Objective information and less acceptance of screening by women

Marc Gourmelon, MD, Cécile Bour, MD

September 8, 2020

A French study in 2016 showed that when women are given slightly more objective information about breast cancer screening by mammography, they are less likely to attend it.

https://www.oncotarget.com/article/7332/text/ : "Decision aid on breast cancer screening reduces attendance rate: results of a large-scale, randomized, controlled study by the DECIDEO group"

Background and methods

This study was conducted in 2016 by Aurélie BOURMAUD who was working at the time for the Cancer Institute of Loire Lucien Neuwirth 1408, Saint Priest en Jarez, France, very invested in screening as shown by her support for the events of October Rose [1].

She is now an Associate Professor in public health and currently works at the clinical epidemiology unit of the Robert Debré Hospital (Paris) and at the University Paris Diderot. Her research themes are prevention, patient education, complex intervention and patient care pathways.

The summary of his study indicates the following:

“The aim of this study was to assess the impact of a decision aid leaflet on the participation of women invited to participate in a national breast cancer screening program. This Randomized, multicentre, controlled trial. »

« 16 000 women were randomized and 15 844 included in the modified intention-to-treat analysis. »

« This large-scale study demonstrates that the decision aid reduced the participation rate. The decision aid activate the decision making process of women toward non-attendance to screening. These results show the importance of promoting informed patient choices, especially when those choices cannot be anticipated. »

In introduction is explained :

« Benefits in terms of mortality reduction are not clearly documented. It has been suggested that prevention campaigns should change from persuasive approaches to approaches based on information and women’s decision empowerment. »

In order to carry out this study, a decision support tool, DECIDEO, was distributed to the participants (Outil DECIDEO, in two languages starting on page 7).

« A decision aid, known as the DECIDEO leaflet, was developed following international guidelines for the ‘provision of information and the construction of decision aid tools ».

The hypothesis of this study was as follows:

« Our hypothesis was that this decision aid would increase informed choice in the intervention group. We estimated the effect of this written decision aid on informed choice, by measuring the participation rate of a population-based breast cancer screening. »

This 2016 study was brought to our attention because it is cited by Italian authors who demonstrated that manipulating the message to women likely to get screened by mammography, increases their participation in screening. We had recently analyzed this study (Italian study analysis).

The Italian study shows that information on the risks of screening reduces women's participation in breast screening, which is a real problem for the Italian authors. They therefore suggest manipulating the information given to women by selectively presenting the negative effects (according to them) of not getting screened.

What are the results of the 2016 study by A.Bourmaud et al.?

"The overall participation rate at 12 months (Table 2) was significantly higher in the control group: 42.13 per cent versus 40.25 per cent in the decision support group (p = 0.02). »

This clearly means that women participating in the decision support group were less likely to be screened than women in the control group.

In other words, when women are given information about screening, they attend less the screening. This finding is critical.

“This study is the first to compare a decision aid to real life: the control group consisted of women aged 50 to 74, receiving the usual information about screening. Our results are however in accordance with previous trials in this field suggesting a decreased attendance as results of the implementation of a decision aid on cancer screening”.

“Our results demonstrate that a decision aid, designed following specific guidelines, sent with a formal invitation to attend breast cancer screening, resulted in a lower attendance rate and a decrease in the delay of attendance for the women who did participate.”

This confirms what the recent Italian study showed: in order to increase participation in breast cancer screening by mammography, the information must be manipulated in the sense of less disclosure of the true risk/benefit balance of screening.

Discussion and analysis

A-Analysis of the tool

According to the authors themselves, the DECIDEO tool has some shortcomings, and not the slightest:

 "Another limitation (of the study, editor's note) is that recent data on over-diagnosis and over-treatment have not been implemented in the decision aid. »

These elements to be informed are however capital among the risks of screening.

The tool's figures (starting on page 8) are not referenced anywhere, and, as stated in the introduction, once again in the authors' own words: "The benefits in terms of mortality reduction are not clearly documented".

However, what women want to know first and foremost when they undergo a medical procedure is whether it can guarantee them less death from the disease and whether the procedure has no major side effects.

Overdiagnosis and overtreatment being the two major adverse effects of screening, there is clearly a form of manipulation by not communicating to women these two fundamental and essential data for their health and well-being.

Furthermore, it is noteworthy that contrary to what is implied by the references cited in the study (reference 26 on IPDAS criteria), this tool distributed to participants in the study does not meet IPDAS criteria in any way.

The IPDAS criteria are very specific items that the tool must meet in order to guarantee quality information[2]

The mention of overdiagnosis and over-reatment is thus an absolute imperative.

In this respect, we were already concerned about the shortcomings in the completeness and quality of the information provided by the National Cancer Institute itself, whose mission it is, however, to do it [3].

B-the ethical problem

In this study, as in the Italian one, the authors have a question that does not miss to surprise:

"the DECIDEO leaflet discouraged older women, as well as those with a low mean household income, from attending the national breast cancer screening program. “

Women with a lower educational level could have had difficulty in understanding the decision aid. Those two phenomena could partly explain the effect of the DECIDEO leaflet on those specific populations, additional studies being needed to confirm this hypothesis.

This hypothesis put forward by the authors, seems to come straight from their lack of knowledge of the social environment of modest women to which, it seems to us, "social class beliefs " are added.

Indeed, there is an aspect that is not at all addressed nor only mentioned by the authors, but that any "field" doctor understands very quickly, provided that he offers an attentive ear to the most socially and economically deprived patients. Low-income women, and even populations with a low socio-economic level in general, do not have such prohibitive problems of understanding that the authors of the DECIDEO group imply that they do, if indeed efforts are made to make medical information available to them.

On the other hand, these populations fear the disease much more than others. In fact, falling ill makes them even poorer and more ostracized; women who have low-paying jobs panic about losing this often thankless job and being deprived of an income that is indispensable to the family. The jobs of these women often require physical commitment (household, home work, labour); they know that they will no longer have the professional skills required of them after certain treatments, and they fear being further discredited as " ill " at the expense of society.  Further studies could demonstrate this, but simply by questioning these economically weak people, the diagnosis appears obvious to explain their lesser compliance with screening recommendations, of all kinds, moreover.

The actual questioning of the need to provide honest information that might decrease participation seems unethical to us, since the obligation to provide fair and complete information is stated in the law [4].

« In this large, randomized, clinical trial we observed that the DECIDEO decision aid resulted in decreased breast cancer screening attendance although it accelerated the decision to attend, for those women who did attend. These results suggest that this leaflet have accomplished its main purpose which was to inform the decision-making process. 

We believe that our results highlight the dilemma between the goals of population health initiatives and individual choices.”

Conclusion

This study went unnoticed.

And for reason, it proves that the more exhaustive the information given to women about breast cancer screening by mammography, the less they participate in the organized screening program set up and promoted by official structures.

And we are surprised that the DECIDEO form, far from meeting the IPDAS standards of exhaustive information on screening, achieves such results in terms of reduction in recourse to screening.

The more women are informed, the less incentive campaigns such as the Pink October campaign can reach them.

Screening uptake does not have strong evidence of an effect on mortality reduction, as stated at the outset in the introduction :

“Benefits in terms of mortality reduction are not clearly documented [10-13]. It has been suggested that prevention campaigns should change from persuasive approaches to approaches based on information and women’s decision empowerment ”

We must therefore stop trying to persuade women at all costs to get screened, stop manipulating the so-called decision-making tools to such an extent; on the contrary, we must inform them so that they can make an informed decision.

This is nothing less than the conclusions of the consultation on screening mammography in 2015 [5].

In the end, one rather amusing thing to note is that even with a biased decision support tool, such as DECIDEO is, women are very difficult to fool and send to a screening test to which, despite the misleading and pink incentives, they do not massively comply…

It therefore seems obvious to us that, as requested by the 2015 citizens' consultation, and in accordance with the ever-increasing scientific evidence on the ineffectiveness of mammography screening, this organized breast cancer screening by mammography need to be stopped in France.

Read also our previous article on the manipulation of women, as a scientific topic.

References

[1]https://www.icloire.fr/wordpress/icln-octobrerose2018/

[2]https://cancer-rose.fr/2020/01/22/faisabilite-dun-outil-daide-a-la-decision-sur-le-depistage-du-cancer-du-sein-a-la-francaise-selon-les-criteres-ipdas/

[3]https://cancer-rose.fr/en/2020/12/31/david-versus-goliath-which-is-better-at-informing-women-cancer-rose-or-national-institute-of-cancer-inca-in-france/

[4] Information is legally required in the french public health code: https://www.legifrance.gouv.fr/affichCode.do?idSectionTA=LEGISCTA000006196409&cidTexte=LEGITEXT000006072665&dateTexte=20180522

[5]https://cancer-rose.fr/en/2020/12/14/final-report-of-the-citizen-consultation-report-of-the-steering-committee/

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.

Scaling back in health care: more shared decision making and thoughtful consideration of recommendations

Identify recommendations for stopping or reducing unnecessary routine primary care

Summary by Cécile Bour, MD, September 15, 2020

September 14, 2020 "Identifying Recommendations for Stopping or Scaling Back Unnecessary Routine Services in Primary Care".

https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2770724

A study by Eve A. Kerr, MD, MPH; Mandi L. Klamerus, MPH; Adam A. Markovitz, BS; et al.

Eve A. Kerr is a Research Professor of Internal Medicine at the University of Michigan School of Medicine. She is an elected member of the American Society of Clinical Investigation and the Association of American Physicians, a Fellow of the American College of Physicians and a member and responsible for measures of Choosing Wisdom International. 

The concept of Less is More[1][2] medicine emerged in North America in 2010. It is an invitation to practice medicine with an awareness of the potential dangers of over-medicalization, challenging the principle that more medicine means better care.

In response, several medical societies around the world have launched campaigns focusing on choice and appropriateness of care (Choosing wisely [3]) and calling for discussion with patients about the usefulness of medical tests, treatments and procedures.

As the rate of discoveries in therapeutics slowed in the late 1980s, the focus shifted from the search for further innovation to a more reasonable application of existing knowledge. Evidence-based medicine (EBM) was born and is the current driving force for achieving a better level of general practice.

What is EBM?

The EBM is based on a tripod:

1) external experience, basically scientific studies

2) Internal experience: what we learn from our professional practice

3) patient preferences and values.

Among these criteria, guidelines, or recommendations, serve as standards to facilitate medical practice.

Guidelines are a kind of... ways developed to help clinicians and patients make better decisions together, in a spirit of sharing perspectives, all in the best interests of the patient. 

But...

The guidelines, as the authors describe, generally act in the cumulative sense of 'more is better'. The solution proposed by the authors is that the guidelines should be reshaped in the sense of de-escalation, in order to achieve 'less is more'.

The problem often pointed out is that the guideline is the result of a more or less valid consensus reached among several experts. Uncertainties about the health processes that are analyzed by the experts are hardly mentioned and often replaced by the opinion of the expert(s). The independence of the experts can also be a subject of discussion...

Recommendations that drive decisions for patients and clinicians may unintentionally discourage real sharing in decision making, and encourage compliance with the guideline, or may result in rejection and less compliance, depending on the patient's values.

Another challenge is the need to re-evaluate the guideline over time as new knowledge about the risk-benefit balance becomes available.

In addition, we are continually witnessing an encouragement to do rather more tests and treatments, an incentive that is societal, administrative and financial at the same time, by remunerating doctors when including patients in screening procedures.

What does Kerr's study say, and what is its purpose?

The conclusion is that a large part of health care involves the agreed and routine use of medical processes as part of the treatment of chronic disease or as part of what is referred to as 'prevention'. It is the latter that interests us.

The authors argue that it is essential to stop these processes and health services when the evidence on their relevance changes, or if the benefits no longer outweigh the risks as is the case with screening. 

 Yet currently most guidelines focus on escalation of care and procedures, and provide few explicit recommendations for reducing or even stopping treatment and screening tests.

The objective of the Choose Wisely group is to develop a systematic, transparent and consistent approach to identifying, specifying and validating recommendations for deintensification in routine adult primary care [4].

A targeted review of existing guidelines and recommendations was conducted to identify and prioritize potential indications of deintensification. 

Validity of these recommendations is examined according to several items: high-quality evidence that deintensification is likely to improve patient outcomes, evidence that intense testing and/or treatment could cause harm in some patients, absence of evidence on the benefit of continued or repeated intense treatment or testing, and evidence that deintensification is consistent with high-quality care.

Finally, in this study, a total of 178 opportunities to deintensify primary care services were identified, 37 of which were validated as high-priority deintensification recommendations. To date, this is the first study to develop a model for identifying, specifying and validating deintensification recommendations that can be implemented and monitored in clinical practice.

Concerning screening, what are these recommendations for deintensification (de-escalation?)

There is no great revolution in this area except that in the additional recommendations given by Choosing Wisely, clinicians are no longer supposed to recommend screening for breast, colorectal, prostate or lung cancer without considering life expectancy (no screening if life expectancy is less than 10 years) and without considering the risks of screening: overdiagnosis and overtreatment.

This is in contrast to the USPSTF and American College of Physicians' guidelines that urge screening with a strong recommendation for women aged 50-74 years, and the American Cancer Society's recommendations for screening as young as 45 years, all of these bodies not considering information on overdiagnosis or overtreatment in the recommended age groups.

For prostate cancer screening, its non-recommendation is recalled by the Choosing Wisely group, which is asking for at least a shared decision aid for men who would like to be screened.

Conclusion

The guidelines for deintensification proposed by Choosing Wisely, although modest on screening, can initiate this necessary change that will enable health care professionals to reverse the trend of 'more care'.

But the evolution towards sharing medical decision making with patients cannot take place, in our opinion, without active assistance through decision support tools, and without the willingness of official health authorities to support practitioners.

Public health education is also needed. Between financial incentives (ROSP: remuneration of doctors on public health objectives in France) to physicians and societal messages to screen more and more (general public TV programs such as "naked stars" [5] and Pink October campaigns in France), there is for the moment only a very timid effort to achieve this informed sharing, too little academic training in this sense (despite local initiatives in medical schools), and certainly too little official and media support to make it clear that it is in the best interests of patients to review our practices towards a deintesification of routine care.

References 

[1] https://www.revmed.ch/RMS/2013/RMS-381/Less-is-more

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

[3] http://www.lessismoremedicine.com/blog/tag/choosing+wisely

[4] https://www.irdes.fr/documentation/syntheses/soins-de-sante-primaires.pdf Primary care includes : - prevention, screening, diagnosis, treatment and follow-up of patients; - dispensing and administration of drugs, medical products and devices, as well as pharmaceutical counselling; - orientation in the health care system and the medico-social sector; - health education.

[5]https://cancer-rose.fr/2020/02/06/ah-mais-quelle-aubaine-ce-cancer/

 

 

 

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.

Carcinoma in situ, the problem of its overdiagnosis in screening mammography

Cécile Bour, MD

October 21, 2020

What is carcinoma in situ?

Carcinoma in situ (CIS) of the breast is defined by the proliferation of cancer cells within a milk duct without the cells spreading beyond the wall of the duct into the rest of the breast.

It is either strict ductal, developing in the milk excretory duct (ductal carcinoma in situ or DCIS), or in the lobule, the excretory unit around the duct (lobular carcinoma in situ or LCIS).

We have synthesized the main information in a summary for quick reading here: https://cancer-rose.fr/en/2020/11/30/what-is-a-ductal-carcinoma-in-situ-dcis/

In the media library you will also find some examples of images:

A very interesting blog by Donna Pinto is dedicated to DCIS with a lot of very practical and useful information: https://dcis411.com/

Ductal carcinoma in situ (DCIS) was rarely diagnosed before the introduction of breast screening, and now it accounts for 20-25% of all breast cancers, with this increase being directly correlated to over-detection by national routine breast cancer screening programs. 

Yet most DCIS lesions remain indolent. 

The problem

Despite being a pre-invasive or even non-invasive lesion, and although the natural evolution of this intra-ductal process is unknown, DCIS is still considered the early, non-obligatory form of (stage 0) breast cancer. The fear of not being able to distinguish between harmless lesions and potentially invasive forms, leads to over-treatment of this condition in many patients.

Therefore the classical patient management, and also in France, is to treat all DCIS lesions with a treatment that includes either mastectomy or breast conservative surgery supplemented by radiotherapy. 

The Marmot report in the United Kingdom (screening assessment report, 2012), recognized the burden of excessive treatment on women's well-being[1]. 

As a matter of fact, women with DCIS are labeled as "cancer patients", with concomitant anxiety despite the fact that most DCIS lesions are unlikely to ever progress to invasive breast cancer. ... The inflicted treatment (surgery followed or not by  radiotherapy) is therefore excessive for some, and very likely for many women, having a strong negative impact on their quality of life.

This particular form of cancer, that some call "pre-cancer" or " false cancer",  and some even consider as a non-cancer and only as a risk marker for breast cancer, greatly contributes to overdiagnosis, i.e. the discovery of abnormalities that, if they had remained unknown, would never have endangered the woman's life or health.

The problem with DCIS is that it is very easily revealed by mammography because of its association with calcifications, which are easily detected by mammography.

The data

The number of women diagnosed with DCIS in recent decades follows largely the introduction of  breast cancer mass screening, and is growing in parallel with the participation in screening[2] [3] [4] [5] [6].

The European standardised rate (i.e. the age-adjusted rate for the European population) of in situ lesions has quadrupled from 4.90 per 100,000 women in 1989 (representing 4.5% of all registered breast cancer diagnoses) to 20.68 per 100,000 women in 2011 (representing 12.8% of all registered breast cancer diagnoses[7] ). Of all reported in situ breast lesions, 80% are DCIS [8] [9].

Nevertheless, the incidence of breast cancer mortality has not decreased with the detection and treatment of DCIS, indicating that the management of DCIS does not reduce specific mortality from breast cancer.

A review of autopsies in women of all ages revealed a median prevalence (existing cases) of 8.9% (range 0-14.7%).  For women over 40 years of age, this prevalence was 7-39% [10], whereas breast cancer is diagnosed in only 1% of women in the same age group [11]. 

This means that these lesions are present more frequently than they are diagnosed in women in the living population, and that a large number of women carry undetected DCIS that would never become symptomatic, since more of them are found in women who have died from other causes than in the living population at the same time.

Classical lobular carcinoma in situ (LCIS), on the other hand, confers a risk of 1-2% per year of developing into invasive disease[12] [13].

What is also known, is that the stage of carcinoma in situ detected, is not a good and reliable indicator of the risk of progression of this lesion [14] [15].

In addition, patients diagnosed with DCIS have an excellent breast cancer specific survival rate, of approximately 98% after 10 years of follow-up [16] [17] [18] [19] and a normal life expectancy. If low-grade DCIS (considered a low-risk lesion) progresses to invasive breast cancer, it will often be a slow-growing, early-detectable, lower-stage invasive disease with an excellent prognosis.

However, despite this excellent prognosis and normal life expectancy, women diagnosed with DCIS suffer from stress and anxiety [20].  Studies report that most women with DCIS (and early breast cancer) have little knowledge about their condition and have misperceptions about the risk of disease progression, and this misperception is associated with significant psychological distress [21] [22] [23] [24] [25] [26].

In view of all these elements, it is considered that the current management of DCIS involves excessive treatment.

The problem of overtreatment

Currently, a conservative breast treatment for DCIS is frequently recommended. A mastectomy is advised if the DCIS is too large to allow breast conservation. Radiotherapy is often combined, which has been proven effective in reducing the risk of local recurrence.

However, it is also known that treating ductal carcinoma in situ does not reduce breast cancer mortality; also preventing recurrence by radiotherapy or mastectomy has also been shown not to reduce the risk of breast cancer mortality. Treatment would also not extend either breast cancer-specific survival or overall survival [27].

Due to the side effects of hormone therapy and ambiguous clinical trial results, postmenopausal women with DCIS are rarely treated with endocrine therapy in many countries. 

Some leads

Given the disappointing results of DCIS management in terms of reduction of invasive cancers, considering the absence of impact on survival, the implementation of treatments that were ultimately too severe for the results observed, and the major psychological impact, several countries have undertaken clinical trials aimed at testing a simple active surveillance, particularly for low grade CIS, rather than aggressive treatment.

Three clinical trials have randomized patients with low risk DCIS into two groups, one group under active surveillance versus one group receiving standard therapy. 

- COMET(US) [28] [29]
- LORIS(UK) [30]
- LORD(EU) [31]

A research program (PRECISION) has been initiated, encompassing these 3 international trials. https://www.dcisprecision.org/wp-content/uploads/2020/08/DCIS-Nieuwsbrief-Final_140820.pdf

CONCLUSION

There is an uncertainty regarding the manner in which DCIS develops, and there is a lack of global consensus on the best way to manage this lesion in an optimal manner. 

A better understanding of the biology of DCIS and the natural course of the disease is needed to help patients and health care professionals make more informed treatment decisions, to reduce the current over-treatment of DCIS that results in physical and emotional harm to patients and unnecessary costs to society. 

There is even an urgent need to reframe patients' perceptions of risk.

Initiatives and trials will hopefully contribute to better knowledge and informed decision-making between patients and clinicians.

Read also: https://www.nature.com/articles/s41416-019-0478-6

References

[1] Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet 380, P1778–P1786 (2012).

[2] Bleyer, A. & Welch, H. G. Effect of three decades of screening mammography on breast-cancer incidence. N. Engl. J. Med.367, 1998–2005 (2012).

[3] Bluekens, A. M., Holland, R., Karssemeijer, N., Broeders, M. J. & den Heeten, G. J. Comparison of digital screening mammography and screen-film mammography in the early detection of clinically relevant cancers: a multicenter study.Radiology 265, 707–714 (2012).

[4] Ernster, V. L., Ballard-Barbash, R., Barlow, W. E., Zheng, Y., Weaver, D. L., Cutter, G. et al. Detection of ductal carcinoma in situ in women undergoing screening mammography. J. Natl. Cancer Inst. 94, 1546–1554 (2002).

[5] Esserman, L. J., Thompson, I. M. Jr. & Reid, B. Overdiagnosis and overtreatment in cancer: an opportunity for improvement.JAMA 310, 797–798 (2013).

[6] Kuerer, H. M., Albarracin, C. T., Yang, W. T., Cardiff, R. D., Brewster, A. M., Symmans, W. F. et al. Ductal carcinoma in situ: state of the science and roadmap to advance the field. J. Clin. Oncol. 27, 279–288 (2009).

[7] https://www.nature.com/articles/s41416-019-0478-6

[8] Kuerer, H. M., Albarracin, C. T., Yang, W. T., Cardiff, R. D., Brewster, A. M., Symmans, W. F. et al. Ductal carcinoma in situ: state of the science and roadmap to advance the field. J. Clin. Oncol. 27, 279–288 (2009).

[9] Siziopikou, K. P. Ductal carcinoma in situ of the breast: current concepts and future directions. Arch. Pathol. Lab. Med.137, 462–466 (2013).

[10] Welch, H. G. & Black, W. C. Using autopsy series to estimate the disease ‘reservoir’ for ductal carcinoma in situ of the breast: https://www.acpjournals.org/doi/10.7326/0003-4819-127-11-199712010-00014

[11] Siziopikou, K. P. Ductal carcinoma in situ of the breast: current concepts and future directions. Arch. Pathol. Lab. Med. 137, 462–466 (2013).

[12] Lakhani, S. R., Audretsch, W., Cleton-Jensen, A. M., Cutuli, B., Ellis, I., Eusebi, V. et al. The management of lobular carcinoma in situ (LCIS). Is LCIS the same as ductal carcinoma in situ (DCIS)? Eur. J. Cancer 42, 2205–2211 (2006).

[13] Ottesen, G. L., Graversen, H. P., Blichert-Toft, M., Christensen, I. J. & Andersen, J. A. Carcinoma in situ of the female breast. 10 year follow-up results of a prospective nationwide study. Breast Cancer Res. Treat. 62, 197–210 (2000).

[14] Elshof, L. E., Schaapveld, M., Schmidt, M. K., Rutgers, E. J., van Leeuwen, F. E. & Wesseling, J. Subsequent risk of ipsilateral and contralateral invasive breast cancer after treatment for ductal carcinoma in situ: incidence and the effect of radiotherapy in a population-based cohort of 10,090 women.Breast Cancer Res. Treat. 159, 553–563 (2016).

[15] Bijker, N., Peterse, J. L., Duchateau, L., Julien, J. P., Fentiman, I. S., Duval, C. et al. Risk factors for recurrence and metastasis after breast-conserving therapy for ductal carcinoma-in-situ: analysis of European Organization for Research and Treatment of Cancer Trial 10853. J. Clin. Oncol.19, 2263–2271 (2001).

[16] Worni, M., Akushevich, I., Greenup, R., Sarma, D., Ryser, M. D., Myers, E. R. et al. Trends in treatment patterns and outcomes for ductal carcinoma in situ. J. Natl. Cancer Inst.107, djv263 (2015).

[17] Morrow, M. & Katz, S. J. Addressing overtreatment in DCIS: what should physicians do now? J. Natl. Cancer Inst. 107, djv290 (2015).

[18] Fisher, E. R., Dignam, J., Tan-Chiu, E., Costantino, J., Fisher, B., Paik, S. et al. Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) eight-year update of Protocol B-17: intraductal carcinoma. Cancer 86, 429–438 (1999).

[19] Elshof, L. E., Schmidt, M. K., Rutgers, E. J. T., van Leeuwen, F. E., Wesseling, J. & Schaapveld, M. Cause-specific mortality in a population-based cohort of 9799 women treated for ductal carcinoma in situ. Ann. Surg. 267, 952–958 (2017).

[20] Ganz, P. A. Quality-of-life issues in patients with ductal carcinoma in situ. J. Natl. Cancer Inst. Monogr. 2010, 218–222 (2010).[21] Hawley, S. T., Janz, N. K., Griffith, K. A., Jagsi, R., Friese, C. R., Kurian, A. W. et al. Recurrence risk perception and quality of life following treatment of breast cancer. Breast Cancer Res. Treat. 161, 557–565 (2017).

[22] Ruddy, K. J., Meyer, M. E., Giobbie-Hurder, A., Emmons, K. M., Weeks, J. C., Winer, E. P. et al. Long-term risk perceptions of women with ductal carcinoma in situ. Oncologist18, 362–368 (2013).

[23] Liu, Y., Pérez, M., Schootman, M., Aft, R. L., Gillanders, W. E., Ellis, M. J. et al. A longitudinal study of factors associated with perceived risk of recurrence in women with ductal carcinoma in situ and early-stage invasive breast cancer. Breast Cancer Res. Treat. 124, 835–844 (2010).

[24] van Gestel, Y. R. B. M., Voogd, A. C., Vingerhoets, A. J. J. M., Mols, F., Nieuwenhuijzen, G. A. P., van Driel, O. J. R. et al. A comparison of quality of life, disease impact and risk perception in women with invasive breast cancer and ductal carcinoma in situ. Eur. J. Cancer 43, 549–556 (2007).

[25] Partridge, A., Adloff, K., Blood, E., Dees, E. C., Kaelin, C., Golshan, M. et al. Risk perceptions and psychosocial outcomes of women with ductal carcinoma in situ: longitudinal results from a cohort study. J. Natl. Cancer Inst. 100, 243–251 (2008).

[26] Davey, C., White, V., Warne, C., Kitchen, P., Villanueva, E. & Erbas, B. Understanding a ductal carcinoma in situ diagnosis: patient views and surgeon descriptions. Eur. J. Cancer Care 20, 776–784 (2011).

[27] https://jamanetwork.com/journals/jamaoncology/fullarticle/2427491

[28] Comparison of operative versus medical endocrine therapy for low risk DCIS: the COMET Trial. http://www.pcori.org/research-results/2016/comparison-operative-versus-medical-endocrine-therapy-low-risk-dcis-comet.

[29] Hwang, E. S., Hyslop, T., Lynch, T., Frank, E., Pinto, D., Basila, D. et al. The COMET (Comparison of Operative to Monitoring and Endocrine Therapy) Trial: a phase III randomized trial for low-risk ductal carcinoma in situ (DCIS). BMJ Open 9, e026797 (2019).

[30] Francis, A., Thomas, J., Fallowfield, L., Wallis, M., Bartlett, J. M., Brookes, C. et al. Addressing overtreatment of screen detected DCIS; the LORIS trial. Eur. J. Cancer 51, 2296–2303 (2015).

[31] Elshof, L. E., Tryfonidis, K., Slaets, L., van Leeuwen-Stok, A. E., Skinner, V. P., Dif, N. et al. Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ - The LORD study. Eur. J. Cancer 51, 1497–1510 (2015).

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Hormone Replacement Therapy (HRT) and Breast Cancer

Synthesis by Cécile Bour, MD, 

December 29, 2020

The debate on the question of the link between HRT and breast cancer is long-standing, dating back to 2002 when an American study suggested an over-risk of cancer in patients on HRT. This first study resulted in great controversy. This WHI (Women Health Initiative) trial is a large randomized American study whose objective is to evaluate the risks and benefits of different dietary and medical strategies that can reduce the incidence of cardiovascular disease, breast cancer, colorectal cancer and fractures in postmenopausal women.

Planned to last more than 8 years, the trial was prematurely stopped in the first half of 2002 after a little more than 5 years, as the risks were deemed to outweigh the benefits, in particular due to the appearance of unfavorable and unexpected cardiovascular effects of HRT.

Indeed, the study confirmed a vertebral and femoral anti-fracture effect, a beneficial effect on the decrease of colon cancer rate, but found an increase in cerebrovascular accidents, myocardial infarction, phlebitis and pulmonary embolism, and breast cancer.

The results were contested in France on the basis that the products used in the study were orally administered and normodosed equine estrogens (whereas in France were used transdermally or orally estradiol), and medroxyprogesterone acetate which was not used in France. Great relief therefore when JAMA[1], in 2017, came back on these first rather frightening results and contested this excess mortality in the WHI study, the French gynecologists then considering HRT globally as a "good thing if the treatment is not standardized but personalized"[2].

However, in medicine, nothing is ever set in stone, and in 2003, another study, an English one[3] conducted from 1996 to 2001 including more than a million menopausal women between 50 and 64 years old, showed an over-risk of breast cancer under HRT, even with treatments commonly used in Europe. The result of the study was that the risk of developing breast cancer as well as the risk of cancer-related death was greater in treated women than in untreated women, and greater in women treated with combined estrogen-progestin therapy than in women receiving estrogen therapy alone. This English study examined many of the treatments used in Europe, both for the types of estrogen-progestin and for their means and routes of administration.

The controversy was such that the systematic prescription of HRT was drastically slowed down in 2004. And it is true that a decrease in the incidence of this cancer was observed around 2004, when HRT was stopped being prescribed on a large scale and for long periods of time. [4]

A 2019 study – an over-risk of cancer confirmed under HRT treatment

This is a review of 58 epidemiological studies on the subject of the association between HRT and breast cancer, mostly observational, involving more than 100,000 women in total. Published in 2019 in The Lancet [5], this review demonstrates an increased risk of breast cancer in women undergoing hormonal treatment for the effects of menopause. While this excess risk decreases well after stopping treatment, it persists for at least ten years.

The study is innovative in that it quantifies the risk for each type of treatment.

For example, a fifty-year-old woman who has been on HRT combining estrogen and progesterone continuously for 5 years has a risk of developing breast cancer within 20 years of starting treatment of 8.3%. The risk would be only 6.3% for women of the same age who have had no treatment.

The risk of developing breast cancer after 20 years would be 7.7% for women who have been treated with estrogen and progesterone but intermittently, and 6.8% for those treated with estrogen alone, according to the researchers.

What should be learned essentially from the study?

  • All hormonal treatments for menopause are associated with increased risk, with the exception of estrogen gels for local application.
  • The risk would also increase with the duration of treatment, the use of HRT for 10 years would result in an excess risk of breast cancer about twice as high as the risk of a 5-year treatment alone.
  • Conversely, using HRT for less than a year would result in a low risk.

Adapt according to the need

Currently the practice aims to individualize prescriptions, carefully considering the risks and benefits of treatment for each woman and taking into account whether or not to use HRT, depending on the woman's climacteric disorders (Climacteric refers to the years of hormonal change experienced by the woman before and after menopause).

The recommendation of the High Authority of Health (HAS-France)

In 2004 the French High Authority for Health (HAS) issued a recommendation[6] that is still in force: HRT should be prescribed for a short period of time. The HAS specifies that there is no need to prescribe additional or specific radiological examinations for women treated with HRT, but the HAS does request that all women treated be systematically included in the screening program. The following is recommended  [7]:

  •  In case of hormone replacement therapy or menopause hormone treatment in progress :

In case of prescription before the age of 50 and in the absence of sufficient data to determine the benefit-risk balance of mammography, no specific radiological monitoring is recommended.
In case of prescription after the age of 50, no specific radiological monitoring is recommended. The woman should be encouraged to participate in the national organized screening program.

Therefore, in the case of prescribing HRT, the prescribing physician cannot, at the risk of legal action, manage the treatment without recommending the systematic screening of his patient for breast cancer[8].

References

[1] https://jamanetwork.com/journals/jama/article-abstract/2653735

[2] https://www.lequotidiendumedecin.fr/actus-medicales/recherche-science/thm-letude-whi-montre-finalement-une-absence-de-surmortalite

[3] https://www.ansm.sante.fr/S-informer/Communiques-Communiques-Points-presse/Traitement-hormonal-substitutif-et-risque-de-cancer-du-sein

[4] Page 6 of the document: " STATUS AND KNOWLEDGE REPORT / GUIDELINE FILES".

FEBRUARY 2015

HORMONE TREATMENTS/MENOPAUSE AND RISKS OF CANCERS

Document written and coordinated by the Prevention Department, Public Health and Care Unit (PSPS)-INCa. "Although this hypothesis needs to be further explored, the decrease in breast cancer incidence has also been described in other countries where the drop in the prescription of THMs (hormonal treatment for menopause) has been spectacular, such as in Canada, Germany, the United States, Belgium and Australia".

[5] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31709-X/fulltext

[6] https://www.has-sante.fr/jcms/c_1754596/fr/traitements-hormonaux-de-la-menopause

[7] https://www.has-sante.fr/jcms/c_1741170/fr/depistage-du-cancer-du-sein-en-france-identification-des-femmes-a-haut-risque-et-modalites-de-depistage#toc_1_2

[8] https://cancer-rose.fr/2020/03/02/depistage-et-paradoxe-lors-de-lusage-de-certains-medicaments/

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DIABETES AND CANCER

By Dr. C. Bour, January 5, 2021

The link between diabetes and cancer in general and diabetes and breast cancer in particular is well known, as shown in a 2012 meta-analysis [1].

This meta-analysis revealed a significant increase in the risk of breast cancer in women with diabetes compared to non-diabetic women. However, the association between diabetes and breast cancer risk appeared to be limited to postmenopausal women. Type 1 diabetes and diabetes in premenopausal women were not associated with a significant increase in breast cancer risk.

People with type 2 diabetes have a higher risk of developing cancers of the breast, pancreas, liver, kidney, endometrium and colon. 
While patients with type 1 diabetes are more likely to develop cervical and stomach cancers.

Several studies have also shown that patients with diabetes and cancer have a poorer prognosis than those without diabetes. Diabetes and hyperglycemia are associated with higher infection rates, shorter remission periods and shorter median survival times, as well as higher mortality rates[2].

Several mechanisms might explain why type 2 diabetes could increase the risk of cancer are being implicated: hyperinsulinemia, hyperglycemia and inflammation. The increase in blood glucose levels is believed to have carcinogenic effects by causing DNA damage.

Particular case of breast cancer

The meta-analysis discussed at the beginning of this article was conducted using a random effects model to study the association between diabetes and breast cancer risk [3].

The risk of breast cancer in women with type 2 diabetes is increased by 27%, a figure that decreases to 16% after adjusting for BMI. Obesity is an aggravating factor as shown in other studies.  

No increase in risk has been observed in women in pre-menopausal age or with type 1 diabetes.

In addition to the over-risk of cancer in the diabetic patient, what about the management of the patient with both diabetes AND cancer? [4] [5]

The management of the diabetic patient requires treatment not only by hygienic and dietetic measures but also by a finely tuned medication protocol that may include insulin and one or more oral agents.

Chemotherapy and analgesics can affect glucose homeostasis[6] and insulin sensitivity; drug interactions can interfere with the patient's tolerance to diabetes drugs; decreased appetite, nausea, vomiting and weight loss resulting from both disease and cancer treatment can cause imbalances in blood glucose levels.

Chemotherapeutic agents

Several chemotherapies are known to cause or exacerbate these adverse conditions. For example, cisplatin is known to cause kidney failure, and anthracyclines can cause cardiotoxicity. Cisplatin, paclitaxel and vincristine may be neurotoxic. Unfortunately, many of these side effects may remain permanent.

For cancer treatment to be effective, at least 85% of the chemotherapy dose must usually be administered. Patients with diabetes should be carefully monitored before the start and during chemotherapy. Treatment decisions should be based on the patient's clinical picture, but always be aware that any change in dose, or alteration in the timing of administration, or substitution of another chemotherapeutic agent may compromise results by reducing the response rate to treatment.

Corticosteroids

They represent an important part of treatment in cancer pathologies and are widely used to improve nausea and vomiting associated with chemotherapy, as well as to suppress neurological symptoms when the cancer has metastasized to the spine or brain. And they cause significant hyperglycemia within hours after administration. 

The treatment of hyperglycemia resulting from glucocorticoids then depends on the type of diabetes, the severity of the hyperglycemia levels, the dose and the duration of therapy. Administering steroids in multiple doses throughout the day instead of a single bolus dose, or administering the entire daily dose of steroids intravenously over 24 hours, can help control hyperglycemia.

Patients with pre-existing diabetes can be maintained on oral hypoglycemic agents and closely monitored. However, these medications are generally unsuitable for managing hyperglycemia in this setting and insulin is used.

Patients using insulin prior to glucocorticoid therapy will typically require both basal and preprandial insulin. These patients may require two to three times their usual insulin dose. Insulin is the preferred drug for the management of steroid-induced or steroid-exacerbated hyperglycemia in patients with known diabetes.

Patients with type 1 diabetes will need to adjust their dose. Type 2 patients who are already taking oral agents at baseline will add insulin, but only during this period when their blood glucose levels are high.

Several studies of cancers as disparate as small cell lung cancer and breast cancer have found an association between poorly controlled hyperglycemia and poor outcomes in these patients with both diabetes and cancer. Hyperglycemia also increases the risk of infection.

In patients with active cancer, the management of hyperglycemia focuses on the prevention of long-term complications to avoid acute and sub-acute outcomes, such as dehydration due to polyuria, infection, catabolic weight loss, hyperosmolar non-ketotic states and diabetic ketoacidosis [7].

Analgesics

Analgesics can cause constipation that affects patients in two ways. It can make them want to not eat, but also, by slowing down intestinal motility, narcotics may delay the absorption of nutrients. This can lead to a mismatch between the administration of insulin and the absorption of glucose. The patient faces the risk of hypoglycemia.

Statins and chemotherapy [8]

Statins and chemotherapeutic agents are metabolized by the same enzymes in the liver. 

If the liver enzymes are all captured by statin therapy, this may result in less elimination of chemotherapy. Some research suggests that it also works the other way around. If you give a statin to a patient on chemo and then stop the statin, he or she will eliminate the chemotherapy drug much more quickly. 

In general, therefore, there is a reluctance to start statin therapy in someone just starting chemotherapy because of possible hepatotoxicity," says Lavis [9] . If patients are already on statins, it is important to be aware of their effects and monitor them carefully. 

It is appropriate to target therapeutic interventions according to the patient's prognosis. If the prognosis is poor, we should be less demanding about the goals and not overburden the patient's treatment based on excessive expectations.

Prognosis and comfort

Prognosis, longevity and quality of life are important considerations in setting blood glucose targets. A pragmatic approach to the management of hyperglycemia in these patients is necessary.

The interest of a very strict glycemic control is to try to prevent complications in 10, 15, 20 years. 

But in a person with a poor prognosis or a life expectancy of only a few years, one must be more concerned about comfort and quality of life in the remaining years.

The goal would then be to avoid the effects of acute hyperglycemia, such as dehydration and ketoacidosis.

Conclusion

There is strong epidemiological evidence that diabetic diseases are associated with an accumulated risk of several cancers. There is also growing evidence that the degree of hyperglycemia and the treatment modalities for hyperglycemia influence cancer risk. 

The risk of breast cancer in women with type 2 diabetes is increased and obesity is an aggravating factor. On the other hand, there is no over-risk observed in women in pre-menopausal age or with type 1 diabetes.

The management of blood glucose levels in patients with diabetes and cancer can pose a significant clinical challenge. As there is no clear evidence that tight glucose control improves cancer outcomes, hyperglycemia must be managed pragmatically to ensure that the patient remains asymptomatic and at low risk of acute decompensation. 

Proactive management of glucocorticoid-induced hyperglycemia can help reduce large fluctuations in glucose levels. 

Read also :

https://www.healthline.com/diabetesmine/living-with-cancer-and-diabetes#1

References

[1] Diabetes and breast cancer risk: a meta-analysis  British Journal of Cancer (2012) 107, 1608–1617 https://pubmed.ncbi.nlm.nih.gov/22996614/

P Boyle M Boniol A Koechlin .....and P Autier1/Prevention Research Institute, 95 cours Lafayette, 69006 Lyon, France

[2] Clinical Challenges in Caring for Patients With Diabetes and Cancer
Helen M. Psarakis, RN, APRN-Diabetes Spectrum Volume 19, Number 3, 2006

https://spectrum.diabetesjournals.org/content/19/3/157

[3] https://pubmed.ncbi.nlm.nih.gov/22996614/

[4] https://endocrinenews.endocrine.org/july-2014-double-jeopardy/

[5] Clinical Challenges in Caring for Patients With Diabetes and Cancer-Helen M. Psarakis, RN, APRN-Diabetes Spectrum Volume 19, Number 3, 2006

https://spectrum.diabetesjournals.org/content/19/3/157

[6]  Phenomenon by which a key factor is regulated to persist around a beneficial value for the body.

[7] https://www.cancernetwork.com/view/diabetes-management-cancer-patients

[8] https://endocrinenews.endocrine.org/july-2014-double-jeopardy/

[9] Victor Lavis, MD, professeur au Département de néoplasie endocrinienne et des troubles hormonaux à l'Université du Texas MD Anderson Cancer Center à Houston.( https://endocrinenews.endocrine.org/july-2014-double-jeopardy/)

 

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Study of three pairs of countries compared

October 27, 2017

Breast cancer mortality in neighbouring European countries, with different levels of screening but similar access to treatment: trend analysis of WHO mortality database

Pr. Philippe Autier research director (International Prevention Research Institute), Mathieu Boniol senior statistician
(Northern Ireland Cancer Registry, Belfast, Northern Ireland, UK; Department of Public Health, Norwegian University of Science and Technology, Trondheim, Norway)
BMJ 2011;343:d4411 doi: 10.1136/bmj.d4411

https://www.bmj.com/content/343/bmj.d4411

Setting

Breast cancer mortality is compared (non-randomized comparative study) by matching countries in pairs, with the second country having introduced screening ten years later.

Northern Ireland (United Kingdom) 1990 / Republic of Ireland 2000
Sweden 1986 / Norway 1996
The Netherlands 1989 / Belgium and Flanders (Belgian region south of the Netherlands) 2001

The study concludes that breast cancer mortality declines similarly despite a significant difference in the year of introduction and participation in screening. Therefore, there is no link between screening activity and decreased mortality. Metastatic invasive cancer remains at the same rates. One of the best proofs that this screening is not effective.

Between 1989 and 2006, deaths from breast cancer decreased by 29% in Northern Ireland and by 26% in the Republic of Ireland; by 25% in the Netherlands and by 20% in Belgium and by 25% in Flanders; by 16% in Sweden and by 24% in Norway. The time trend and year of the downward inflexion was similar between Northern Ireland and the Republic of Ireland and between the Netherlands and Flanders. In Sweden, mortality rates have decreased steadily since 1972, with no downward inflexion until 2006. Countries of each pair had similar health care services and prevalence of risk factors for breast cancer mortality, but different implementation of mammography screening, with a gap of about 10-15 years.

Conclusion of the authors

The contrast between the time differences in implementation of mammography screening and the similarity in reductions in mortality between the country pairs suggest that screening did not play a direct part in the reductions in breast cancer mortality.

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Miller’s Study

Miller's study, published in 2014, is a randomized controlled trial, which corresponds to the highest quality criteria for population-based studies. Data are analyzed from groups whose subjects are randomly selected and then compared.

Here, the study involves 90,000 women, 45,000 with screening, 45,000 without screening. In fact the trials (NBSS 1 and 2 , National Breast screening studys ) were conducted in Canada in the 1980s with women screened annually for 5 years with annual mammography and clinical examination, and then followed up for 10 years. Here Miller proposes a re-evaluation after 25 years of follow-up for these two groups.

What are the conclusions?

1°-No difference in mortality between the two groups (mortality = number of deaths in relation to the total number of people screened).

2° Survival rates are identical, regardless of tumor stage(survival = number of deaths in relation to the number of cancers diagnosed)

3° 22% over-diagnosis

No difference between the two groups in the rate of fatal cancers.

More precisely, Miller finds 22% overdiagnosis, or 1 overdiagnosis (and thus overtreatment) for every 424 women who received mammography screening, for a zero benefit regarding the reduction of mortality  from breast cancer.

The criticisms that have been made against Miller have been varied. First, it was argued that there could have been contamination of both groups because of the length of follow-up. In fact, some of the follow-ups stop after 7 to 10 years, which limits two drawbacks: some women in the non-screening group could still have had a mammogram one year or the other, while some women in the screening group could have "missed" a year of mammography. Waiting another 20 years would dilute or blur the results.

-First, the effect of non-compliance in the screening group and contamination in the non-screening group will rather lead to an underestimation of over-diagnosis.

-Secondly, the detractors of these studies argued that it would take a very long time to see the effectiveness of screening, as it would only be over a very long period of time that the danger of undetected cancers in the non-screened group would be seen. But here, even after 25 years, we still do not see this famous " dormant cancer " finally appearing, and no excess mortality of women who are not screened, perhaps because dormant cancer does not exist...

Miller was also criticized for not being representative of the French system, which screens every two years and begins at age 50 (whereas the Canadian trials targeted women aged 40-59). However, in the United States there was a debate about starting screening at 40 years of age.

It is clear that mammography was prematurely marketed to us as the ideal way to reduce the danger of cancer, particularly the killer one.

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

Ref : Miller AB, Wall C, Baines CJ, Sun P, To T, Narod SA. Twenty five years follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial. The BMJ. 2014 Feb 11;348:g366

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Breast Cancer Screening, a good intention, a bad theory, an aberrant result

Une bonne intention, une mauvaise théorie, un résultat aberrant Volume 2, issue 8, Octobre 2006, DOI: 10.1684/med.2006.0009  

Concepts

With 11,172 deaths in metropolitan France in 2002, breast cancer is a major public health problem. It is responsible for 19% of women deaths from cancer and 31% of malignant tumor deaths before the age of 65. Mass screening has intensified in France over the past several decades. The size of the tumor has never ceased to decrease at the time of diagnosis, but the mortality rate has remained desperately stable from 1980 to 2000. Over the same period, the annual number of diagnosed breast cancer cases doubled. These findings bring into question the soundness of screening and the necessity to quantify overdiagnosis.

Bernard Duperray St Antoine Hospital, Radiology Department, Paris
Bernard Junod National School of Public Health, Assessment of risks related to the environment and the health care system Rennes
Keywords : benefit/risk, breast cancer, screening DOI: 10.1684/med.2006.0009

It is claimed that after an initial preclinical phase of several years, the threshold for clinical detection is reached when the tumor measures approximately 1 cm. Thanks to mammography, screening would take place 1 to 3 years earlier, thus limiting the possibility of developing metastases that would only occur at a given tumor size.

These phases are assumed to mechanically follow one another[1]. A small volume lesion would mean an early diagnosed lesion. "Small" and therefore "early" would be synonymous with curable. The classic pattern (Figure 1), where atypical epithelial hyperplasia develops into cancer in situ and then into invasive cancer which gradually increases to a critical size, suggests that the use of screening could be sufficient in breaking this sequence before invasive cancer develops.

Yet, clinical findings in daily practice show that the progression of the disease is neither linear nor obligatory over time. Sudden changes, static situations and even regressions are observed."Small" does not mean "early". A tumor can develop clinically in a few weeks or even days. A millimetre-sized lesion can be associated to metastases, just as a small tumor which can remain small for many years without becoming a deadly cancer. On the other hand, large, widespread tumors may have no radiological translation.

Although the size of the tumor is apparently associated with the prognosis, it is not with time. In his reference book on breast diseases[2], Professor Charles Gros noted as early as 1963: "The chances of survival with our locoregional therapeutics are linked to the small size of the intramammary lesions. But the smallness of intramammary lesions is only very partially related to time. There is no rigorous parallelism between early diagnosis in time and in space". In most cases, ductal cancer in situ does not evolve into an invasive lesion .

A revision of more than 10,000 breast biopsies completed in Nashville, Tennessee, between 1952 and 1962, revealed cancers in situ in women who were considered not affected by cancer and therefore untreated. After 10 years, 75% of these women did not develop invasive cancer [3]. A wide range of potential clinical evolutions are observed for the same histological abnormality that defines breast cancer : some cancers develop and kill no matter what is done, others seem to respond to treatment, some remain silent, some regress or even disappear spontaneously. The alternative model diagram ( figure 1) takes into consideration these observations.

The question is to know whether these two types of cancer that can not be histologically distinguished are the same disease with varying evolutions, or whether they are entirely different entities with the same breast  stigma.

At present, breast cancer in all its histological forms is a disease whose natural history is not well known and whose strictly histological definition is reductive at a given time, once associated with a linear evolutionary model.

The drop in mortality is not there in spite of screening

The only argument for continuing screening despite scientific evidence was the result of some randomized studies, such as the so-called "two Swedish counties" study published in 1985. It promised women who would be screened a 25-30 % reduction in breast cancer mortality.

Examination of all the results of the seven controlled trials, including a mammography screening, shows the level of knowledge available on its effectiveness. Figure 2 illustrates, first of all, that the importance of mortality value varies between studies. This is mainly due to variations in the age structure of the cohorts of women studied.  The greatest difference in mortality between the screened and the control group is noted in the Edinburgh and Guildford study. It is now acknowledged that this difference is the result of a flaw in the so-called random allocation of women to each group.

Thus, this study does not allow to argument for or against the screening.The second largest difference observed is headed in opposite direction in a Canadian study. This result also prompted to an expertise on the quality of random allocation.

However, after this expertise, the procedures used and the results obtained were considered as valid. Overall, the differences in mortality between studies are not coherent, both in terms of their meaning and their importance [6, 7]. This finding is consistent with the Cochrane review published in 2001 [8]. In particular, it highlighted the precarious nature of the study of the two Swedish counties and of the Health Insurance Plan in New York, once we take into account the method of drawing the samples, the comparability of the groups, the exclusions during the study after randomization and the way in which death was attributed to breast cancer. This may explain why in Sweden, where screening has the longest tradition, the gain in mortality noted in practice is insignificant: 0.8% for 11% expected.

Although the reduction in mortality is not met, the perverse effects are present

The title of the lecture presented  in the summer of 1994 already by Dr. Marie-Hélène Dilhuydy asked the following question about screening : “A generous and life-saving purpose or a sanitary ideology with a perverse ethic, is the breast cancer screening useful for women ?” She clarified that mass screening probably reduces breast cancer mortality, but that the benefit is very limited and very difficult to demonstrate before alerting about the perverse effects that have already been observed. Since then, the extent of these effects has led to a continuous reconsideration of the practical modalities of screening.

False-positives

This refers to women who test positive even though they are not affected by cancer. The rate of false-positive mammograms has been particularly studied in Great Britain. Cumulative risk of false-positives after 10 mammography tests is 49.1%.

The positive predictive value (PPV) represents the probability that a woman with a positive test is affected by the disease. In France, the PPV for mammography testing using a single image per breast has never exceeded 9% at best, whereas a test judged as good should reach at least 30% or more [9]. Thus, 91% of women with a positive test were alarmed and had to undergo unnecessary diagnostic tests. The consequences are more and more aggressive complementary tests, including even biopsy, since it is becoming more and more difficult to reassure without histological evidence.

The evolution of the classification of radiological images according to the Breast Imaging Reporting and Data System (BIRADS) of the American College of Radiology (ACR) illustrates the difficulty of trying to make a practical attitude dependent on an imagery which is not very sensitive and not very specific.

The classification of microcalcifications in ACR 3, which should lead to easy monitoring, has been progressively diminished in favor of ACR 4, where histological verification is recommended. These tests are all the more inevitable as patients are firmly convinced that the smallest delay in diagnosis leads to a loss of chance and considerable prejudice [10].

Overdiagnosis and overtreatment

This is definitely a major deleterious effect of screening. It corresponds to diagnosis by excess. Overdiagnosis does not only concern cancers in situ but also invasive cancers that are slowly evolving or regressing spontaneously. It corresponds to the detection of cancer cells that would never have evolved.

As shown in figure 3,  there has been an "epidemic" increase in breast cancer diagnosis in France since 1980 [11]. How can that be explained?

An advance in diagnosis reaching an average of 12 months would only lead to 10% of the rise observed between 1980 and 2000. If this "epidemic" of diagnoses reflected a real increase in the incidence of progressive cancers, therapeutic effectiveness would have to be significantly improved. Indeed, we had only one cancer cured for a lethal cancer in 1980, while we have three cancers cured for a lethal cancer in 2000. In view of the results of controlled trials and the relative stability of treatment methods, such progress is implausible.

Another way to address the issue of over-diagnosis is to evaluate the reservoir of asymptomatic breast cancers present in the population of women. What is clinically observed is only the tip of the iceberg. Similarly to prostate cancer, there are occult breast cancers that will not reveal themselves during the patient's lifetime. Evidence of this is illustrated by a series of autopsies performed on women who did not know they had breast cancer during their lifetime. Studies published between 1984 and 1988 provide the results of a systematic search for breast cancer in a series of autopsies that were not selected on the basis of breast pathology. They concern, for example, women who died of a violent death and were examined in a forensic medical institute.

The difference between the number of invasive cancers diagnosed at autopsy and the expected number estimated from the incidence data for the time is considerable: there are more invasive cancers and, above all, far more in situ cancers at autopsy. The discovery of these cancers was all the more frequent as the number of cuts made by anatomopathologists increased. Thus, the more we search, the more we find [12].

More recently, longitudinal observations have documented the existence of overdiagnosis. Since mammography screening has existed for several decades, there are now sufficient retrospective data to show that cohorts of women with multiple screening examinations in succession had significantly more diagnoses than those screened only at the end of an equivalent observation period [5, 13].

Overtreatment is a consequence of overdiagnosis, whose it enhances its deleterious effects. Paradoxically, the results of the treatment of quiescent or pseudo-cancers are always considered to be satisfactory since they do not threaten the woman's life.

Importunate treatment

Several publications report the acceleration of metastases in vital organs following diagnostic and/or therapeutic interventions in breast cancer [4, 14]. Among the mentioned mechanisms, these authors suggest, for example, that a blunt diagnostic or therapeutic procedure releases circulating products responsible for stimulating metastases or that the excision of the primary tumor removes an inhibition of their growth.

Irradiations

Even if irradiation can be controlled and assessed by a quality procedure, its repetition in increasingly short periods of time represents an accumulation of small doses that increase the risk of cancer. According to estimates by the National Cancer Institute in the United States, an accumulated individual dose of 10 mSv would lead to between 9.9 and 32 cancers per million women. Patients carrying the BRCA genes show an increased radiation risk in vitro, yet they are proposed annual check-ups starting already at 30 years of age.

Perspectives of salutary advances?

Following the logic of a theoretical model based on the linear evolution of cancer, industrialized countries have engaged in screening programs to solve the problem of breast cancer mortality. The major concerns of French screening are currently of two kinds: its accessibility for all women and the improvement of senology practices. Thus, the National Cancer Institute is seeking to establish a culture of screening and to strengthen quality control, both in terms of the training of the practitioners involved and of the equipment they use. The interest in cancer screening has revealed its ineffectiveness. The indicators chosen to observe the disease do not allow progress to be made in understanding it. They create perceptions that contradict reality.

The mortality rate remains desperately stable in France, even though all the indicators used are reassuring: reduction in tumor size, reduction in the number of lymph node invasions and detectable metastases upon discovery of the disease, apparent improvement in survival at 5 or 10 years.

In most industrialized countries, two observed contradictory trends need to be clarified and quantified : on the one hand, iatrogenic effects due to inadequate therapies, considering the diversity of the evolution of the disease, of which the natural history is not well known, that contributes to deterioration of the prognosis, and on the other hand, therapeutic advancement in relation to better targeted treatments that improve survival.

In the current context, overdiagnosis inevitably leads to unnecessary and dangerous overtreatment, since lesions unjustifiably diagnosed as cancerous "diseases" would never have manifested themselves. Such "successes" are used to justify the continuation of the screening. They reassure practitioners that their activity is well-founded, while they only mask the ineffectiveness of the followed directions.

Potential improvements as a result of awareness-raising of the extent of the observed facts are considerable.

Conclusion

The willingness to act through systematic screening for a disease whose causes and natural history are not well known implies major disadvantages, in particular :

- unnecessary diagnostic tests;

- harmful treatment of tumors that would have had no consequences if they had not been diagnosed;

- possible acceleration of the manifestation of metastases;

- the induction of cancers by ionizing radiation in a healthy population.

A reorientation of research and health care is necessary to improve the specificity of the definition of cancer and limit the downside of a generalized systematic screening.

Conflicts of Interest: The authors declare that they have no conflict of interest in the subject covered by this article.

Summary: Breast Cancer Screening

Insufficiencies in the definition of breast cancer based on the results of punctual examinations and a linear theoretical model of the history of the disease bring into question the validity of its systematic screening.

Overdiagnosis and overtreatment are the major risks to avoid.

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Références :

1. Ménégoz F, Chérié-Challine L, et al. Le cancer en France : Incidence et mortalité, situation en 1995 et évolution entre 1975 et 1995. Ministère de l’emploi et de la solidarité et réseau Francim eds. Paris : La Documentation française ; 1998.

2. Gros C. Les maladies du sein. Paris : Masson, 1963, 573 pp.

3. Page DL, Dupont WD, Rogers LW, et al. Continued local recurrence of carcinoma in situ 15-25 years after a diagnosis of low grade ductal carcinoma in situ of the breast treated only by biopsy. Cancer. 1995;76:1197-200.

4. Baum M, Demicheli R, et al. Does surgery unfavourably perturb the “natural history” of early breast cancer by accelerating the appearance of distant metastases? Eur J Cancer. 2005;41:508-15.

5. Zahl PH, Strand BH, Maehlen J. Incidence of breast cancer in Norway and Sweden during introduction of nationwide screening: prospective cohort study. BMJ. 2004;328:921-4.

6. Black CB, Haggstrom DA, Welch HG. All-cause mortality in randomized trials of cancer screening. J Natl Cancer Inst. 2002;94:167-73.

7. Mammographies et dépistage des cancers du sein. La revue Prescrire. 2006;272:348-71.

8. Olsen O, Gotzsche PC. Cochrane review on screening for breast cancer with mammo-graphy. Lancet. 2001;358:1340-2.

9. Renaud R, Gairard B, Schaffer P, Haehnel, Dale G. Définition et principes du dépistage du cancer du sein. 11 Journées de la Société Française de Sénologie et de Pathologie Mammaire, Tours, septembre 1989.

10. Berlin L. Malpractice issues in radiology. The missed breast cancer : perceptions and realities. AJR. 1999;173:1161-7.

11. Remontet L, Estève J, Bouvier et al. Cancer incidence and mortality in France over the period 1978-2000. Rev Epidemiol Santé Publique. 2003;51:3-30.

12. Welch HG. Dois-je me faire tester pour le cancer ? Peut-être pas et voici pourquoi. Laval ; Presses de l’université : 2005, 263 pp.

13. Zackrisson S, Andersson I, Janzon L et al. Rate of over-diagnosis of breast cancer 15 years after end of Malmö mammographic screening trial: follow-up study. BMJ. 2006;332:689-92.

14. Cox B. Variation in the effectiveness of breast screening by year of follow-up. J natl Cancer inst. Monogr 1997;22:69-72.

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.

Explanation of our study on mastectomies in France carried out by Cancer Rose

October 17, 2017

Dr. Cécile Bour, MD

Dr. Jean Doubovetzky, MD

 Dr. Vincent Robert, MD

PREAMBLE

Our collective has conducted a study (see news release) to verify the assertion of defenders of systematic screening that, after implementation of generalized screening, there would be a decrease of surgical practices. As this postulate has not been verified in France, we are relying on the PMSI (program for the medicalization of information systems) which records hospital stays in an exhaustive manner. The findings of the article to be published in the October issue of the journal Médecine, and in open access by following this link, show that the de-escalating of surgical procedures has not occurred:

Study in Médecine/oct 2017

Or here : Researchgate

Our study on our website

Following the feedback and questions received from readers, we provide below some explanations to clarify the most frequently asked questions.

_____________

 WHAT DOES THE STUDY SAY?

 First of all, contrary to what our opponents say, the PMSI (program for the medicalization of information systems) is completely reliable. The rating errors that could occur here and there are not significant, in fact the quotation of mastectomy procedures does not change, the surgeons know them very well. If there were errors, they would be made in both directions. It should be noted in this regard that the figures put forward in studies other than ours on surgical procedures come from the same data source that surgeons use to report their data. In France, there is no other data base for epidemiological and statistical analyses due to the lack of a national cancer registry, an information system that exists in other countries. Any "cheating" on the quotations is highly visible, leads to severe sanctions by the national insurance fund against fraudsters, and is not credible, as the figures for total mastectomy procedures, which are more remunerative, would then be at the expense of those for partial mastectomies, but this is not the case, as all procedures are on the increase. Over the last four years, an average of 19,966 total mastectomies have been performed annually, compared with 18,351 annually in the four years preceding the generalization of organized screening (2000-2003), an increase of 8.8%.

Indeed, at the same time, the number of breast cancers diagnosed each year has increased. But, even in relation to this figure, the numbers don't add up.

In 2012, there are still practiced 4 total mastectomy procedures for 10 new cancers, as in the year 2000. And there are 15 partial mastectomy procedures for 10 new cancers compared to less than 13 in 2000.

In other words, the number of partial mastectomies is increasing faster than the incidence of invasive cancers. And the number of total mastectomies is increasing in parallel with the number of invasive breast cancers.

Under these circumstances, we should speak of a therapeutic escalation, not of a de-escalation.

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Role of individual screening

Indeed, some patients have recourse to individual screening; the changes in breast cancer surgery that we have noted cannot be explained by the screening coverage that has remained stable (organized and individual screening added) in recent years.

On the other hand, while the lack of decrease in screening coverage may explain the lack of decrease in total mastectomies, it does not exonerate screening from any responsibility for the significant increase in the number of lumpectomies and partial mastectomies. This increase in the number of surgery procedures depends less on the number of women screened than on the sensitivity and specificity of the screening. With technical progress, double reading of mammograms, the switch to numerical mammography, and an improvement in the skills of radiologists, the sensitivity of mammography is steadily improving.

Therefore, it is rather the performance of screening in detecting increasingly small tumors that is responsible for the increase in the number of surgery procedures, as it leads to an increase in over-diagnosis, and consequently over-treatment.

Once again, the truth is that an unfulfilled promise was made to women, by announcing that the generalization of organized screening would result in "lighter" treatments.

_______

On the issue of total mastectomies

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Some are satisfied with the decrease in the ratio of total mastectomies to partial mastectomies, or the ratio of total mastectomies to "total procedures". This apparent improvement is only due to the fact that partial mastectomies are increasing significantly compared to total mastectomies, which are also increasing, but to a lesser extent. However, this is not a good indicator of a de-escalating treatment. It would only be gratifying if the number of total mastectomies were reduced. Unfortunately, this is not the case.

The annual number of total mastectomies is not decreasing, neither the number of total mastectomies relative to the incidence of invasive cancers. How can these results be explained?

    - The re-intervention rate (partial mastectomies complemented afterwards) is only 3% and cannot account for the data; see page. 53 of the report: "Improving the quality of the healthcare system and controlling expenses: Health Insurance proposal for 2015" Report to the Minister in charge of Social Security and to the Parliament on the evolution of Health Insurance expenses and revenues for 2015 (law of August 13, 2014).

    - The recommendations requesting that conservative surgery be favored whenever possible are perhaps not followed, in such a way that the intended benefit of screening is cancelled out.

    - Or total mastectomies are performed for non-invasive tumors (notably CIS). These procedures represent an over-treatment associated with over-diagnosis. They would make lose the benefit of a general trend towards more conservative surgery for invasive cancers.

When the progression is considered without even considering the time scale, the general picture is one of an increasing trend, almost linear with a fairly high random variability.

We do not note any definite break in this linear trend and it would be impossible to locate the year when screening under invitation became generalized if the years on the x-axis were not indicated (2004). (This can be confirmed by a Davies test). Therefore, the trend in the annual number of total mastectomies has  not been modified by the generalization of organized screening. No reduction in this rate can be claimed.

concerning total mastectomies

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In the statistics of cancer incidence presented by INCA (French National institute of Cancer) site, only the figures concerning invasive cancers are reported, since cancers in situ (CIS) correspond to a separate entity, wrongly referred to as 'cancer' and not considered as 'real' cancer, and they are not taken into account.

It has been shown that surgery does not improve the prognosis of in situ cancers. This is why we have studied the ratio of the number of mastectomies to the incidence of invasive cancers and not invasive + cancers in situ.

The number of mastectomies (of all types) is greater than the number of new cancers. It therefore seems that in situ cancers are surgically operated on "in doubt", not only by partial mastectomy, but also sometimes by total mastectomy.

QUANTIFIED APPROACH :

Our observation is as follows: for every 1,000 invasive cancers, 213 more surgical operations were performed  in 2012 compared to 2000 (a).

This is an excess of 10,387 interventions compared to what the incidence of invasive cancers indicates (b).

Another method of calculation can be used: in 2012 there are 71,916 interventions compared to 53,876 in 2000. There are therefore 18,040 additional interventions in 2012 (c). Of these 18,040 additional interventions, 7,663 can be explained by a rise in the incidence of invasive cancers (d).

The remaining 18,040-7,663 = 10,377 interventions cannot be explained by the rise in invasive cancers. To the nearest rounding errors, the 10,387 given by the other method of calculation are included.

Re-interventions have a limited part to play, since they account for just 3% of mastectomies. Our hypothesis is therefore that, for the most part, these 10,377 additional procedures are attributable to over-diagnosis leading to over-treatment.

a) (ratio of total acts in 2012 year x 1000) – (ratio of total acts in 2000 year x 1000) = (1.475 x 1000) - (1.262 x 1000) = 213

b) 213 x 2012 year incidence = 213 x 48,763 = 10,387

c) 71.916 - 53.876 = 18.040

d) 2012 year incidence x ratio acts/incidence year 2000 = number of acts related to the increase in incidence between year 2000 and year 2012 = (48,763 x 1.262) - 53,876 = 7,663

THE PART OF TOTAL MASTECTOMIES

Chart

There is a statistically significant decrease in the proportion of total mastectomies (p < 0.00001 in Spearman's rank correlation test). However, this decrease in the proportion of total mastectomies is not synonymous with a lighter surgical procedure. Indeed, as shown in the graph below, the decrease in the part of total mastectomies is not due to a decrease in total mastectomies but to a greater increase in partial mastectomies than in total mastectomies.

click on the image to enlarge :

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CONCERNING THE AGING OF THE POPULATION

The increase in total mastectomies could be attributed to the increase and aging of the female population.

To test whether this hypothesis stands true, the annual number of mastectomies can be related to the annual number of new cases of breast cancer.

A mastectomy is performed because there is cancer and not because of being a woman.

In summary, two arguments allow us to claim that screening has not lead to a de-escalating in surgical procedure of breast cancer.

1. The trend towards an increase in the annual number of total mastectomies has not changed as a result of the generalization of the screening under invitation.

2. The number of total mastectomies per 1,000 new invasive breast cancers has not been decreased due to the generalization of screening under invitation.

Thanks to Dr Vincent Robert for all these analyses.

_____________

Our study was presented at the congress of the French Society of Breast Senology and Pathology, November 2017 in Lille.

Here is the presentation :  SFSPM Lille PC

Abstract

Poster

diaporama SFSPM Lille PC

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.

Citizen and Scientific Consultation on Breast Cancer Screening in France- Steering Committee Report

September 2016

MEMBERS OF THE STEERING COMMITTEE

Steering Committee members of the Citizen and Scientific Consultation on Breast Cancer Screening are the authors of this report.

Chantal CASES

Economist, statistician

Director of Demographic and Social Statistics, INSEE President of the Health Data Institute

Mario DI PALMA

Medical Oncologist

Head of the Ambulatory Department of the Gustave Roussy Institute IGR

Éric DRAHI

General practitioner

Therapeutic Education Trainer

Sylvie FAINZANG

Anthropologist, Inserm research director

Member of Cermes3 (Research Center, medicine, sciences, health, mental health, society, CNRS Inserm EHESS University Paris 5 Descartes)

Paul LANDAIS

Professor of Public Health, Nephrologist

Director of the Laboratory of Biostatistics Depidemiology and Public Health UPRES EA 2415 University Institute of Clinical Research of Montpellier)

Head of the BESPIM department (Biostatistics, Epidemiology, Public Health and Medical Information) of the CHU of Nîmes

Sandrine de MONTGOLFIER

Lecturer in the history of life sciences and bioethics at the University of Paris Est Créteil Val de Marne / ESPE,

Researcher lIRIS Institute for Interdisciplinary Research on Social Issues, EHESS CNRS Inserm Paris 13)

Fred PACCAUD

Professor of Public Health at the Faculty of Medicine of Lausanne

Director of the University Institute of Social and Preventive Medicine of Lausanne

Jean-Philippe RIVIÈRE

General practitioner

Editorial and community manager of the Vidal.fr website

Dominique THOUVENIN

Emeritus Professor of Private Law at the École des hautes études en santé publique EHESP

Co-director of the Research Center "Normes, Sciences et Techniques" (CRNST), Institut des Sciences Juridique et Philosophique de la Sorbonne (UMR 8103)

KEY POINTS

Breast cancer screening is organized at the national level by health authorities. A scientific controversy has arisen because of doubts about the reality and magnitude of the decrease in the risk of death from breast cancer due to screening and the fear that it generates a greater or lesser number of over-diagnoses and over-treatments.

This consultation allowed the Steering Committee, with the support of INCa, to identify and interview citizen, health professionals, experts and to extensively work on this complex issue. The committee was consequently able to confront multiple opinions and reflections, and it relied on INCa's human and bibliographical resources, as well as on knowledge, discussions, personal and group research to observe, analyze, develop and then formulate recommendations and two potential scenarios for the future.

From a scientific point of view, the committee noted that most of the studies used were not French, and therefore obtained under different conditions from those set up in France, which can distort the interpretation that can be made. Moreover, it is not up to the committee to decide whether the benefits of organized screening outweigh the risks. Nevertheless, the committee was able to note the existence of numerous reviews on the subject, in particular numerous randomized or observational studies, as well as meta-analyses and synthesis reports, whose conclusions on the importance of reducing mortality, over-diagnosis and over-treatment diverge greatly. The question is therefore not resolved, in view of the differences observed between the results and the interpretations. These variations and the doubts that accompany them, fuel the controversy on the subject at the French and international levels.

The committee also noted dysfunctions in the current organization of screening and its consequences: unequal access, misunderstanding of the issues, confusion between primary prevention, screening and early diagnosis, lack of information on the risks and uncertainties of screening in the invitation letter sent every two years, absence of general practitioners in the organized screening pathway (they can certainly talk about it with the women who consult them, but only in the context of a consultation for another subject), misleading and outrageous marketing of the Pink October promotional month, partial reimbursement of ultrasounds exams poorly explained to women, doubts about the effectiveness of certain therapeutic strategies etc.

Committee recommendations :

  • Taking the controversy into consideration in the information provided to women and in the information as well as the education (initial and continuing) of professionals in this area, to ensure that women concerned by breast cancer screening have access to balanced and complete information, and professionals involved in breast cancer screening receive a training enabling them to acquire the relevant knowledge for accompanying women, offering them adequate aid for making their decision.
  • Improving scientific knowledge on breast cancer and conducting an ambitious evaluation of existing and future strategies by :
    • Implementation of research projects to study the natural history of breast cancer and its nature, in order to better differentiate the types of cancers and their possible progression;
    • Implementation of ambitious information and monitoring systems in order to allow a permanent evaluation of programs.
  • Evolution of breast cancer screening program enabling systematically :
    • Integration of the general practitioner in the screening process, while also taking into account other health actors such as the midwife and the gynecologist;
    • Double reading for all screening mammograms. It is not acceptable that today two screening systems coexist, with different criteria; 
    • Evaluation of ultrasound practice as a complementary act to mammography;
    • Stopping all early screening before the age of 50 for women with no particular risk factor by implementing a delisting of the procedure.
  • Integration of breast cancer screening strategies into a more global approach to prevention and screening, by the implementation of a dedicated consultation. This consideration of the person as a whole would allow a more adapted follow-up for each individual. Breast cancer screening, dissociated from other screening and prevention actions, does not really make sense in terms of public health.
  • Development of a strategy for breast cancer screening and follow-up that is hierarchically organized according to the level of risk. With the progress of knowledge in the research of markers of evolution, it might be possible to better identify for each woman both the over- and under-risk, which could prevent her from taking part in screening as it currently exists. It will then be necessary to set up a system for identifying risk levels and monitoring according to recommendations validated in reference manuals, with a real evaluation of recommendations implementation and a very strong reactivity for recommended actions according to the advancement of knowledge and the results from evaluations.

In conclusion, the committee considers that the implementation of these recommendations should significantly improve the current situation, which does not meet the requirements of informed decision-making and scientific validity recommended for proposing screening to healthy women.

In addition to these recommendations, the committee proposes two scenarios for making breast cancer screening strategy to evolve and for achieving the same objective: enabling the implementation, in the coming years and with validated technological tools, of a screening strategy adapted to the level of risk. To reach this objective, the committee has made the above recommendations and proposes two ways to achieve this through one or the other of these scenarios :

  • Scenario 1: Termination of the organized screening program, the relevance of a mammogram being assessed in the context of an individualized medical relationship.
  • Scenario 2: Discontinuation of organized screening as it exists today and implementation of a new organized screening, profoundly modified.

It is not the role of the committee to take a position on the proposed scenarios, but a significant improvement in the program seems essential to it, as a response to the existing controversy, in such a way that confidence in the chosen mechanism could be maintained.

These two scenarios reflect the diversity of opinions of the committee members, who consider as a whole that breast cancer screening should ultimately be part of an integrated and comprehensive public health approach.

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.