Аn urgent need to re-address the role of mammography in breast screening, BY DR ECCLESBlog

An Urgent Need to Re-address the Role of Mammography in Breast Screening: Earlier and Safer Detection is Required.

Breast Thermal Imaging Specialist

By Dr Nyjon K. Eccles BSc MBBS MRCP PhD

“Fresh doubts over breast cancer tests: Harvard finds routine screening fails to cut deaths”

This was the headline published by the Daily Mail newspaper (UK) just a few weeks ago. It refers to a study published in JAMA (Journal of American Medical Association). The authors concluded from their study of 16 million women that routine mammograms in women of a certain age is leading to significant numbers of ‘false positives’. The upshot of this being that it “leads to some women having unnecessary but gruelling chemotherapy” (Harding et al, 2015).

A recent study published in British Medical Journal (BMJ) — one of the largest and longest studies of mammography to date — involving 90,000 women followed for 25 years found that mammograms have absolutely NO impact on breast cancer mortality. (Miller et al, 2014). Add to this to this the Cochrane Collaboration review by Gøtzsche & Jørgensen in 2013 that also found no evidence that mammography screening has an effect on overall mortality, which, taken together, seriously calls into question whether mammography screening  really benefits women.

In April 2014 a Swiss Review Board published their conclusions of a one year review of mammographic screening after which they took the unprecedented decision to phase out screening mammography. This was an independent health technology assessment initiative. The team of experts on the board included a medical ethicist, a clinical epidemiologist, a pharmacologist, an oncologic surgeon, a nurse scientist, a lawyer, and a health economist. They concluded: The “evidence” simply did not back up the global consensus of other experts in the field suggesting that mammograms were safe and capable of saving lives.

The report caused an uproar among the Swiss medical community, but it echoes growing sentiments around the globe (based on published science as referred to above) that mammography for breast cancer screening in asymptomatic populations no longer makes sense.

The Swiss team drew 3 main conclusions from their review (This article was published on April 16, 2014, at NEJM.org).

Clinical Trials were out dated

They stated “Could the modest benefit of mammography screening in terms of breast-cancer mortality that was shown in trials initiated between 1963 and 1991 still be detected in a trial conducted today?” They referred to the more recent large BMJ study and the Cochrane review already referenced above.

The Benefits Did Not Clearly Outweigh the Harms

The experts noted they were “struck by how non-obvious it was that the benefits of mammography screening outweighed the harms.”

Women’s Perceptions of Mammography Benefits Do Not Match Reality

The authors state “It is easy to promote mammography screening if the majority of women believe that it prevents or reduces the risk of getting breast cancer and saves many lives through early detection of aggressive tumors. We would be in favor of mammography screening if these beliefs were valid. Unfortunately, they are not, and we believe that women need to be told so. From an ethical perspective, a public health program that does not clearly produce more benefits than harms is hard to justify. Providing clear, unbiased information, promoting appropriate care, and preventing over diagnosis and overtreatment would be a better choice.”

The BMJ published (BMJ 2014;348) a useful summary based on US statistics of the state of detection with Mammography (as below):

• For every breast-cancer death prevented in US women over a 10-year course of annual screening beginning at 50 years of age:
• 490 to 670 women are likely to have a false positive mammogram with repeat examination
• 70 to 100, an unnecessary biopsy
• Three to 14, an over-diagnosed breast cancer that would never have become clinically apparent

It is worth mentioning here the responsibility for Doctors to report the truth based on the weight of current evidence. The casualness with which the current mammography data is handled by some Doctors and then the Press is in my opinion is scandalous. We are continuing to mislead women into a false sense of security with the current screening program. It is already late in the day but not too late to change. The Swiss should be congratulated in taking a decision that should have been taken by all Medical fraternities years ago. The evidence has been there but we have chosen to turn a blind eye to it. What does the weight of evidence tell us? It tells us that Mammography does not save lives! The evidence also suggests that it does more harm than good. Therefore, it is not fit for the purpose that it was instituted for.  An independent award-winning* film “The Promise” (2014), brings together useful and insightful commentary from various experts on breast screening and in particular why we need to reconsider mammography as a screening tool.

Is Mammography Early Detection?

There are enough concerns over the safety and accuracy of Mammography as a screening tool but there is another serious discussion to be had in relation to its use as in Early Detection of Breast cancer.

It is generally accepted that Mammography, and for that matter MRI scanning of the breast, can not reliably detect tumours less than 1 cm in size. This fact alone should raise concerns over its use as an early detection method for the following reasons:

• It takes 10 years for a tumour to grow 1cm in size. This is based on the following information.
• It is estimated that there are approximately 1 billion cancer cells in a cubic inch of breast tissue.
• It takes approximately 120 days for cancer cells to replicate i.e. 3 divisions per year. (Beinfield & Beinfield, 1997).
• The number of blood vessels supplying a tumour is proportional to likelihood of metastasis of that tumour.
• It takes 5 years from a cell becoming malignant to the time it can metastasize (Folkman ,1994).

The net result of these cellular changes is that a cancer may have metastatic potential 5 years before it can be detected on conventional screening such as mammography or even MRI. Data derived from wide excision of tumours (4cm of breast tissue) thought to be a single mass on a mammogram shows that as many as two thirds of these detected cancers turn out to be multi-focal (i.e. there are other smaller deposits of cancer in the 4cm of tissue removed that were not seen on the mammogram) (Bleicher & Morrow. 2007). So, this leads us to the logically conclude that Mammography is NOT a method that detects tumours early enough. This is likely to be one of the reasons that the above more recent studies, referenced above, conclude that there is NO evidence that Mammography screening saves lives. It is detecting cancers 5 years too late! There is an urgent need for a method that detects breast cancers earlier and a method that can be more reliably used to screen younger women.

Thermography has a role

In a recent article in the Sunday Mail in the UK (published July 12^th 2015), Dr Wollaston MP called for the banning of Breast Thermography, whilst defending Mammographic screening. This makes absolutely no sense based on the existing scientific data when it is viewed in its entirety. As a responsible Physician, I have never argued that Thermography should replace Mammography but that the evidence supports that it has every right to have a place as an adjunctive tool in the earlier detection of developing breast cancers. I have lost count of the number of patients for whom the first sign of a developing breast cancer has been an abnormal thermogram and this has enabled a much earlier therapeutic intervention.

Thermography of the breast is not a new technology and even in early studies in the 1980’s with non-digital infrared cameras, there were some impressive results confirming its ability to detect early cancers. I reference some of these below. The technology is based on detection of heat coming from the breasts using digital infrared cameras sensitive to 0.03 degree temperature changes. The evolution of digital infrared has certainly added to the sensitivity of detection that is possible with these cameras. It is true to say that defined protocols are not always standardised across studies and this may be one of the reasons for some of the variable conclusions. Correct and standardised patient preparation, inclusion of dynamic autonomic cold challenge and computerised analytics of images have added greatly to the sensitivity and specificity of Breast Thermography.

A study published in 2014 in The International Journal of Surgery reported on Thermographic screening of 1008 subjects in India with thermography. Forty-nine female breasts had thermograms with temperature gradients exceeding 2.5 and were subjected to triple assessment. Forty-one of these which had ?T ? 3 were proven to be having cancer of breast and were offered suitable treatment. Eight thermograms had temperature gradients exceeding 2.5 but less than 3. Most of these were lactating mothers or had fibrocystic breast diseases. As a screening modality, Thermography showed sensitivity of 97.6%, specificity of 99.17%, positive predictive value 83.67% and negative predictive value 99.89%. The authors concluded that Thermography was a very useful tool for screening. Because it is non-contact, pain-free, radiation free and comparatively portable it can be used as a proactive technique for detection of breast carcinoma (Rassiwala et al, 2014)

A study published in The American Society of Breast Surgeons in 2008, concluded a high sensitivity and predictive value of Breast Thermography. The authors Thermally imaged 92 patients undergoing breast biopsy. Sixty of 94 biopsies were malignant and 34 benign. Thermography identified 58 of 60 malignancies. There was a 97% sensitivity, 44% specificity and 82% negative predictive value. The author’s conclusion – that Thermography was a valuable adjunct to mammography and ultrasound especially in women with dense breasts.

Because Thermography is detecting physiological change (heat created by increased cell metabolism and/or new blood vessel formation i.e. angiogenesis) that precede the establishment of a visible structural on a mammogram, ultrasound or MRI, it gives us an opportunity to detect a developing cancer sooner. I will cite two further studies here but refer the reader to a more detailed review of other Breast Thermography studies in another paper by this author- available on request).

Spitalier and associates (1982) screened 61,000 women using thermography over a 10-year period. Ninety one percent of non-palpable cancers were detected by thermography

The authors also noted “in patients having no clinical or radiographic suspicion of malignancy, a persistently abnormal breast thermogram represents the highest known risk factor for the future development of breast cancer”

Gros  & Gauthrie, (1980) studied 58,000 women screened with thermography, and then followed 1,527 patients with initially healthy breasts but abnormal thermograms for 12 years. Of this cohort, 40% developed malignancies within 5 years. The study concluded that “an abnormal thermogram is the single most important marker of high risk for the future development of breast cancer”

What do we conclude from these studies? Firstly, that they should not be ignored. Second, that Thermography is not a diagnostic tool i.e. an abnormal thermogram does not mean cancer. Third, that a serially abnormal thermal image identifies a woman who is at higher risk of developing cancer. Furthermore, the potential of this technology to be a screening tool is highlighted in the large study by Spitalier, cited above, in that 91% of non-palpable cancers i.e. tumours that could not be felt by hand or radiographically were reliably detected by Breast Thermography.  Other than the potential earlier detection of breast cancers, this technology has several other advantages that are worth mentioning:

• It is a comparatively cheap technology – a simple room that can be cooled can be used and cameras are relatively inexpensive
• It is an easily-portable technology
• Latest computerised analysis of images saves dramatically on Doctors time for interpretation and reporting
• It is completely non-invasive and does not use ionising radiation (cameras are detectors of infrared heat emitted from the breast tissue
• It can therefore be repeated as often as required without any fears of potential damaging effects to the patient
• Compression of the breasts is not required- so it is a completely painless procedure
• It can be used to examine young women’s breasts – it is not influenced by dense breast tissue (this contributes another early detection advantage; women can be scanned from a younger age than with mammography)

The author uses Breast Thermography in his practice and has done so for 10 years. It is used adjunctively as per the FDA approval in 1982. Women with abnormal Thermograms are referred for the age-appropriate structural scans (Ultrasound, MRI or mammograms) to exclude an existing measurable structural lesion. Future studies should use defined and approved protocols incorporating autonomic challenge and proper patient preparation and preferably computerised analysis of images to avoid interpretation variability. Computer-assisted Breast Thermography is now available and should be the method of choice in clinical research.

Lastly, it is naive to assume that women have not researched or are unaware of some of the information above and especially that relating to the unreliability of Mammography. These women are choosing NOT to have mammograms. Is it not better to offer these women who refuse mammograms some form of screening? Is it right for the Government to interfere and remove this choice from well-informed women? What about young women who have a family history of breast cancer, for whom mammography is not suitable and less sensitive due to their denser breast tissue? (In addition young breasts seem to be more sensitive to the damaging effects of ionising radiation). Should be not be offering these younger at risk-women something different. Breast MRI may be indicated for these young women, but is this structural scan early enough detection? Thermography could be used to screen these young women without the worry of damage of ionising radiation and to help identify which women are at risk and need closer monitoring.

What do we do when we identify women at risk who have an abnormal breast thermogram but a normal structural scan? This takes us to another topic, which is outside the objective of this article. However, this clinical scenario presents us with a golden opportunity to be pro-active over women’s breast health and not just to “watch and wait”. In the authors practice, in a high percentage of cases, correcting specific nutritional deficiencies has successfully returned abnormal thermal images to normal within 6 months. This illustrates another potential advantage of Thermography i.e. the opportunity to make sensible non-invasive interventions to lower risk of long-term breast health compromise.

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References  

Gøtzsche PC, Jørgensen KJ. Screening for breast cancer with mammography. Cochrane Database Syst Rev 2013;6:

Miller AB, Wall C, Baines CJ, Sun P, To T, Narod SA. Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial. BMJ 2014; 348:p366.

Beinfield H, Beinfield M. Revisiting accepted wisdom in the management of breast cancer. Alt Ther. September 1997;3(5):35-53. 5.

Folkman J. J. Angiogenesis and Breast cancer. Clinical Oncology. 1994; 12(3): 441-443

Bleicher RJ, Morrow M. MRI and breast cancer: role in detection, diagnosis, and staging. Oncology (Williston Park) 2007;21(12):1521-1528, 1530; discussion 1530, 1532-1523.

Spitalier, H., Giraud, D., et al: Does Infrared Thermography Truly Have a Role in Present-Day Breast Cancer Management? Biomedical Thermology, Alan R. Liss New York, NY. pp. 269-278, 1982

Gros, C., Gautherie, M.: Breast Thermography and Cancer Risk Prediction. Cancer 45:51-56, 1980

Rassiwala M,  Poonam P,  Mathur R,  Farid K,   Shukla S, Gupta PK, Jain B. Evaluation of digital infra–red thermal imaging as an adjunctive screening method for breast carcinoma: A pilot study. Int J Surgery, 2014, 12, 1439-1443

* “The Promise” (2014)- Award winning film. Best Science and Education Award at Film makers Festival London for World Cinema

 

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