Author: Cancer Rose

In August 2017 the National Cancer Institute (INCa) published a new information booklet on breast cancer screening entitled: "Breast cancer screening; be informed and decide". (1)

INCa presents this booklet on its website as follows: "This booklet is intended for women aged 50 who are invited for the first time to have a breast cancer screening test. It is intended to be joint to the invitation letter. By answering the main questions about breast cancer and screening tests, the booklet enables women to make an informed decision in response to the invitation. It can also be distributed at information meetings. »

In September 2017 we conducted a critical analysis of this booklet.

Three years later, in January 2021 we can make the observation that nothing has been changed in the content of this booklet.

________________________________________

September 17, 2017

Cécile Bour, MD
Marc Gourmelon, MD
Philippe Nicot, MD

The National Cancer Institute (INCa) has published a new information booklet on breast cancer screening entitled: "Breast Cancer Screening; Be Informed and Decide". (1)

The 2016 citizens' consultation had clearly pointed out the miscommunication and misinformation committed in the past by the institute, on page 85 of the full report available at the following link  http://www.concertation-depistage.fr/wp-content/uploads/2016/10/depistage-cancer-sein-rapport-concertation-sept-2016.pdf

"...the public consultation on organized breast cancer screening...highlighted the very limited information available to women on this screening. And for the information specifically intended for them, we note that this information does not include any mention of the controversy of which it has been the subject for several years, nor of the existence of real uncertainty regarding the benefit/risk ratio, nor of its limits...".

The criticisms on the communication provided by the INCa, fragmented, sometimes contradictory, tendentious, unclear on the over-diagnosis, continue from page 87 to 95.

Two studies published in the British Medical Journal (one Australian, the other by researchers from the Nordic Cochrane Collaboration) listed 17 key points that should be addressed in brochures on breast cancer screening, for a scientific and objective information. (2,3)

We used these 17 scientific criteria to evaluate the INCA booklet on breast cancer screening by mammography and to determine whether, in accordance with the requests of the citizen's consultation, the Institute has met the expectations for improving the quality of information.

For details of these two studies, see Dr. Nicot's article in Voix Médicales: http://www.voixmedicales.fr/2011/11/14/depistage-organise-du-cancer-du-sein-information-ou-communication/

ARTICLE PLAN
PART I: Analysis according to the 17 criteria
PART II: Other issues raised

PART I: The 17 key points to assess the quality of the information

These 17 key points are :

    1. Lifetime risk of developing breast cancer.

    2. Lifetime risk of dying from breast cancer.

    3. Survival after breast cancer.

    4. Relative risk reduction.

    5. Absolute risk reduction.

    6. The number of women who need to be screened to avoid death from breast cancer.

    7. Proportion of women who will be recalled.

    8. Proportion of breast cancer detected (sensitivity).

    9. Proportion of women without breast cancer who are screened positive (lack of specificity/false positive).

    10. Proportion of women with a positive test who have cancer (positive predictive value).

    11. Reduction of the relative risk of total mortality.

    12. Carcinoma in situ.

    13. Over-diagnosis.

    14. Over-treatment.

    15. Effect of screening on the number of mastectomies.

    16. Relative risk of radiotherapy, psychological distress in relation to false positives.

    17. Pain during mammography.

These 17 key points were reviewed in the new brochure issued by INCa in order to assess its informative value as objectively as possible.

1. Lifetime risk of developing breast cancer.

The brochure answers this first point: 3 out of 100 women aged 50 will develop breast cancer within 10 years. The different risk factors are detailed on page 4.

2. Lifetime risk of dying from breast cancer.

The question which, indeed, is of most interest to women is: what is the real risk of dying from breast cancer? "We can measure the risk of dying from breast cancer in France, in 2010 this risk was 4.1%...., of which 1.9% was between 50 and 79 years of age". (4)

This data is not present in the booklet of the INCa.

3. Survival after breast cancer

The brochure talks about it and highlights the 99% survival rate for cancer detected "early". But without explaining what this means.

" Survival" is rather a measure of a cancer lifetime

It gives an optical illusion: by anticipating the date of "birth" of the cancer detected during a screening, one has the impression of a longer life after cancer, whereas the lifetime of the person is in no way changed. Let's take a life expectancy for a given woman of 73 years, if this woman is diagnosed with cancer by screening at the age of 67, she will enter the 5-year survival statistics. If the diagnosis is made later, around the age of 72, when a symptom occurs for example, then this same woman will not be included in the survival statistics. Survival at 5 years leads to an illusion of success, whereas the life expectancy of women in France has not changed at all since screening is performed.

4. 5. 11. Relative risk reduction. Absolute risk reduction.

On page 8 it is written: "International studies estimate that these programs prevent between 15% and 21% of breast cancer deaths. "

This is an indication of relative risk only. The editors are ignoring the claim of women citizens to stop being fooled by numbers that do not mean what they seem to say. The 20% fewer deaths does not mean that 20 less women out of 100 will die of breast cancer, if they get screened.

This 20% corresponds only to a relative risk reduction between two comparative groups of women.

In fact, according to a projection made by the Cochrane Collective (6) based on several studies, 4 out of 2,000 women screened over 10 years, die of breast cancer; 5 out of a 2000 women group not screened over the same period of time, will die of breast cancer, the change from 5 to 4 mathematically corresponds to a 20% reduction in mortality, but in absolute terms only one woman's death will be avoided (absolute risk of 0.1% or 0.05%).

Actually, this corresponds to an absolute risk reduction of 0.05% (1 woman in 2000) to 0.1% (1 woman in 1000) at the end of 10 to 25 years of screening, according to the estimates used (American journals, Prescrire magazine, US TaskForce). (5)

This is why the citizens had requested during the citizen consultation a presentation based on real data, and not on percentages that embellish the situation.

6. The number of women needed to be screened to prevent a breast cancer death

We search unsuccessfully for this indication. According to the Cochrane Collaboration synthesis, for example, 2000 women must be screened over 10 years in order to find a benefit of a life saved through screening. (6)

7. Proportion of women who will be recalled.

One of the causes of recalling women is the examination judged "technically insufficient" by the second reader who receives the images validated by the first reader, but which he considers insufficiently well done. This causes additional anxiety for the patients, and of course, additional irradiation, due to the sometimes very formalistic questions of incidence.

The second cause of recall and not the least are false positives, i.e. a positive screening test for a woman who does not present a cancerous lesion (which overlaps with criterion n°9).

8. Proportion of breast cancer detected (sensitivity).

9. Proportion of women without breast cancer who have a positive detection (lack of specificity/false positives).

10. Proportion of women with a positive test who have cancer (positive predictive value).

The brochure announces well in " To know" section on page 11: "The false positive - In most cases, it turns out that the abnormalities discovered are benign and that it is not cancer. This is referred to as a false positive", but without giving the proportion, the criterion is therefore not met.

We provide you with the estimate according to Prescrire magazine, Cochrane and US Task Force: out of 1,000 to 2,000 women screened over a period of 10 to 25 years, depending on the synthesis, between 200 and 1,000 women will receive a false alarm, leading to at least 200 unnecessary biopsies. (5)

This precise data is not included in the brochure.

We recommend that our readers refer to the explanations provided on our site: https://www.cancer-rose.fr/cancer-du-sein-un-peu-de-technique/.

12. Carcinoma in situ.

This point is not addressed at all.

In the cancer statistics posted on INCa site, only invasive cancers are considered. However, in situ cancers, which are the main cause of over-diagnosis, are estimated to account for 15 to 20% of breast cancers. They are all the more frequent, as participation in screening is important. Most of the cancers qualified as "early detected" are in situ cancers for which it is known that treatment does not change much the prognosis, since most of them would not have developed.

When a non-fatal disease is treated unnecessarily, it is normal that survival (see criterion 3) is high.

The booklet does not address this issue.

13. Over-diagnosis.

14. Over-treatment.

Over-diagnosis is addressed on page 7, but only briefly.

The problem of over-treatment is not mentioned.

15. The effect of screening on the number of mastectomies.

This issue is not addressed. Large scale international studies (Harding (7)) as well as meta-analyses of the Prescrire review (8, 9 ,10) and the Cochrane Collaboration (6) ) show a significant increase in mastectomies, radiotherapy and chemotherapy since screening, while the detected lesions are more and more smaller in size.

16. The relative risk of radiotherapy, psychological distress in relation to false positives.

This point is not addressed.

17. Pain during mammography.

This point is discussed on page 9.

Let's now do the math: of the 17 key points for informed and objective information, only 5 are addressed in the INCa brochure (no. 1, no. 3 although imperfectly, no. 4 but without explanation, no. 13, no. 17).

PART II: Other points of concern

A-Studies

The INCa booklet mentions the scientific controversy over screening, which it refers to as being based on "few studies and difficult to compare".

According to INCa, the debate is not about whether lives are saved, but about how many lives are saved.

However, since the 2000s, numerous studies have been regularly published in the major independent international journals (New England Journal of Medicine, British Medical Journal, JAMA, Lancet, etc.).

The studies cannot be described as "few" when, on the contrary, they abound.

For example, we will cite only three of the major studies published in recent years: Bleyer Welch, 2012 (11), A. Miller, 2014 (12), Harding, 2015 (7).

The first shows the rise in breast cancer incidence since the introduction of screening without a decrease in the most severe forms. The second shows the absence of significant impact of screening on mortality, revealing identical survival rates regardless of the stage of cancer in two groups of women compared, one group screened and the other not, with a follow-up at 25 years.

Finally, the third shows that a 10% increase in participation in screening leads to a 16% excess of diagnosis without any impact on mortality, but with a surge in less aggressive forms, stability of advanced forms, and a significant increase in the most severe treatments.

It is not clear which studies enable INCa to assert that the debate would not be about saving lives because it is not possible to identify any significant decrease in mortality.

B-The radiation delivered

Concerning X-rays during a mammographic examination, for which the dose required after 50 years would be lower (page 12), the problem is not the low dose theoretically delivered, but the reality of the repetition of doses, no matter how low they are.

Moreover, quite frequently, several incidences per breast are necessary, their dose being added to those of the routine examination.

The real problem, however, is radiation for therapeutic purposes in the case of over-treatment, which is itself a consequence of over-diagnosis by mammography, with real and serious consequences on health (coronary heart disease, radiation-induced cancers of the oesophagus, skin, mediastinum and lung).

C-Natural history of the disease

On page 3, we find :

"In general, the earlier breast cancers are detected, the greater the chances of a cure.
"

There is confusion between the smallness of the cancer detected and its early detection.

A small cancer is not synonymous with early detection, it can be small and be present for many years without ever manifesting itself. A large lesion is not necessarily late either, it may have developed in a very short period of time, which is often the case with what are called interval cancers. These rapid cancers are often the most aggressive, occurring after a normal mammogram and before the next one scheduled two years later. Screening cannot anticipate them.

The problem is the insufficient knowledge of the natural history of cancer, which the booklet itself admits on page 2, where it says that there are several types of cancer evolution and kinetics. This would justify treating all cancers, according to the booklet (page 7) which threatens that a woman who is not screened regularly, will inevitably have a more advanced cancer, a heavier treatment and a reduced chance of recovery.

"If you develop breast cancer and you have not been screened regularly, the cancer will be diagnosed at a more advanced stage. This will reduce the chances of a cure and have a greater impact on your quality of life. Indeed, heavy treatment, sometimes dangerous, and its consequences are significantly greater in the presence of cancer diagnosed at an advanced stage".

There are two problems with this statement. It is needlessly alarmist and is not based on any studies, the real question being "What are the benefits of not getting tested? "(The brochure asking this one, page 7: "What are the risks of not being screened for breast cancer?"). The assertion that the burden of treatment is reduced thanks to "early" detection is contradicted by the Harding study (7) in the United States, by the meta-analyses of Cochrane (6) and the Prescrire Review (8 9 10), which report an increase in chemo- and radiotherapy, with consequences in the form of thrombo-embolic, cardiac and radiation-induced neoplasia complications not even mentioned in the booklet. These studies and meta-analyses also objectivize the increase in mastectomies, which logically should drastically decrease since the lesions discovered are smaller in size. Hence the second subsequent question: "What is the situation in France with regard to the promised decrease in total mastectomies, and what is the status of the evaluation?"

D-Over-diagnosis

Overdiagnosis is quickly addressed in the booklet (page 7), we will not argue about its extent, as the latest studies put forward the figure of 50%. However, justifying the treatment of all cancers with the same aggressiveness, because we do not know how to apprehend, it is a rather lapidary approach to the problem.

The third source indicated by INCa at the bottom of the document refers to the "Handbooks of Cancer Prevention", which is presented here: https://www.youtube.com/watch?v=4ejAL_pzLGI

The CIRC (International Agency for Research on Cancer, Lyon) itself (from about 7:54 minutes) opts for a red coding ('missing or incomplete data') of over-diagnosis in the context of breast cancer screening.

IN CONCLUSION

The information quality score is therefore 5/17, i.e. 6/20.

Click here to enlarge:

In view of all these elements, this new INCa brochure does not seem to meet the expectations of the citizen consultation.

P.S. In the meantime, at the beginning of April 2018, the INCa has added references at the bottom of the document, but the sources added are only reports or legislative texts or sources from the INCa itself...

References

1 http://www.e-cancer.fr/Expertises-et-publications/Catalogue-des-publications/Livret-d-information-sur-le-depistage-organise-du-cancer-du-sein

2 Slaytor EK, Ward JE . How risks of breast cancer and the benefits of screening are communicated to women: analysis of 58 pamphlets.http://www.bmj.com/content/bmj/317/7153/263.full.pdf

3 Jørgensen KJ, Gøtzsche PC. Presentation on websites of possible benefits and harms from screening for breast cancer: cross sectional study. bmj.com 2004;328:148. Sur : http://www.bmj.com/content/328/7432/148.full.pdf+html

4 http://www.unaformec-idf.org/documents/lagny/KseinHill2014.pdf

5 https://cancer-rose.fr/en/2020/12/15/the-over-diagnosis-in-a-graph-and-a-table/

6 https://www.cochrane.org/CD001877/BREASTCA_screening-for-breast-cancer-with-mammography

7 http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2363025

8 Dépistage des cancers du sein par mammographie Deuxième partie Comparaisons non randomisées : résultats voisins de ceux des essais randomisés. Rev Prescrire. 2014 Nov;34(373):842–6.

9 Dépistage des cancers du sein par mammographie Première partie Essais randomisés : diminution de la mortalité par cancer du sein d’ampleur incertaine, au mieux modeste. Rev Prescrire. 2014 Nov;34(373):837–41.

10 Dépistage des cancers du sein par mammographies Troisième partie Diagnostics par excès : effets indésirables insidieux du dépistage. Rev Prescrire. 35(376):111–8.

11 http://www.nejm.org/doi/full/10.1056/NEJMoa1206809#t=article

12 http://www.bmj.com/content/348/bmj.g366

January 2, 2020, Marc Gourmelon, MD, Cécile Bour, MD

In 2016, the citizen and scientific consultation on organized breast cancer screening conducted in France, called to consider a halt of screening [1].

Moreover, the information posted on the INCa (National Institute of Cancer in France) website was described as "fragmented, difficult to identify, sometimes contradictory, overdiagnosis approached in an unclear manner".

In April 2018, our collective expressed its concern about the persistent lack of information in the INCa documents [2] [3], which again and again minimizes overdiagnosis and is silent on overtreatment.

We had expressed our concerns in a response letter published in CMAJ (Canadian Medical Association Journal) under the title  « Principles for Screening: Too few concerns for informed consent and shared decision making ? » [4] [5]. 

The principle of informed choice, promotion of autonomy and protection of the rights for screening participants is simple to implement, with pictograms [6] using absolute numbers. These pictograms use a consistent denominator, such as the benefits and harms associated with 1,000 screenings, based on evidence-based data.

Belgium has implemented this since 2013 for breast cancer screening.

On the other hand, French National Cancer Institute (INCa), like other French health agencies, is acting unethically, refusing to provide such information despite requests expressed during citizen and scientific consultation in 2016 and even a more recent request in the form of an open letter supported by the leading French consumer non-governmental organization UFCQC (UFC Que choisir). [7]

The inclusion breast cancer screening as an indicator in the ROSP (Remuneration of doctors for Public Health Objectives) french system was denounced during 2016 citizens' consultation [8].

With the legalization of an unbalanced information, as is proposed by INCa, this is absolutely outrageous.

The general practitioner is thus in a conflict of interest and he is still not trained on how to provide informed consent to the patient during the consultation.

A study in the Journal of Epidemiology and Public Health

A study published in the Journal of Epidemiology and Public Health [9] in December 2019, acknowledges that the information due to women and delivered by INCa it is still not up to standard.

The ostrich policy of the French authorities feeds heavy suspicions of interest links with "pro-detection" lobbies.

The current situation is unacceptable for women and their dignity in health.

This study is carried out in the perspective of creating a French decision aid tool in the context of organized breast cancer screening, in collaboration with INCa.

The study: Information about organized breast cancer screening. Do INCa and Cancer Rose meet the criteria for decision aid tools?

 1. Background

Controversies around organized breast cancer screening increase women's need for information. In France, the National Institute of cancer (INCa) is in charge of providing this information. Its mission is to "promote the appropriation of knowledge and best practices by patients, users of the healthcare system, the general population, healthcare professionals and researchers".

Cancer Rose (CR) site produces complmentary information, considering that the INCa's information is incomplete.

The objective of this study was to assess whether INCa and CR sites meet the IPDAS (International Patient Decision Aid Standards) [10] [11] criteria for decision aid tools.

 2. Method

A comparison of available tools is performed.

• For INCa, the video of the last campaign launched between September 23 and October 14, 2018, the press kit, the web platform, the information booklet and the information leaflet have been selected for analysis.
•  For Cancer Rose (CR), the different sections of the home page are: the information videos, the downloadable brochure and leaflet, the presentation, the studies section and the posters.

The information booklet and press kit for INCa and the studies section of the CR website were the documents meeting most IPDAS criteria [12].

The document meeting fewer criteria were the video for INCa and the information leaflet for Cancer Rose (a synthesis produced, after the exhaustive brochure, simply as a document that could be delivered to the patient at the end of the information consultation with the general practitioner).

Videos are more accessible tools for people with lower levels of so-called health literacy [13].

IPDAS criteria were used and an average was calculated using a software program.

3. Results

They are summarized into percentages in table 2, click on the image to enlarge:

It can be noticed that for all criteria Cancer Rose scores significantly better than INCa.

The data in this table are listed in the text, for example :

For INCa, the validated data on which the information was based were absent in the video and leaflet. The press kit contained references in the text or annotated at the bottom of the page. The two documents addressing the overall risks of organized screening, were the web platform and the information booklet. The campaign video addressed over-diagnosis and over-treatment without citing them: "Screening: zero risk or not? It happens sometimes that a cancer which wouldn't have progressed at all or only slightly, will be diagnosed and treated, the zero risk doesn't exist". Screening at an early stage was emphasized without describing the natural history of the disease. The advanced time to diagnosis, an IPDAS criterion, was not explained. »

This finding is serious and presented in a factual manner.

For Cancer Rose the authors write this:

"For Cancer Rose, apart from pain, the risks inherent to screening were all described (false positives, over-diagnosis and over-treatment in all the documents; interval cancers, false negatives, radio-induced cancers and anxiety in the videos). When describing the benefits, the documents described the absence of effect on overall mortality. The benefits of "a woman who avoids death from breast cancer and whose life may be somewhat prolonged" were immediately counterbalanced in the video discourse by "a woman who will succumb to a serious effect of the treatment, a treatment she would not have needed in the absence of screening".

The natural history of the different types of breast cancer was described. The data on which this information was based, was documented by references."

There is therefore a more than notable discrepancy between the information provided by INCa and that of the Cancer Rose collective.

Here is an illustration of these results in diagrams, with the kind permission to reproduce them from Jérémy Anso, author of these tables and editor of the site "Hard to swallow", Doctor of Science; see his article on the subject.

• Present criteria must be the most numerous
• Incomplete criteria, must be the least numerous
• Absent criteria must be the least numerous as well.
  
  

4. Discussion

4.1. MAIN RESULTS AND COMPARISON

• « The documents that best meet the IPDAS criteria are the information booklet and press kit for INCa and the Studies section for Cancer Rose.»
  However, without pointing out the disastrous figures of INCa compared to the higher scores obtained by Cancer Rose, this flagrant imbalance would have deserved to be further highlighted.

• « The INCa video scored 6.3% in terms of content versus 50% for the Cancer Rose video. »

"The video (from Cancer Rose, editor's note) appeared to the researchers as being more oriented towards the disadvantages/risks than the benefits/advantages. »

Thus, while the Cancer Rose video gets 50% and the INCa video gets 6.3%, the only criticism expressed is the one of a committed video from Cancer Rose, but to be fair, a comment on the insufficiency of INCa's video is missing.

The discussion is limited to this observation and then presents a paragraph praising the Canadian colleagues and their video support [14].

4.2. OUTLOOK

This can be summarized in the last sentence of the study :

« This study is carried out in the perspective of creating a French decision aid tool in the context of organized breast cancer screening, in collaboration with INCa. »

Summary 

This study demonstrates by the published figures, in the same way as we have pointed out in the past, that INCa is not fulfilling its function and its mission of information, as illustrates the comment comparing with our fellows in Canada.

"The Canadian Public Health Group on Preventive Health Care (supported by the Public Health Agency of Canada) provides women with a three-page general information document and one page documents by age (50-59, 60-69, 69-74). A 12-minute video is also available for viewing.

All of these tools encourage women to discuss screening with their family doctor. The video is very far from that of INCa in both form and content. "

This study even shows that INCa is doing "indigent" work, as evidenced by the 6.3% score obtained on its video. The authors, although transparent and factual in their results, hardly make the slightest criticism towards INCa. They do, however, acknowledge our work in the paragraph presenting the results.

Conclusion

According to the authors,the informational documents proposed by INCa require a high level of health literacy (or education, or alphabetization, see ref 12) from the public. On the other hand, videos are known as information tools that are more suitable for people with low health literacy levels.

At any moment INCa does not reach the average for the criteria expected to be present, reaching at best only 37.5%, which is very insufficient, where the Cancer Rose collective, with its own resources, which are those of the members and a few donations, reaches 62.5%.

With respect to the absent criteria, here again INCa is unbeatable with a maximum of 56.3% where Cancer Rose reaches only 25% of absent criteria.

Finally for incomplete criteria, INCa is still well ahead of us in all publications, reaching even 50% in 2 cases.

We are very satisfied that a review of epidemiology finally points out this problem of persistent institutional misinformation with regard to women.

We regret that this fact is mentioned only in the text of the document.

Unfortunately many readers often stop at reading the abstract.

It is unfortunate that there is no explicit questioning of the work of INCa, while this unethical and scandalous situation has persisted for many years already.

The mission of the French National Cancer Institute (INCa) is to "promote the appropriation of knowledge and best practices by patients, users of the healthcare system, the general population, healthcare professionals and researchers. As part of this mission, this agency provides tools and regularly conducts information campaigns", with a 2019 budget for prevention and screening of 6.4 million euros [15].

We would like that this public budget to be used for an objective information of women and not for the marketing of breast cancer screening by mammography.

For our part, of course, we admit the criticisms that have been made, of which we were already aware. The missing criteria and the scattered nature of our information will be corrected in a MOOC (Massiv Online Open Course) which is currently under construction and scheduled to be online in 2020. This tool, by its pedagogical and interactive nature, will compensate for these imperfections and will complete the information that the doctor and the patient need to make an informed decision in a collaborative exchange.

It is true that our information, in an assumed way, denounces more the risks than the benefit of screening, for two reasons:

• No authority, institution or information site denounce or inform women about the harm of screening in France.
• No recent studies since the 2000s have been able to demonstrate the proven benefits of screening, while publications alerting women to the risks are multiplying, including the growing over-diagnosis, a real public health issue.

References

[1] https://cancer-rose.fr/2016/12/15/nouvelles-du-front-premiere-manche/

[2] https://cancer-rose.fr/2017/09/17/analyse-critique-du-nouveau-livret-dinformation-de-linca/

[3] https://cancer-rose.fr/2018/02/11/2175-2/

[4] https://cancer-rose.fr/2018/04/25/reponse-dans-le-cmaj-principes-de-depistage-trop-peu-de-preoccupations-pour-un-  consentement-eclaire/

[5] https://www.cmaj.ca/content/190/14/E422/tab-e-letters#principles-for-screeni

[6] https://cancer-rose.fr/wp-content/uploads/2019/07/affiche_depistage-mammographiqueA4-2.pdf

[7] https://cancer-rose.fr/2018/03/30/lettre-ouverte-a-linstitut-national-du-cancer/

[8] https://cancer-rose.fr/en/citizen-consultation/

[9] https://www.sciencedirect.com/science/article/abs/pii/S039876201930522X?via%3Dihub

[10] http://ipdas.ohri.ca/

[11] https://decisionaid.ohri.ca/Azsumm.php?ID=1881 ; criteria listed at the bottom of the page

[12] International Patient Decision Aid Standards : https://decisionaid.ohri.ca/francais/

[13] https://www.santepubliquefrance.fr/docs/la-litteratie-en-sante-un-concept-critique-pour-la-sante-publique

[14] Canadian Task Force on Preventive Health Care. Cancer du sein (mise à jour). Calgary (Alberta) Canada: Screening tool involving 1000 people; 2018, . Available on https://canadiantaskforce.ca/tools-resources/cancer-du-sein- mise-a-jour/outil-de-depistage-aupres-de-1000-personnes/?lang=fr

[15] https://www.e-cancer.fr/Institut-national-du-cancer/Qui-sommes-nous/Budget

Be Wise!

Cécile Bour, MD

June 9, 2020

This blog is the testimony of a young woman, Donna Pinto, who decided to share her story after being diagnosed with breast ductal carcinoma in situ at age 44, in 2009. After a period of fear, Donna decided to do extensive research on her own and make informed choices. This is more than a sharing of personal experience, as the pages of "DCIS 411" also contain a wealth of valuable resources gathered here: https://dcis411.com/bewise/ , under the theme "be wise", calling for empowerment in health.

According to Donna «#BeW I S E is a woman’s health initiative with an urgent public health mission — to ensure all women are properly informed about serious potential harms of breast cancer screening. Conflicts of interest and well-funded marketing campaigns have created an imbalance of information — promoting a one-sided story of « life-saving » benefits of mammography while ignoring or downplaying serious harms».

"Be wise" recalls the more general "choosing wisely" movement calling for enlightened information of women for an informed and shared decision making, which we have recently discussed[1]... Obviously, there is a general public demand for transparency in health information, and for shared decision making, with all the data in hand.

Ductal carcinoma in situ (DCIS) [2]

DCIS are largely contributing to over-diagnosis.Trials and research indicate that increasing DCIS detection has not decreased mortality from breast cancer. DCIS accounted for less than 5% of all breast cancers before the screening era, rising to 15-20% in all countries where screening campaigns occur. They are not counted in the incidence figures (rate of new cases) given by the French National Cancer Institute, as they are considered separately and not as "true" cancers.

In addition, there is a lack of a real consensus among anatomo-pathologists for the classification of these lesions when analyzing the biopsies they receive, with a tendency to overclassify them in poorer prognosis categories, for fear of underestimating a "disease".

Most DCIS are considered to be non-mandatory precursor lesions to invasive cancer; paradoxically, the dramatic increase in their detection followed by their surgical ablation has not been followed by a proportional decrease in the incidence of invasive cancers.

The major problem is that these particular breast cancer entities are treated with the same aggressiveness as breast cancer.

In October 2015 a study carried out by University of Toronto came up with the following results:

    -Their treatment makes no difference to women's survival.

    - Women with DCIS are heavily treated (sometimes by bilateral mastectomy) and have the same probability of dying from breast cancer as women in the general population.

    - Treating DCIS does not decrease their recurrence.

    - Prevention of recurrence with either radiotherapy or mastectomy did not prevent death from breast cancer.

Similarly, our study of mastectomies in France revealed a steady increase in the number of surgical procedures, our first hypothesis being the overtreatment of lesions that are not invasive cancers, but so-called pre-cancerous lesions and DCIS [3] [4].

The long-term consequences of overtreatment can be life-threatening. For example, radiation therapy on these lesions appears to be ineffective in reducing the risk of death from breast cancer, but it is associated with a dose-dependent increase (10-100% over 20 years) in the rate of major coronary events. [5]

In several countries, clinical trials are being conducted to test a simple active surveillance, especially for low-grade DCIS, rather than aggressive treatment:

- COMET(US)

- LORIS(UK)

- LORD(EU)

For Philippe Autier [6], from the International Prevention Research Institute (IPRI), the problem is undoubtedly inherent to routine mammography, in particular digital mammography, which is too performant for the detection of small calcifications; these are the most frequent radiological sign of these forms, and the mammography has an excellent sensitivity for the detection of these microcalcifications.

You will find in our media library several clinical cases of carcinoma in situ, abusively called carcinoma [7].

Based on her experience, Donna created an informative blog to help women world-wide receive the same information and useful resources, as well as to provide a space for emotional support and connection.

The "resources" page contains, in addition to videos, a dotted visual "fact box" reflecting the risk/benefit balance of screening, similar to our poster published at the bottom of our home page, which can be downloaded.

Our opinion and conclusion

We applaud the presence of this blog, which will surely soothe and inform women who are certainly exaggeratedly frightened by DCIS, currently considered more as a marker of breast cancer risk than as true cancers, and whose detection is enhanced by intensive screening. DCIS percentage is steadily increasing, while their treatment has no impact on mortality. They contribute to over-diagnosis and over-treatment.

Ductal carcinomas in situ (DCIS) of the breast account for 85% to 90% of in situ breast cancers. These lesions are asymptomatic and frequently diagnosed during mammographic screening, particularly in the form of microcalcifications.

In France there is no recommendation to propose active surveillance as an alternative to local treatment, i.e. surgical removal, outside of supervised clinical trials.

All these resources are therefore very useful to know.

But even better would be the distribution of prior information to all women, before urging them to be screened, in order to give them the possibility of choice. The choice, among other options, is one of not opting for routine mammography, which does not save lives, which does not lower the rate of serious cancers, but instead increases the number of heavy treatments without any proven benefit, considering the three decades of experience that we now have with screening.

Driving citizens into a "disease" with screening tests that don't work, without informing them, is the worst thing in medicine, because it is selling lies by taking advantage of the trust that patients place in us.

References

[1] https://cancer-rose.fr/en/2020/12/15/less-is-more-medicine/

[2] See 10th point from the top, in the article https://cancer-rose.fr/en/2020/12/17/mammography-screening-a-major-issue-in-medicine/

[3] https://cancer-rose.fr/en/2020/12/17/our-study-does-organized-screening-really-reduce-the-surgical-treatments-of-breast-cancers/

[4] https://cancer-rose.fr/en/2020/12/17/explanation-of-our-study-on-mastectomies-in-france-carried-out-by-cancer-rose/

[5] SC Darby, M. Ewertz, P. McGale, AM Bennet, U. Blom-Goldman, D. Bronnum, et al.

Risk of ischemic heart disease in women after radiation therapy for breast cancer

N Engl J Med, 368 (11) (2013), p. 987-998

[6] https://cancer-rose.fr/en/2020/12/17/mammography-screening-a-major-issue-in-medicine/

[7] https://cancer-rose.fr/mediatheque/mediatheque-cas-cliniques/