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Guidance

Guidance

  1. All needle biopsies performed as part of the BreastScreen Australia program should be reviewed and documented in the context of a multidisciplinary team meeting. [CBR1
     
  2. It is recommended that needle biopsy be performed using image guidance (either ultrasound or mammography). As per the BreastScreen Australia data dictionary, the guidance method should be recorded.2 [CBR1]

    Core Biopsy
  3. Core biopsy (including vacuum-assisted core biopsy) is the procedure of choice for the assessment of the majority of screen-detected breast abnormalities. Core biopsy provides histological confirmation of invasive status of malignant breast lesions, tumour subtype, and an indication of tumour grade in breast malignancies, which cannot be reliably obtained from FNA. In addition, it is recommended that assessment of receptor/biomarker status (ER/PR and HER2 status) be performed on core biopsy specimens (The Royal College of Pathologists of Australasia 2018). This information is important in guiding pre-operative treatment planning and informing patient decision-making. Core biopsy also aids in the definitive diagnosis of benign lesions and, in the context of a screening program, reduces the need for repeat procedures compared with FNA. [EBR3]

    FNA
  4. The use of FNA in the screening setting is appropriate for simple cysts, some complex cystic lesions, axillary lymph nodes4 and rare situations where a core biopsy is not possible (for example in women with lesions close to a breast implant capsule or in some women on anticoagulation therapy). [CBR1]
     

Table 1: Circumstances where FNA and/or core biopsy are appropriate in the BreastScreen Australia program (see Guidance for further details and exceptional circumstances)5

Lesion type on imaging

(identified through the BreastScreen Australia program)

Recommended pathological investigation6

Fine needle aspiration (FNA)

Core biopsy (including vacuum assisted core biopsy; VACB)

1. Simple cyst

Asymptomatic simple cysts generally do not require needle biopsy.

If fluid from a simple cyst is aspirated for diagnostic purposes, a sample of the fluid should be sent for cytopathological assessment for confirmation of imaging findings.

Core biopsy is not recommended.


 

2. Complex cystic lesion

FNA is appropriate. If fluid is aspirated, it should be sent for cytopathological assessment. However, core biopsy is required if:

  • no material is aspirated,
  • no definitive benign diagnosis is provided,
  • there is a residual mass.

Core biopsy is appropriate.

3. Circumscribed solid mass lesion

FNA is not recommended. 

Core biopsy is recommended.

4. Spiculated lesion

FNA is not recommended.

Core biopsy is recommended.

5. Architectural distortion

FNA is not recommended.

Core biopsy is recommended.

6. Calcifications with no mass lesion

FNA is not recommended.

Core biopsy is recommended with a strong preference for VACB.

7. Lymph node

FNA or core biopsy is appropriate. 

8. Multiple cystic lesions

Manage as per single simple cyst and complex cystic lesion.

9. Multiple circumscribed solid mass lesions

Manage as per single circumscribed solid mass lesion, noting that not every lesion may need to be biopsied.

10. Multiple suspicious solid lesions

FNA is not recommended.

Multiple suspicious solid lesions require a definitive diagnosis by core biopsy, of more than one lesion. At least the two furthest apart lesions or the two most suspicious lesions on imaging, should be sampled by core biopsy.

Table 2: Summary of benefits and limitations of fine needle aspiration and core biopsy*

 

 

Fine needle aspiration

Core biopsy

Sensitivity and specificity  

Sensitivity (95% CI)7

74% (72-77)8

87% (84-88)8

Specificity (95% CI)9

96% (94-98)8

98% (96-99)8

Procedural advantages and disadvantages

Ability to distinguish between in situ and invasive cancer

Low

High

Degree of invasiveness of technique

Low

Low to moderate

Success rate (rate of sufficient sampling)

Moderate 

High 

Complication rate

Very low

Low

Use of local anaesthetic  

Optional

Required

Time taken to perform biopsy

Short duration (5-10 mins)

Moderate duration (15-20 mins)

Assessment of prognostic and predictive biomarkers

Ability to assess tumour grade10

Low 

Moderate to High

Ability to assess HER2 and ER/PR receptors

Receptor testing is recommended on core biopsies of the primary tumour11


1 Consensus-based recommendation (CBR) – a recommendation formulated in the absence of systematically reviewed evidence, based on expert opinion and formulated via a deliberative process that sought to achieve consensus.

2 Australian Institute of Health and Welfare 2015. BreastScreen Australia data dictionary: version 1.1. Cancer series no. 92. Cat. no. CAN 90. Canberra: AIHW

3 Evidence-based recommendation (EBR) – a recommendation formulated after a systematic review of the evidence, with a clear linkage from the evidence base to the recommendation.

4 Core biopsy may be appropriate, where technically feasible, for the investigation of axillary lymph nodes in situations where there is a large asymmetrical axillary lymph node and no known primary lesion in the breast.

5 This Position Statement is not intended to provide guidance on the use of biopsy techniques outside of the BreastScreen Australia program and applies only to the assessment of screen-detected abnormalities.

6 Needle biopsy is recommended to be performed under image guidance (either ultrasound or mammography). As per the BreastScreen Australia data dictionary, the guidance method should be recorded.
Source: *Willems 2012: Table 1, page 290; supplemented by Mitra 2016: Table 1, page 2.

7 The sensitivity of a diagnostic test quantifies its ability to correctly identify subjects with the disease. It is the proportion of true positives that are correctly identified by the test.

8 Wang 2017 – the limitations of this review are discussed within the text of the Position Statement including that Ultrasound guidance was used in 5 of the 12 studies included in Wang.

9 The specificity of a diagnostic test is the ability of a test to correctly identify subjects without the disease. It is the proportion of true negatives that are correctly identified by the test.

10 Using Nottingham histological score (Elston, CW; Ellis, IO. Pathologic prognostic factors in breast cancer. I. The value of histological grades in breast cancer. Experience from a large study with long-term follow-up. Histopathology 19(5):403–10. Republished Histopathology 41:154–161. 2002).

11 Royal College of Pathologists of Australasia 2018
Abbreviations: ER, oestrogen receptor; HER2, human epidermal growth factor receptor 2; PR, progesterone receptor;