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Population-based screening programs for breast cancer are directed at asymptomatic women at average risk. Generally, these women do not have signs of breast cancer, a strong family history of breast cancer (i.e., three or more first-degree or second-degree relatives on the same side of the family with breast cancer) or a diagnosis of BRCA gene mutations.

Population-based screening is not a diagnostic process. Its purpose is to identify women with mammographic abnormalities that are indicative of possible breast cancer for follow-up investigation. See the Principles of screening chapter of the National Cancer Prevention Policy for more information.

Mammography is the only means of population-based screening shown to reduce breast cancer mortality. Population-based mammography screening is carried out in Australia through the BreastScreen Australia program.



Mammography

Mammography refers to X-ray examination of the breast. It is used to visualise abnormalities in the breast tissue, including cancer. Mammography is used both as a screening tool and a diagnostic tool.

The aim of screening mammography is to reduce breast cancer mortality and morbidity by detecting breast cancer early while it is small and confined to the breast ‒ features associated with increased treatment options and improved survival[1][2]. Currently, mammography is the most effective population-based screening tool for breast cancer available[3][4] and is recommended as a population-based screening tool by Cancer Australia[5].

Mammography can be performed using analogue or digital systems. Analogue mammography involves the printing of X-ray images onto film whereas digital mammography uses computed or digital radiography for image acquisition and allows images to be stored as digital files.

In 2007, the Medical Services Advisory Committee (MSAC) reviewed the safety, effectiveness and cost-effectiveness of digital mammography for screening purposes for BreastScreen Australia[6]. MSAC found that digital mammography to be as safe and effective as film-based mammography, and recommended its use[6]. BreastScreen services began transitioning from film-based to digital mammography in 2008.

In addition to screening, mammography is also used as one of a suite of diagnostic tests to determine whether cancer is present in women with symptoms.



Screening age range and intervals

Age range

A recommendation for screening in any age group is made when the benefit from screening is considered to exceed the harms, that is, when there is a net benefit. Many factors are taken into account, including the incidence of the disease being screened for, the mortality reduction associated with screening, screening accuracy and the risk of overdiagnosis in each age group. The potential harms and benefits associated with population-based breast cancer screening are outlined below.

Evidence shows the net benefit from mammography screening in Australia is greatest for women aged 50–69 years[3]. In Australia, mammography screening is actively targeted to women in this age group, and is being extended to include women up to 74 years. For more information on screening policy in Australia see the Policy context section of this chapter.

Women aged 50-69 years

The recommendation for targeted mammography screening of women aged 50–69 is based on a combination of high breast cancer incidence and evidence that screening in this age group provides benefits that outweigh the potential harms.

More than three quarters (79%) of breast cancers in Australia are diagnosed in women over the age of 50[7].

The mortality benefit associated with population-based mammography screening is greatest for women aged 50–69. The introduction of the BreastScreen Australia program is associated with a 22% decrease in breast cancer mortality in the 50-69 age group[3].

The US Preventive Services Task Force (USPSTF) recommends screening mammography for women aged 50 to 74, advising that there is "high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial"[8].

An even greater improvement in relative risk of breast cancer death was found for women aged 60 to 69 years who screened with mammography[8][9].

The accuracy of screening is highest in women aged 50–69. While the risk of false negative screening results decreases with age[10][11]false positive results are least common in women aged 50–69[11][12].

Women aged 40-49 years

In Australia, the mortality benefit for women aged 45–49 years is second only to the benefit for women aged 50–69[3] (see Table 1). However, for women aged 40–44 years, there is limited evidence of benefit coupled with a higher risk of harms[3].

There is mixed evidence of a benefit associated with mammography screening in this age group. Some studies suggest screening results in diagnosis of smaller tumours[13] and better breast cancer outcomes[14][15]. Meta-analysis of randomised controlled trials (RCTs) found that screening in this group was associated with a 15% reduction in breast cancer mortality[16]. However, a Canadian review found that population-based screening of women aged 40–49 was not effective in reducing mortality [17].

It has been suggested that the harms outweigh the benefits associated with screening in this age group[18]. This is due to a high false positive rate[8][10][11][19], coupled with low cancer detection rates[20].

Recommendations for screening among women aged 40–49 vary, with the American College of Physicians’ clinical practice guidelines and the USPSTF recommending that mammography screening for women aged 40–49 should be based on patient preferences and other contextual factors[21].

Women aged 70 and over

The BreastScreen Australia Evaluation concluded that there is some evidence of a mortality reduction associated with screening in women aged 70–74 years, however the reduction was about half that seen among women aged 50–69[3]. Evidence to support screening of women aged 70–74 in Australia includes increasing life expectancy for women, high breast cancer incidence, good mammography sensitivity and high cancer detection rates[3]. There is little evidence of benefit of screening in women aged 75 years and over[3].

Internationally, there is a lack of evidence for the mortality benefit of mammography screening in women aged 70 and above, primarily due to few studies being conducted in this age group[8][22]. Among these women, some studies indicate that modest mortality reductions are coupled with high levels of overdiagnosis[19] and other burdens from screening, including false negative and false positive screening results[23].

The sensitivity of mammography is highest in women aged 70 years and over: the cancer detection rate is around 50% greater than that of women aged 50–69 years[3].

Meta-analysis of the impact of population-based mammography screening on breast cancer survival suggests that screening is most appropriate for patients with a life expectancy greater than 10 years[24].

Screening interval

For screening to be effective, the interval between mammograms needs to be short enough to detect cancers early enough for effective treatment, but long enough to avoid unnecessary screening and to minimise the potential harms associated with mammography. Most population-based mammography programs offer screening annually, or every two to three years.

There are few studies directly comparing the relative benefits associated with different screening schedules, while controlling for the effect of other screening policies and protocols.

Biennial screening has been shown to achieve around 80% of the mortality benefit of annual screening[19][25] with less than half the number of recalls due to false positive results[19].

There is mixed evidence on the impact of extending screening intervals to longer than biennially[14][26][27].

There is some evidence that annual screening may improve outcomes for women younger than 50 years[3].



Potential benefits and harms of mammography screening

Screening tools for detecting early signs of disease in asymptomatic populations usually confer both benefits and harms; screening should only be recommended if evidence indicates that the benefits outweigh the harms according to the World Health Organization principles of screening[28] and more recent frameworks such as the USPSTF recommendations[8].

While the potential benefits and harms of mammography screening continue to be debated[29], Cancer Council supports the Australian Government’s interpretation of the evidence and endorses population-based screening for breast cancer, provided participants are well-informed of the risks and benefits.



Potential benefits

Mortality reduction

Early estimates of the mortality benefit of breast screening came from clinical trial data, derived from a series of studies dating back to 1963. An expert group convened by the International Agency for Research on Cancer found that evidence from clinical trials indicated a mortality reduction of about 35% among women aged 50–69 who chose to participate in screening programs[30]. A later Cochrane review of clinical trial evidence concluded that screening reduces breast cancer mortality by 15% in women offered screening, corresponding to an absolute risk reduction of 0.05%[31].

The BreastScreen Australia Evaluation found that, with the current level of participation, biennial screening of women in Australia aged 50–69 years reduces breast cancer mortality risk by 21–28%[3]. Table 1 shows the mortality benefits associated with participation in BreastScreen Australia among different age groups. (Note that these are observational analyses and could be affected by lead time and length time bias.) Other Australian studies have similarly reported significant reductions in breast cancer mortality, with estimates ranging from about a 34% to 50% mortality reduction among those screened[32][33][34][35].


Table 1. Mortality benefit associated with 60% participation in BreastScreen Australia, shaded area indicates BreastScreen Australia target age[3]

Internationally, estimates of a reduction in breast cancer specific mortality due to population-based mammography screening vary widely. The wide range of estimates of the impact of breast cancer screening programs on breast cancer mortality has led to much discussion on the effectiveness of screening mammography. The differences seen in the literature can at least partially be explained by differences in study design, which strongly influence estimates of the mortality benefit associated with screening[36][37].

However, there is broad agreement that studies identified as having stronger methodologies support a significant reduction in breast cancer mortality associated with screening[37][38][39][40][41][42].

The Independent UK Panel on Breast Cancer Screening international review reported an estimated a 20% reduction in breast cancer mortality in women invited to screen. While the report noted a "great deal of uncertainty [surrounding] this estimate", it represented the review panel's overview of the evidence and corresponded to one breast cancer death averted for every 235 women invited to screening for 20 years, and one death averted for every 180 women who screen[42][43]. The report noted that "the more reliable and recent observational studies generally produced larger estimates of benefit", while noting that these studies might also be biased[42][43].

A major systematic review published by the USPSTF in 2009 reconfirmed that screening mammography reduces mortality[9]. Improvements in relative risk for death due to breast cancer for women aged 39–49 years and 50–59 years were similar at 0.85 and 0.86, respectively[9]. (Note that false positive results are most common in women aged 40–49 and least common in women aged 50–69[11][12]. As discussed, the potential harms associated with false positive screening results weigh against the net health benefits of population-based screening for the 40-49 age group.)

Most studies indicate that the greatest mortality benefit of screening is among women aged 50–69, with estimates ranging from 13–48%[19][44][45][46][38][41][47][48]. By comparison, a recent Canadian study found no mortality benefit associated with annual mammography in women aged 50–59 (compared with annual physical breast examination)[49]. A review of international evidence suggests that the mortality reduction achieved by screening programs is comparable to evidence generated from clinical trials[50].

Among women in other age groups, evidence for a mortality benefit is limited. For 40–49 years, the limited available evidence suggests that annual screening results in a 15% reduction in breast cancer mortality; however the evidence had not reached statistical significance in Australia[3]. A Canadian study found no mortality benefit for annual mammography in women aged 40–49 (compared with usual care)[49].

Evidence for a mortality benefit associated with population-based mammography screening for women over the age of 70 is also limited but suggests that screening reduces breast cancer mortality in this group[3].

Debate continues on the respective effects of screening versus improvements in treatment on reduced breast cancer mortality, with advances in diagnosis and treatment occurring in the same period as the introduction of screening programs. Analysis of the Norwegian breast cancer screening program determined that of the 28% reduction in breast cancer mortality compared with historical controls, 10% was attributed to screening[51]. Other European studies suggest that treatment has been responsible for reductions in breast cancer mortality seen over time and that screening does not play a role in these reductions[52][53]. An Australian study analysing age-specific trends in breast cancer mortality and screening participation in women aged 40–79 since 1991 concluded that reduced rates of breast cancer mortality may be attributed, in the most part, to advances in treatment[54]. However, the balance of evidence suggests that, in Australia, mammography screening is associated with a significant reduction in breast cancer mortality.

Potential harms

The potential harms associated with screening mammography are primarily related to overdiagnosis, inaccuracies associated with screening mammography resulting in false negative and false positive screening results, and radiation exposure.

These potential harms are an unavoidable part of mammography screening. The goal is to minimise potential harms while maximising the detection of potentially harmful tumours at a stage when earlier interventions would be beneficial. Cancer Council Australia supports Australian, US and UK government interpretations of the evidence which conclude that the benefits of reduced mortality from population-based mammography outweigh the potential for harm[3][8][42].

It is, however, important that women invited to screen for breast cancer are informed about the potential harms. As recommended by the 2012 Independent UK Panel on Breast Cancer Screening international review of mammography benefits and harms, information should be made available in a transparent and objective way to women invited to screen so they can make informed decisions[42].

Overdiagnosis

Overdiagnosis from breast screening describes breast cancer cases diagnosed by screening that would not otherwise have been diagnosed during a woman’s lifetime. It does not refer to error or misdiagnosis. Overdiagnosis includes all instances where cancers detected through screening might never have progressed to become symptomatic during a woman’s life – that is, cancers that would not have been detected in the absence of screening[4].

At present, there is no way to identify which cancers constitute overdiagnosis and which do not. Overdiagnosis of breast cancer is associated with overtreatment, including surgery, radiotherapy and endocrine therapy.

There is no consensus on the level of overdiagnosis associated with screening mammography, with a paucity of reliable data[46] and available estimates varying so widely that interpretation is difficult[46][55][56].

Estimates of the proportion of cases overdiagnosed through population-based screening programs range from negligible[57][58][59][60] through to over 30%[61][62][31][63][49].

The Euroscreen review found that the most plausible estimates of overdiagnosis, taking into account trends in underlying risk and lead time bias (caused by the difference in diagnosis time due to screening), ranged from 1–10%, and averaged 6.5% for screened women[64][65].

Studies not adequately adjusting for these biases obtained higher estimates, with a maximum of 54%[64][65]. Another review noted that even among the least biased studies, estimates of overdiagnosis among women aged 50–59 years ranged from 2–54%, and 7–21% for women aged 60–69 years[66].

The 2012 Independent UK Panel on Breast Cancer Screening international review estimated that for 10,000 women invited to screen, from age 50 over 20 years, 681 cancers (invasive and DCIS) would be diagnosed, of which 129 (19%) would represent overdiagnosis[42].

Australian estimates of overdiagnosis due to screening come from a single study and put the estimate at the upper end of the range, with overdiagnosis estimated to account for a 30–42% increase in number of cases diagnosed among women aged 50–69[67].

Impact of overdiagnosis on screening intentions

The impact of overdiagnosis on intended screening behaviour in Australian women is dependent on the extent of overdiagnosis described. While low to intermediate estimates have only a limited influence on screening intentions, estimates of 50% overdiagnosis prompt women to make more careful personal decisions about screening[68].

A UK analysis found that, although women expressed surprise at the possible extent of overdiagnosis, it had little impact on intended screening behaviour[69]. Similarly, another analysis has indicated that while many women consider it important to take overdiagnosis into account in order to make an informed choice, they still want to be encouraged to participate in screening[68].

False negative screening results

Sensitivity describes the ability of a test to identify people who have the disease being screened for. A test with poor sensitivity will miss cases and produce a large number of false negative screening results – where people with the disease are incorrectly told that they are free of disease. Interval cancers, tumours diagnosed in between screening rounds, are used to estimate false negative screening results.

The sensitivity of mammography through BreastScreen Australia increases with age, meaning that biennial mammography screening is less able to detect cancers in women in younger age groups[10]. Program sensitivity for BreastScreen Australia has increased over time[3]. Program sensitivity for each age group (up to 24 months after a negative scan) is presented in Table 2.


Table 2. BreastScreen Australia program sensitivity by age group for all screening rounds combined[70]

International studies confirm that the sensitivity of mammography screening is lower in younger women[71]. This lower sensitivity is due to lowered tumour detectability by mammography among these women, rather than age-specific differences in tumour growth rates[72]. Higher breast density is associated with much lower sensitivity of mammography[73]. In general, as women age and after menopause, breast density decreases[74][75].

False positive screening results

Specificity describes the ability of a test to correctly identify people who do not have the disease. A test with poor specificity will result in a high rate of false positive screening results – where people without the disease incorrectly test positive. A false positive screening result leads to a recommendation for further assessments due to an abnormal screening mammogram, without a subsequent breast cancer diagnosis. This is distinct from overdiagnosis.

Estimates of the frequency with which false positive screening results occur in population-based mammography screening programs vary, ranging from around 1–10%[76][77][78][79].

The risk of receiving a false positive screening result is highest on the initial screen, with the risk decreasing for subsequent individual screens[77][76][76][79]. However, there is a cumulative effect; the more mammograms a woman has over time, the higher the risk of a false positive result. The cumulative false positive risk over 10 sequential mammograms for women who start screening at age 50–51 has been estimated to be approximately 20%[80], with higher estimates coming from the US[81].

A range of factors can affect the specificity of screening and hence the frequency of false positive results[80]. Previous benign breast disease, pre- and perimenopausal status, higher body mass index and use of HRT are associated with increased risk of false positive results[12][79][80][82][83].

False positive results are most common in women aged 40–49 and least common in women aged 50–69[11][12]. The positive predictive value (the proportion of positive test results that are true positives) of screening mammography is much lower in women younger than 50[84][85].

The risk of a false positive result is disproportionately borne by women who undergo intermittent screening[86][87].

Other factors associated with increased false positive results are use of film-based mammography compared with digital mammography[88], double reading of scans[12][80] and fewer years of experience of interpreting radiologist[78]. The risk of false positive result is lowest with a screening interval of 21–27 months[83].

Impact of false positives on screening intentions

Receiving a false positive mammogram result has been reported to be associated with greater anxiety and distress about breast cancer, more frequent breast self-examinations, and higher perceived effectiveness of screening mammography[89][90]. While breast cancer-specific outcomes are affected, little impact on generalised psychological outcomes has been reported[89]. One study of 454 women with abnormal findings in screening mammography found that the psychological distress of a false positive result could last for at least three years after over-diagnosis[91].

The impact of false positive mammography results on screening behaviour in women is uncertain[90]. Australian evidence suggests that women receiving a false positive mammography result are less likely to attend rescreening[92]. While similar results have been reported by Spanish, French and Canadian screening programs[90][93][94][95], a reverse finding has been reported in Irish and US-based studies[90][96], where as other European studies have reported no impact of false positive results on screening behaviour[77][90].

Radiation exposure

While mammograms only require very small doses of radiation, the risk of radiation-induced cancer due to screening is cumulative with each mammogram performed. Radiation has been identified as a concern by women participating in screening, however evidence suggests that the level of harm due to radiation from screening is very low in the age groups eligible for population-based screening in Australia[3].

The BreastScreen Australia Evaluation concluded that the benefit of screening mammography exceeds the radiation risk for women from the age of 40 years[97][14]. The radiation dose from annual mammography for women aged 40–80 years had been estimated to lead to a lifetime attributable risk of fatal breast cancer of 20–25 cases per 100,000 women screened[97]. (Note that the estimate from the Hendrick study is based on 40 episodes of mammographic screening. BreastScreen Australia suggests 12 episodes only, so the corresponding estimate of fatal cancers per 100,000 would be expected to be lower.)

Younger women are more susceptible to the risk associated with radiation exposure: lifetime risk is considerably greater for women exposed from 40 years of age, compared with those exposed from 80 years[97]. An analysis of women participating in the UK NHS breast screening program concluded that the benefit safely exceeds the risk of possible cancer due to radiation exposure, but that caution is required for women screened under the age of 50[98].

Women at higher risk of breast cancer, such as those with BRCA1 and BRCA2 gene mutations are more susceptible to radiation-induced cancer, but this risk is still small compared with the benefits obtained by screening in this group[98][99]. Annual screening among these women results in a net benefit from the age of 35 years[99].

Balancing benefits and harms

The BreastScreen Australia Evaluation concluded that participation in the screening program provides significant benefits to women, despite the associated risks[3]. Since the release of the BreastScreen Australia Evaluation report however, there has been much discussion in Australia as to whether the benefits of population-screening for breast cancer outweigh the harms.

Having analysed the evidence, the USPSTF recommends mammography screening be offered or provided as a service to women aged 50 to 74. The USPSTF framework that grades specific public health services according to likely benefit weighed against risk on a population basis found that there is "high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial"[8].

The 2012 Independent UK Panel on Breast Cancer Screening international review of the benefits and harms of breast cancer screening estimated that, for 10,000 women invited to screen from age 50 over 20 years, 681 cancers (invasive and DCIS) would be diagnosed, of which 129 will represent overdiagnosis (using the 19% estimate of overdiagnosis) and 43 deaths from breast cancer will be prevented[42].

A Cochrane review of international evidence from RCTs reported that it was not clear whether screening does more good than harm[31]. The review found that for every 2000 women invited to screening in a 10 year period, one would have her life prolonged and 10 would have cancers diagnosed and treated unnecessarily. Furthermore, over 200 women would experience psychological distress due to false positive screening results[31].

The Euroscreen study estimates suggested that for every 1000 women screened biennially from age 50 to 69 years, about 7–9 lives may be saved and four cases may be over-diagnosed[100].

Informed choice

Analysis of screening literature in a number of countries found that the information provided to women participating in BreastScreen Australia addressed the potential benefits and harms of screening relatively well, covering the potential benefits and risks associated with screening[101]. The BreastScreen Australia Evaluation reported that Australian women participating in mammography screening generally feel well informed, with the exception of Aboriginal and Torres Strait Islander women, and women from non-English speaking backgrounds[3]. Despite this, many women regularly attending the program could not identify any potential harms associated with screening[102].

Internationally, there has been a reported lack of information on the potential harms of screening presented in the material provided to women participating in screening[103][104] and a failure of health care professionals to discuss the potential harms associated with breast cancer screening[105].

There is some evidence that women's decision-making is not based on the information provided[106][107]. A Swedish study found that the desire for information about screening varied widely[108]. The study found that 14% of women wanted detailed information, 36% wanted general information and 39% were not interested in detailed information on the limits and adverse consequences of screening[108].

There is evidence that providing decision aids to women not in the target age group for BreastScreen Australia improves knowledge and helps women to make an informed choice, without affecting screening participation[109][110]. These studies were conducted in women aged 38-45 and 70 years of age, who were not in the target age group for BreastScreen Australia at the time of the study, but were approaching or at an age where they were able to access the program.



Cost-effectiveness of mammography

Mammography screening in Australia through BreastScreen Australia is considered to be cost-effective[3]. Generally, the cost-effectiveness of screening is less favourable for women aged 40–49 years and women aged 70 years and over, compared with women aged 50–69 years[111].

Biennial screening of 50–69 year old women, using film-based mammography has an estimated cost-effectiveness of $38,302/LYG over a period of 20 years[111]. Evidence of the cost-effectiveness of digital mammography screening compared with film mammography screening in Australia is limited. However, digital mammography was estimated to have a cost-effectiveness estimate of $40,650/LYG (when used with the current screening policy)[111][112].

Cost-effectiveness of population-based screening with mammography is highly dependent on screening policies: increasing the frequency to annual screening results in a cost-effectiveness of $55,411/LYG; decreasing to triennial screening results in a cost-effectiveness of $30,602/LYG[111]. Likewise, varying the target age group has a strong impact on cost-effectiveness[111]. Increasing program participation improves cost-effectiveness[111].

Comparisons of cost-effectiveness are not possible between countries, due to differences in healthcare systems, breast cancer incidence and prevalence, screening programs, treatment patterns, and healthcare costs[111].

The overall cost of implementing BreastScreen Australia was $124 million in 2008, with the cost projected to increase to $147 million by 2017, due to increasing population size[111].

For further information on cost modelling, see the BreastScreen Australia Evaluation Economic Evaluation and Modelling Study.



Other breast screening tools

Clinical breast examination

There is no evidence that population-based screening with clinical breast examination is effective in reducing breast cancer mortality. The USPSTF states that current evidence is insufficient to assess any additional benefits or harms due to clinical breast examination, beyond screening mammography in women above 40 years of age[8]. A 2003 Cochrane review found no evidence to support clinical breast examination for early detection of breast cancers[113].

Cancer Australia does not make a firm recommendation on clinical breast examination, due to lack of evidence. It is noted that clinical breast examination does not offer additional benefit to mammography screening[5].

Clinical breast examination is however recommended as a diagnostic tool for women with breast symptoms as part of the triple test, which includes: clinical breast examination and personal history; imaging tests (mammogram, ultrasound and/or magnetic resonance imaging); and a biopsy to remove cells or tissue for examination[114].

Breast self-examination

Breast awareness is important as a large percentage of breast cancers are not detected through population-based screening. The BreastScreen Australia Evaluation found that, in the target age group of women aged 50–69, 17.1% of breast cancer cases were interval cancers (detected in women participating in screening, between screening rounds), and 37.1% were cancers detected in women not participating in screening[3].

In 2003, a Cochrane review of breast self-examination found no evidence to recommend it as a screening tool for the early detection of breast cancer[113]. The study found that self-examination had no impact on breast cancer mortality, compared with no intervention, but did lead to increased harm due to the detection of benign lesions and their biopsy[113].

The position of Cancer Australia is that, while evidence suggests that women can detect changes due to early breast cancer through breast awareness, there is no evidence to promote the use of any one self-examination technique over another[5].

The USPSTF recommends against clinicians teaching women how to perform breast self-examination[8].

Magnetic resonance imaging screening in high-risk women

While magnetic resonance imaging (MRI) is not recommended for population-based screening for breast cancer, there is evidence to suggest it is a useful tool in high-risk groups. Studies have suggested that for carriers of BRCA1 and BRCA2 gene mutations, MRI is an effective screening tool, either alone or in combination with mammography[115][116][117][118]. Annual surveillance with MRI is associated with a significant reduction in the incidence of advanced-stage breast cancer in BRCA1 and BRCA2 carriers[119].

However, MRI screening is also associated with an increased number of false positive test results compared with mammography[115][116][118]. MRI screening is more sensitive than mammography screening (77% compared with 40%), but also less specific (87% compared with 94%), when used for screening women at high risk of breast cancer[120].

A 2007 report from the Medical Services Advisory Committee concluded that breast MRI combined with mammography is safe and effective in the diagnosis of breast cancer in asymptomatic women at high risk, when used as part of an organised surveillance program and recommended its funding[121]. From 2009, screening MRI has been available through Medicare for women under 50 years who are at high risk, but with no signs or symptoms of breast cancer.

Cost-effectiveness of MRI

Significant time, staff and equipment are required to run an effective breast MRI screening program in Australia[122]. However, MRI may potentially be cost-effective for screening very high-risk women in the Australian setting[121][122][123], specifically for women with BRCA1 mutations aged 35–54 years[121]. For women in other high-risk groups such as BRCA2 carriers, or women with a wider risk or age distribution, MRI is unlikely to be cost-effective as a screening tool[121].

Screening programs involving MRI are more cost-effective for high-risk women than for women at population risk[124]. International studies have found that for high-risk women, combined MRI and mammography screening is effective and cost-effective[116][125][126]. Screening strategies incorporating MRI for women at high risk of breast cancer are more cost-effective for BRCA1 carriers (with estimates of $55,420 to $74,200 per QALY) than BRCA2 carriers (at $130,695 to $215,700 per QALY)[116][126]. Downstream savings in treatment and mortality costs are outweighed by increases in up-front screening and diagnosis costs[116].

Thermography

Breast thermography, also known as thermal imaging, is a technique that produces infrared images of the breast, showing patterns of heat and blood flow. The rationale for using thermography as a screening tool for breast cancer is that the skin overlying a malignant cancer can be warmer than that of the surrounding area.

The National Advisory Committee to BreastScreen Australia does not recommend the use of thermography for the early detection of breast cancer, based on the lack of evidence[127]. Likewise, in their 2012 statement, the National Health and Medical Research Council found there was no evidence of sufficient quality to support thermography for effective early detection or screening for breast cancer[128]. This position is consistent with the statements from Cancer Australia[129] and the Royal Australian and New Zealand College of Radiologists[130].

Currently, thermography is available to Australian women on a ‘user-pays’ basis. As regulatory control by the Therapeutic Goods Administration is not required for thermography, there is concern for the impact of direct marketing of thermography as a breast cancer screening tool to consumers[3].


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