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ESMO 2019 guidelines for early breast cancer diagnosis

M3 India Newsdesk Sep 30, 2019

As per the ESMO clinical guideline for early breast cancer, regular (annual or every 2 years) mammography is recommended in women aged 50–69 years. Breast imaging should include bilateral mammogram and ultrasound of breasts and axillae in all cases. The guideline recommends the stage of the disease to be established as per the AJCC TNM staging system.

Breast cancer accounts for one in four cancer cases among women. The introduction of mammography screening has led to an increased incidence of breast cancer and this continues to grow with the ageing of the population. In most Western countries, the mortality rate has decreased in recent years, because of improved treatment and earlier detection

The ESMO clinical guideline for early breast cancer lays down recommendation for the management of early breast cancer.

Breast cancer screening

Regular (annual or every 2 years) mammography is recommended in women aged 50–69 years. Regular mammography may also be followed for women aged 40–49 and 70–74 years, however, the evidence to support this is not well established.

Annual MRI and annual mammography are recommended in women with a strong familial history of breast cancer, with or without proven BRCA mutations.

Diagnosis and pathology/molecular biology

Breast cancer diagnosis is based on clinical examination, which is done in combination with imaging. Clinical examination for breast cancer diagnosis includes:

  • Bimanual palpation of the breasts and regional lymph nodes
  • Assessment for distant metastases (bones, liver and lungs; a neurological examination if symptoms are present)

Breast imaging should include bilateral mammogram and ultrasound (US) of breasts and axillae in all cases. In case of uncertainties after standard imaging and in special clinical situations, an MRI can be done.

Results from clinical examination should be confirmed by pathological assessment, which includes histology from the primary tumour and cytology/histology of the axillary nodes (if involvement is suspected). Pathological diagnosis should be based on a core needle biopsy. A typical pathological report should include

  • Histological type
  • Grade
  • Immunohistochemistry (IHC) evaluation of oestrogen receptor (ER) status, progesterone receptor PgR, human epidermal growth factor receptor 2 (HER2) (for invasive cancer) and proliferation markers such as Ki67.

As per the histology and IHC data, tumours should be grouped into surrogate intrinsic subtypes; this helps in prognostication and treatment decision making.

  • Luminal A-like tumours are typically low grade, strongly ER-positive/PgR-positive, HER2-negative and have low proliferative fraction.
  • Luminal B-like tumours are ER-positive but may have variable degrees of ER/PgR expression, are higher grade and have higher proliferative fraction.

Tumour-infiltrating lymphocyte (TIL) scoring may help predict a patient’s prognosis in triple-negative breast cancer (TNBC) and HER2-positive breast cancer. However, TIL should not be used to take treatment decisions or escalate or de-escalate treatment.

For breast cancer patients in high-risk groups, genetic counselling and testing for germline BRCA1 and BRCA2 mutations is recommended.

Staging and risk assessment

The disease stage should be established as per the AJCC TNM staging system. Extensive laboratory testing including tumour markers and radiological staging is not necessary for all patients.

Minimum blood work-up (a full blood count, liver and renal function tests, alkaline phosphatase and calcium levels) should be carried out before surgery and systemic (neo) adjuvant therapy.

Imaging of chest, abdomen and bone is recommended in higher-risk patients. Higher-risk patients include those with high tumour burden, aggressive biology, signs, symptoms or laboratory values suggesting the presence of metastases. A computed tomography (CT) scan of the chest, abdominal imaging (US, CT or MRI scan) and a bone scan can be considered for patients with:

  • Clinically positive axillary nodes
  • Large tumours (e.g. ≥5 cm)
  • Aggressive biology
  • Clinical signs and symptoms or laboratory values suggesting the presence of metastases

When traditional methods are inconclusive, functional and anatomical information such as fluorodeoxyglucose (FDG) positron emission tomography (PET)-CT scanning may be useful. FDG-PET-CT scanning is also recommended for staging in high-risk patients. The use of FDG-PET-CT in the staging of locoregional disease is not recommended due to its limited

sensitivity compared to sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND), which are the gold standard.

Evaluation of cardiac function is required in patients planned for (neo) adjuvant systemic treatment with anthracyclines and/or trastuzumab. A cardiac US or a multigated acquisition (MUGA) scan should be used for cardiac function evaluation.

The pathological TNM system should be followed for postoperative pathological assessment of the surgical specimens. The assessment should include:

  • The number, location and maximum diameter of the tumours removed
  • The total number of removed and positive lymph nodes, as well as the extent of metastases in the lymph nodes [isolated tumour cells, micrometastases (0.2–2 mm), macrometastases]
  • The histological type and grade of the tumour(s) using a standard grading system
  • Evaluation of the resection margins, including the location and minimum distance of the margin
  • Vascular invasion
  • A biomarker analysis

For small tumours diagnosed by core biopsy, it is recommended to correlate imaging, clinical and gross findings to microscopic observation. This is because measuring only the residual tumour in the excision may result in understaging.

To gain additional prognostic and/or predictive information validated gene expression profiles may be used in addition to pathology assessment. This may also help in deciding the adjuvant chemotherapy.

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