Screening

Breast Cancer Early Detection Policy

Mammography

Mammography refers to x-ray examination of the breast, which uses very small doses of radiation (about 0.7 mSv for four x-rays)⁽¹⁾ to detect abnormalities in the breast tissue. The aim of mammography screening is to reduce breast cancer mortality and morbidity by finding breast cancer early, while it is still small and confined to the breast.

Benefits and risks of breast cancer screening

Screening is effective at detecting breast cancer early. Breast cancers detected by BreastScreen Australia are more likely to be small (≤15mm in diameter) compared to breast cancers detected outside the program (59% versus 28%).⁽²⁾ Breast cancers which were detected through the BreastScreen Australia program were found to have a 54-63% lower likelihood of causing death, as compared to breast cancers diagnosed in women who had never participated in BreastScreen Australia.⁽²⁾

These differences in mortality rates will be partly due to deaths prevented through earlier treatment of screen-detected breast cancers, and partly due to the screen-detection of breast cancers that would not have become symptomatic (overdiagnosis). However, the International Agency for Research on Cancer (IARC) has confirmed that breast cancer screening has a net effect of significantly reducing mortality,⁽³⁾ and this has been supported in multiple Australian studies, and in a comprehensive review of the BreastScreen Australia program.^(4-7)

Additional benefits of early detection, particularly prior to the onset of symptoms, include reduced treatment intensity⁽⁸⁾ and the treatment of pre-invasive breast disease (i.e. Ductal Carcinoma In Situ (DCIS)).

Mammography screening can also cause harm in several ways. The main harms are related to overdiagnosis and radiation exposure. Estimates for overdiagnosis have indicated that for every 1,000 women who are screened biennially between 50 and 74 years, an estimated eight breast cancers may be identified and treated that would not have otherwise required treatment in a woman’s lifetime.^{(9, 10)} Further cohort studies have also confirmed these findings.^(11-14)

As is inherent to health screening programs (and to diagnostic services), breast cancer screening tests are not perfect and this can lead to false negative and false positive screening results. For breast cancer screening, false negative results are breast cancers that were present but missed at the time of screening. These may then arise as interval cancers (cancers arising between scheduled screens), although interval cancers comprise a mix of missed and new cancers. False positive breast screening results involve referral of screened women to BreastScreen assessment services for further investigation, with a final result of a benign outcome.

Rates of false negative outcomes can potentially be reduced through improved sensitivity of the screening test, but this is also likely to increase overdiagnosis. The sensitivity of mammography through BreastScreen Australia differs by time since screen (0-12 months and 0-24 months), and increases with age.⁽¹⁵⁾ Program sensitivity is reported by 10-year age groups and aggregated over a 3-year period.⁽¹⁵⁾ Program sensitivity (the proportion of cancers diagnosed by screening rather than as interval cancers) differs by screening round, being highest at the first screening round due to the screen-detection of slow-growing breast cancers prior to commencing screening; subsequent round screening tends to find newer, faster-growing cancers.⁽¹⁵⁾ Higher breast density (fibro-glandular breast tissue) is also associated with markedly lower sensitivity of breast imaging, including mammography.^{(16, 17)} Breast density is determined by a combination of genetics and lifestyle factors, and it decreases with age.^{(18, 19)} Breast density is also a risk factor for breast cancer.⁽²⁰⁾

BreastScreen Australia program specificity (the proportion of recalled screens that lead to a breast cancer diagnosis) has been demonstrated to be highest on the initial screen (10%), with a decrease for subsequent-round screens (3%).⁽²¹⁾ There is a cumulative effect demonstrated, with the more mammograms a woman has over time, the higher the risk of experiencing a false positive result.^{(22, 23)} Women with false positive results can experience increased breast-cancer worry and decreased mental functioning and vitality,⁽²⁴⁾ which can last for at least three years following a false positive result.⁽²⁵⁾ However, the impact on rescreening rates appears to be marginal, with 67.6% of women with a false-positive screen rescreening within 27 months (67.6%), compared to 70.7% for women with a negative screen (risk ratio, 0.96; P < 0.001).⁽²⁴⁾

While the risk of radiation-induced breast cancer increases with each mammogram performed, the level of harm is considered low among Australian women aged 50-74 years.⁽²⁶⁾ The number of deaths associated with radiation-induced cancer from digital mammography screening is estimated to range from two to 11 per 100,000 women, depending on age and screening intervals.⁽²⁴⁾

Introduction to risk-based screening

Currently, population-based screening programs for breast cancer are directed at asymptomatic women, who are considered to be at average risk, and are between 50-74 years old. Generally, these women do not have 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.

The purpose of population-based screening is to identify asymptomatic women with mammographic abnormalities that are indicative of possible breast cancer for follow-up investigation. The BreastScreen program also provides this follow-up investigation by providing further assessment of women with suspected abnormalities in screening mammograms. Further information can be found on the principles of screening page.

A risk-based approach to breast cancer screening has the potential to reduce the impact of breast cancer in Australia through a more personalised approach to population screening, to ensure that it is as effective as possible for different groups of women based on various risk factors.⁽²⁷⁾ Critical to the consideration of risk-based screening, any changes to the BreastScreen program must maintain the integrity of population screening, as it is defined in the national framework.⁽²⁷⁾

There are many risk factors which could be considered when identifying higher-risk groups for targeted screening, including high breast density, information from genetic tests, hormonal and reproductive histories, alcohol use, and overweight or obesity.⁽²⁸⁾Potential imaging tests that could be offered to these higher-risk groups include supplemental ultrasound, 3D mammography (digital breast tomosynthesis), and imaging involving contrast e.g., MRI tests and contrast-enhanced mammography.⁽²⁸⁾ Screening schedules and targeted screening entry age could also be tailored according to risk.

ROSA Project

The ROSA project findings indicated risk-based breast cancer screening could save lives, and would help future-proof the BreastScreen Australia program.⁽²⁹⁾ The project also indicated that there are multiple risk factors (in addition to age) which increase breast cancer risk, however, the evidence on how to best identify and screen these higher-risk groups remains in development.⁽²⁸⁾ It is also clear that there is widespread activity in cancer detection and referral which takes place both within and outside the BreastScreen Australia program, and there are a range of professionals involved in the early detection process, yet limited coordination takes place between disciplines.⁽²⁸⁾ Whilst there is some ad hoc tailoring of services both within and outside the program, based on individual risk, data on the evidence of improved outcomes is limited and varied.⁽²⁸⁾

The ROSA Roadmap 2023-2027

In 2019, the ROSA project delivered its first Roadmap, which identified priority activities to help consider the best approach to risk-based breast cancer screening in Australia.

The ROSA Roadmap incorporates complementary activities that align with the ROSA recommendations. Together, these activities will support the trialling of risk-based breast screening and help prepare health services and the population for routine risk-based screening.⁽²⁷⁾

The ROSA Roadmap includes a staged trial program to enable a full-scale trial of risk-based breast screening, to provide a rigorous, independent and accountable framework to develop, test and evaluate considerations in the Australian environment. This includes considerations such as routine risk assessment and advice staff training programs, costs, and communication tools.⁽²⁷⁾ The staged trial program is recommended to commence with smaller trials and pilot studies in various BreastScreen sites, to help ensure that a large-scale trial is safe and effective.⁽²⁷⁾

The ROSA Roadmap has five pillars, identified to help build momentum and provide a framework for implementation. The five pillars of the Roadmap are:

Current health services: Policy review, monitoring, data collection, linkage and analysis
Risk assessment: Evidence reviews, clinical studies, strategy development
Risk-based screening protocols: Evidence reviews, clinical studies, modelled evaluations
Implementation: Data analysis, evaluation of COVID-19 impacts, equitable service delivery, consumer studies and decision aids
Trial program: Design trial program in detail, co-ordinate clinical studies in other pillars, pilot and large-scale trial of risk-based breast screening

Key actions recommended in the five-year Roadmap include:

Revise policies and develop guidelines designed to adapt to evidence/technological changes and promote greater national consistency in the management of women with different levels of breast cancer risk, within and external to BreastScreen
Conduct new studies in Australian screening settings including careful evaluation of breast density and breast cancer risk assessment tools and trials to assess the targeted use of digital tomosynthesis, ultrasound, MRI, and contrast-enhanced mammography for risk-stratified women
Monitor international clinical trials and related evidence to adapt to Australian implementation studies and trials
Develop a national framework for data collection and linkages designed to inform and monitor potential long-term changes in screening policy and practice, including options for systematically screening women aged 40-49 years
Enhance reporting on outcomes for under-screened populations (e.g., Indigenous, rural/remote, culturally diverse, low income) to help ensure any policy changes do not widen gaps in screening outcomes by population group
Expand stakeholder engagement in promoting the recommendations, to ensure optimal stakeholder consultation underpins the Roadmap’s implementation.

Detailed information on the project recommendations can be found in the public summary document of the ROSA project, and on the ROSA webpage.

Alternative screening modalities

Breast self-examination

Breast awareness is important as it has been estimated that in 2020, only 46% of all breast cancer cases in women aged 50-74 were detected via the BreastScreen Australia Program.⁽²⁾ Breast awareness can assist people to understand what is normal for them and seek medical advice if they notice any changes. However, a Cochrane review found no evidence to recommend self-examination as a screening tool for breast cancer, and that it had no impact on breast cancer mortality, when compared with no intervention, but did lead to increased harm resulting from the detection of benign lesions and associated biopsies. ⁽³⁰⁾ These findings were consistent with that of the IARC Working Group.⁽³⁾

Clinical breast examination

Several randomised controlled trials (RCTs) of screening at a population level using clinical breast examination compared to no screening found that breast cancers detected at baseline tended to be smaller in size and less advanced in stage in the group of women that had clinical breast examination.^(33-35) However, the IARC Working Group states that there is inadequate evidence that clinical breast examination reduces breast cancer mortality.⁽³⁾

While clinical breast examination does not offer additional benefit to mammography screening,⁽³¹⁾ it is recommended as a diagnostic tool for women with breast symptoms as part of the triple test. The triple test includes clinical breast examination and personal history; imaging tests (mammogram, ultrasound and/or MRI); and a biopsy to remove cells or tissue for examination.⁽³⁶⁾

Digital breast tomosynthesis

Digital breast tomosynthesis (DBT) enables pseudo-3D imaging of the breast, resulting in better discrimination of tissue structures and potentially improved visualisation of cancer.^{(37, 38)} DBT involves breast compression as done for mammography, with additional images captured through repeated, low-dose x-rays.

In 2018, a systematic review found that DBT alone or combined with digital mammography improved cancer detection rates compared with digital mammography alone across all risk groups.⁽³⁹⁾ Recall rates are lower for DBT combined with mammography,⁽⁴⁰⁾ and false positives higher in women with low breast density compared to women with high breast density.⁽⁴¹⁾ Higher specificity with DBT compared to mammography is reported for women with dense breasts in the first screening round, but not subsequent screening rounds.⁽⁴²⁾

Contrast enhanced mammography

Contrast enhanced mammography (CEM) refers to the addition of an intravenous contrast agent prior to a mammogram examination.^{(43, 44)} Contrast-enhanced mammography has been shown to offer higher sensitivity than standard mammography and can offer lower costs and greater accessibility than MRI.⁽⁴⁵⁾ CEM produces a slight increase in radiation when compared to standard mammography, which may be of clinical significance to young, high-risk patients (e.g. BRCA1 gene mutation carriers), and the potential for an allergic reaction to the contrast dye, which are typically infrequent and mild.⁽⁴⁵⁾

Magnetic resonance imaging

Magnetic resonance imaging (MRI) is used to detect breast cancer and other abnormalities in the breast by creating a two-dimensional image of the breasts through a strong magnetic field and radiofrequency pulses.⁽⁴⁶⁾

There is evidence that MRI is an effective screening tool, either alone or in combination with mammography, for women with a lifetime risk of breast cancer greater than 20-25%.^(47-51) This markedly higher-risk group includes women who are carriers of BRCA1 and BRCA2, and those with Li-Fraumeni, Cowden or Bannayan-Riley-Ruvalcaba syndromes.^(52-54) Incorporating MRI into breast screening is estimated to be more cost-effective for BRCA1 carriers ($55,420 to $74,200 per QALY) than BRCA2 carriers ($130,695 to $215,700 per QALY).^{(48, 55)} For asymptomatic women at high risk of breast cancer, MRI is recommended as a supplemental tool with mammography when used as part of an organised surveillance program, such as population breast cancer screening programs.^{(48, 55-57)}

Ultrasound

Ultrasound imaging of the breast is used to show differences in breast tissue characteristics. Ultrasound, whether automated whole breast ultrasound (ABUS) or hand-held, is effective in increasing breast cancer detection rates by 1.9%-4.2% depending on the population, as opposed to mammographic screening alone.⁽⁵⁸⁾

Evidence shows that ultrasound screening increases false positive investigations, which increases the costs of screening participation.⁽⁵⁹⁾ Further research is required before ultrasound can be included as a breast screening modality for asymptomatic women with dense breast tissues. This is one of the activities included in the ROSA Roadmap and will help to identify appropriate screening modalities for at-risk groups.

Thermography

Breast thermography, also known as thermal imaging, is a non-invasive technique that uses infrared images of the breast to measure the differences in temperature on or near the surface of the skin. 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.

Evidence to support the use of thermography in the early detection of breast cancer and reduction of mortality is insufficient and is not recommended.^{(51, 60-62)} There is concern for the impact of direct marketing of thermography as a breast cancer screening tool to consumers,⁽²⁶⁾ especially women who rely on this technique as they are at an increased risk of not being adequately diagnosed.⁽⁵¹⁾

Multi-cancer early detection tests

There is growing interest into the use of multi-cancer early detection (MCED) tests, in which a biological sample is taken from asymptomatic individuals and analysed for a range of tumour biomarkers known to indicate cancer.⁽⁶³⁾ The aim is to detect cancer at an earlier stage, before symptoms present, to allow for more treatment options and more effective treatments to be offered.⁽⁶⁴⁾ A large clinical trial is currently underway in England, investigating the implementation of MCED as part of a routine screening program (NHS-Galleri trial).⁽⁶⁵⁾ In a US study, one percent of participants who were part of a trial utilizing MCED tests as a part of cancer screening underwent PET-CT imaging based on false-positive blood tests, and 0.22% underwent a futile investigative diagnostic procedure.⁽⁶⁶⁾ More evidence is needed on the potential benefits and harms of emerging tests for cancer screening and early detection.

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