Recommendations from the European Breast Cancer Guidelines

Should stereotactic-guided needle core biopsy or stereotactic-guided vacuum assisted needle core biopsy vs. ultrasound-guided needle core biopsy or ultrasound-guided vacuum assisted needle core biopsy be used to diagnose breast cancer in individuals with breast calcifications?

Recommendation

For women with calcium deposits in their breast (called calcifications or microcalcifications) that might be a sign of cancer, the ECIBC's Guidelines Development Group recommends a stereotactic-guided needle core biopsy to diagnose breast cancer rather than an ultrasound-guided needle core biopsy (strong recommendation, low certainty evidence).

Recommendation strength

  •   Strong recommendation against the intervention
  •   Conditional recommendation against the intervention
  •   Conditional recommendation for either the intervention or the comparison
  •   Conditional recommendation for the intervention
  • Strong recommendation for the intervention

A recommendation can be strong or conditional.

When a recommendation is strong, most women will want to follow it. When a recommendation is conditional, the majority of women want to follow it but may need more discussion with their healthcare professional first.

What would following this recommendation mean for you?

It might be important to speak with your healthcare professional about the abnormal results of your mammogram or other screening tests.
You may wish to speak with your healthcare professional about how the stereotactic-guided needle core biopsy is performed and how you feel about

  • your comfort during and after the needle core biopsy,
  • any concerns you have about whether a biopsy could cause cancer to grow faster or spread,
  • the chances of finding breast cancer or chances of an incorrect diagnosis, and
  • what happens after you have the results of the needle core biopsy.

Who is this recommendation for?

  • You had a mammogram or other screening test and the results were abnormal.
  • You may have been told that you have calcium deposits in your breast, called calcifications or microcalcifications, that may or may not be a sign of cancer.
  • You wish to have the lesion tested and now need a sample of tissue to be taken from your breast to test for cancer.

Justification

This recommendation, having stereotactic guided needle core biopsy for diagnosis when you have calcifications that may be the only sign of cancer, is strong because there may be greater benefits and fewer harms with stereotactic guidance than with ultrasound guidance. Benefits with stereotactic guidance are that more women may be correctly diagnosed with breast cancer than with ultrasound guidance. There may also be fewer women told they have breast cancer when in reality they do not. The stereotactic guided needle core biopsy can take a more representative sample of the lesion associated with the calcification.

The ECIBC’s Guidelines Development Group noted that equipment for stereotactic-guided needle core biopsy may not be available everywhere. This means that women may need to be referred to places where it is available.

Considerations

Subgroup

None considered.

Implementation

1. Training for radiologists who currently biopsy for calcifications using US-NCB.
2. The GDG noted that effective communication strategies are critical so that women can make informed-decisions throughout all phases of the screening process.
3. In settings where stereotactic equipment is not widely available there may be a need to consider how to refer patients to a reference setting where they can have access to stereotactic-guided biopsy.

Monitoring and Evaluation

None considered.

Research Priorities

1. Research was suggested to be done by the GDG on communication strategies for diagnostic tests that are used in different settings, in order to promote informed decision-making by women.

Evidence

Download the evidence profile

Assessment

Background

Calcifications (microcalcifications in previous Breast Imaging Reporting and Data System- BIRADS) constitute about one third of the lesions sampled for cyto/histological examination from patients with screen detected abnormalities (Farshid 2014). In women with calcifications, tissue sampling may be challenging because the suspicious area may not be well demarcated on imaging; calcifications are often not visible on ultrasound (US) and the associated histological change is usually impalpable. These considerations suggest that stereotactic-guided needle core biopsy (NCB) and, in particular, vacuum assisted needle core biopsy (VANCB) should be the preferred modality for sampling these lesions. Ultrasound-guided biopsy is easier and less time consuming so, it is important to assess if ultrasound-guided or stereotactic-guided biopsy is preferable for sampling calcifications. Ductal carcinoma in situ (DCIS) typically presents with calcifications and may be accompanied by invasive carcinoma. Detection of invasion in DCIS predominant cases is important as it may influence the choice of primary surgical treatment, particularly with regards to sentinel node sampling. It is, therefore, important that the area of calcification be adequately sampled to maximise the chance of detecting invasion on the biopsy specimen. Although approximately two thirds of biopsies performed for assessment of calcifications do not show malignancy, DCIS or invasive carcinoma, a percentage of these biopsies show changes that are of uncertain malignant potential. In particular lesions such as flat epithelial atypia may be accompanied by DCIS. Similarly, some intrinsically benign lesions such as radial scar and papilloma that may, on occasion, present as calcification may be associated with a malignant change. Adequate sampling is imperative to permit a thorough histological examination of the abnormal area and to assess the need for further investigations, treatment or follow up. Another recommendation in the European Breast Guidelines, examining the sampling method in suspicious imaging lesions, recommended using needle core biopsy over fine needle aspiration cytology (FNAC). Taking into account this recommendation, in this comparison between US-guidance and stereotactic-guidance the literature search has been limited to NCB and VANCB, excluding FNAC.
Description of the technology
Ultrasound-guided biopsy (NCB or VANCB): sampling of the suspected lesion with a needle ranging from11 to 18 Gauge in case of NCB and from 8 to 11 Gauge in case of VANCB. The sampling can be assisted by vacuum (VANCB) or not (NCB). A histological sample is obtained. The needle is guided by ultrasound. If the results are not conclusive, VANCB (in case the first sampling was done using NCB) and then open biopsy are considered.

Stereotactic-guided biopsy (NCB or VANCB): The sampling can be assisted by vacuum (VANCB) or not (NCB). Sampling of the suspected lesion with a needle ranging from 11 to 18 Gauge in case of NCB and from 8 to 11 Gauge in case of VANCB. A histological sample is obtained. The needle is positioned under stereotactic radiographic guidance. It can be performed either in a sitting or lying in prone position, on a special table, and using either mammography or tomosynthesis as a guiding device. If the results are not conclusive, VANCB (in case the first sampling was done using NCB) and then open biopsy are considered.


Management of Conflicts of Interest (CoI): CoIs for all Guidelines Development Group (GDG) members were assessed and managed by the Joint Research Centre (JRC) following an established procedure in line with European Commission rules. GDG member participation in the development of the recommendations was restricted, according to CoI disclosure. Consequently, for this particular question, the following GDG members were recused from voting: Jan Danes, Lydia Ioannidou-Mouzaka, and Elsa PĂ©rez. Miranda Langendam was not allowed to vote due to the established rules for external experts.
For more information please visit http://ecibc.jrc.ec.europa.eu/gdg-documents

Is the problem a priority?
Yes *
* Possible answers: ( No , Probably no , Probably yes , Yes , Varies , Don't know )
Research Evidence
Calcifications (microcalcifications in previous BIRADS) account for 30-40% of the screen detected lesions with a probability of being malignant of around 13% pending on the type of calcification )). Calcifications are a typical sign of DCIS, but DCIS might be associated with invasive cancer. Nevertheless, the majority of the lesions that are biopsied because of suspicious calcifications are benign. However, some of these have uncertain malignant potential, like flat epithelial atypia (FEA) or atypical ductal hyperplasia (ADH). Therefore, the clinical consequences are quite variable and depend on the histological diagnosis. It is crucial that the calcifications have been adequately sampled to ensure that women are offered adequate treatment based on the histologically detected lesion that is associated with the calcification. Inadequate sampling of the calcifications could result in false-negative primary biopsies and additionally require further biopsies or surgical interventions.
Additional Considerations

The GDG selected this question as a priority for ECIBC. As agreement within the GDG could not be reached, voting among the members without CoI resulted in the following: 16 members voted "yes", 1 member voted "probably yes".

How accurate is the test?
Very accurate *
* Possible answers: ( Very inaccurate , Inaccurate , Accurate , Very accurate , Varies , Don't know )
Additional Considerations

The GDG noted that both tests, compared to the reference standard, are very accurate as both have a sensitivity and specificity above 90%. The reference standard in both comparisons was open biopsy after surgery or follow-up.

How substantial are the desirable anticipated effects?
Moderate *
* Possible answers: ( Trivial , Small , Moderate , Large , Varies , Don't know )
Research Evidence




Additional Considerations

There is a paucity of studies reporting the use of US guidance for evaluating breast calcifications (microcalcifications in previous BIRADS). This is likely to be due to the limitations of ultrasound in visualising calcifications.

For several years, it has been debated in the literature the potential of US to detect mammary calcifications.

To date, no imaging modality other than x-ray mammography has an accepted role in the detection of mammary calcifications. Despite this, since the implementation and improvement of high-frequency US equipment, the quality of breast US has markedly improved. However, the capability and reliability of this improved US equipment in detecting calcifications has not been adequately studied yet.

The GDG noted that with the lower test accuracy estimate,, when using stereotactic-guided biopsy there were 27 more true positives and 27 fewer false negatives per 1000 women with calcifications compared to using ultrasound- guided biopsy (See table labelled part C).

How substantial are the undesirable anticipated effects?
Small *
* Possible answers: ( Large , Moderate , Small , Trivial , Varies , Don't know )
Research Evidence