Including the method of detection for breast cancer in the Surveillance, Epidemiology, and End Results database is long overdue.

Debates about breast cancer screening have continued in part because the Surveillance, Epidemiology, and End Results database, which began in 1974, has never included the method of detection so that it has been impossible to determine the role that early detection has played in the major decline in deaths from breast cancer that we have seen in the US since 1990. Method of detection should be added to the Surveillance, Epidemiology, and End Results database as soon as possible.

Breast cancer outcomes based on method of detection in community-based breast cancer registry.

PURPOSE: The impact of opportunistic screening mammography in the United States is difficult to quantify, partially due to lack of inclusion regarding method of detection (MOD) in national registries. This study sought to determine the feasibility of MOD collection in a multicenter community registry and to compare outcomes and characteristics of breast cancer based on MOD. METHODS: We conducted a retrospective study of breast cancer patients from a multicenter tumor registry in Missouri from January 2004 - December 2018. Registry data were extracted by certified tumor registrars and included MOD, clinicopathologic information, and treatment. MOD was assigned as screen-detected or clinically detected. Data were analyzed at the patient level. Chi-squared tests were used for categorical variable comparison and Mann-Whitney-U test was used for numerical variable comparison. RESULTS: 5351 women (median age, 63 years; interquartile range, 53-73 years) were included. Screen-detected cancers were smaller than clinically detected cancers (median size 12 mm vs. 25 mm; P < .001) and more likely node-negative (81% vs. 54%; P < .001), lower grade (P < .001), and lower stage (P < .001). Screen-detected cancers were more likely treated with lumpectomy vs. mastectomy (73% vs. 41%; P < .001) and less likely to require chemotherapy (24% vs. 52%; P < .001). Overall survival for patients with invasive breast cancer was higher for screen-detected cancers (89% vs. 74%, P < .0001). CONCLUSION: MOD can be routinely collected and linked to breast cancer outcomes through tumor registries, with demonstration of significant differences in outcome and characteristics of breast cancers based on MOD. Routine inclusion of MOD in US tumor registries would help quantify the impact of opportunistic screening mammography in the US.

Misinformation and Facts about Breast Cancer Screening.

Quality medical practice is based on science and evidence. For over a half-century, the efficacy of breast cancer screening has been challenged, particularly for women aged 40-49. As each false claim has been raised, it has been addressed and refuted based on science and evidence. Nevertheless, misinformation continues to be promoted, resulting in confusion for women and their physicians. Early detection has been proven to save lives for women aged 40-74 in randomized controlled trials of mammography screening. Observational studies, failure analyses, and incidence of death studies have provided evidence that there is a major benefit when screening is introduced to the general population. In large part due to screening, there has been an over 40% decline in deaths from breast cancer since 1990. Nevertheless, misinformation about screening continues to be promoted, adding to the confusion. Despite claims to the contrary, a careful reading of the guidelines issued by major groups such as the U.S. Preventive Services Task Force and the American College of Physicians shows that they all agree that most lives are saved by screening starting at the age of 40. There is no scientific support for using the age of 50 as a threshold for screening. All women should be provided with the facts and not false information about breast cancer screening so that they can make "informed decisions" for themselves about whether to participate.

The randomized trial of mammography screening that was not-A cautionary tale.

Two randomized trials were conducted in Canada in the 1980s to test the efficacy of breast cancer screening. Neither of the trials demonstrated benefit. Concerns were raised regarding serious errors in trial design and conduct. Here we describe the conditions that could allow subversion of randomization to occur and the inclusion of many symptomatic women in a screening trial. We examine anomalies in data where the balance would be expected between trial arms. "Open book" randomization and performance of clinical breast examination on all women before allocation to a trial arm allowed women with palpable findings to be mis-randomized into the mammography arm. Multiple indicators raising suspicion of subversion are present including a large excess in poor-prognosis cancers in the mammography trial arm at prevalence screen. Personnel described shifting of women from the control group into the mammography group. There is compelling evidence of subversion of randomization in Canadian National Breast Screening Study. Mis-randomization of even a few women with advanced breast cancer could markedly affect measured screening efficacy. The Canadian National Breast Screening Study trials should not influence breast screening policies.

Misinformation About Breast Cancer Screening and the Possible Unanticipated Importance of Detecting Ductal Carcinoma In Situ.

For decades there has been an unrelenting effort to limit access to breast cancer screening based on scientifically unsupportable arguments. As each argument has been raised against screening it has been refuted by science. These issues are summarized below. Within the larger debate have been legitimate concerns about the importance and treatment of a range of lesions classified as Ductal Carcinoma In Situ (DCIS). These are almost certainly precursor lesions to invasive breast cancer. What has been lost in the discussions is the fact that, in the U.S., the incidence of invasive breast cancer had been increasing steadily since 1940, at 1-1.3% per year. However, since the start of screening the incidence of invasive breast cancer is lower than the extrapolated expectation. It is likely that the removal of DCIS, due to mammographic screening, has resulted in fewer subsequent invasive cancers.

Design, implementation, and pitfalls of TMIST.

The early detection of breast cancer has been shown to reduce deaths through randomized, controlled trials. Numerous observational studies, failure analyses, and "incidence of death" studies have confirmed that screening reduces deaths in the general population. Digital Breast Tomosynthesis (DBT) which collects mammographic images from different angles and uses them to synthesize planes through the breast is simply another advance in mammography among others that have been made over the years. DBT "absolutely" detects more cancers at a time when cure is more likely while also having the advantage of reducing recall rates. The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) has been designed to compare DBT with 2-Dimensional Full Field Digital Mammography (FFDM), but it's major design issues may provide misleading results. Instead of using a reduction in deaths as the endpoint, benefit in TMIST is predicated on a reduction in advanced cancers in the DBT group. This is a questionable "endpoint" (a reduction in advanced cancers is not necessary as proof of benefit). In addition, the trial may be underpowered so that even if DBT shows a benefit it may not be able to achieve "statistical significance". The six CISNET models of the National Cancer Institute have shown that annual mammography beginning at the age of 40 will save the most lives. Yet TMIST will only include women ages 45 and over and will screen postmenopausal women every two years instead of annually. Consequently, TMIST results may be used, inappropriately, to limit access to breast cancer screening starting at the age of 45, and only offer biennial screening for post-menopausal women.

A history of DMIST and its implications - Limited resources should be better spent.

Randomized, Controlled Trials (RCT), the most rigorous tests of efficacy, had proven that mammography screening reduces deaths by early detection. This had been validated in studies that showed that screening in the community also resulted in fewer deaths. Film mammography (FM) had been replaced by Xeroradiography (XM) which had been replaced by Screen/Film Mammography (SFM) which was being replaced by Full Field Digital Mammography (FFDM). The FDA required FFDM to undergo a Premarket Approval (PMA) instead of the usual 510 K required for conversion for other x-ray studies to digital imaging. In addition, the FDA was going to require that even after a PMA, the FFDM systems were going to have to undergo a post approval RCT comparison to SFM. Experience and science were able to convince the FDA that a post-approval trial was not needed, and the requirement was dropped. Congress, however, had earmarked $25 million to support the trial that was no longer required. It appears that the Digital Mammographic Imaging Screening Trial (DMIST) was undertaken to take advantage of the earmarked money and was used to compare SFM to FFDM for cancer detection. The historical issues involved with DMIST provide an important background for the Tomosynthesis Mammographic Imaging Screening Trial (TMIST). Just as the monies for DMIST could have been better spent on an RCT of MRI for screening, the monies for TMIST could be better spent to improve our ability to detect more breast cancers at a time in their growth when cure may be possible.

Major failings of trial procedures and quality of screening fatally compromise the results of the Canadian National Breast Screening Studies.

Despite overwhelming evidence of a major reduction in deaths, the debate about the efficacy of breast cancer screening has continued for over 50 years. The poor results in the Canadian National Breast Screening Studies (CNBSS) have been used to challenge the benefits shown by the other randomized, controlled trials. They continue to be used in assessing the value of breast cancer screening despite their unblinded allocation process, which first identified women with breast abnormalities and then assigned them on open lists allowing for nonrandom assignment, compromising the trials and rendering their results unreliable. There were, statistically significantly, more women with advanced cancers who were assigned to the screening arm in CNBSS1. The early results for CNBSS1 showed an excess of women dying in the screening arm, and an (otherwise inexplicable) greater than 90%, 5-year survival for the control women. The failure of random assignment also explains why the clinically evident cancers were larger in the screening arms than the cancers in the "usual care" arms, despite the fact that the screened women underwent very intense clinical breast examinations each year by highly skilled examiners. The claim that balanced demographic factors prove random assignment is also false. Nonrandom allocation of a hundred or more women with clinically evident abnormalities would have no detectable influence on the distribution of demographic factors. In summary, policy decisions about mammography should not be influenced by the results of the CNBSS.

The wisdom trial is based on faulty reasoning and has major design and execution problems.

PURPOSE: To evaluate the design and plan of execution of the "WISDOM" trial. METHODS: The rationale and reasoning behind the WISDOM Trial were reviewed and analyzed. The published parameters of the trial were reviewed. RESULTS: The study is based on a failed understanding of the available data about breast cancer screening and is based on faulty assumptions, false reasoning, a scientifically unsupportable study design, ignoring advances in screening, a questionable endpoint, the likely lacking of power to answer the primary question, and support by insurance companies whose primary goal is almost certainly to reduce their costs. CONCLUSION: A major part of the premise is that there is a "debate" about the efficacy of screening. WISDOM ignores the fact that the "debate" has been manufactured and is not science-based. The results of the WISDOM Trial may be misleading.

Lifting the fog of confusion about breast cancer screening guidelines: Surprise - it's about the money!

Large amounts of misinformation denigrating the benefits of breast cancer screening have been published over the past 50 years and continue to be published. Each effort to reduce breast cancer screening has been refuted, scientifically, but the efforts continue. The motivation has been unclear until the recent guidelines issued by the American Society of Breast Surgeons who support annual screening starting at the age of 40 contrasted with the American College of Physicians who advocated delaying screening until the age of 50 and then biennially. An analysis of the facts can only lead to the conclusion that delayed screening has been chosen to save money rather than lives.

Antecedents: A Half-Century of Imaging the Breast.

The field of Breast Imaging evolved because a fairly small number of dedicated individuals realized the lifesaving potential of detecting breast cancer earlier. They persevered despite persistent efforts to curtail screening. From the first attempts to produce X-ray images of the breast to magnetic resonance and digital breast tomosynthesis, investigators have worked continuously to develop better ways to detect breast cancer at a time when cure is possible, while working continuously to preserve access for women to screening. Consequently, the death rate from breast cancer has declined by more than 40%. Therapy has improved, but therapy saves lives when breast cancers are treated early.