Recommendation

Compulsory items in the pathology report of a histological needle biopsy

  • classifying diagnosis; use of the following categories is recommended:
    • benign laesion, namely …….. (specify)
    • not clearly benign, or suspected malignancy
    • malignant, namely ….. (specify: invasive, in situ, primary, metastasis, etc.)
    • correlation with the clinical imaging findings (especially the presence or absence of microcalcifications)

The following may be added on indication:

  • hormone receptor status and HER2
  • grading (a histological biopsy is less suitable for reliable grading of the tumour than tumour excision)

 

When can primarily be chosen for histology?

Histology is suited to the diagnosis of poorly delineated solid laesions, architecture distortions, radial scars and microcalcifications and for additional diagnostics, as mentioned above.

 

In this group, both the stereotactic needle biopsy and stereotactic vacuum-assisted biopsy are a good alternative for the diagnostic excision biopsy.

 

Multiple biopsies should be taken during histological biopsy procedures, in order to prevent sampling error:

  • a minimum of 5 biopsies is recommended if there is doubt as to whether results are representative
  • use of the phenomenon that a good biopsy sinks in formalin can be used during ultrasound-guided punctions of solid laesions
  • at least 5 microcalcifications need to be found radiologically during stereotactic punctions of microcalcifications, preferably divided over 3 biopsies
  • a specimen radiogram must be performed as a standard component of the procedure during stereotactic punctions of microcalcifications

 

Each breast care team should have access to a centre where MRI-guided biopsies can be performed.

 

Placement of a marker is strongly recommended, especially in a stereotactic biopsy and MRI-guided biopsy.

Conclusions

 

Level 3

The percentage of false negative results of histological ultrasound-guided needle biopsies is   approximately 4% with 5 biopsies. The reliability is comparable to that of a diagnostic excision biopsy.

 

A2        Fajardo 2004

C          Helbich 2004, Youk 2007

 

Level 1

The percentage of false negative results of histological stereotactic needle biopsies is also an average of approximately 4% with 5 biopsies. The reliability is again comparable to that of a diagnostic excision biopsy.

 

A2        Verkooijen 2002, Fajardo 2004

C          Helbich 2004

 

Level 1

Stereotactic and ultrasound-guided histological biopsies have almost the same accuracy as open   surgical biopsy. There is a lower chance of complications developing.

 

A1        Bruening 2010

 

Level 1

In the population of patients with (non-palpable) abnormalities detected by screening who are   eligible for stereotactic punction, the use of vacuum-assisted biopsy equipment leads to a lower underestimate rate and less missed abnormalities.

 

A1        Fahrbach 2006

B          Jackman 2009

 

Level 2

MRI-guided biopsies (thick needle and vacuum-assisted) have a success percentage of 87.2-100%. The number of false negatives is 2-7%.

 

A2        Perlet 2006

B          Han 2008, Li 2009, Malhaire 2010, Peters 2009

Literature summary

In general, a radiologist will decide during clinical imaging which technique will be used. This will depend on the nature and morphology of the abnormality. If the results of clinical breast examination, imaging and punction correspond, the accuracy of the triple-diagnostics is greater than 99%.

In doing so, it is less important how the PA material was obtained and if the laesion is palpable [Wallis, 2007]. In this regard, the term ‘triple diagnostics’ (which stood for palpable abnormality, imaging and cytology) has gradually broadened: the surgeon, radiologist and pathologist independently form an opinion on the basis of their findings, and further patient management is determined by consensus.

The more biopsies and the bigger the biopsies, the more certainty regarding the definitive diagnosis. With ultrasound-guided needle biopsies, the phenomenon that a good biopsy sinks in formalin can be used to evaluate quality. With microcalcifications, at least five microcalcifications must be found using radiology, preferably divided across three biopsies [Fishman, 2003; Margolin, 2004; Wallis, 2007]. When taking a biopsy of microcalcifications, the procedure should always be completed with a specimen radiography, to evaluate whether the sample is representative. In the case of larger biopsies, more complications need to be taken into account, especially hematoma formation and with the use of anti-coagulants.

 

After biopsy of non-palpable small abnormalities and calcifications, the abnormality may have disappeared on a mammogram; for this reason it is recommended that a marker is left behind for localisation at a later stage [Fahrbach, 2006]. This is also recommended for ultrasound-guided needle biopsies [Wallis, 2007]. A marker must always be left behind with MRI-guided needle biopsies [Schrading, 2010].

The concern for seed metastases as a result of thick needle biopsies is unfounded given the study by Diaz (1999): displaced tumour cells were found, on average in 32% of 352 biopsies, but the incidence was inversely proportional to the time between the biopsy and excision. It can be derived from this that the tumour cells can be displaced, but that they do not survive.

Each breast care team must have ultrasound-guided and stereotactic punction procedures at their disposal within their own team. The MRI-guided punction procedures are not performed everywhere, but each team must have access to a location in which the procedure is performed.

 

Histology with ultrasound-guided thick-needle biopsy

The global standard is ultrasound-guided 14G biopsy, in which an average of 5 biopsies are taken. In the multicentre study by Fajardo (2004), only ultrasound-guided procedures of non-palpable abnormalities have been evaluated. The results under palpation usually remain behind those of ultrasound-guided procedures [Agarwal, 2003; Lorenzen, 2002; Shah, 2003]. The distinction between palpable and non-palpable laesions disappears with ultrasound-guided punctions, and this aspect therefore does not play a role in most studies.

Similar to cytology, the following play a role: the size of the laesion, the expertise of the person performing the punction and the pathologist evaluating the material. Sample errors may occur if it is hard to immobilise the laesion, if the needle cannot be positioned well or if it pushes the (small) laesion forward. Fishman (2003) took 4 ultrasound-guided 14G biopsies per tumour for 73 solid tumours:1 biopsy was in diagnostic in 70% of cases, 2 biopsies in 92%, 3 biopsies in 96% and 4 biopsies in 100%.

In a review of 8 studies [Youk, 2007], the procedure needed to be repeated again in 10% of cases on average, because the punction results were inconclusive or discordant.The percentage of malignancies was still substantial for this subgroup: 17%. The final percentage of false negative results was low. In the follow-up, the percentage of false negatives averaged 4% (0-8%). The conclusion each time is that results are comparable with results of a diagnostic excision biopsy [Helbich, 2004; Fajardo, 2004; Youk, 2007]. This is confirmed by a systematic review by Bruening (2010).

 

Histology with X-ray-guided, stereotactic thick-needle biopsy

A non-palpable laesion, which can only be seen by mammogram, can be obtained by puncture using the X-ray-guided, stereotactic procedure. This can be performed using a special table, in which the patient undergoes the procedure in prone position or with an accessory piece that is attached to the mammography equipment, so that the procedure can be performed in a sitting or recovery position. The results of these procedures are comparable. This procedure is more time-consuming and invasive and is especially used with microcalcifications.

The best results are obtained after at least 5 biopsies, correspondence with the definitive PA diagnosis varies from 87-96% [Verkooijen, 2000; Helbich, 2004; Fajardo, 2004]. Here too, it can be concluded that the results are comparable with results of a diagnostic excision biopsy [Verkooijen, 2002; Helbich, 2004; Fajardo, 2004].

 

Histology with vacuum-assisted biopsy equipment

Vacuum-assisted biopsy equipment enables multiple biopsies to be obtained at high speed with needles of 10-11G. Thanks to the vacuum system, biopsies are greater in size and are obtained semi-automatically. As a result, the number of biopsies can easily increase to 6 lots or a multiple of this. This equipment is suited par excellence to obtaining stereotactic histologic biopsy. This procedure is more invasive than the ‘usual’ stereotactic thick needle biopsy and has a higher complication percentage, especially haematoma formation. Again it largely concerns microcalcifications here, and in addition radial scars and architecture distortions. The studies included by Fahrbach (2006) looked in particular at the reduction in laesion miss rates by needle biopsy and a possible improvement in the underestimate rate, i.e. if there was a reduced occurrence in the diagnosis atypical ductal hyperplasia (ADH) in the needle biopsy while a DCIS was found during excision, or the diagnosis DCIS on the needle biopsy while an invasive carcinoma was found during excision. The reference, if available, was the diagnosis of the excision and a clinical/radiological follow-up of at least 1 year if available. Most abnormalities were not palpable (97%) and consisted of microcalcifications (64%), mostly evaluated as BI-RADS 4 or 5 (90%) (Fahrbach, 2006). The biopsy was taken using prone equipment for most of the patients. The following differences were notable in comparing vacuum-assisted biopsy and conventional needle biopsy: the number of biopsies averaged 13.3 (range 10-17) in the studies with vacuum-assisted biopsy equipment and 6.6 (range 5-10) for conventional needle biopsy. The number of failed procedures was lower for vacuum-assisted biopsy equipment (1.5% vs 5.7%) and the number of non-diagnostic biopsies was also lower (0% vs 2.1%). This is also concluded in the study by Jackman (2009). However, a false negative result cannot be fully ruled out in this manner: in a German multicentre study cited by Fahrbach, in which 20 biopsies were taken using vacuum-assisted procedure for 2,874 laesions, a false negative result was still obtained in one case [Kettritz, 2004] .

 

MRI-guided histological biopsy

MRI-guided biopsy is indicated for BI-RADS 4 and 5 laesions, which are at least 5 mm or larger and are not found during second-look ultrasound or mammography unless the PA of the laesion has consequences for the surgical management plan. Cytology is not worthwhile: it is easy for sample error to occur due to tissue displacement. If the laesion is difficult to reach, wire guided localisation may be performed.

A prospective multicentre cohort study has been conducted [Perlet, 2006] and an increasing number of retrospective cohort studies, either with thick needle, or with vacuum systems [Han, 2008; Li, 2009; Malhaire, 2010; Peters, 2009; Schrading, 2010]. This enables a larger number of 10G biopsies to be taken, so that the sample error is reduced. A control series is recommended after the biopsy, both before and after clip placement. The technical execution requires expertise. Using console equipment instead of performing the procedure freely by hand makes the procedure faster and more accurate [Schrading, 2010].

The number of MRI series required and sliding the patient in and out of the scanner is determinant for the examination duration [Noroozian, 2009]. The technical success percentages are high and vary between 87.2-100%. False negative results occur in 2-7% of cases. This is comparable with the results of tissue biopsies under ultrasound-guidance and by stereotactic biopsy, but the series are still too small to draw a definitive conclusion. The advice by Heywang (2009) to take 24 biopsies as a standard is based on the aim of completely or partially removing the laesion. This is not always necessary; however, radiologic-pathologic correlation is required.

Considerations

Cytology and histology overlap and partly supplement one another and their role is therefore less sharply defined in current preoperative diagnostics than in the past.

More important than the choice between cytology or histology is the consultation between the surgeon, radiologist and pathologist. They independently formulate a conclusion; the further treatment plan is determined by consensus during preoperative multidisciplinary consultation.

Authorization date and validity

Last review : 13-02-2012

Last authorization : 13-02-2012

The national Breast Cancer guideline 2012 is a living guideline, in other words there is no standard term of revision. NABON continually watches at new developments and clinical problems in the areas of screening, diagnostics, treatment and aftercare, and whether this requires an update.

Initiative and authorization

Initiative : Nationaal Borstkanker Overleg Nederland

Authorized by:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Psychiatrie
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging voor Radiotherapie en Oncologie

General details

Approximately 14,000 women (and 100 men) are diagnosed with invasive breast cancer each year in the Netherlands, and about 1,900 have an in situ carcinoma. A woman's risk of having breast cancer over the course of her life is 12-13%. This means that breast cancer is the most common form of cancer in women in the Netherlands. Early detection, particularly via national breast cancer screening, combined with adjuvant therapy followed by locoregional treatment, improves the prognosis in women with breast cancer

The guideline on Breast Cancer Screening and Diagnostics, published in 2000, was updated in 2007. In 2002, the first multidisciplinary National Breast Cancer Guideline was published, it was revised in 2004, 2005 and 2006. In 2008 both guidelines were combined to Breast Cancer Guideline, which 2012 revision is now effected.

Scope and target group

This guideline is written for all the members of the professional groups that have contributed to its development.

 

This guideline is a document with recommendations and instructions to support daily practice. The guideline is based on the results of scientific research and expert opinion, with the aim of establishing good medical practice. It specifies the best general care for women with (suspected) breast cancer and for those who are eligible for screening. The guideline aims to serve as a guide for the daily practice of breast cancer screening, diagnostics, treatment and aftercare. This guideline is also used in the creation of informational materials for patients, in cooperation with the KWF (Dutch Cancer Society).

Member of workgroup

A core group consisting of a radiologist, surgeon, pathologist, medical oncologist and radiation therapist began preparing for the revision of the breast cancer practice guidelines in 2009. A multidisciplinary guideline development group was formed in early 2010 to implement the revision. This group consisted of mandated representatives from all of the relevant specialisations concerned with breast cancer, plus two delegates from the BVN (Dutch Breast Cancer Society) (see list of guideline development group members). The benefits of such a multidisciplinary approach are obvious: not only does it best reflect the care, but it offers the greatest possible expertise for the guideline. In composing the development group, geographic distribution of the members, balanced representation of the various organisations and agencies concerned, and a fair distribution in academic background were taken into account as much as possible.

 

The guideline development group received procedural and administrative support from IKNL (Comprehensive Cancer Centre for the Netherlands) and support on methodology from Bureau ME-TA. Partial funding was obtained from SKMS (Quality Funds Foundation of Dutch Medical Specialists). This subsidy would not have been possible without the extensive assistance provided by the NVvR (Radiological Society of the Netherlands).

Declaration of interest

Partial funding for the guideline revision was obtained from the Society of Dutch Medical Specialists in the framework of the SKMS. IKNL sponsored some of the cost. On two occasions, as well as at the beginning and end of the process, all of the members of the guideline development group were asked to fill out a statement of potential conflicts of interest, in which they stated their relationship with the pharmaceutical industry. A list of these statements of interest can be found in the appendices.

Patient involvement

In developing this guideline, four clinical questions were formulated. These questions emerge from an inventory of clinical problems collected in the field from professionals, patients and patient representatives.

 

Also, A multidisciplinary guideline development group was formed in early 2010 to create and implement the revision. This group consisted of mandated representatives from all of the relevant specialisations concerned with breast cancer, plus two delegates from the BVN (Dutch Breast Cancer Society).

 

Method of development

Evidence based

Implementation

Feasibility has been taken into account in developing the guideline. This included attention to factors that could promote or hinder putting the advice into practice. Examples include the implementation of an analysis of problems, the multidisciplinary composition of the guideline development group, and making active use of support from the guideline development group members. Presenting the draft guideline to the field and communicating what, if anything, is being done with the responses, also promotes implementation. In this manner, a guideline has been developed that answers current questions in the field.

The guideline is distributed widely and is available in digital form on the Dutch Guideline Database. The guideline may also be brought to the attention of a wider audience in other periodicals or continuing education sessions, for example. To promote use of the guideline, we recommend that the regional tumour working groups and group practices, as well as scientific and professional organisations, repeatedly bring the guideline to the attention of their members. Any problems that may arise in using the guidelines can then be discussed and, when appropriate, submitted to the national guideline development group, as it is a "living" guideline. If desirable, parts of the guideline can be made more explicit by formulating regional additions or translation to the local situation in departmental and/or hospital protocols.

In principle, indicators are determined during development of the guideline that can be used to monitor implementation of the recommendations. Via a documentation project, these indicators can then be used to determine the extent of compliance with the guideline. The information from the documentation project becomes input for the revision of the guideline.

Methods and proces

This module has been evidence-based revised in 2008 and consensus based updated in 2012.

 

A revision of an existing guideline consists of revised and updated text. Revised text is new text based on an evidence-based review of the medical literature; updated text is the old guideline text which has been edited by the experts without performing a review of medical literature. Each section of the guideline states what type of revision has taken place. Each chapter of the guideline is structured according to a set format, given below. The purpose of this is to make the guideline transparent, so that each user can see on what literature and considerations the recommendations are based on.

 

Description of the literature

To the greatest extent possible, the answers to the fundamental questions (and therefore the recommendations in this guideline) were based on published scientific research. The articles selected were evaluated by an expert in methodology for their research quality, and graded in proportion to evidence using the following classification system:

 

Classification of research results based on level of evidence

A1

Research   on the effects of diagnostics on clinical outcomes in a prospectively   monitored, well-defined patient group, with a predefined policy based on the   test outcomes to be investigated, or decision analysis research into the   effects of diagnostics on clinical outcomes based on results of a study of   A2-level and sufficient consideration is given to the interdependency of   diagnostic tests.

A2

Research   relative to a reference test, where criteria for the test to be investigated   and for a reference test are predefined, with a good description of the test   and the clinical population to be investigated; this must involve a large   enough series of consecutive patients; predefined upper limits must be used,   and the results of the test and the "gold standard" must be   assessed independently. Interdependence is normally a feature of situations   involving multiple diagnostic tests, and their analysis must be adjusted   accordingly, for example using logistic regression.

B

Comparison   with a reference test, description of the test and population researched, but   without the other features mentioned in level A.

C

Non-comparative   trials

D

Opinions   of experts, such as guideline development group members

 

Conclusions

Based on the medical literature, one or more relevant conclusions are made for each section. The most important literature is listed according to the level of evidential strength, allowing conclusions to be drawn based on the level of
evidence. All the medical literature included in the conclusion is described in the bibliography.

 

Classification of conclusions based on literature analysis

1

Based   on 1 systematic review (A1) or at least 2 independent A2 reviews.

2

Based   on at least 2 independent B reviews

3

Based   on 1 level A2 of B research, or any level C research

4

Opinions   of experts, such as guideline development group members

 

Other considerations

Based on the conclusion(s), recommendations are made. However, there are other considerations that contribute to formulation of the recommendation besides literature evidence, such as safety, the patients' preferences, professional expertise, cost-effectiveness, organisational aspects and social consequences. The other considerations are mentioned separately. In this manner, it is clear how the guideline development group arrived at a particular recommendation.

 

Recommendations

The final wording of the recommendation is the result of the scientific conclusion, taking into account the other considerations. The purpose of following this procedure and drawing up the guidelines  in this format is to increase transparency.

 

References

An alphabetical list of literature references can be found at the end of the guideline.

 

All draft texts have been discussed by the guideline development group.

Search strategy

Searches are available upon request. Please contact the Richtlijnendatabase.