Clinical Practice Guidelines for Pre – operative Evaluation of Breast Cancer: 2021

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Clinical Practice Guidelines for Pre-operative Evaluation of Breast Cancer: Chinese Society of Breast Surgery Practice Guidelines 2021

Breast cancer remains the most prevalent cancer among women in China, making its management a critical aspect of healthcare. Surgery has been the cornerstone of breast cancer treatment since the introduction of radical mastectomy by Halsted. However, the success of surgical intervention heavily relies on a comprehensive and standardized pre-operative evaluation. This evaluation aims to identify factors that could increase surgical risks, impede recovery, or influence the disease’s subsequent course. Recognizing the importance of this process, the Chinese Society of Breast Surgery (CSBrS) has developed the Clinical Practice Guidelines for Pre-operative Evaluation of Breast Cancer (2021 Edition). These guidelines are based on a thorough literature review, expert discussions, and evidence evaluation, tailored to China’s national conditions, and designed to serve as a reference for breast surgeons.

Level of Evidence and Recommendation Strength

The guidelines employ a structured approach to categorize the level of evidence and strength of recommendations. The evidence is graded according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. The strength of recommendations is classified as Level I (strong evidence) or Level II (moderate evidence), with corresponding recommendation strengths of A (strong recommendation) or B (moderate recommendation). A committee of 84 members, including breast surgeons, oncologists, radiologists, pathologists, radiation therapists, and an epidemiologist, was responsible for reviewing and voting on the guidelines.

Target Audience

The guidelines are primarily intended for Chinese breast disease specialists, providing them with a standardized framework for pre-operative evaluation. However, they explicitly state that these guidelines should not be used for medical evaluation or dispute resolution and are not intended for patients or non-specialists.

Recommendations

The guidelines are divided into three main categories of recommendations: General Evaluation, Anesthesia-related Evaluation, and Tumor-related Evaluation. Each category is further broken down into specific components, with detailed guidance on the level of evidence and strength of recommendation.

Recommendation 1: General Evaluation

The general evaluation focuses on assessing the patient’s overall health status and identifying any conditions that could complicate surgery or recovery. The components include:

  1. Evaluation of Vital Signs: Vital signs should be monitored to ensure the patient is stable before surgery. This is supported by Level I evidence and a strong recommendation (A).

  2. Laboratory Evaluation: Routine laboratory tests are essential to identify abnormalities such as anemia, electrolyte disturbances, or coagulation disorders. This recommendation is based on Level I evidence with a strong recommendation (A).

  3. Clinical Examination: A thorough clinical examination helps detect any physical abnormalities or comorbidities. This is also supported by Level I evidence and a strong recommendation (A).

  4. Blood Pressure Monitoring and Pre-operative Management: Patients with hypertension should have their blood pressure controlled before surgery. This is based on Level I evidence with a strong recommendation (A).

  5. Glucose Monitoring and Pre-operative Management: Diabetic patients require careful glucose monitoring and management to reduce surgical risks. This recommendation is supported by Level I evidence and a strong recommendation (A).

  6. Specific Clinical Conditions in Patients with Breast Cancer: This includes evaluating cardiovascular disease, respiratory disease, liver disease, renal disease, diabetes, old age, obesity, anemia, coagulation disorders, thrombosis risk factors, and electrolyte disturbances. All these components are supported by Level I evidence and a strong recommendation (A).

Recommendation 2: Anesthesia-related Evaluation

The anesthesia-related evaluation ensures the patient is fit for anesthesia and identifies any potential risks. The components include:

  1. Evaluation of Pre-operative Medications: Patients should be assessed for medications that could interact with anesthesia. This is supported by Level I evidence with a strong recommendation (A).

  2. Pre-operative Evaluation of the Airway: A thorough airway assessment is crucial to prevent complications during anesthesia. This recommendation is based on Level I evidence and a strong recommendation (A).

  3. Comprehensive Evaluation of Anesthetic Safety: A complete evaluation of the patient’s fitness for anesthesia is essential. This is supported by Level I evidence with a strong recommendation (A).

Recommendation 3: Tumor-related Evaluation

The tumor-related evaluation focuses on assessing the primary tumor, regional lymph nodes, and distant metastases. The components include:

  1. Evaluation of Primary Tumor:

    • Breast Ultrasound: This is recommended for initial assessment of the tumor. It is supported by Level I evidence with a strong recommendation (A).
    • Mammography: Mammography is essential for detecting microcalcifications and assessing tumor size. This is supported by Level I evidence and a strong recommendation (A).
    • Breast MRI: MRI is recommended in specific scenarios, such as uncertain findings on mammography or ultrasound, defining the extent of cancer, or identifying occult primary breast cancer with axillary lymph node metastases. These recommendations are supported by Level II evidence with a strong recommendation (A).

  2. Determination of Tumor Estrogen/Progesterone Receptor and HER2 Status: This is crucial for guiding treatment decisions and is supported by Level I evidence with a strong recommendation (A).

  3. Evaluation of Regional Lymph Nodes:

    • Needle Biopsy of Suspicious Lymph Nodes: This is recommended for confirming lymph node involvement and is supported by Level I evidence with a strong recommendation (A).

  4. Evaluation of Distant Metastasis:

    • Bone Scan: Recommended for patients with localized bone pain or high serum alkaline phosphatase. This is supported by Level II evidence with a strong recommendation (A).
    • Chest Diagnostic CT with Contrast: Recommended for patients with pulmonary symptoms. This is supported by Level II evidence with a strong recommendation (A).
    • Abdominal ± Pelvic Diagnostic CT or MRI with Contrast: Recommended for patients with abnormal liver function tests, abdominal symptoms, or abnormal physical examination findings. This is supported by Level II evidence with a strong recommendation (A).
    • PET/CT: Can be used to investigate suspicious or inconclusive findings in standard staging studies, locally advanced breast cancer, or distant metastases. This is supported by Level II evidence with a moderate recommendation (B).

  5. Concomitant Evaluation of Patients with Breast Cancer:

    • Genetic Counseling: Recommended for patients at risk of hereditary breast cancer. This is supported by Level II evidence with a strong recommendation (A).
    • Pregnancy Testing: Recommended for all potentially pregnant women. This is supported by Level II evidence with a strong recommendation (A).
    • Assessment of Mental Health Status: Recommended to address the psychological impact of breast cancer. This is supported by Level II evidence with a strong recommendation (A).

  6. Evaluation of Neoadjuvant Therapy:

    • Marking of Tumor Before Commencing Neoadjuvant Therapy: Recommended to ensure accurate localization of the tumor post-therapy. This is supported by Level II evidence with a strong recommendation (A).
    • Imaging Evaluation Every Two Cycles: Recommended to monitor the response to neoadjuvant therapy. This is supported by Level II evidence with a strong recommendation (A).
    • Primary Tumor Evaluation After Neoadjuvant Therapy: Includes breast ultrasound, breast MRI, and mammography if the lesion was clearly shown on a pre-treatment mammogram. These recommendations are supported by Level I and Level II evidence with a strong recommendation (A).
    • Regional Lymph Node Evaluation After Neoadjuvant Therapy: Includes breast ultrasound and breast MRI. These recommendations are supported by Level I and Level II evidence with a strong recommendation (A).

Discussion

The pre-operative evaluation is a critical determinant of the success of breast cancer surgery, particularly for older or frail patients and those with serious comorbidities. The CSBrS emphasizes the importance of a thorough pre-operative oncology evaluation, including breast ultrasound, mammography, and breast MRI, to accurately assess the number, location, and size of lesions, regional lymph node status, and distant metastases. The tumor node metastasis (TNM) stage should be determined according to the eighth edition of the Cancer Staging Manual issued by the American Joint Committee on Cancer.

Breast MRI is highlighted for its high sensitivity in detecting multi-focal, multi-centric, or occult tumors, as well as its ability to assess the relationship between the tumor and the chest wall and axillary lymph node metastasis. However, its moderate specificity and limitations in displaying microcalcifications mean that surgical decisions should not be based solely on MRI findings.

Conclusion

The Clinical Practice Guidelines for Pre-operative Evaluation of Breast Cancer (2021 Edition) provide a comprehensive and standardized framework for breast surgeons in China. By addressing general health, anesthesia-related risks, and tumor-specific factors, these guidelines aim to optimize surgical outcomes and improve patient care. The recommendations are based on robust evidence and expert consensus, ensuring their relevance and applicability in clinical practice.

doi.org/10.1097/CM9.0000000000001520

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