Decision-aid Cochrane / Baum

This graphic is based on the Cochrane meta-analysis and M. Baum's study on the consequences of screening when treatment effects are considered.

Cochrane Data

The Cochrane Collaboration (currently the Cochrane Organization) is a non-profit organization composed of volunteer researchers from all over the world who are financially independent of the pharmaceutical industry.

This collaboration aims to systematically organize scientific information and medical research data based on properly conducted clinical trials. The scientifically validated data are summarized in an accessible way and published in the Cochrane library.

To assess the screening results and weigh the benefits and risks, researchers gathered data from all previous screening studies, which included 600,000 women – both screened and not screened. They combined the findings of all studies conducted since the 1970s to compare the benefits and harms of each situation. To make their results more concrete, they projected them onto two fictitious populations of 2 000 women in the form of a "dot chart."

Each dot represents a woman. Researchers from the Cochrane Collaboration indicate overdiagnosis (red dots), false alarms (blue dots), avoidable deaths (dark dots), and deaths (black dots) to provide a comparative picture of what happens when you have a screening versus when you don't.

Their calculations are summarized here. https://www.cochrane.org/CD001877/BREASTCA_screening-for-breast-cancer-with-mammography

English brochure is here: https://www.cochrane.dk/screening-breast-cancer-mammography

Study of Professor Michael Baum, BMJ 2013

We incorporated the results of M.Baum's study, published in the BMJ journal in 2013.

Michael Baum is an Emeritus Professor of Surgery, Division of Surgery and Interventional sciences, University College London, London WC1E 6BT, United Kingdom.

According to this researcher, when treatment-related deaths are included in the mortality count, the harms of breast cancer screening outweigh the benefits.

These deaths must be considered because the expected benefit of screening (the golden dot materializing the 'life saved') is outweighed by the death due to therapeutic complications (the green dot materializing the 'life shortened' by damage caused by surgery, radiotherapy, chemotherapy, and hormone therapy).

Quote from the last paragraph of the study:

"If each of those were translated into total lives saved from all causes then I would remain content but, unfortunately, when 10 000 are screened along the way about 120 to 140 cases will be overdiagnosed with the current age group invited. Four fifths of these women would receive radiotherapy and would be at an increased risk of dying of ischaemic heart disease and lung cancer. Knowing the background risks (box 2) and multiplying these by the factors 1.27 and 1.78 gives us increases of 2% for lung cancer and 1.33% for myocardial infarction. Adding that to all cause mortality rates I crudely estimate that an additional one to three deaths might be expected from other causes for every breast cancer death avoided."

THE POSTER, download

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.

Screening can only detect slow cancers

NOVEMBER 5, 2021 BY CANCER ROSE

Observation of our colleague, Dr. Granger, Senology Specialist, November 2021Cancer with high invasive potential, Mrs. NP

Cancer with high invasive potential, Mrs. NP

Mrs. NP, 53 years old, consulted following her last breast assessment, classified ACR 4 due to discovering an attenuating ultrasound lesion in the left breast. There would finally be nothing suspicious after a quick micro biopsy and MRI.

Mrs. NP, wonders, however, what "truth" is hidden behind this "ACR 4" that has suddenly become "non-suspicious" and what follow-up I can provide her.

Clinically, her breasts are soft and regular, with no discernible nodules. There was no discharge or adenopathy. The mammogram reveals dense fibrosis: if the images were considered "normal," they are very uninformative due to the opacity of the tissues, and we can only note the absence of calcifications. Ultrasound confirmed the presence of multiple disseminated hypoechoic areas. At the intersection of the left external quadrants, the most important one is effectively attenuating and evokes in priority an old cystic structure, rounded and finely echogenic. Puncture under ultrasound guidance with an 18 G needle allows evacuation of a pasty serosa perfectly translucent and homogeneous on the slide: a simple gel cyst.

Conclusion: a typical gel cyst (cytology of the smear will confirm). A one-year ultrasound examination is recommended.

Monitoring was uneventful for 4 years. Then a new check-up revealed the appearance of a hypoechogenic lacuna with irregular contours about 5 mm in diameter, of very doubtful appearance, in the right supra-internal part (i.e., contralateral to the initial cystic image): its puncture under the guidance, was poor, a slide was taken for cytological analysis. This puncture will be acellular, therefore not informative: further investigations are necessary.

The 3-month check-up by palpation revealed the presence of a slightly firmer and poorly bounded area, which had not previously been noted. The hypoechogenic lacuna was verticalized on some sections (a significant sign of malignancy), absorbing, measuring 3 to 6 mm depending on the section axis, and most likely mitotic.

Conclusion: the presence of a very suspicious ultrasound lesion in the right supra-internal region which needs to be excised after ultrasound localization. Because the lesion was so small, a micro biopsy was not performed to avoid diluting it for a proper definitive histological examination (instructions from my anatomo-pathologist).

The chosen surgeon will agree to proceed "the old way" based solely on my ultrasound imaging. Histological diagnosis: infiltrating lobular carcinoma with two foci of 2 and 4 mm, separated by less than 5 mm, moderately differentiated (SBR 2), and peri-nervous sheathing. The lymph node dissection involves the removal of two massively metastatic lymph nodes. Chemotherapy, radiotherapy, and hormone therapy will be used in the treatment.

The first nine years are a "remission" phase. After that, there was a significant increase in CA 15-3, from 28 (normal value for the laboratory) to 48 U/ml in one year. A PET scan revealed a single hypermetabolic lesion of the scapula. Biopsy confirmed the lesion's metastatic nature, which is consistent with its known breast origin. A focused EBRT was carried out (inclusion in the STEREO-OS trial).

After 3 months, monitoring PET scans will reveal the appearance of new iliac, costal, and clavicular hypermetabolic foci.

This observation, which is still ongoing, raises at least two particular points for Senology practice and Screening.

1 - The initial senological evaluation classified as ACR 4 immediately triggered micro biopsy and MRI: this heavy artillery, set off and organized by the radiologist himself, without any concertation, may have "reassured" him... but not the patient, who was left without a precise diagnosis of the anomaly.

One simple procedure was needed to clarify the problem: a puncture with a fine needle under ultrasound guidance.

This overlooked technique often provides the correct answer: a simple glance at the slide with a light spot is reassuring, revealing a thin, homogeneous, and translucent layer pathognomonic of an old gel cyst. As a reminder: a simple blue needle (6/10th of external diameter, i.e., 23G) is all that is needed; the procedure is painless, much less invasive than a micro-biopsy, and twice as less expensive in the nomenclature of medical procedures).

If this puncture is performed with an 18G needle, the cyst is usually completely evacuated, depending on the degree of cyst gelation. And this immediately reassures everyone, including the patient, even before the subsequent laboratory reading.

This point concludes that our response must be graduated to avoid turning a simple, functional detail - breast cysts being extremely common during the menopausal period - into a nightmare for the patient and ruin for the health insurance system.

2 - The discovery of an abnormality in the other breast four years later did not result in such a simple diagnosis. The clinical examination and mammography were normal, as they had been the last time, but the ultrasound was suspect. The puncture proved inconclusive, necessitating close monitoring.

I would like to point out that 3 months later, the clinical status had become clear, and the imaging was more obvious. The surgery done at the same time showed a very progressive cancer since it was bifocal from the start, although small, with two massively invaded lymph nodes and phenomena of nerve sheathing, with a poor prognosis. After a few asymptomatic years, a series of bone localizations appeared quickly after the first one, confirming an all-sided evolution. The remission was only apparent; the cancer was preparing to explode.

This observation illustrates a case of cancer with high invasive potential: these cancers are always one step ahead, and we just follow their galloping tracks. They constantly put us in failure, and it is indeed against this type of cancer that a screening, even very voluntarist, is ineffective.

Screening, like all screenings, can only detect slowly progressing cancers with a good spontaneous prognosis.



Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.

Why does INCa instrumentalize women’s fear of having breast cancer and dying from it?

November 5, 2021

By Dr. Alain Rauss, MD, Biostatistician, for the Cancer Rose collective

INCa and Cancer Rose have been at odds for years over the usefulness of breast cancer screening. Furthermore, Cancer Rose's criticism is directed at the INCa's failure to provide clear, objective, and neutral information to women, trapping them in a process initiated by the INCa based on successive cancer plans [1].
However, the question is not to favor or against screening but rather to allow each woman to make a personal decision based on her history and fears, rather than a decision guided by factors other than sanitary ones.
Finally, it appears that the issue is elsewhere. Why frighten people and use methods that are more akin to manipulation and propaganda?

Instrumentalization of fear

Today, if we look closely, we can see that INCa uses the fear of having breast cancer and dying to achieve its goals.

The fear of death has enabled us to live, save our lives, and arrive here. Despite all our societies' evolutions, we still have this fear in us. On the other hand, playing on fear is a shameful attitude because when fear is present, it becomes more difficult to use discernment, which is the problem. As previously stated, playing on people's fears is manipulation.

Awareness of all risks

There are numerous risks of dying throughout one's life, one of which is breast cancer. The INCa's hype of breast cancer causes at least a part of the population to lose sight of the fact that there are numerous other risks in life. This hype leads us to stop relativizing and consider that if screening is implemented, it will somehow make the woman "immortal."

The table below shows the total causes of death for men and women and changes between 2015 and 2016. Notably, of the 290,300 deaths observed in women in 2016, breast cancer is the 8th leading cause of death. Before the mortality from breast cancer, there were other causes, nervous system diseases, respiratory system diseases, cerebrovascular diseases, mental and behavioral disorders, external causes, and ischemic heart disease.

Thus, breast cancer mortality, although not negligible, represents only 4.27% of women's deaths. In contrast, the first 7 causes of death represent 48.5% of deaths (and we are not counting the other causes of death of the circulatory system that are not precisely individualized, representing 44,000 deaths per year, i.e., nearly 15% of deaths).

If women had to feel all their fears to the level that the INCa tries to bring out for breast cancer (as shown in the box in the latest INCa leaflet below), a woman's life would quickly become unbearable. With the risk of dying from another cause nearly 25 times higher, everyday life with this pressure on the risk of death would quickly become intolerable.

Taking advantage of a situation in which there is no consciousness of all the risks

We can see that INCa takes advantage of the fact that all other sources of risk of dying are absent from the media hype, leaving the field open for INCa on breast cancer and highlighting a fear that can stimulate irrationality in a woman's attitude toward breast cancer screening.

The INCA takes up 1 MONTH of the year in the media space for 4.2% of the deaths, with this month's "Pink October" being enormous. Imagine what life would be like if we had a particular month for one or another risk that kills more than breast cancer?

It is evident that if fields of cardiology, neurology, or pneumology put forward the risk of dying from cardiovascular disease, nervous system disease, or respiratory disease with tenfold means in light of the risks that may exist, the "noise" about breast cancer would be stifled.

However, on closer examination for these causes, which account for most deaths, prevention exists in many instances instead of screening. This means that it is possible to implement measures that will significantly reduce the risk, potentially saving hundreds of lives (as opposed to a battle over 1 or 2 fewer deaths over a 10-year follow-up in the case of breast cancer screening in 1000 women).

Thus, INCa takes advantage of a situation in France that could be described as monopolistic in terms of the fear of dying.

Reducing the fear of dying from breast cancer

All of this seems to indicate that it is critical to be aware of the numerous risks of death!

Women have multiple risks of dying in everyday life, not just from breast cancer, far from it. We accept risky behaviors that are responsible for many deaths, such as smoking and drinking. The rise and decline of cancer deaths follow those of smoking, with a few decades lag. Smoking increases the risk of many cancers, particularly lung cancer, which is by far the deadliest, accounting for more deaths than colon, breast, and prostate cancer combined. [2]

Is it reasonable to be afraid of dying from breast cancer and being manipulated but not be scared of dying due to our risky behaviors?

A return to common sense appears to be necessary to ease the stress that the INCa places on women, especially since it focuses on one single cancer.

The right to choose AFTER adequate information

Each woman must evaluate all the risks of death for her based on clear, reliable, complete, and honest information. Each woman must be able to determine which risks she is willing to accept and which she is not.

Her decision will then be in harmony with her history, her preferences, her environment... This choice is her own, and it should not be influenced by anyone, especially not by the medical profession or any other organization. This is what every woman should require from our health authorities:information and respect for her choices.

If there was only the fear of dying

In this screening propaganda, INCa is not only playing on the fear of death by cancer but also on the fear of developing breast cancer. The fear of losing her identity and her femininity is perhaps even more devastating for a woman. Without even thinking about death, the psychological consequences for this particular cancer are enormous. Many healthy women believe that by getting regular screenings, they will be able to avoid breast cancer.

Arguments such as "The earlier breast cancer is detected, the better the chances of recovery" or "I participate in organized breast cancer screening every two years. It has finally become a habit, and it reassures me and my family " are only there to instill the idea that by participating in screening regularly, healthy women will avoid damage to their bodies and of their identity as women. INCa lies to them exploits their naivety on the subject and especially their fear.

The appeal to fear is an influence technique used to increase screening participation, as detailed in an academic article outlining all the methods used to persuade women to undergo screening; we had discussed it[3] [4].

A culture of understanding risk

Living today without understanding the risk (as we have just seen with the INCa play without any notion of relativization) exposes the population to a climate of fear easily exploitable by unscrupulous people who want to achieve their goals.

 Because of this lack of explanation of what a risk is, these ultimately ill-intended people can use a kind of "hysteria" around risk.

As we mentioned earlier, without understanding the risk, fear arises, and discernment becomes extremely difficult to exercise.

Gerd Gigerenzer, a Berlin psychologist and author of "Thinking about Risk - Living with Uncertainty," denounces the misuse and torture of statistical data that occurs every pink October in every country.[5]

Let us defend the end of the use of fear to guide women's decisions, let us support clear information about the risks (without catastrophism)

References

[1] https://cancer-rose.fr/en/2021/02/08/new-french-cancer-plan-2021-2030-a-soviet-plan/

[2] https://blogs.scientificamerican.com/cross-check/the-cancer-industry-hype-vs-reality/

[3] https://cancer-rose.fr/en/2021/04/20/methods-of-influencing-the-public-to-attend-screenings/

[4]  https://cancer-rose.fr/wp-content/uploads/2021/04/Supplementary-Tables-Rahbak-et-al-210421.pdf

(summary table of institutions using influence methods).

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.

Increasing the importance of early clinical diagnosis

NOVEMBER 5, 2021 BY CANCER ROSE

A Lancet study

Duggan C., Trapani D., Ilbawi A., Fidarova E., Laversanne M., Curigliano G. et al.
National health system characteristics, breast cancer stage at diagnosis, and breast cancer mortality: a population-based analysis
DOI:https://doi.org/10.1016/S1470-2045(21)00462-9

Concept of early clinical diagnosis

The authors make a distinction in their article between screening and early detection of breast cancer symptoms.

We therefore distinguish :

-Anticipated diagnosis = screening, which is based on repeated mammograms, as practiced in many countries.

- Early clinical diagnosis = the earliest possible detection of the first symptoms of breast cancer; this detection relies on the training and information of women and physicians and/or midwives (caregivers in general), on the one hand by raising their awareness (remembering to look for the symptom in the breast), and on the other hand by educating them on 'what' to look for.

- This concept of early clinical diagnosis contrasts with a late diagnosis due to the presence of symptoms of existing cancer that have been neglected for a long period due to a lack of information for women and a lack of training for caregivers.

The authors note that some countries do as well with early symptom detection as countries that use screening.

The Lancet article suggests that early diagnosis may work as well as screening.

Indeed, the WHO promotes early clinical diagnosis as an alternative to screening in countries that lack the resources for mass screening, which is not the case in France. We talked about it here: https://cancer-rose.fr/en/2021/09/04/screening-campaigns-a-move-toward-greater-caution/

Ukraine appears to have chosen this option, which is appropriate for developing countries that cannot afford routine mammography screening.

However, we can draw a pertinent question and a lesson from these findings for our countries where campaigns are in full swing, with mammographic screening, which no longer demonstrates its effectiveness and has drawbacks: What if early detection had a better benefit/risk ratio than routine mammographic screening?

Reducing breast cancer mortality with less overdiagnosis

The findings of the study, published in The Lancet Oncology, support the WHO recommendation, implying that early clinical diagnosis may be as effective as screening in avoiding advanced cancers and lowering mortality from breast cancer. 

The benefit-risk balance of early diagnosis may be better than that of mass screening because it eliminates overdiagnosis and overtreatment caused by mammographic screening.

A serious alternative

As explained in detail on the website of Dr. Vincent Robert, statistician, this is an alternative to both screening and "doing nothing."

The idea, promoted by the WHO and confirmed by the Lancet study, is to offer this option to women to broaden their range of options and allow them to choose the path that appears to be most suitable for them, with full knowledge of the facts.

Read: https://mypebs-en-question.fr/actus/duggan_lancet.php#ref



Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.

Bad statistic of the month October

https://www.hardingcenter.de/en/node/285

https://www.rwi-essen.de/unstatistik/120/

Translation by Cancer Rose, nov 5, 2021

Bad statistic of the month October: Breast cancer month October - Pink ribbons instead of information

Bad Statistic of the Month

Berlin psychologist Gerd Gigerenzer, economist Thomas Bauer from Bochum, and statistician Walter Krämer from Dortmund began publishing the “Bad Statistic of the Month” (“Unstatistik des Monats”) in 2012. Katharina Schüller, managing director and founder of STAT-UP, joined the team in August 2018. Every month they question recently published statistics and their interpretations. Their underlying aim is to help the public deal with data and facts more rationally, interpret numerical representations of reality correctly, and describe an increasingly complex world more adequately. Further information on this initiative can be found at www.unstatistik.de  and on the Twitter account @unstatistik.

October is Breast Cancer Awareness Month. You would think that women would be particularly well informed during this month. To do this, we typed "Breast Cancer Month October 2021" into Google and looked at the entries on the first page. All of them promote early detection, but none of them report what the scientific studies have found about its benefits and harms. Before we look at the entries, it's good to take a look at the results of scientific studies involving more than 500,000 women so far.

They show: When 1,000 women age 50 and older go for screening, 4 of the women die of breast cancer within about 11 years, and for women who don't go for screening, 5. So one fewer woman dies of breast cancer for every 1,000.

However, the total number of women dying from any cancer (including breast cancer) does not change; 22 in both groups. That is, one fewer woman in the screening group dies with a diagnosis of breast cancer, but one more woman dies of another cancer. So, overall, there is no evidence that screening saves or prolongs lives.

But women who go for screening face two harms. One in 100 out of 1,000 receive unnecessary biopsies due to false alarms, and 5 women have part or all of their breast removed unnecessarily. This information should be delivered in October, Breast Cancer Awareness Month, so that women can make an informed decision for or against early detection (see also the "Fact Box on Early Breast Cancer Detection through Mammography Screening"  „Faktenbox zur Brustkrebs-Früherkennung durch Mammographie-Screening“
by the Harding Center for Risk Literacy, led by "statistician" Prof. Dr. Gerd Gigerenzer).
https://www.hardingcenter.de/en/early-detection-of-cancer/early-detection-of-breast-cancer-by-mammography-screening

Google hit pages provide almost no information about the benefits and harms of screening

So what do the Google search results or web pages tell us? Euronews.com gives no information at all about the benefits and harms of screening. Instead, the website promotes pink ribbons and a pink duck parade. The womens.es website, on the other hand, gives a figure: Early detection "reduces the likelihood of death by 25 percent." Does that mean that for every 100 women, 25 fewer will die of breast cancer? No. This figure is found by reporting the reduction from 5 to 4 in 1,000 women as "20 percent less" and rounding it up to 25 percent. Here, I suspect readers are unaware of the difference between a relative risk (25 percent less) and an absolute risk (1 in 1,000). Indeed, studies show that many women (and men) do not see through this trick.

On their website, the Cancer League of Eastern Switzerland Krebsliga Ostschweiz encourages mammography screening, giving many figures (like the number of women and men who have breast cancer) but none about benefits and harms.  The Ministry of Social Affairs, Health, Integration, and Consumer Protection in Brandenburg Webseite again advises early detection on its website. It reports many figures, such as the average age at which women are diagnosed, but none that allows an informed decision - quite different from that in the fact box. Among other things, the company health insurer HMR advises self-testing of the breast by palpation, without mentioning that studies show that this does not reduce breast cancer mortality but can raise false alarms and unnecessary fears. The website also recommends mammography, again without information about benefits and harms.

Early detection is also mislabeled as "prevention," - which is widespread and one of the reasons why many people think that mammography prevents cancer. Vaccination is prevention and prevents diseases; early detection, on the other hand, means that an already existing disease is detected. On the rest of the web pages, it went on like this - entirely without information about benefits and harms, but with celebrities, pink ribbons, teddy bears, and flamingos.

Since different users get different results on the first page of a Google search, you should try it yourself. However, most of us find reliable information only on the later pages, and about 90 percent of all clicks reach the first page only.

In 2021, "Breast Cancer Awareness Month" still fails to provide balanced information

In October 2014, we had already reported on Breast Cancer Awareness Month's commercialization and the missing or misleading figures on benefits and harms. In October 2021, it's the same. In a society where people argue about gender stereotypes, at the same time, they tolerate the practice of withholding the scientific results about early detection from women. Women and women's organizations should be the ones to tear the pink ribbons and not tolerate this finally. Every woman should make her own informed decisions instead of being emotionally controlled by teddy bears and commercial interests.

Your contact for more information:

Prof. Dr. Gerd Gigerenzer Tel.: (030) 805 88 519

Sabine Weiler (Communications RWI), Tel.: (0201) 8149-213, sabine.weiler@rwi-essen.de 

Unstatistics author Katharina Schüller is also a co-initiator of the "Data Literacy Charter," which promotes comprehensive data literacy education. The charter is available at www.data-literacy-charta.de.

RWI - Leibniz Institute for Economic Research

https://en.rwi-essen.de/das-rwi/

RWI - Leibniz Institute for Economic Research (formerly Rheinisch-Westfälisches Institut für Wirtschaftsforschung) is a leading centre for economic research and evidence-based policy advice in Germany. 

Harding Center for Risk Literacy

https://hardingcenter.de/en/the-harding-center/about

University of Potsdam-Faculty of Health Sciences

Our aim is to study how people behave in risk situations. We believe that our work can contribute towards the ideal of a society that knows how to calculate risks and live with them.
Gerd Gigerenzer, Director

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.

Mrs. PL, 22 years of shared life with breast cancer, or the fight from a fierce “NO” to a half-hearted “YES.”

Testimony from the practice of Dr. M. Granger, Senologist, October 2, 2021

February 1999: Mrs. PL, 58 years old, consulted for a nodule in her right breast, which had existed for two years, but which had recently undergone an inflammatory change. Clinically this nodule is typically a sebaceous cyst located on her right breast.

However, the mammogram showed, in addition to an oval subcutaneous opacity very well limited and in agreement with the clinical diagnosis, a cluster of punctiform and dusty calcifications, at a distance from this nodule, distributed in half a dozen small foci with numerous tight elements, without densification or associated architectural distortion. The conclusion of this first encounter, for a benign pattern, is the probable presence of a "right retro-mammary intraductal carcinoma, a histology is necessary."

As this lady was followed by a homeopathic doctor who was very close to his patients, no instructions for treatment were given, except for the conclusion reported above. Without any news during the following months, I wrote to my colleague: Mrs. PL was indeed undergone surgery, and the answer was "positive."

Having obtained the operative and histological reports, I learned that it was a 6 mm infiltrating ductal carcinoma, with more than 2 mm clean surgical margins. The peripheral intra-ductal contingent had fine regular calcifications, and it comes into contact with the limits of the excision. The second stage dissection (no initial extemporaneous examination, as this was a simple surgical biopsy of micro-calcifications [we were in 1999]), associated with the resection of the tumor bed, showed: no tumor residue and a negative dissection of the 3 layers (0/15).

September 1999: first postoperative follow-up at 6 months. This examination was satisfactory, with a trivial area of steatonecrosis at the surgical site. A new appointment is given at 6 months, classical surveillance.

June 2000: follow-up 14 months after the initial surgery.

Mrs. PL stated that she had not consulted an oncologist. She was afraid of radiation and would not do it, advised by her homeopathic doctor, who considered it useless to do radiation "for nothing" as the results of the tumour bed resection and curage were normal.

Mrs. PL will then scrupulously return, every year in June, for 12 years. In 2011, she informed me that she was getting divorced. The following year the imaging was transformed: a micro opacity, not significant until then, doubled in volume, appeared spiculated, and measured 6 mm on ultrasound. Same breast, close to the initial bed. The cytopunction immediately shows a cellular mass characteristic of carcinoma, and it is, therefore, a recurrence in situ. Reoperation is necessary.

July 2012: Mrs. PL chooses not to see her initial surgeon again and to consult a Parisian celebrity. The surgery performed in July 2012 will be limited to a "large quadrantectomy," as the patient refused the recommended mastectomy. Despite this, the histology of the surgical specimen is... negative: the pathologist did not find any tumor proliferation.

October 2012: when Mrs. PL comes back for a new postoperative check-up at 3 months, I discover this "discrepancy": I question - Mrs. PL also finds out, and I end up choking... Because I have absolute faith in my puncture method and the accurate reading of my cytopathologist, trained at the Zajdela school of the Curie Institute: where is the error? The MRI will show the persistence of an intense and early enhancement corresponding to the sought-after lesion. My ultrasound found the mitotic gap, unchanged, of 6 mm. The conclusion is evident with a sigh: the lesion has remained in place.

November 2012: the patient is then reoperated in the same Parisian clinic: "right hemi-mastectomy," taking away the spotting hook. One could see in this hemi-mastectomy either a certain " broadness " of the surgeon, perhaps embarrassed by this involuntary reoperation, or a poorly mastered spotting technique? What is certain is that the histological analysis still does not show the tumour lesion but rather ordinary inflammatory changes. This recurrent discordance still does not raise any metaphysical question.

April 2013: new control examination, difficult. The breast is disfigured, the scar is stuck after a very large postoperative hematoma. Doubt about the persistence of the initial anomaly, still at the union of the external quadrants of the right breast. A new MRI will, however, come back normal. OUF, the tribulations of this cancer seem to be over (?), but with the bitter taste of not having understood everything: where did this 6 mm tumor disappear?

October 2013: six months later, Mrs. PL reveals that she is being followed in Belgium and taking 2LC1-N to support her immunity. She will, however, accept my regular follow-up.

May 2016: I see her regularly, every year now. In May 2016, she reported a small intradermal granule at the union of the external quadrants of the right breast, thus always in the exact localization. The cytology is... stubbornly malignant. This time, a bit tired of all these missteps, I explain loud and clear that the choices made have not solved the problem and that it would be appropriate to do a "real" mastectomy associated with a radiotherapy of the chest wall. This opinion is confirmed by the Faculty (University Hospital of P...). However, Mrs. PL continues to refuse both the micro biopsy and the mastectomy.

September 2016: under pressure from another university hospital (T...), Mrs. PL will accept the biopsy removal of her nodule: the carcinoma is this time infiltrating ductal carcinoma is well stamped, the hormone receptors are strongly positive. A mastectomy was scheduled: it was refused, as was hormone therapy. As well as radiotherapy, once again.

March 2017: the nodule will recur again, after its localized removal, at the same place... A new puncture (malignant) will finally convince the patient... A simple mastectomy, without radiotherapy, will eventually be performed in May 2017, that is to say, 18 years after the first lumpectomy, and three "conservative" operations which had already largely damaged the breast...

October 2020: three and a half years later. After this (final?) episode, Mrs. PL is doing well; she is now 80 years old, she remains a gentle and pleasant person. She is getting used to her mastectomy scar. She never had a word of doubt about her Parisian surgeon or pathologist, nor about the successive disfigurements that were imposed on her.

This observation has several salient points, to say the least: what can we learn from it for the Defense and Illustration of Senology?

1- How can we respond to this homeopathic colleague who wonders about the interest of radiotherapy "for nothing"?

First of all: that there is no "nothing" since his patient has invasive cancer, certainly not very locally developed, at least in appearance. But can one know in advance and with certainty the evolutionary potential of cancer? History has proven its high potential for recurrence.

Secondly, the fact that the surgical margins were healthy at the initial surgery was undoubtedly good news. Still, it did not in any way prejudge the biological reality, which was inaccessible to the pathologist. The notion of the carcinogenesis field confronts us with this obvious fact: in 2021, we still cannot know the biological boundaries of a carcinogenesis process. Surgery is, therefore, necessarily approximate.

In the context of conservative treatment, radiotherapy is the preferred weapon to drastically reduce the incidence of local recurrence, which would otherwise be almost systematic. In summary: conservative surgical treatment should necessarily be associated with adjuvant radiotherapy.

Finally, we must agree with this colleague that the patients of a homeopathic doctor always have great "faith" in the method and that his doubts have fed, knowingly or unknowingly, the phobia of the X-ray of Mrs. PL.

2- Like everything else, this history must follow a logical pattern: if a diagnosis of malignant recurrence has been made and the histology of the operative specimen is normal, there is a contradiction and, therefore, an error somewhere, which must be resolved. This error can be the initial diagnosis (false positive of one of the techniques used...), the operative methodology (location of the area to be biopsied, topography/extent of the sample...), or the histological analysis itself (identification difficulties, number of slices taken... [cuts every 5 mm may miss the smallest tumors]).

Unfortunately, this investigation was not done after the first recurrence... This case was not the judiciary, so we will not know the end of the story.

A word about the initial diagnosis: it did not include a micro biopsy which, as we know, has become the grail of oncologists, because the patient refuses it. However, it must be admitted that fine-needle aspiration, a straightforward technique, usually provides very rich and unambiguous cytology for a trained cytopathologist. I do not know of any false positives in my experience. In this story, all the cytologies were characteristic, and the final diagnosis proved them correct. So it was not the initial diagnosis that was wrong.

3- The constant attitude of Mrs. PL questions us, the physicians, on the level of risk we place on our patients. A very anxious and/or very enterprising radiologist, who wishes to macrobiopsy the slightest grouping of microcalcifications (without waiting for the test of minimal surveillance, which would make it possible to judge their change), and Mrs. PL, who waited until the 4th local recurrence to be persuaded, merely to undertake the recommended treatment, are living in radically opposed and incompatible medical worlds.

4- It did come to your attention that Mrs. PL's first recurrence appeared the year after her divorce. In contrast, the first 12 years of her follow-up had gone smoothly, despite an incomplete initial treatment, radiotherapy having been rejected. Once again, cancer is shown in its true light, that of a psycho-somatic disease, the psyche being most often the initiator/accelerator of this process.

Cancer Rose Commentary

We would add another lesson from this observation, and that is "the lesson of humility."

Women are often made to feel the urgency of the situation as soon as a cancerous lesion is diagnosed as if every minute counts. Everyone is running, busy, panicking; we must act, react, operate as quickly as possible! However, in this case, the patient has been living with cancer for years, and she has reached the age of 80 without losing her life!

So it's never too late to do the right thing; it's never too late to treat and cure.

So, where is the urgency in which we propel the diagnosed women? If the cancer is metastatic, it is so immediately; in most cases, it is clear that there is no need to panic women as we do, and we are not a minute away. Yes, we can sometimes give ourselves time for surveillance (the ACR3 classifications (simple surveillance) have almost disappeared; in our emergency, we immediately consider taking samples and performing interventions).

Yes, we must treat, of course, but without panicking! Cancer does not metastasize in 5 minutes (unless it has already done so, and in that case, we are a step behind); it does not kill on the spot; we are not going to die tomorrow!

This case shows us the humility that the medical profession should have and shows us that it is necessary to leave the 'panic' and the 'emergency' that we inflict on women when we find them cancer, giving them the impression of imminent death, but that we are going to save their life because we have been quick.

The fate of the patients is not in our hands as great "saviors." It is never "too late" to treat and heal.

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.

Dream of a senologist

A testimonial from Dr M. Granger, Senologist, July 21, 2021

Mrs PS, 50 years old, from Paris, consulted in August 2010 for advice.

On June 23, 2010, she had a 3rd mammogram in a Parisian SENOLOGY CENTER, classified as ACR4 for a "poorly systematized zone of architectural distortion in the upper right quadrant." She had microbiopsies the same day, which resulted in the "diagnosis": "Proliferative fibrocystic mastopathy with atypia, ductal type (Atypical ductal hyperplasia)." She has an MRI appointment in a few days and is very concerned about the speed and bad turn of events: what is she supposed to do?

My findings:

After carefully inspecting the mammograms that were brought to me, I notice, with some initial concern, that this "zone of poorly systematized architectural distortion" escapes my sagacity.

The magnifying glass brings nothing: I see, in comparison with the left breast, which underwent a total adipose involution, only a banal aspect of a glandular remnant.

The appearance was identical on a mammogram done precisely seven years earlier.

Moreover, my clinical and ultrasound examination was strictly normal.

Surprised by the Parisian radiological diagnosis but reassured by the constant imaging, I advised this lady to wait for the MRI results and send them to me. These results arrived three days later, on the same evening as the examination.

"The zone of right superior-external architectural distortion is confirmed, with no suspicious morphological character on MRI." However, we are aware of the underestimation of MRI for intra-canal lesions. A surgical excision of the atypical area should be planned”.

The patient, caught in the "concordant" vise of 3 reports - mammogram, biopsy, and MRI - consulted a breast surgeon at the Gustave Roussy Institute (IGR).

A few days later, she sent me the following report: "I have received the result of your breast MRI, which confirms the elements described on the mammogram, i.e., a poorly systematized area of the upper right quadrant. However, given the histological findings of the biopsy, which revealed fibrocystic mastopathy with ductal atypia,  an excision surgery of this area is necessary".

I am sending this email back to Mrs. PS

Dear Mrs,

In response to your email, here are my conclusions:

- Your MRI is normal; the exact text is: "area of right superior-external architectural distortion that does not show, on MRI, any suspicious morphological character." As usual, the rest of the report ("however...") is just an umbrella formula.

- The letter from the IGR retains the negative part of this report ("poorly systematized zone" [which means what, by the way?]), opening the umbrella in turn: "an excision surgery is necessary...". A surgeon operates.

I warned you about this logic. I encounter it every day. It's not mine, given the mammograms you brought me, which haven't changed in seven years. This stability, in my opinion, is worth all of the umbrellas in all of the institutions on the planet, especially when the MRI is normal.

I remain in favor of simple surveillance, the specifics of which have to be determined for your moral comfort and safety: I would recommend a first X-ray and ultrasound control of the right breast within a year or less (contact my secretary), and then we will see.

You are thus confronted with choosing between following your new provincial senologist and the big Parisian machinery! Make this decision in your soul and conscience, discarding all Hierarchies and listening only to your deep feelings: the good answer will be found there.

Sincerely yours. M Granger

Mrs. PS finally chose to follow her provincial senologist.

She "comes from far away" but "knows why." I saw her until 2017, without noticing anything new, with clinical and X-rays and ultrasound examinations remaining unchanged for over 15 years. One who has been saved...

What can we learn from all this for the teaching of Senology?

Several observations, among many others, appear to be beneficial to me:

- The radiologist's initial description ("poorly systematized architectural distortion") was the starting point for a path that the patient had to climb alone... until the anxiety became too much for her and she decided to seek advice.

-This initial description was at no time questioned, and the radiologist's opinion was final.

However, it should be noted that the ACR classification can be easily "twisted" to achieve the desired result: if the radiologist accepts simple surveillance, he will grade the images as ACR2; if he wants close surveillance, he will grade them as ACR3; and if he wants a biopsy, especially if he can do it immediately, he will grade them as ACR4, as in this case.

A detached viewpoint will see things differently: simply comparing all of the mammograms taken, sometimes a dozen(!), will lead to a different conclusion, in this case normal (or ACR 2, if you are a fan of the Americas). That would have put an end to this lengthy diagnostic rambling.

-As previously mentioned, the initial description/classification was not discussed: because each professional works independently, without controversy, and is thus not directly accountable to the patient. In fact, this chain can be described as a vertical commercial agreement from which all parties have benefited. In the wild animal world, this is known as "horde hunting," and we know that if all of the subjects in the cohort are potentially targeted, only the strongest will escape .

Mrs. PS, a graduated lady working in the high public service, was able to get out of it by making the Cornelian decision to resist the IGR Institute... many others are not.

The remedy to this chain of medical control without counter-power is NOT to be found in the RCP (multi-disciplinary consultation meeting, editor's note): I have never seen a pathologist, a surgeon, or a radiotherapist oppose and break the chain biased from the start towards biopsies - micro, macro or surgical.

As a result, there is a de facto agreement not to question the initial diagnosis, and individual psychoanalysis of the "validated decisions" in RCP would be fascinating. The breast is a highly invested organ that everyone loves to argue about and share.

You may have realized that I am living the dream that our father (Charles-Marie Gros, from the Hospices Civils de Strasbourg) had in the 1960s: that the SENOLOGIST is recognized as that breast specialist, a little/lots/passionately a specialist in all the disciplines involved-from the various forms of imaging to anatomopathologist, to the relative interest of surgery and the oncologists' panoply... a specialist who coordinates and tempers everyone's enthusiasms and anxieties, a specialist ultimately accountable to the patient.

A communicator who is willing to take his time and sometimes loses it. But, as you're probably aware, the dream is still a dream, and SENOLOGY is a beautiful utopia. Mrs. PS and her struggle sisters occasionally awaken it.

 

A few comments from Cancer Rose

It is absolutely clear that screening has increased the number of unnecessary mastectomies.
We presented our study on mastectomies in France at the French Society of Senology's annual meeting in Lille.
It is undeniable that non-cancerous lesions are "over-operated," and this is yet another example of an over-detection drift, namely over-treatment.
Yet, this obviously explains why, as described in our study, there are increasingly more mastectomies in comparison to the incidence of invasive cancers.

The observation also confirms the ACR classification drifts: ACR3 hardly exists any longer, there is a tendency to classify very quickly in ACR4, and we voluntarily "upgrade" our examination classifications to have immediate access to a tissue sample, to avoid omitting anything, rather than taking time, settling down, and possibly rechecking at a later date.
The ACR4 becomes a catch-all for anything that appears "abnormal." More information can be found at https://cancer-rose.fr/en/2020/12/30/arc-classification/.


Finally, while there is a double reading during screening for cases classified as "negative" (see here: https://cancer-rose.fr/en/2021/03/30/what-is-a-screening-mammogram/), there is none for cases classified as "positive." This is not entirely logical.
But, even if there was, who would have the courage to "negate" an image previously classified as positive by another colleague...

 

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.

The cat knew it

Cancer Rose offers you a forum for citizens. You can also testify.

Testimony of Dr Granger, Châteauroux, July 2021

Story of Mrs AH, 75 years old

My secretary stops me at the beginning of the afternoon:

"I have added a patient to your list at the end of consultation... "
- Well…

Nothing more to say, that's the rule: if a woman "felt something" and wants to see me, it’s right away...That's how it is with the breast. She hesitated... dared to call... she wants to talk, now. As much as possible don't stop that momentum.

- What brings you here today ?...
- You have seen a friend, she told me that I could... I had surgery for a very small breast cancer in 1991 [she was 45 years old at the time, no one in the family had been concerned]... I have been medically followed for a long time. And then I stopped the surveillance: I was told before the intervention that the cancer was not visible on the mammogram. So why continue to do it ? I have the impression that I feel something there (she holds her right breast, under the collarbone), it's not at all in the same place…My friend says he doesn't feel anything, but I think he wants to reassure me. He has glaucoma problems... I told him I was going to the cinema. 
-You're going to the cinema?
-... Yes

At first glance, the right upper-inner quadrant is as if filled, while the symmetrical area on the left side is empty. The hand perceives a large indurated plate, as if frozen. The diagnosis is obvious. The initial lumpectomy scar, at the union of the lower quadrants, is very small, thin and flexible. It is definitely not the same place at all. Upon contact with the ultrasonic probe, another evidence.

- Do you see something?... 
- Yes
-...
-...
- How big is it?...
- It's about 2 cm... (...) How long has it been since you had a mammogram?
- I stopped... It hurts. I saw my gynecologist...it's been maybe 3 years...she told me she didn't feel anything, she asked me for a mammogram, I didn't get it. I'm tired of being sick. I'm a former nurse, I won't go to the hospital anymore. I won't go for any more tests unless I'm sick.

When the examination is over, she gets dressed. We'll say more.
- I think it's a repeat of the original problem...
- I knew it. 

Her look is direct, clear. 

-That's why I said I was going to the cinema. I didn't want to tell him unless I was sure.
A nurse once told me: "Cats can sense when their owner is sick, they stick to him". For some time now my cat has been sticking to me, so I understood. Now what to do?...
- You had a conservative treatment, and a radiotherapy, right?... 
- Yes
- The radiotherapy can only be done once...
- Yes, I know
- We have only one thing left to do : surgery. You need to have the breast removed.
- Yes. The sooner the better. I don't want a biopsy, I heard that cells can leave

I did not insist on the interest of this biopsy for the surgeon, on the "procedure", I had neither the heart nor the certainty. On the doorstep her final words:

- Thank you. At least you didn't tell me it was my fault... 
- ?... 
- How could anyone say that?
- Oh you know I've heard so many things!

That was my last consultation. Nothing afterwards to remove these words, these impressions. What does this mean for the teaching of Senology?

  • A woman "knows" when she has breast cancer. All women fear it, all women fear to feel it. Only those who have it really "know". Cats also know, their sense of smell guides them. You should always listen to your cat, its cuddle is a sure guide.
  • In the surveillance loop, there is always someone other than the woman herself, someone else who motivates her or makes her reluctant. We must enter this loop if we want to be useful. First of all, by not saying anything that could be misinterpreted, so we have to be several steps ahead of her.
    For example, don't say that "nothing was visible on the mammogram" because 20 years later this will be a demobilizing argument. Then by telling it like it is: this "tiny little cancer" minimized will become another demobilizing argument one day.
    The initial mammogram, which she had brought to me, although in silver technique in 1991, showed perfectly the cancer, its spicules and the retraction of the sub mammary fold.
  • It is important to remain calm and factual in the announcement. The genius of cancer is infinite, so there is no such thing as a " small " or " good " cancer (don't mistake the enemy for a friend), nor a cancer " that often becomes bilateral " (don't mistake a friend for an enemy). What unjustified prophecies that mask our ignorance! There is no "emergency" either, cancer is always a long story. Things will be named, defined and explained as the consultation progresses. These consultations take time, they do not happen in a waiting room or on a table corner. Radiologists who no longer see their patients and refer them to their imaging site have paradoxically made a wise decision: it prevents them from saying what they don't know!...
  • It is necessary to offer an alternative to mammography for screening or surveillance. This examination is often painful, invasive, and not very informative, since it is usually completed by an ultrasound. Ultrasound which should explain what cannot be seen or understood with X-rays... Ultrasound is indeed an alternative, in trained hands: it could even be sufficient in most cases, for screening and monitoring, but this is another debate. The ultrasound alternative, which is widely implemented, would prevent clinicians and imagers from making women feel guilty by telling them that "it's your fault" or "you had it coming," "why didn't you get the mammogram you were asked for? ".
  • Remember the last words on the doorstep, they are the most important ones, the ones that could not be uttered earlier, and which are truly liberating: this woman, despite the shock of the announcement, was grateful: I had not accused her.

Cancer Rose Comments

This testimony has caused a lot of reactions, and we receive many questions and comments from our readers. Hence this short deciphering:

The patient's strongest message is that of being tired of surveillance, because to continue surveillance is to continue to be sick. 
The examinations are necessary when you are sick, that's what the patient expressed. 
This is an interesting point in the context of screening women with no symptoms, forgetting that screening is intended for healthy people, who have no complaints.
Here the situation is different in that the patient has been ill and has developed cancer, a situation for which annual monitoring is actually recommended, but this is her opinion, and the opinions, choices and preferences of patients must be heard.

The doctor's strongest message: refusal to accuse, refusal to make patients feel guilty. The patient liked that the doctor did not blame her ("you had it coming, you should have done your follow-up"; this is what women hear, although it cannot be said that this would have changed the situation much).
Gratitude of the patient for a too rare attitude of the medical profession: not to reproach a patient for a defect of a monitoring which she judged too long, tiresome, uncomfortable and distressing. 
This removal of guilt is extremely important, because we also see this feeling of guilt in healthy women who do not undergo screening, even though they are not suffering from anything.

On the substance, the doctor is right to point out that "the genius of cancer is infinite, so there is no "small" or "good" cancer". In fact, it is impossible to know if this is a recurrence of the disease, so long after, or if it is a new disease (another location in the breast than the first), if the mammo would have changed much (discovery of the mass immediately voluminous). It is also impossible to eliminate an induced disease (multiplication of mammograms, second radiation-induced cancer since it occurred in the same treated breast, long afterwards).

One will never know, hence the importance of respecting the choice of the patient, to leave the pattern "cancer, sooner taken better is", because, as the colleague writes it, the evolution of cancer does not work according to this automatismpre-...designed by an intellectually comfortable theory (read: https://cancer-rose.fr/en/2020/11/30/how-does-a-cancer-develop/)
Looking for alternatives to the sacrosanct mammogram in which so many hopes are based and yet which "misses" genuine cancers is also a line of reflection.

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.

Sophie’s testimonial

June 6, 2021

By Sophie, testimonial and point of view

Ethics of screening, information for women, training of professionals on breast cancer screening: what is the strategy of the new Cancer Plan?

A testimonial

...Before age of 50, I had a breast cancer screening test prescribed by my doctor as part of a health check-up, for no particular reason, just to be reassured. I showed up at the radiology center with a simple prescription, without the least information on the radiation, nor on the additional examinations, or the consequences of the test in case of abnormality, just as I would have a blood test for a general check-up. I was not given any information about what they were really looking for in the absence of symptoms, nor about the fact that they will be using a super-powerful tomosynthesis technology that detects the smallest anomaly of a few millimeters, for which no one can tell the outcome, nor on the doses of radiation delivered by the ten x-ray images with enlargements, with a total dose (16.5 mGy) of radiation four times higher than the dose delivered by a classic mammographic examination (3-4 mGy), and that I will have to repeat in 6 months, then 12 months and then 24 months. If all goes well, if not something else will happen?

If I were to draw a parallel with a drug, I would have had an information leaflet listing potential side effects.  But a mammogram is considered a harmless, banal examination.  I don't have any doubt about my doctor's good intentions, but unfortunately the tests and the anxious waiting were  overwhelming, then came the regret of having  this exam which should better not have been done.
I should have been able to decide, with the right information, but I didn't have it.

I may be told that this is a test done to save my life, although studies by independent researchers from the Cochrane organization have shown that for every 2000 women invited for screening throughout 10 years, one will avoid dying of breast cancer and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. 
Would I be that lucky one, although I did not feel in any imminent danger, I had no particular concern for breast cancer, nor any family history of it, I was not even 50 years old, which is the starting age for screening mammography in France? Or on the other side, could I be one of the other 10 women unnecessarily treated ? In any case, it was up to me to weigh the benefits and risks and choose. And it's not fair that I didn't get all this information in advance.

... Among close contacts of mine, a woman had a screening mammogram at her age of 72, without any information except invitation letters. She gave in to the reminder letters and decided to undergo the exam so that, she would be left in peace. Similarly, after the mammography followed additional tests and anxious waiting of results for the whole family, with regrets for having done this exam without being properly informed.

Once again, lack of honesty and transparency…

......Another woman I know, in her forties, with no particular risk factors, had pressure from her gynecologist to have a mammogram, with no particular reason, and  without receiving any information. She tries to hold on and hope to not upset her gynecologist, because it is difficult to find another one.

Where is the information?

And there are many such cases... Here, we are talking about healthy women with no symptoms suggestive of breast cancer. It’s not about women who have a symptom and who should consult, because in this case the mammography is necessary.

These cases show the lack of information and training of professionals, whether it is the GP, the radiologist or the gynaecologist, who focus on mammographic screening examinations to find existing, hypothetical or future breast cancers in healthy women, forgetting to inform them correctly and without taking into account their autonomy of decision.

And yet it could be done better. Information on the benefits and risks of breast cancer screening, in the case of a healthy woman with no particular symptoms, is a due to women: it is up to them to choose according to their own values and preferences if they wish to undergo it or not, especially since the benefits are not clear; the controversy between the benefits and the real damage has been going on for 40 years now.

This was also one of the first recommendations of the steering committee following the 2016 citizen and scientific consultation on breast cancer screening in France :  "The consideration of controversy in the information provided to women and in the information and training (initial and continuous) of professionals in this area, so that women concerned by breast cancer screening are provided with balanced and complete information, and that professionals involved in breast cancer screening are trained to acquire the relevant knowledge to accompany women, offering them adequate support to make their decision" (1).

Why women are not told the truth, why doctors do not humbly acknowledge their doubts about the appropriateness of this exam in the absence of any symptoms? They prefer to put forward benefits that they are not sure of, forgetting everything else, including informed consent and patient autonomy.

A new cancer plan, situation in France

The ten-year strategy of the new cancer plan has been adopted by decree (2).

We expected measures to improve information for women while respecting the autonomy of patients, as is done in Great Britain, Australia, Canada and Germany. Elsewhere, the objective is to inform and not to persuade, the emphasis is on the women's decision without making them feel guilty, by providing decision support tools, which correctly communicate risks in absolute numbers and not in percentages by minimizing them.

As for this decision aid in Canada (3) which states:

« Why is shared decision making important? 
Screening is a personal decision. It is important to understand and weigh the benefits and harms for women in your age group (as shown below) with your health care provider. This will help you get a better understanding of the issues so that you can decide what is best for you. Some women may wish to not be screened if they are concerned about potential harms. »

Click to enlarge

Instead of developing such tools, in France the focus is on the number of screenings and the participation rate, without the slightest concern for informed consent, the objective of the Cancer Plan being "to achieve one million more screenings by 2025 for the three screening programs, including organized breast cancer screening and to exceed the coverage targets recommended at the European level in terms of screening and join the leading group in terms of adherence with a participation rate of 70% for organized breast cancer screening, while today the participation rate announced for 2018-2019 is : 49.3% + 10-15% (organized + individual). "((2), action sheet I.12, p.20)

And yet the rate of participation in screenings should not be a goal of these programs. The real goal should be related to informed patient decision. As danish researchers (Rahbek et al, 2021) point out, instead of evaluating cancer screening programs on the basis of participation rates, the measure of engagement could be the rate of informed decisions, regardless of participation or non-participation (4). The authors note that authorities assume that for most citizens, participation is the right choice. This view is not necessarily shared by informed citizens. Indeed, current evidence suggests that the more informed citizens are, the less likely they are to participate in cancer screening (4). (see also : https://cancer-rose.fr/en/2021/01/24/objective-information-and-less-acceptance-of-screening-by-women/ )

Yet the 2020 WHO guide (5) on screening provides very clear information on the principles to be followed. The guide points out that the risk of these measures to increase participation rates is that people's autonomy to make an informed decision is threatened.

To avoid this, the guide recommends taking care to enable informed consent and to protect individual autonomy.

However, none of the actions in the roadmap of the Cancer Plan address the improvement of information to the population on the benefits and risks of screening, as recommended by the WHO 2020 guide. Similarly, there is no measure on the training of professionals in risk communication as recommended by the WHO. Yet the WHO guide gives as examples tools such as infographics, videos and decision aids can facilitate understanding and promote informed consent as well as evidence-based practices. And it points out that both lay people and clinical physicians tend to overestimate the benefits of screening and underestimate its harms. (see also https://cancer-rose.fr/en/2020/12/18/perception-and-reality-2/)

The WHO guide also indicates the principles that must be respected in a screening policy: 

« 1. Respect for dignity and autonomy. Autonomy is the capacity to make an informed and uncoerced decision. »

2.Non-maleficence and beneficence. Non-maleficence means doing no harm to people; beneficence aims to do good for people.

3.Justice and equity. In health care, justice concerns fair allocation of resources and that resources are allocated proportionate to the need.

4.Prudence and precaution. The precautionary principle requires foresight, planning for the potential outcomes of screening and making wise judgements based on these future concerns.

5.Honesty and transparency. This requires clear and transparent communica- tion, thus promoting accountability. » One may wonder whether these fundamental ethical principles will be respected in the new roadmap of the Cancer Plan, which focuses as much on the participation rate, with the ambition of exceeding the European objectives, but without worrying about information to the population and the training of professionals

How to make an informed decision when information is not provided or is incomplete and biased (see :

https://cancer-rose.fr/en/2021/01/01/critical-analysis-of-the-new-inca-information-booklet/ )?

The INCA booklet should be reviewed, particularly with regard to the targets for participation rates. It should be produced by an independent committee without conflict of interest and with the involvement of a panel of women as was done by the National Health Service in the UK and described by Forbes et al, 2014 (6). The 25 women on the panel, aged 47 to 73 years and recruited from the streets of London, came from a variety of professional and ethnic backgrounds. The NHS brochure does not seek to encourage screening or ask citizens to make decisions without guidance. And the committee that wrote UK brochure states that :  « policy of judging the performance of cancer screening only on measures of uptake is, arguably, inconsistent with the policy of supporting informed choice. » (6)

How can the principle of non-maleficence be respected when some women suffer the effects of overdiagnosis, without being properly informed of these risks beforehand?

Concerning the principle of honesty and transparency, danish researchers in screening (Rahbek et al, 2021 (4)) have cited the official INCA brochure as an example of presenting statistics in a misleading way, such as relative % reduction in mortality. And according to these scientists, this misrepresentation is an influence technique to increase participation in screening. The bias introduced by these relative mortality reduction values is also explained and criticized in the GIJN guide developed by RecheckHealth for investigative journalists reporting on health affairs and issues (7).

According to Rahbek et al, 2021 (4) insofar as patient autonomy and informed choice are important, the use of these types of influence remains ethically dubious in cancer screening programs where the benefit/harm ratio is complex and scientifically contested.

In addition, this INCA brochure, even if biased and incomplete, is not transmitted to all women, since it is sent only one time at age of 50, so women who were over the age of 50 in 2017, when the brochure started to be sent, have not received it.

Conclusion

Elsewhere than in France, efforts are being made to provide better information. Increasingly, the scientific literature emphasizes the need to inform citizens in order to make an informed decision about the benefits and harmful effects of screening for healthy people.

Especially this is the case in screening programs where the benefit/harm ratio is complex and scientifically contested and where the consequences of screening are complex and require personal choice, as in the case of breast cancer screening.

The ten-year strategy could have taken this into account in France as well, but it missed this opportunity, at the cost of a lack of information for women and training for professionals. 

References

  • (1) Citizen and scientific consultation, 2016

Report Key points Translated in English https://cancer-rose.fr/en/2021/03/16/citizen-and-scientific-inquiry-report/

https://www.re-check.ch/wordpress/en/projects/gijn-guide/

Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.

Breast density, a viewpoint in JAMA

Synthesis by Dr. Cécile Bour, May 12, 2019

About https://jamanetwork.com/journals/jama/fullarticle/2733521

Foreword

With the emergence of predictive software [1] the radiological criterion of breast density, i.e., the predominance of fibroglandular tissue over fatty tissue in the female breast, has become, despite the lack of conclusive studies, a risk factor for breast cancer on its own. Breast density is generally high in young, non-menopausal women (but may persist after menopause), in leaner women with low body fat, and in women undergoing hormone replacement therapy during menopause.

As we said, it is a radiological criterion; whether this characteristic is really associated with an increased risk of cancer, opinions diverge and the question is far from being decided in the course of studies, which does not prevent opinion leaders from raising the scarecrow of dense breasts to terrorize women, if need be....[2]

What is established, however, is that with high breast density the discriminating power of mammography and the ability of the radiologist's eye to detect a lesion are greatly diminished, and it is only a short step from there to make a shortcut between breast density and cancer risk.

Available studies

Several studies are available, starting with the Wolfe study [3] on the relationship between breast density and breast cancer risk. This old study was strongly contested at the time, even by the supporters of screening.

Other studies have since been published, studying the relevance of linking this density factor with other risk factors, in order to develop models for calculating the risk of contracting breast cancer within 5 years. [4] [5] [6] [7] [8] [9] [10]

Today, there is no convincing evidence that high breast density is associated with risk of death from breast cancer.
Today, no tool for estimating the risk of breast cancer using breast density has yet proven its relevance.

The HAS(Higher Authority for Health in France), in a work on the identification of risk factors, writes:

 "High pre-menopausal breast density was not retained as a risk factor at the end of the work of part 1."[11]

The viewpoint published in JAMA on May 9, 2019[12]

The background is the adoption by the US Congress of legislation on breast density.[13]

More precisely this legislation requires the US Food and Drug Administration (FDA)[14] as part of the regulatory process to ensure that all mammography reports and summaries provided to patients include information on women' s breast density. This authority, which oversees the regulation of mammography facilities and quality standards, has previously required the reporting of breast density in radiologists' reports.

Based on published studies (see our bibliography), and according to the authors of this viewpoint published in JAMA, breast density as a risk factor for developing breast cancer draws attention to the fact that the associated increase in cancer risk is modest, and that for women diagnosed with breast cancer, increased breast density was not associated with an increased risk of poor-prognosis cancer or death from breast cancer.

Dense breasts are common (43% of women aged 40 to 74 years) and the majority of women with dense breasts will not develop breast cancer....

According to the editors of this article, notification of breast density may increase confusion and anxiety related to mammography and breast cancer, without providing clear recommendations on what women with dense breasts should do.

The USPSTF [15], in 2016, concluded that there was insufficient evidence to recommend additional breast imaging in women with dense breasts. This group raises several points of concern with this legislation requiring notification of breast density information to women.

  • Significant variability and limited reproducibility in the determination of dense breasts. This variability exists on an examination whether it is read by one radiologist or by different radiologists. The exam for a given patient may have different classifications and lead to misunderstandings leading to a reduction in a woman's confidence in screening in general, and confusion about her own breast cancer risk.
  • Uncertainty about initiatives undertaken by women who have been notified of significant breast density to reduce their risk of dying from breast cancer. 
    This refers to the request for additional tests for which there is no evidence to support the indication, as there is no evidence that the addition of imaging other than mammography in women with dense breasts will reduce cancer mortality; instead, these additions increase false positives, unnecessary biopsies, and overdiagnosis. The recall rate is significantly increased by the addition of ultrasound (by 14%), and by the addition of MRI (from 9 to 23%) with low PPVs[16] and an obvious additional cost. The authors remind us that MRI, often considered to be harmless, is likely to have a (small) excess risk of nephrogenic systemic fibrosis, and uncertain risks of gadolinium deposition in the brain when the examinations are repeated. Tomosynthesis (TS) is mentioned as an additional technique used, but the authors point out that longer-term studies are needed to determine whether the routine use of TS in women with dense breasts leads to a real improvement in breast cancer outcomes (mortality, decrease in the rate of serious cancers).
  • Difficulty in communicating information about breast density to patients. 
    Experts consider this communication difficult and dependent on the literacy level of the population. Study results show poor understanding and confusion and misinformation of patients when information about breast density is given.

Impact Analysis of FDA[17]

In this analysis the FDA claims that mandating breast density reporting would reduce breast cancer mortality in women, as well as costs through early detection of cancers .... But the authors of the viewpoint point to a troubling lack of evidence to support this arbitrary conclusion.

The FDA analysis failed to include in its calculation the costs associated with overdiagnosis, with overtreatment due to additional tests, and the costs of additional visits to primary care physicians.

In conclusion

The authors believe that breast density notification has implications for public health and that physicians, researchers, public health experts, and organizations should take a stand against this imposed rule.

Breast density notification could give clinicians and patients the opportunity to discuss a particular woman's risk of breast cancer, which depends on many factors other than breast density.

Predictive models of breast cancer risk include breast density, but its addition improves predictive estimates little. The addition of complementary imaging should be limited to high-risk women based on other risk factors to be included than breast density alone.

Discussions about the potential benefit of additional imaging for dense breasts should focus on the lack of evidence for a reduction in breast cancer deaths, and the well-known increase in false positives, unnecessary biopsies, and increased health care costs, as well as increased overdiagnosis and overtreatment.

In particular, when deciding on annual surveillance for high-risk women, these elements should be taken into consideration.

Clinicians should also engage patients in discussions about the importance of lifestyle (limiting alcohol, avoiding obesity, regular exercise) to reduce breast cancer risk.

Research will be needed to improve the coherence of reports on breast density and the quality of communication.

Additional research will also be essential to judge the long-term outcomes of complementary imaging to determine whether the benefits outweigh the harms.

But the authors point out that such studies will be increasingly difficult to conduct if the use of complementary imaging is routinely incorporated into screening mammography in women with dense breasts, which is currently the case (Editor's note).

Bibliography

[1]  see for example the software

Mammorisk http://mypebs.cancer-rose.fr/le-logiciel-mammorisk/

[2] http://sante.lefigaro.fr/article/les-seins-denses-un-risque-accru-de-tumeur/  itw du Dr Cutuli à propos d'une étude du NEJM de 2007( https://www.nejm.org/doi/full/10.1056/NEJMoa062790 )

[3] Wolfe JN. Breast patterns as an index of risk for developing breast cancer. AJR 1976;126:1130-9.

Breast patterns as an index of risk for developing breast cancer

JN Wolfe - American Journal of Roentgenology, 1976 - Am Roentgen Ray Soc

[4]  2011 Annals of Internal Medicine Personalizing Mammography by Breast Density and Other Risk Factors for Breast Cancer: Analysis of Health Benefits and Cost-Effectiveness- John T. Schousboe, MD, PhD; Karla Kerlikowske, MD, MS; Andrew Loh, BA; and Steven R. Cummings, MD
https://annals.org/aim/article-abstract/747009/personalizing-mammography-breast-density-other-risk-factors-breast-cancer-analysis?doi=10.7326%2f0003-4819-155-1-201107050-00003

"Mammographic screening should be individualized based on a woman's age, breast density, history of breast biopsy, family history of breast cancer, and knowledge regarding the benefits and harms of screening." 

[5] https://www.researchgate.net/publication/273154592_The_Contributions_of_Breast_Density_and_Common_Genetic_Variation_to_Breast_Cancer_Risk

The Contributions of Breast Density and Common Genetic Variation to Breast Cancer Risk
Article (PDF Available) in JNCI Journal of the National Cancer Institute 107(5) · May 2015 with 77 Reads
DOI: 10.1093/jnci/dju397 · Source: PubMed
Celine M Vachon

[6] McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006;15(6):1159–1169
https://www.ncbi.nlm.nih.gov/pubmed/16775176

[7] KERlikowske K, Cook AJ, Buist DS, et al. Breast cancer risk by breast density, menopause, and postmenopausal hormone therapy use. J Clin Oncol. 2010;28(24):3830–3837.
https://www.ncbi.nlm.nih.gov/pubmed/20644098

[8] https://link.springer.com/article/10.1007/s10549-011-1853-z

Breast Cancer Research and Treatment
May 2012, Volume 133, Issue 1, pp 1–10| Cite as

Risk prediction models of breast cancer: a systematic review of model performances Thunyarat Anothaisintawee, Yot Teerawattananon, Chollathip Wiratkapun

"Most (risk prediction) models have produced relatively low discrimination in internal and external validations. This low discriminative accuracy of existing models may be due to a lack of knowledge of risk factors, heterogeneous subtypes of breast cancer, and different distributions of risk factors among populations." 

[9] McCarthy AM, WE Barlow, Conant EF, et al; Consortium PROSPR. Cancer du sein de mauvais pronostic diagnostiqué après mammographie de dépistage avec résultats négatifs.  JAMA Oncol . 2018; 4 (7): 998-1001. doi: 10.1001 / jamaoncol.2018.0352 

ArticlePubMedGoogle ScholarCrossref

"Breast density has received much attention as a primary factor identifying the need for additional screening, but it may be more effective to consider both breast density and age to identify women at risk for poor prognosis breast cancer."

[10] Gierach GL, Ichikawa L, Kerlikowske K, et al. Relation entre la densité mammographique et la mortalité par cancer du sein dans le Consortium de surveillance du cancer du sein.  J Natl Cancer Inst . 2012; 104 (16): 1218-1227. doi: 10.1093 / jnci / djs327

"High mammographic breast density was not associated with risk of death from breast cancer or any cause after controlling for other patient and tumor characteristics. Thus, risk factors for breast cancer development may not necessarily be the same as factors influencing risk of death after breast cancer development."

[11] https://www.has-sante.fr/portail/upload/docs/application/pdf/2014-05/depistage_du_cancer_du_sein_chez_les_femmes_a_haut_risque_volet_1_vf.pdf

Page 53

[12] https://jamanetwork.com/journals/jama/fullarticle/2733521

May 9, 2019

New federal requirements to educate patients about breast density will help patients?

Nancy L. Keating, MD, MPH 1,2; Lydia E. Pace, MD, MPH 2,3

Dr. Nancy L. Keating is Professor, Health Care Policy, Harvard Medical School, Associate Physician, Medicine, Brigham And Women's Hospital

[13] Hoeven J. An Appropriations Bill Relating to Agriculture, Rural Development, Food and Drug Administration Appropriations, 2019, S 115-259, 115th Congress, 2nd Session (2018). https://www.congress.gov/congressional-report/115th-congress/senate-report/259/1?q=%7B%22search%22%3A%5B%22farm%22%5D%7D

[14] The Food and Drug Administration is the U.S. Food and Drug Administration.

[15] Melnikow J, JJ Fenton, Whitlock EP, et al. Supplemental breast cancer screening for women with dense breasts: a systematic review for the US Preventive Services Task Force. 

Ann Intern Med . 2016; 164 (4): 268-278. doi: 10.7326 / M15-1789PubMed 

(USPSTF, United States Preventive Services Task Force is an independent U.S. preventive services task force of primary care and prevention experts that systematically reviews evidence of effectiveness and develops recommendations for clinical preventive services).

16] Positive predictive value, which is the likelihood that the subject actually has cancer when he or she has a positive test.

[17] Office of Policy, Planning, Legislation and Analysis, Office of the Commissioner, Food and Drug Administration. Mammography Quality Standards Act; Amendments to Part 900 Regulations: File No. FDA-2013-N-0134.

Mammography Quality Standards Act; Amendments to Part 900 Regulations (Proposed Rule) Regulatory Impact Analysis

https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/mammography-quality-standards-act-amendments-part-900-regulations-proposed-rule-rule-regulatory-impact-


Cancer Rose est un collectif de professionnels de la santé, rassemblés en association. Cancer Rose fonctionne sans publicité, sans conflit d’intérêt, sans subvention. Merci de soutenir notre action sur HelloAsso.


Cancer Rose is a French non-profit organization of health care professionals. Cancer Rose performs its activity without advertising, conflict of interest, subsidies. Thank you to support our activity on HelloAsso.