailed recommendations on the injection site, emphasizing intradermal or subcutaneous injection around the affected areola.
SLNB in the Context of Neoadjuvant Therapy
The guidelines address the use of SLNB in patients undergoing neoadjuvant therapy. For patients initially classified as cN0, SLNB can be performed either before or after neoadjuvant therapy. For patients with initial cN1 status who convert to cN0 after neoadjuvant therapy, SLNB is recommended after therapy. However, direct ALND is advised for patients with initial cN1 status who remain cN+ after neoadjuvant therapy.
Pathological Diagnosis and Follow-Up Surgery
Intraoperative evaluation of sentinel lymph nodes is primarily conducted using rapid frozen section pathological examination, while postoperative evaluation involves paraffin section and immunohistochemical examination. The guidelines provide detailed criteria for SLN status evaluation, distinguishing between macrometastases, micrometastases, and isolated tumor cell clusters. Recommendations for follow-up surgery based on SLN status are also provided, including the exemption of ALND for patients with 1-2 positive SLNs undergoing breast-conserving surgery with planned radiotherapy.
Complications and Prevention
The guidelines discuss potential complications of SLNB, such as bleeding, wound hematoma, and seroma, and provide strategies for prevention. Emphasis is placed on meticulous surgical technique, including proper ligation of lymphatic vessels and careful dissection to avoid vascular injury.
Technical Specifications for SLNB with Methylene Blue Dye
A detailed appendix is included, providing technical specifications for SLNB using methylene blue dye. This includes preoperative preparation, patient positioning, anesthesia, dye injection, axillary incision selection, key points in the operation, SLN confirmation, and surgical drainage. The appendix also highlights the importance of selecting appropriate tracers and injection sites to ensure accurate SLN identification.
Pathological Examination of SLNB
The guidelines provide specific recommendations for the pathological examination of SLNB specimens. Intraoperative evaluation can be conducted using frozen tissue sections or cytological impression smears, while postoperative evaluation involves routine paraffin-embedded hematoxylin and eosin (H&E) section histological examination. The guidelines emphasize the importance of standardized sampling and reporting processes to reduce the false-negative rate of SLNB.
Conclusion
The 2021 CSBrS Clinical Practice Guidelines for Sentinel Lymph Node Biopsy in Patients with Early-Stage Breast Cancer provide comprehensive, evidence-based recommendations for the use of SLNB in clinical practice. These guidelines aim to standardize SLNB techniques, improve patient outcomes, and reduce complications associated with axillary lymph node assessment. By incorporating the latest research and clinical evidence, the CSBrS guidelines serve as a valuable resource for breast surgeons in China and beyond.
doi.org/10.1097/CM9.0000000000001410
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