Question

Is screening by means of regular breast self-exam a viable way of determining breast cancer?

Recommendation

Regular breast self-exams are not recommended as a method for reducing mortality from breast cancer.

 

A woman's request for information and explanations with regard to breast self-exams and with regard to self reported lumps should always be honored; it is very important to reassure young women who are worried.

 

In each case it must be decided whether a palpable abnormality found by the woman herself qualifies for imaging or referral to a breast cancer clinic.

Conclusions

Breast cancers detected through regular breast self-examination have no better prognosis than breast cancers detected by other means.

Level 1: A1 Kösters 2003, Elmore 2005, Weiss 2003, Nelson 2009

 

A self reported lump by the woman is positively associated with an actual mass being present.

Level 1: A2 Barlow 2002, Lumachi 2002, Aiello 2004

 

The sensitivity of the mammogram increases for a self reported lump by the woman, but the specificity decreases, especially in very young women.

Level 1: A2 Barlow 2002, Kavanagh 2000, Thomas 2002

Literature summary

Four systematic reviews have evaluated screening by means of regular breast self-exam [Kösters, 2003; Weiss, 2003; Elmore, 2005; Nelson, 2009]. In addition, there are both prospective and retrospective cohort studies comparing regular breast self-exams as a screening method with not performing them, and comparing cancers that are found by women themselves with those that are not.

Women can detect pre-symptomatic breast cancer by performing regular breast self-exams. This does not lead to a reduction in mortality, however. After analyzing the results of two large RCTs from St. Petersburg, Russia and Shanghai, comparing one group of women who were given extensive training in how to perform regular breast self-exams with another group of women who were not advised to, the Cochrane review by Kösters (2003) found that the average tumour size was the same, as was the rate of death from breast cancer. Women who perform regular breast self-exams have a greater chance of having unnecessary breast surgery for a benign condition. This has been confirmed by other comparative studies. [Elmore, 2005; Weiss, 2003; Humphrey, 2002; Nelson, 2009]. This is one reason that the US Preventive Services Task Force no longer recommends instructing patients to perform regular breast self-exams [USPSTF, 2009].

On the other hand, the percentage of cancers detected because they are palpable is still significant. In a retrospective study of 41,427 diagnostic mammograms, Barlow (2002) found that when a breast lump was felt by the woman herself, the sensitivity of the mammogram increased. The percentage of cancers was larger in this group than when there was no self-detected lump: 72.2% versus 48.4%. In other words, an abnormality felt by the woman herself is positively associated with an actual mass being present. This has been confirmed in multiple studies and applies in particular to the palpable abnormality, not to other symptoms such as nipple discharge, local pain, etc. [Kavanagh, 2000; Lumachi, 2002; Aiello, 2004]. The specificity is adversely impacted, however, especially in the young age groups, due to a relatively small chance of breast cancer compared with a much greater chance of benign abnormalities [Thomas, 2002].

Furthermore, Barlow's test results (2002), cannot be traced back exclusively to mammography, because additional ultrasound was performed when indicated, which is also daily practice in the Netherlands.

Women who have undergone breast-conserving therapy (BCT) for breast cancer form a separate group. The locoregional recurrences that develop are found just as often by the woman herself as they are by clinical breast exams and mammograms [Orel, 1992; Elkhuizen, 1998].

Considerations

The finding that regular breast self-exams have no value as a screening method has caused confusion. In general, knowledge of one's own body is seen as positive (breast awareness)and can be propagated. Questions, women ask their doctors, the breast cancer team, and patient organisations, etc., about how and why to do breast self-examination should be answered likewise .

Regular breast self-examination is not recommended, but that does not mean that palpable abnormalities and any other symptoms found by a woman at any given moment should not be taken seriously. The potential presence of a palpable abnormality causes worry, so it should be investigated regardless of the woman's age or risk profile. If the finding is not clearly benign, additional imaging should be done and low threshold referral to a breast outpatient clinic is recommended.

Women at screening age should be told that a lump is a reason for further imaging and that screening is not suited to this. What must be avoided is having the symptomatic woman feel unjustifiably reassured by screening.

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.