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Over-diagnosis from mammography screening

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Created: January 2008
Revised and updated: September 2010

This position statement has been endorsed by Cancer Council Australia, Cancer Institute NSW, Clinical Oncological Society of Australia and the Screening Subcommittee of the Department of Health and Ageing.

“Over-diagnosis” from screening refers to a diagnosis of cancer that would not have otherwise been diagnosed during the woman’s lifetime. Because the future cannot be predicted with any certainty, it is not possible to determine to which women this might apply. The term does not signify error or misdiagnosis.

National Breast and Ovarian Cancer Centre* first released a position statement on over-diagnosis from mammography screening in 2008. The present statement is an update following a review of scientific literature published to March 2010.

Mammography screening has been shown in field trials to reduce death rates from female breast cancer.1-12 The reduction was estimated by an Expert Group of the International Agency for Research on Cancer (IARC) to approximate 35% in 50-69 year old women who participate in regular screening.12 Some researchers have estimated lower and others higher reductions than the IARC figure.12-14

Evaluation of mammography screening services introduced in many countries following the screening trials has indicated mortality reductions generally of a similar magnitude to the figure from IARC for field trials.12, 15-27 Three evaluation studies were undertaken in Australia, covering New South Wales, South Australia, and all of Australia, respectively, providing internally consistent results that were broadly consistent with the trial data.25-27

Mortality reductions from mammography screening are associated with downsides, in that women can experience anxiety when screened, and some have further investigations of screen-detected abnormalities that are not found to be cancer. 12, 28 Another consequence would be over-diagnosis, if there were diagnosis of a cancer that would never have been found during the lifetime of the woman, had there not been a screening test.12, 28

Breast screening is designed to bring forward the date of diagnosis of breast cancers to improve prospects for reducing mortality. As defined, “over-diagnosis” includes all instances where women with screen-detected cancers are destined to die earlier of other causes before their breast cancers would have arisen in the absence of screening.12 Extreme examples include women with screen-detected cancers who die prematurely from road accidents or other acute causes, or who are at risk of early death from heart disease or other chronic diseases. In addition, there would be screen-detected cancers that would not progress for many years because of their biology.12, 28-33 Further, there are suggestions that a number of cancers might regress without treatment, although this would generally be regarded as an unlikely event.31, 33-35

It is not possible with present methods to distinguish at an individual person level a sub-set of cancers that would not progress to a symptomatic stage within a woman’s lifetime, if left untreated.12 The presence of over-diagnosis is assessed by statistical inference in groups of women. Moreover, statistical inferences can vary substantially, depending on underlying statistical assumptions and choices of research design, all of which carry a measure of uncertainty.12, 14

Researchers have interpreted data from the original mammography screening trials differently,36-43 producing estimates of over-diagnosis ranging widely from zero to around 25% of diagnoses.13, 14, 32, 43-53 Estimates of over-diagnosis also come from studies undertaken outside trial settings and from simulation studies.14, 44, 45, 46, 47, 52, 54-79 Estimates from these sources also vary widely, depending on methodology and research assumptions, from around zero to as high as one in three lesions.75, 78

There are many reasons for the wide variation in estimates, including whether ductal carcinoma in situ is included with invasive breast cancer in the study; whether results apply to populations offered breast screening or only individual women invited to breast screening, screening participants, regular screening participants or just screen-detected lesions; whether adjustments are made for differences in breast-cancer risk factors between screened and unscreened women and what estimates are used when making these adjustments; the duration for which women are followed after screening cessation; the estimates used for lead-time effects (i.e., the time diagnosis was brought forward through screening); whether account is taken of non-diagnostic mammography outside the screening program and how this is done; the age range of women screened; the screening protocols and the policies for recall for assessment of women with screen-detected abnormalities in the relevant screening services; and death rates from other diseases and hence variations in life expectancy at time of screening.32, 46, 47, 59, 80, 81 Different mathematical and statistical assumptions are another source of variation.

While a range of 5% to 13% of all breast carcinomas (i.e., invasive plus DCIS lesions) was cited as a plausible estimate of level of over-diagnosis in the first position statement of National Breast and Ovarian Cancer Centre*, publications since then have presented widely varying estimates, some at zero or near zero levels of over-diagnosis and others indicating levels of up to 30% or more.75, 78

Differences in study design, methodology and assumptions bring different strengths and weaknesses, are open to debate, and the resulting over-diagnosis estimates can be sensitive to these differences. As indicated in a review for the US Preventive Task Force, the results of the many studies are too variable and methodologies too different to pool them to obtain a summary estimate.52

An international effort is needed to gain consensus on the most appropriate methodologies and research assumptions, such that estimates of over-diagnosis can be developed that have less uncertainty. In the meantime, it is reasonable to conclude from the collective evidence that the great majority of breast cancers found in well-organised screening programs would be progressive. The detection of progressive cancers at screening is considered to be a principal reason for the comparatively low incidence of symptomatic breast cancers presenting between screens.82, 83

This leaves a sub-set of lesions that might be left, or be treated more conservatively, if they could be identified with enough certainty. While it may not be possible to identify women destined to die prematurely before their breast cancers become symptomatic, it may be possible to identify a sub-set of cancers that are likely to be non-progressive, or to progress very slowly. Research is underway, including molecular and genetic research, to find means of identifying this sub-set of cancers with enough certainty to manage them using more conservative treatment methods.84-95 In addition, research is needed to better identify women at risk, to more effectively stratify and customise screening and surveillance.

Summary statement

Mammography screening significantly reduces death rates from breast cancer by enabling earlier and more effective treatment.

Most breast cancers found through screening are progressive and would become symptomatic within the women’s lifetime if left untreated. It is likely, however, that there is a sub-set that would be non-progressive or progress so slowly that they would not otherwise be found in a woman’s lifetime.

Estimates of the size of this sub-set vary widely and are dependent on study design and research assumptions. While a range of 5% to 13% of all breast carcinomas was cited in the first position statement of the National Breast and Ovarian Cancer Centre* as a plausible estimate of levels of over-diagnosis, publications since then have provided such widely varying estimates that a summary pooled estimate cannot be derived with any confidence.

Research is underway, including molecular and genetic research, to find means of identifying cancers at minimal risk of progression.

References

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Created: January 2008
Updated: September 2010

This Position Statement is a statement based on the literature and is not intended to be a decision-making aid for women considering screening.

 

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