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3D mammography is on the upswing in the US, as experts argue about its value

BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l4506 (Published 17 July 2019) Cite this as: BMJ 2019;366:l4506

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Re: 3D mammography is on the upswing in the US, as experts argue about its value

TMIST IS A WASTE OF $100 MILLION!

The article about “3D Mammography” in the BMJ ([1]) contains important misunderstandings, but I am limited to 1000 words.

As its inventor ([2]), its name is “Digital Breast Tomosynthesis (DBT)”. “3D Mammography” (it is only quasi 3D) was coined to avoid my patent. The article implied that my comments were based on financial conflicts of interest. I have none. My patent has expired and I have no financial interest in the dissemination of DBT.

A 2D mammogram is like a book with clear pages. Hold it up to the light and you can see all the words, but they are superimposed and difficult to read. Cancers can be hidden on 2D mammograms by normal breast tissue. Like shadows on the wall, normal breast structures can also superimpose and create pseudo lesions. DBT allows us to “read each page” revealing cancers hidden by normal tissues on 2D mammography, while eliminating recalls for superimposed tissues.

The title is misleading. I know most of the “experts” in breast cancer screening. Few, if any, who use DBT for screening all women, “argue about its value”.

DBT is evolutionary. Xeroradiography replaced film mammography. Screen/Film mammography (SFM) replaced Xeroradiography. Full Field Digital Mammography (FFDM) replaced SFM. The study comparing FFDM and SFM (DMIST) involved fewer than 50,000 women ([3]) and showed little improvement in cancer detection. More than 7 times that number have participated in multiple studies of DBT ([4],[5],[6],[7],[8],[9],[10],[11]), consistently detecting more small invasive cancers than FFDM while reducing the number of recalls for additional evaluation.

Experts in breast cancer screening were prevented from serving on The U.S. Preventive Services Task Force (USPSTF) that gave DBT an “inconclusive” rating. No one on the USPSTF even provided care for women with breast cancer.

The claim that the evidence for DBT is “inconsistent” is false. When used for screening, DBT consistently finds more early cancers while reducing the recall rates compared to FFDM.

DBT does not increase the detection of DCIS. Dr. Baum disparaged finding "small invasive" cancers, yet this is when lives can be saved ([12]).

Storage is not a problem. Digital storage has exploded in capacity and plummeted in cost.

The claim that “traditional 2D units cost between $80,000 and $100,000” is based on obsolete S/F systems. Regardless, for every $100,000 that a system costs, if used fairly efficiently, this amounts to about $3 per patient.

Radiation risk to the breast falls rapidly with age with no direct data showing any risk for women ages 40 and over. The extrapolated risk is so small that it is outweighed by even the smallest benefit ([13]).

The death rate from breast cancer among women, unchanged for 50 years, has declined by more than 40% since 1990 ([14]) while it has not budged for men with breast cancer ([15]). Men are not screened.

The incidence of death from breast cancer is 40-60% lower among women who participate in screening compared to those who do not, despite everyone having access to modern therapy ([16]).

Early detection saves lives. TMIST is wasting $100 million to test a technology that is superior to FFDM. The money would be better spent on finding additional ways to detect more breast cancers at a time when cure is possible to further reduce deaths.

REFERENCES

[1] Lenzer J. 3D mammography is on the upswing in the US, as experts argue about its value. BMJ. 2019 Jul 17;366:l4506. doi: 10.1136/bmj

[2]. Kopans DB. Digital breast tomosynthesis from concept to clinical care. AJR Am J Roentgenol. 2014 Feb;202(2):299-308

[3] Pisano ED, Gatsonis C, Hendrick E, Yaffe M, Baum JK, Acharyya S, Conant EF, Fajardo LL, Bassett L, D'Orsi C, Jong R, Rebner M; Digital Mammographic Imaging Screening Trial (DMIST) Investigators Group. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med. 2005;353:1773-83.

[4] Skaane P, Gullien R, Bjørndal H et al. Digital breast tomosynthesis (DBT): initial

experience in a clinical setting. Acta Radiol. 2012 Jun 1;53(5):524-9.

[5] Skaane P, Bandos AI, Gullien R, et al. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology 2013; 267:47–56

[6] Ciatto S, Houssami N, Bernardi D, et al. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol 2013; 14:583–589

[7] Lång K, Andersson I, Rosso A, Tingberg A, Timberg P, Zackrisson S. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmö Breast Tomosynthesis Screening Trial, a population-based study. Eur Radiol. 2015 May 1. [Epub ahead of print] PubMed PMID: 25929946

[8] Haas BM, Kalra V, Geisel J, Raghu M, Durand M, Philpotts LE. Comparison of

tomosynthesis plus digital mammography and digital mammography alone for breast

cancer screening. Radiology. 2013 Dec;269(3):694-700

[9] Rose SL, Tidwell AL, Bujnoch LJ, Kushwaha AC, Nordmann AS, Sexton R Jr. Implementation of breast tomosynthesis in a routine screening practice: an observational study. AJR Am J Roentgenol. 2013 Jun;200(6):1401-8

[10] Friedewald SM, Rafferty EA, Rose SL, Durand MA, Plecha DM, Greenberg JS, Hayes MK, Copit DS, Carlson KL, Cink TM, Barke LD, Greer LN, Miller DP, Conant EF. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25;311(24):2499-507. doi: 10.1001/jama.2014.6095

[11] Sharpe RE Jr, Venkataraman S, Phillips J, Dialani V, Fein-Zachary VJ, Prakash S, Slanetz PJ, Mehta TS. Increased Cancer Detection Rate and Variations in the Recall Rate Resulting from Implementation of 3D Digital Breast Tomosynthesis into a Population-based Screening Program. Radiology. 2015 Oct 9:142036. [Epub ahead of print]

[12] Saadatmand S, Bretveld R, Siesling S, Tilanus-Linthorst MM. Influence of tumour stage at breast cancer detection on survival in modern times: population based study in 173,797 patients. BMJ. 2015 Oct 6;351:h4901. doi:10.1136/bmj.h4901. PubMed PMID: 26442924

[13] Mettler FA, Upton AC, Kelsey CA, Rosenberg RD, Linver MN. Benefits versus Risks from Mammography: A Critical Assessment. Cancer 1996;77:903-909.

[14] Hendrick RE, Baker JA, Helvie MA. Breast cancer deaths averted over 3 decades.

Cancer. 2019 May 1;125(9):1482-1488.

[15]. http://seer.cancer.gov/csr/1975_2010/results_merged/sect_04_breast.pdf Last accessed 7/27/2019 Table 4.6

[16] Tabár L, Dean PB, Chen TH, Yen AM, Chen SL, Fann JC, Chiu SY, Ku MM, Wu WY, Hsu CY, Chen YC, Beckmann K, Smith RA, Duffy SW. The incidence of fatal breast cancer measures the increased effectiveness of therapy in women participating in mammography screening. Cancer. 2019 Feb 15;125(4):515-523.

Competing interests: No competing interests

28 July 2019
Daniel B. Kopans
Professor or Radiology
Harvard Medical School
Boston, Massachusetts