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.

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.

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.

The Canadian National Breast Screening Studies are compromised and their results are unreliable. They should not factor into decisions about breast cancer screening.

The Canadian National Breast Screening Studies were compromised by an unblinded allocation process and poor quality mammography. Contrary to the requirement that allocation in a randomized controlled trial (RCT) be blinded to avoid any possible intentional or unintentional subversion of a random allocation, all women in the CNBSS trials underwent a clinical breast examination prior to assignment to the study arm or the usual care arm. Women with abnormal clinical breast examinations were identified, and this information was available to the coordinators who then assigned the women on open lists. It was, therefore, possible to assign women to whichever arm the coordinator chose. Although subversion was likely unintended, a significant number of women with four or more positive axillary lymph nodes were assigned to the screening arm of CNBSS1. This explains why there were more breast cancer deaths among the screened women in the first ten years of the trial and why the 5 year survival of the control women was better than 90% when the background survival in Canada at the time was only 75%. The trials were further compromised by the poor quality of the mammography which was confirmed by a review conducted by the trials' organizers. These fundamental problems compromise the CNBSS and make their results, which are major outliers in the RCT's of breast cancer screening, unreliable. Consequently, they should not be used to establish guidelines for breast cancer screening.

An open letter to panels that are deciding guidelines for breast cancer screening.

Panels are presently reviewing breast cancer screening guidelines. It is critical that they understand which publications are scientifically valid, and which analyses are methodologically flawed and not valid. The scientific evidence clearly supports annual mammography screening beginning at the age of 40. The analyses that suggest that screening leads to overdiagnosis of invasive breast cancers are flawed and incorrect. There is little if any overdiagnosis of these cancers. The vast majority of breast cancers occur in women who are not at elevated risk so that excluding them from screening and only screening high risk women will deny the benefits of early detection to most women who develop breast cancer. Guidelines panels should not make decisions that exclude women from screening. Women should be provided with accurate information so that they can make informed decisions and have unimpeded access to screening if that is their preference.

Digital Breast Tomosynthesis: State of the Art.

This topical review on digital breast tomosynthesis (DBT) is provided with the intent of describing the state of the art in terms of technology, results from recent clinical studies, advanced applications, and ongoing efforts to develop multimodality imaging systems that include DBT. Particular emphasis is placed on clinical studies. The observations of increase in cancer detection rates, particularly for invasive cancers, and the reduction in false-positive rates with DBT in prospective trials indicate its benefit for breast cancer screening. Retrospective multireader multicase studies show either noninferiority or superiority of DBT compared with mammography. Methods to curtail radiation dose are of importance. (©) RSNA, 2015.

"Off Label" Use of FDA-Approved Devices and Digital Breast Tomosynthesis.

OBJECTIVE: The purpose of this article is to clarify for radiologists the meaning of U.S. Food and Drug Administration (FDA) approval with respect to Digital Breast Tomosynthesis (DBT). CONCLUSION: DBT is a major improvement over 2D mammography in the detection of cancers (sensitivity) and the reduction in recalls resulting from screening (specificity). Most imaging systems that have been approved by the FDA are used "off label" for breast imaging. Although the FDA determines which claims a manufacturer can make for a device, physicians may use approved devices, such as DBT, off label to provide better patient care.

The 20-year effort to reduce access to mammography screening: historical facts dispute a commentary in Cancer.

Mammography screening fulfills all requirements for an effective screening test. It detects many cancers earlier when they are at a smaller size and earlier stage, and it has been demonstrated that this reduces breast cancer deaths in randomized controlled trials. When screening is introduced into the population, the death rate from breast cancer declines. Nevertheless, scientifically unsupported arguments that appear in the medical literature are passed on to the public and continue to confuse women and physicians regarding the value of screening. Methodologically flawed challenges to mammography have been almost continuous since the 1990s. And, as each challenge has been invalidated, a new, specious challenge has been raised. The authors of this report address the long history of misinformation that has developed in the effort to reduce access to screening, and they address the issues raised by commentators concerning their recent publication in this journal.

A failure analysis of invasive breast cancer: most deaths from disease occur in women not regularly screened.

BACKGROUND: Mortality reduction from mammographic screening is controversial. Individual randomized trials and meta-analyses demonstrate statistically significant mortality reductions in all age groups invited to screening. In women actually screened, mortality reductions are greater. Individual trials and meta-analyses show varying rates of mortality reduction, leading to questions about screening's value and whether treatment advances have diminished the importance of early detection. This study hypothesized that breast cancer deaths predominantly occurred in unscreened women. METHODS: Invasive breast cancers diagnosed between 1990 and 1999 were followed through 2007. Data included demographics, mammography use, surgical and pathology reports, and recurrence and death dates. Mammograms were categorized as screening or diagnostic based on absence or presence of breast signs or symptoms, and were substantiated by medical records. Breast cancer deaths were defined after documentation of prior distant metastases. Absence of recurrent cancer and lethal other diseases defined death from other causes. RESULTS: Invasive breast cancer failure analysis defined 7301 patients between 1990 and 1999, with 1705 documented deaths from breast cancer (n = 609) or other causes (n = 905). Among 609 confirmed breast cancer deaths, 29% were among women who had been screened (19% screen-detected and 10% interval cancers), whereas 71% were among unscreened women, including > 2 years since last mammogram (6%), or never screened (65%). Overall, 29% of cancer deaths were screened, whereas 71% were unscreened. Median age at diagnosis of fatal cancers was 49 years; in deaths not from breast cancer, median age at diagnosis was 72 years. CONCLUSIONS: Most deaths from breast cancer occur in unscreened women. To maximize mortality reduction and life-years gained, initiation of regular screening before age 50 years should be encouraged.

Digital breast tomosynthesis from concept to clinical care.

OBJECTIVE: The purpose of this article is to describe the development of digital breast tomosynthesis (DBT) and to describe its advantages over 2D mammography for breast cancer screening. CONCLUSION: Mammographic screening has dramatically reduced breast cancer deaths, but it does not depict all cancer early enough to result in a cure. In addition, because of the recall rates associated with mammography, efforts are underway to reduce access to screening. Use of DBT improves sensitivity and specificity, and there is no longer a need to obtain full-exposure 2D mammograms. DBT will replace standard 2D mammography for breast cancer screening.

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.

Development of wire localization for occult breast lesions: Boston remembrances.

In the 1970s, the four authors of this article each set up mammographic screening programs and independently developed preoperative needle-wire localization techniques at different Boston-area hospitals. These innovations, which facilitated surgical biopsy of nonpalpable abnormalities, helped establish and popularize mammography and have only minimally changed over the ensuing decades. This historical perspective shares personal anecdotes of the early development of mammography and mammographic wire localizations.