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Early detection of breast cancer using mammography –
a position paper of the Swiss Cancer League
Marcel Zwahlen1, Nicole Probst 2, Brigitte Baschung3, Chris de Wolf 4,
Elisabeth Marty-Tschumi 5, Bettina Borisch6
1
Department of Social and Preventive Medicine at the University of Berne, Berne
2
Institute of Social and Preventive Medicine at the University of Zurich, Zurich
3
Swiss Cancer League, Berne
4
FDD-D&P, Développement et perspectives auprès de la Direction générale de la santé,
République et Canton de Genève, Geneva
5
Delegate for Health Promotion and Prevention, Public Health Service, Sion
6
Institute of Pathology, University of Geneva, Geneva
Swiss Cancer League
Effingerstrasse 40, P. O. Box 8219, CH-3001 Berne
Phone +41(0)31 389 91 00, Fax +41(0)31 389 91 60
[email protected]
www.swisscancer.ch
Passed by the executive of the Swiss Cancer League on 6 March 2003
© 2002 Swiss Cancer League
Table of Contents
Summary
3
Position of the Swiss Cancer League
3
Introduction
5
WHO criteria according to Wilson and Jungner for evaluating screening measures
6
Mammography screening: initial situation and available evidence
8
Breast cancer: the epidemiological situation
8
Breast cancer: options for early detection
8
Mammography screening: the scientific evidence
9
Mammography screening: applicability of the available evidence to the Swiss situation
9
Mammography screening: side effects and costs
Organized mammography programs in Europe and Switzerland
10
11
Organized mammography programs in Europe
11
Organized mammography programs in Switzerland
11
References
13
Page 2
Summary
In summary the following observations can be made:
Breast cancer is a significant health problem for women in Switzerland.
Compared to advanced stage diagnosis, treatment of breast cancer in an early stage is
associated with better survival. Until research reveals effective measures for preventing or
curing breast cancer regardless of the stage of diagnosis, early detection will remain essential in
reducing the physical and psychological disease burden associated with breast cancer.
Solid scientific evidence exists that systematic invitation of women between ages 50 and 69 to
mammography examinations reduces breast cancer mortality. The results of randomized
studies of organized mammography programs in several countries show an average reduction
of breast cancer mortality by 25% in the target population.
The reductions actually achieved by nationally or regionally implemented mammography
programs in target populations vary between 5 and 20% and depend on both the frequency and
quality of opportunistic mammography screening as well as the quality of treatment after a
breast cancer diagnosis.
Mammography may have adverse consequences such as insecurity, anxiety as well as
unnecessary diagnostic workup and treatment. In the context of organized mammography
programs the extent of these consequences can be documented and systematically reduced.
The cost-effectiveness ratio achieved in certain countries in the context of organized
mammography programs (up to CHF 20,000 per year of life gained) is comparable to other
specific public health measures such as cervical carcinoma screening. In Switzerland the costeffectiveness ratio must be discussed in the light of a probably relatively high rate of
opportunistic screening, but the respective data is lacking and will only become available after
the implementation of organized mammography screening.
Position of the Swiss Cancer League
Therefore, in support of an informed decision of the women, the Swiss Cancer League has
concluded that all women in Switzerland should have the option of a regular access to quality
assured mammography as an essential service of the basic Swiss health insurance.
The scientific evidence documents a justifiable cost-effectiveness ratio for organized
mammography programs. Organized mammography screening is preferable to opportunistic
screening, in particular because no evaluation of quality and impact is possible for the latter.
Page 3
In the light of the complex structure of the Swiss healthcare system and the cultural differences
between the country's language regions, it is unlikely that an organized national mammography
program will be set up in the near future.
The existing organized mammography programs in the western parts of Switzerland should
carefully be evaluated. Particular consideration must be given to the time trends of the rates of
false positives, of unnecessary biopsies and of interval cancer diagnoses as well as a
comparison of the diagnostic stage at which breast tumors are detected in organized programs
compared to those detected in opportunistic screening. Certainly, a further reduction of the
breast cancer mortality in the context of organized programs cannot be the key measure of
success in a country with a presumably relatively high rate of opportunistic screening.
Expectations and interpretation of the evaluation results should transparently be discussed in
due time with the decision-making committees in healthcare policy.
For those regions of Switzerland that are not currently covered by organized mammography
screening programs measures should be taken to strengthen quality assurance and evaluation
of screening mammography. Ideally, the latter should be defined in a binding manner within the
existing system considering the regional-cultural differences. Constructive cooperation of the
relevant health care providers must be encouraged for this purpose.
All women in Switzerland should be informed in a comprehensive and balanced manner by the
participating institutions (responsible parties in cantonal programs, doctors, health insurance
providers, Federal Office for Social Security etc.) regarding the benefits and limits of the
screening mammography enabling the women to make their own decisions on mammography
use (Empowerment and Informed Choice).
Page 4
Introduction
Worldwide breast cancer is a significant public health problem and, with about 1,500 deaths
annually, it is the most common cause of cancer mortality among women in Switzerland. Until
research reveals effective measures for preventing and curing breast cancer regardless of the
diagnostic stage, early detection remains an essential method for reducing the associated
physical and psychological burden of disease.
Early detection of breast cancer using mammography is one of the few population-based
screening measures that have been scientifically examined in depth and detail [1, 2]. The
scientific discussion on the efficacy of mammography for early detection of breast cancer [3-6] is
now considered closed [1, 2]. Systematic mammography screening of women between ages 50
and 69 is considered to reduce breast cancer mortality.
Since 1997, screening mammography for early detection of breast cancer in women between
ages 50 and 69 has been an essential service of the basic Swiss health insurance system under
the condition that EU quality control requirements are met [7, 8]. This decision was taken
conditionally until 31 December 2007. The evaluations that must be conducted by the end of
2007 will contribute substantially to the decision for or against continuing covering screening
mammography. The quality requirements for systematic early detection of breast cancer using
mammography require organized programs. These are geared towards
•
unrestricted access for the target group,
•
high examination quality to ensure effective disease control while reducing, ideally,
preventing possible harmful effects of the examination, and
•
creating the required conditions for impact assessment.
The introduction and possible implementation of a national mammography screening program in
Switzerland encountered significant problems and resistance by various actors [9]. The current
situation may be described in the following manner:
In early 2003, organized programs are available in three cantons (Geneva, Vaud and Valais). In
three other cantons of the French-speaking part of Switzerland, discussions on a concrete
implementation are underway. For women living in other cantons who wish to have access to a
mammography for early detection of breast cancer, the mammography is not subject to any
systematic or documented quality control system and the health care insurances only cover the
costs in part and subject to franchise restrictions.
Page 5
Definitions
Screening Mammography:
-
Mammography screening program or systematic early detection of breast cancer
using mammography
Systematic early detection of breast cancer using mammography means a qualityassured program with systematic periodical invitation of all women in a particular age
group (in the target group) to a cost-free mammography examination for the purpose of
early detection of breast cancer. Subsequently, the terms "systematic mammography”,
“mammography screening program” and “organized mammography programs” will be
used interchangeably.
-
Opportunistic mammography screening
This means individually chosen access by asymptomatic women to a mammography
examination that is not a response to an invitation in the context of a mammography
screening program. Therefore, quality assurance aspects (that are part of a
mammography screening program) are not uniformly regulated or documented.
Comprehensive and free access for all women – regardless of social or economic
background – to mammography is not guaranteed.
Diagnostic Mammography
By diagnostic mammography we mean the use of mammography x-ray examinations for
determining if a breast tumor is present in a woman having symptoms or a predisposition for
breast cancer.
This position paper discusses screening mammography and not diagnostic mammography.
WHO criteria according to Wilson and Jungner for evaluating
screening measures
In the 1960s the World Health Organization adopted the criteria for judging public health
screening programs set out by Wilson and Jungner [10]. These subsequently updated and
adapted criteria are [11]:
1. The condition to be detected is of public health importance.
2. The natural history of the condition is understood and there is an unsuspected but detectable
(pre-clinical) stage.
3. There is an ethical, acceptable, safe and effective procedure for detecting the condition at a
sufficiently early stage to permit intervention.
Page 6
4. There are ethical, acceptable, safe and effective preventive measures or treatments for the
condition when it is detected at an early stage.
5. There is sufficient political will, and it is feasible to carry out the relevant screening, diagnostic
and intervention practices in a population-based manner with existing resources or with
resources that could be obtained during the planning period.
6. Adoption and implementation of the screening, diagnostic and intervention practices will
strengthen development of the health system and overall societal development in a manner
consistent with the principles of primary health care.
7. The cost of the screening and intervention is warranted and reasonable compared with
alternative uses of resources.
On the following pages we think to demonstrate that mammography screening meets these
criteria and quality-assured programs for optimizing the benefit/risk profile are justified in
Switzerland.
Page 7
Mammography screening: initial situation and available
evidence
Breast cancer: the epidemiological situation
In Switzerland about 4,000 women are diagnosed with breast cancer every year and about
1,500 die from this disease annually [12, 13]. Breast cancer is the most common cause of
cancer mortality among Swiss women [13]. An estimated 15,000 to 18,000 women in
Switzerland have had a breast cancer diagnosis in the last 5 years and live with this disease
(Source: IARC, Lyon). Therefore, breast cancer is a significant health problem in this country.
Comparable breast cancer mortality figures (age standardized mortality per 100,000 women) in
Europe show that the temporal trends in the last decades were relatively stable in most
countries up to 1990. In some countries, such as the Netherlands and the United Kingdom, the
mortality figure has exhibited a downward trend since 1990 [14, 15]. Likewise, after 1990 a
decline in the breast cancer mortality rate is recognizable in the USA [16, 17]. Indications of a
decline in breast cancer mortality are also accumulating in Switzerland [14]. To what extent the
reductions of breast cancer mortality in various countries are due to mammography screening,
improvements in treatment or perhaps even changes in coding causes of mortality is a matter of
ongoing research [17].
Breast cancer: options for early detection
Systematic mammography for early detection of breast cancer has been investigated
scientifically for over 30 years. Large population-based and randomized studies on the efficacy
of screening mammography have been conducted in several countries [1, 2], most notably the
USA, Canada, Sweden and the United Kingdom. In these and other countries, starting from pilot
programs in pilot regions, regional and national mammography programs have been established
since the 1970s and have continuously been evaluated [18-22].
Screening mammography has clearly documented limits of sensitivity and specificity [2].
Therefore, the search for more reliable technologies and methods for the early detection of
breast cancer is the subject of intensive research efforts but so far no alternative method has
been sufficiently well evaluated to justify at this time a systematic population-based application
[23].
Breast self-examination is recommended to women for early detection of breast cancer.
Whether systematic breast self-examination instructions reduce breast cancer mortality was
explored in several studies, but these studies did not provide the expected evidence of efficacy
[1, 24-27]. However, breast self-examination is believed to contribute importantly to increased
body self-awareness and early detection of unusual modifications in the breasts.
Page 8
Mammography screening: the scientific evidence
Efficacy
In various countries large population-based and randomized studies on the efficacy of
systematic invitation to screening mammography have been conducted. Up to the late 1990s
the results of these studies on the efficacy of mammography programs in reducing breast
cancer mortality were judged to provide evidence for a 20 to 30% reduction of breast cancer
mortality [28]. In these studies women who were systematically invited to screening
mammography were compared to women who were not systematically invited. After the
publications in the Lancet in 2000 and 2001 [3, 6], the discussion on the efficacy of
mammography screening resumed in Switzerland [4, 5, 29] and many other countries.
Additionally it was asked whether population-based early detection of cancer should prove its
efficacy by a reduction in total mortality or by a reduction in cancer-specific mortality [6, 30, 31].
Since the publication of two large systematic reviews on the efficacy, the range of side effects
and cost-effectiveness of systematic mammography screening the discussion on
mammography efficacy may be considered as resolved [1, 2, 32-34]. Based on these two
reviews compiled by expert groups from America and Europe one can summarize the situation
in the following manner:
Sufficient solid evidence has accumulated from randomized studies to conclude that systematic
and regular invitation of women of ages 50 to 69 to mammography examinations reduces breast
cancer mortality. The best estimate of the magnitude of the reduction achieved in randomized
studies is 25% when comparing invited intervention groups with ones that were not invited [32,
35].
Effectiveness
Evidence is accumulating from several countries that organized mammography programs
(implemented outside of randomized studies) can reduce the breast cancer mortality in the
target group. The experience in European countries suggests that, in the long-term, a reduction
of about 20 % can be achieved in the target population under real conditions, but achieved
reductions may vary substantially from country to country resulting in a range of effectiveness
estimates of 5 to 20 % [33, 35].
Mammography screening: applicability of the available evidence to the Swiss situation
The life-lengthening and lifesaving effect that a method of early detection of cancer aims for is
always closely linked to the therapeutic options and interventions following a cancer diagnosis,
and treatment options have substantially changed and expanded over the last 20 years both for
breast and other cancers. This expansion of therapeutic approaches over time constitutes a
fundamental problem in applying and generalizing study results of the 1980s to the early 21st
century, even if, at the time they were conducted, the studies satisfied the most up-to-date
methodological requirements.
Page 9
Of course, the maximum reduction of breast cancer mortality achievable with a mammography
screening program in a particular population depends on the frequency and quality of the
opportunistic mammography screening performed before and parallel to program
implementation. Reliable data on the frequency and quality of opportunistic mammography
screening in Switzerland since 1997 appears not to be available (personal communication, Dr.
Gurtner, Federal Office for Social Security). However, based on information collected in the
Swiss Health Survey, it may be assumed that opportunistic mammography examinations are
performed quite frequently.
Based on these aspects, when judging the regional mammography screening programs in the
French-speaking parts of Switzerland a strong emphasis should be put on comparing the profile
of side effects of opportunistic versus organized mammography screening rather than expecting
a striking reduction of breast cancer mortality. The evaluation of these regional quality-assured
mammography screening programs is critical in providing more reliable data on the access to
and quality of screening mammography in Switzerland.
Mammography screening: side effects and costs
In the situation of a high acceptance rate and an optimal quality control system we might expect
that systematic mammography for breast cancer will reduce breast cancer by 20% in the target
population after an introductory phase of about 7 to 10 years. But even under these ideal
conditions the possible adverse effects caused by this population-based measure are of
concern, for example with respect to additional diagnostic workup due to false positive results
as well as psychological and social side effects on women who do or do not want to participate
in the program [1, 2, 36-38]. However, these aspects of adverse effects can only be
documented and evaluated in the context of quality assured mammography screening
programs.
Additionally, questions need to be answered regarding efficient resource use in comparison with
other population-based measures in primary and secondary prevention [39, 40]. The estimated
costs per year of life gained depend on the incidence of the disease, the quality of the screening
program, the participation rate achieved, the form and cost structure of the healthcare system
[34, 40]. If cost estimates for Germany are applicable to Switzerland, then CHF 15,000 to
20,000 per year of life gained need to be expected for long-term mammography screening
programs [40, 41]. For the USA the costs are somewhat higher with estimates of USD 19,000 to
35,000 per quality-corrected year of life gained. This is plausible given that annual
mammography screening is recommended [39]. Even if the absolute cost estimates are not
applicable to Switzerland, this US study contains useful information on the comparison with
other population-based healthcare measures: colon cancer screening appeared to be more
cost-efficient than mammography screening (Graph 3 of [39]) but costs per quality-corrected
year of life gained in mammography screening were in the same order of magnitude as for
cervical carcinoma screening. For Switzerland however, the cost data on opportunistic
Page 10
mammography screening, which is at least in part paid by the health insurance companies, is
lacking. Therefore Swiss specific cost estimations describing the status quo in Switzerland can
not be performed.
Organized mammography programs in Europe and Switzerland
Organized mammography programs in Europe
In the years 1987 to 2002 national or regional mammography screening programs were
implemented in several European countries, and the majority of these were directed at the 50 to
69 year age group and a 2-year screening interval was usually selected [18]. Organized
mammography screening programs exist in almost all European countries, but achieved
coverage of the target population varied between <25 to 100% (Table 10 in [18]).
Most of these programs cooperate in the European Breast Cancer Network (EBCN), which also
includes EUREF, the European Network of Reference Centers (European Reference
Organisation for Quality Assured Breast Screening and Diagnostic Services). This organization
has developed quality assurance guidelines for screening programs [7, 8] and has continuing
education facilities for program directors and radiologists who evaluate screening
mammographies, and accredited continued education sites are located in Sweden, Holland,
England, Italy and France.
The EUREF quality assurance recommendations contain requirements for the implementation
of the screening program, physical and technical requirements for mammography examinations
and guidelines regarding cytopathology and histopathology. Additionally, definitions exists on
the frequency (daily, weekly and annual) of certain quality tests that need to be performed.
Organized mammography programs in Switzerland
In October 1993 in the regions Aigle, Morges and Aubonne of the canton of Vaud a pilot
program for breast cancer screening using mammography was started. The pilot phase was
initially defined to last for 4 years and was eventually extended to March 1999.
In 1997 mammography for early detection of breast cancer in women between ages 50 and 69
became an essential service of the basic Swiss health insurance system under the condition
that EU quality requirements are met. This decision was taken conditionally until 31 December
2007. The evaluations that must be conducted by the end of 2007 will contribute substantially to
the decision for or against continuing covering screening mammography.
On 23 July 1999, the Federal Council passed a regulation regarding quality assurance in
programs for the early detection of breast cancer using mammography. The content of the
regulation is largely based on European guidelines for quality assurance in organized screening
programs, and demands that each screening programs should cover at least the population of
an entire canton.
Page 11
In 1999 the Vaud pilot program was extended to the entire canton. About 11,000 women were
potentially covered in the pilot program, and about 75,000 in the program extended to the entire
canton of Vaud. In March of 1999 implementation of a screening program was started in the
canton of Geneva. The program in Valais followed in the summer of 1999.
In March of 2000 the launch of a national mammography screening program was stopped by
the Foundation for the Early Detection of Cancer. The main reason for this was the fact that no
solution was found for closing the financing gap that had opened between the anticipated costs
according to the service providers and the compensation offered by the health insurance
companies. The Swiss Conference of Cantonal Ministers of Public Health decided against
covering this financing gap.
Currently (in 2003), specific plans for implementing additional mammography screening
programs are only discussed in the French-speaking parts of Switzerland: the Dispositif
intercantonal pour la prévention et la promotion de la santé (DIPPS) developed a feasibility
study for establishing comprehensive, organized mammography screening throughout Frenchspeaking Switzerland.
Page 12
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