False-positive results in screening: tomosynthesis not effective enough

Summary Dr. C.Bour, March 28, 2022

Tomosynthesis and annual screening: half of the women experience a false alarm

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2790521?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=032522

A study conducted by UC Davis Health* found that half of all women screened annually with tomosynthesis** experience at least one false-positive mammogram over a decade of screening.

Reminder: A false positive occurs when a mammogram is indicated as abnormal, but there is no cancer in the breast; this is after verification by other examinations (ultrasound, MRI, sometimes breast biopsy) and after a waiting period for the results between a few days and a few weeks.

Also, to be reminded, false positives in this screening are common. While approximately 12% of 2D screening mammograms are recalled for further investigation because of a false alarm, only 4.4% of these recalls, or 0.5% overall, result in a cancer diagnosis. Thus, women are most commonly alerted and recalled for nothing, resulting in significant moral harm.

* UC Davis Medical Center is part of a major academic health center located in Sacramento, California.

** Tomosynthesis (TDS): Tomosynthesis (or 3-D mammography) is an X-ray imaging technique that decreases the effect of breast tissue overlay by reconstructing a three-dimensional image of the breast from multiple low-dose X-rays acquired at different projection angles.

The objective of the study

This study aims to answer the following question: Is there a difference between screening with digital breast tomosynthesis (3D) vs. digital mammography (2D) in the probability of false-positive results after 10 years of screening?

Method

This is a comparative effectiveness study of 903 495 individuals undergoing 2 969 055 screening examinations.

Results:

The study found that repeated breast cancer screening with 3D mammography only modestly decreased the risk of having a false-positive result compared with standard 2D digital mammography.

The 10-year cumulative probability of at least 1 false-positive result was 6.7% lower for tomosynthesis vs. digital mammography with annual screening and 2.4% lower for tomosynthesis vs. digital mammography with biennial screening.
Therefore, the risk of false positives is lower when screening is performed every two years instead of every year, but also in the case of non-dense breasts and for older women.
However, as can be seen, the difference is modest, and the reduction in false positives with 3D mammography is only 2.4% compared to standard mammography.

Conclusion.

"Screening technology did not have a very large impact on reducing false positives," said Michael Bissell, an epidemiologist in the UC Davis Department of Public Health Sciences and co-leader of the study, on interview.

The first author notes, "We were surprised that the new 3D technology in breast cancer screening did not significantly reduce the risk of having a false-positive result after 10 years of screening; however, the risks of false-positive results are much lower with biennial screening compared with annual screening."

Contribution of this study

An earlier study was published in JAMA Oncol in 2018 and suggested that screening with the 3D technique was associated with better specificity (i.e., fewer false positives) and an increased proportion of breast cancers with a better prognosis (smaller and node-free) across all age and breast density groups. As the false positive rate was lowered, this resulted in a decrease in the number of repeat examinations.

We had analyzed this study here (only in French) and highlighted several limitations of this study, starting with the too-small size of the sample.
The over-detection problem remained unresolved since the claimed improvement in recalling rates was made at the cost of a significant over-diagnosis.

An article in the BMJ in July 2019 by Jeanne Lenzer, a science journalist, questioned the value of adding tomosynthesis to digital mammography, which she said was unproven. According to this author, the information given to women undergoing this technique, which is on the rise in the United States, is more of a marketing argument than neutral and scientific information.

3D technology has not been integrated into the French screening program due to the uncertainties highlighted by the French High Authority for Health.

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.

Respect patient preferences

Summary by Sophie, patient et C.Bour, MD

March 28, 2022

Patient Preferences for Outcomes Following DCIS Management Strategies: A Discrete Choice Experiment*

Chapman BM, Yang JC, Gonzalez JM, Havrilesky L, Reed SD, Hwang ES.

JCO Oncol Pract. 2021 Nov;17(11):e1639-e1648. doi: 10.1200/OP.20.00614. Epub 2021 Mar 12. PMID: 33710917.
https://ascopubs.org/doi/10.1200/OP.20.00614

*The Discrete Choice Method (DCM) analyzes consumer choices. Under specific behavioral hypotheses, it makes it possible to explain the trade-offs individuals make between the various attributes of a good or service.

Summary:

Ductal carcinoma in situ (DCIS) is more frequent as it is routinely screened; estimates indicate that 80% of DCIS are of good prognosis and do not threaten women's health. They thus contribute significantly to the overdiagnosis of breast cancer, i.e., needless diagnoses of lesions that, if they had not been found, would not have impacted either the health or the life of women.
But almost all DCIS are treated aggressively by surgery, often combined with radiotherapy and/or hormonal therapy, depending on the management guidelines in each country. In some countries, active surveillance is proposed; in others, like France, DCIS are treated with the same aggressiveness as "true" invasive cancers.

However, there are few studies on patients' preferences for treatment options.

Here the question asked is: What trade-offs are women willing to make between side effects of treatment for ductal carcinoma in situ (DCIS) and future risk of invasive cancer?

Main result: A majority of women (71%) were willing to accept a small increase in future risk of invasive cancer for treatment scenarios that offered a reduction in treatment-related side effects.

The results of this study underscore the importance of shared decision making, weighing risks and benefits, between the patient and the caregiver managing a low-risk condition.

Background

The term "overtreatment" has been used to characterize treatment for conditions that look like early cancer but are not destined to cause symptoms during a patient's lifetime or to be a cause of death. It has been estimated that as many as one in four patients with breast cancer detected by screening may be subject to overdiagnosis and overtreatment.
Much of this burden relates to treating ductal carcinoma in situ (DCIS or preinvasive breast cancer).
In fact, almost all CCIS are treated aggressively with surgery, radiotherapy, and/or endocrine therapy, especially in France.

The 10-year breast cancer–specific survival among women treated for DCIS is 98%-99%, implying that either current therapy is almost completely effective in eradicating breast cancer mortality or many women with DCIS would not have progressed to invasive breast cancer and thus were overtreated.

The exceptionally high breast cancer–specific survival across alternative treatment options has raised concern that in patients who have an indolent form of DCIS, treatment imposes harm without offering significant benefit.

An alternative to standard guidelines that has been proposed is the active surveillance (AS) approach, as is currently offered for many men with early prostate cancer and for women with other conditions considered high risk for breast cancer, such as atypical ductal hyperplasia, lobular carcinoma in situ, or a hereditary deleterious mutation. An AS strategy would entail close monitoring, with the aim of intervening only upon evidence of disease progression.

At the international level, four active prospective clinical trials are testing the safety and benefits of this approach: the LORD trial, which still includes patients.

(Read here: https://clinicaltrials.gov/ct2/show/NCT02492607
-Since February 2019, are also accepted CIS grade II, in addition to grade I
-Since July 2020, the randomized trial has been transformed into a patient preference trial: women have the choice of the trial arm (either surveillance or conventional treatment)
-Estrogen receptor and HER2 testing has been added before patients are enrolled in the trial to rule out high-grade lesions, to make the trials even safer
-There are now 28 sites open in the Netherlands, 6 in Belgium, including a francophone site opened in Brussels : https://www.chu-brugmann.be/fr/research/trials/trial.asp?num=82
15 sites will open in other countries, including France, to come!)

As awaiting the results of these trials, it is important to discern whether AS might be an acceptable option to some women if they were offered the opportunity to evaluate the benefits and harms of alternative management options.

In other words, would women accept other options such as AS instead of standard treatments if the benefit/risk balance was well explained to them?
To test this hypothesis, this study elicited patient preferences to quantify how women are willing to accept trade-offs among the possible management options for CCIS, including AS.

Discrete choice experiments, as in this case, are survey-based instruments used to obtain information about preferences for different aspects of goods and services of interest.
In a discrete choice experiment, participants are asked to choose between two or more experimentally designed scenarios that require trade-offs across the features (termed "attributes") of a good or a service; here, the management of DCIS; by analyzing participants' choices across questions, it is possible to estimate the relative importance of features on choices and how this orients the choices that persons then make.
In oncology scenarios, this may include trade-offs among the additional survival afforded by a proposed cancer treatment and the side effects, inconveniences, or costs associated with that treatment.

Methods

To better understand patient preferences, using a "discrete choice experiment," Hwang and coauthors recruited 194 healthy women in a screening mammography clinic.

Participants were provided with informational videos about the diagnosis and clinical significance of CCIS.
Then the women were asked to imagine that they had been diagnosed with CCIS and then choose between several management scenarios that included the option of aggressive treatments, less aggressive treatments, which also included the estimated risk of cancer and the side effects of treatments.
Different criteria were defined, such as breast appearance, severity of infection in the first year, chronic pain, hot flashes, and risk of developing or dying from breast cancer within 10 years, to create clinical pictures or "health profiles" for the different scenarios, for a more concrete representation for women depending on the choice they would make.

Results:

Not surprisingly, future risk of breast cancer and its attendant risk of mortality were the most important factors when women evaluated hypothetical management options.
However, the study found that over two-thirds of participants were willing to accept some increase in future breast cancer risk to reduce the extent of surgery or the severity and/or duration of treatment-related side effects.

In other words, a majority of women were willing to accept a small increase in a possible future risk of invasive cancer for treatment scenarios that offered reduced treatment side effects.

Conclusion and implication in real life :

This indicates that there is likely a subset of women who, when diagnosed with DCIS, would prioritize a reduction in side effect burden or extent of surgery over future breast cancer risk in certain contexts,  researchers concluded.

Most women were willing to make trade-offs between treatment-related effects and risk of invasive cancer, underscoring the need for shared decision making between patients and providers regarding treatment strategies for carcinoma in situ.

Although many discussions of management options for CCIS focus almost exclusively on future breast cancer risk and risk reduction, the results of this study confirm that women benefit if they are presented with detailed information about risks and treatment outcomes, allowing them to make a fully informed, personalized health decision.

The study confirms that treatment choice decisions for CCIS are highly sensitive to personal preferences, and that no a priori assumptions can be made about the trade-offs patients would be willing to consider when weighing the risks and side effects of treatment.

These complex considerations are fundamental to efforts to de-escalate treatments for low-risk conditions such as CCIS.

Advice for Oncologists, interview with principal author:

https://www.medpagetoday.com/reading-room/asco/breast-cancer/97547
By Jeff Minerd, MedPage Editor March 8, 2022

In an interview, the principal author provides advice to oncologists on how to discuss CCIS treatment options with patients in a thorough and balanced manner.
Shelley Hwang, MD, on Helping Patients Make DCIS Management Decisions/Excerpts

Ductal carcinoma in situ (DCIS) is common in the United States, but there are few studies of patient preferences for treatment options. Authors :
"Estimates indicate that only 30% of DCIS may progress to invasive cancer. Nevertheless, almost all DCIS is aggressively treated with surgery, often combined with radiation and/or endocrine therapy, according to guideline-concordant care."

To better understand patient preferences, using a "discrete choice experiment, "Hwang and co-authors recruited 194 women without breast cancer from a screening mammography clinic. The women were asked to imagine they had been diagnosed with DCIS and then asked to choose among several scenarios that included aggressive and less-aggressive forms of treatment, estimation of cancer risk, and side effects.
Not surprisingly, future risk of breast cancer and mortality were the most important factors when the women evaluated hypothetical management options. However, the study found that more than two-thirds of the participants were willing to accept some increase in future breast cancer risk to reduce the extent of surgery or the severity and/or duration of treatment-related side effects.

This indicates that there is likely a subset of women who, when diagnosed with DCIS, would prioritize a reduction in side effect burden or extent of surgery over future breast cancer risk in certain contexts," the researchers concluded.

In the following interview, Hwang elaborates on the details of the study and how to discuss treatment options with patients.

Do you have any advice for how oncologists can discuss treatment options for DCIS with patients in a thorough and balanced way?

Hwang: One key step is eliciting how much knowledge a patient has about her diagnosis and its implications. I think a surgical oncologist would tend to jump right in and say, it's a cancer, we need to remove it, these are the surgical options. That's always the easiest thing for us to do, but we sometimes neglect to spend time with the patient upfront talking about the diagnosis itself and what the clinical implications are.
And when you're dealing with a disease that has no immediate clinical or life-threatening implications, and specifically for DCIS when we don't even know if it will turn into cancer even if we don't intervene surgically, I think framing the diagnosis first and making sure the patient understands the implications of the diagnosis is important.

Your study used discrete choice experiments, which were first developed for market research. Can you briefly describe how these work?

Hwang: Discrete choice experiments have been used a lot in areas such as health economics to see how people make decisions and weigh pros and cons of all the different aspects of making that decision. So say you're about to buy a house, not only do you have to consider cost but also location, how many bedrooms it has --there are many different components that go into that decision.
It's never just one driver that makes an individual decide which house to buy. There are some very emotional aspects to that too. So a discrete choice experiment tries to come up with a set of attributes that are important for making a certain kind of decision.

In this case it was a diagnosis of DCIS and the decision about how to manage it. We tried to include attributes we thought would be meaningful for patients. So postoperative pain, for instance -- that's something people wonder about and are concerned about. We included different levels of pain in the experiment. Cosmesis and side effects of treatment are also important considerations. We created different scenarios where we mixed and matched these different attributes. We presented them to patients and asked them to choose which scenario most matched their preferences. That gave us an idea of what values patients considered most important when trying to make a decision about DCIS.

I think this is something that's becoming more and more relevant. Cancer screening detects precancers such as DCIS that have no immediate clinical implications. There are no symptoms, there are no mortality implications, there's just this concern, that we're trying to prevent cancers from occurring. And I think the better we are at screening, the more we're going to find ourselves in this position, not only with cancer but also with cardiac disease and metabolic diseases, where we diagnose a condition before the patient has any symptoms.

So I think balancing the pros and cons is a lot more relevant when you're not dealing with immediate life-threatening illnesses, and learning how to talk to patients about these scenarios will be an increasingly important skill.

Your study included women without an actual diagnosis of DCIS. Do you think this limits the generalizability of your results to the general DCIS population?

Hwang:That's a really good point. We didn't feel we could do this study with women who were diagnosed with DCIS, because we didn't know what information they would come in with already. If someone somewhere along the way said to them you have cancer and it needs to come out, that could certainly affect how they viewed their choices.
To do this discrete choice experiment, we needed a group of patients that didn't have a lot of other sources of information about the disease already.
...........

On the other hand, women in the study were coming in and presenting with an abnormality, or they were coming for a breast cancer screening, so they were  already thinking about what would happen if they did have a diagnosis. So we felt like it wasn't a stretch to use this population.

We as surgeons are taught to focus on cancer outcomes and mortality, and we should focus on those things. However, sometimes our training hasn't incorporated how to balance other things that patients care about and helping them apply these values to a treatment decision that's comfortable or preferable to them.

I've found that sometimes surgical oncologists, and oncologists in general, treat the cancer, but what we really need to do is holistically treat the patient along with the cancer. That's the take-home message of this study, underscoring how important it is to treat each person as a unique individual and someone who may not necessarily share the treating provider's belief system.

There is room in medicine to accommodate many differing views of risk and health.

For more information:

Surtraitement du CCIS du cancer du sein de stade 0

Perspective : Les risques de surdiagnostic - Nature

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.

A Modeling Study on Overdiagnosis

By the Cancer Rose Collective, March 12, 2022

https://www.acpjournals.org/doi/10.7326/M21-3577

According to a modeling study based on data from Breast Cancer Surveillance Consortium (BCSC), about one in six to seven screened breast cancer cases is overdiagnosed.

This study first highlights that overdiagnosis in breast cancer screening is real.

Results of study

An average of 15.4% (95% CI: 9.4%-26.5%) of screened cancer cases were estimated to be overdiagnosed, reports lead author Marc D. Ryser* of Duke University in Durham, North Carolina, and colleagues.

* Ryser: Marc Daniel Ryser, Assistant Professor of Population Health Sciences. Dr. Marc Ryser is an expert in mathematical and statistical modeling. His research uses biological, clinical, and population-level data to inform and guide the early detection and prevention of cancer.

Below are the results by age group and type of cancer detected (Figure 3 and Table 3).

Beyond the average values, we can observe (Fig 3) that for all age groups, the rate of overdiagnosis can reach maximum values higher than 20%, and according to Table 3, the rate of overdiagnosis at the first screening reaches a maximum value of 28%, at 58 years 21.1%, at 66 years 25.4% and at 74 years 31.9%

In this model study, an interesting finding is that the rate of overdiagnosis increased with age and almost doubled depending on the age range analyzed: 11.5% (95% CI, 3.8%-28.3%) at the first screening at age 50 to 23.6% (95% CI, 17.7%-31.9%) at the last test at age 74.

Comparison with previous data

The authors note, "comparison of our estimates against those from other studies is not straightforward because of differences in overdiagnosis definitions and screening practices."

They conclude that their results regarding overdiagnosis are both higher than previous modeling studies (ranging from 1% to 12%, depending on the studies cited in the article) because of differences in screening practices, diagnostic practices, and modeling assumptions, but lower than other studies that have shown rates much higher than the average in this study.
For example, the Canadian screening trial estimated an overdiagnosis rate of 30% (Baines CJ, To T, Miller AB. Revised estimates of overdiagnosis from the Canadian National Breast Screening Study. Prev Med. 2016;90:66-71. [PMID: 27374944] doi:10.1016/j.ypmed.2016.06.033 ) for cancers detected by screening.
In a population-based study, Bleyer and Welch (Bleyer A, Welch HG. Effect of three decades of screening mammography on breast-cancer incidence. N Engl J Med. 2012;367:1998- 2005. [PMID: 23171096] doi:10.1056/NEJMoa1206809 ) estimated that 31% of all diagnosed breast cancer cases were overdiagnosed.

The authors conclude with the hope that their findings will join a consensus and facilitate decision-making regarding mammography screening.

Conclusions of the Editorial "Reducing the Burden of Overdiagnosis in Breast Cancer Screening and Beyond

The editorial published in conjunction with the study emphasizes the importance of informing women about what this overdiagnosis represents.
(Marcondes FO, Armstrong K. Reducing the Burden of Overdiagnosis in Breast Cancer Screening and Beyond. Ann Intern Med. 2022 March 1. doi: 10.7326/M22-0483. Epub ahead of print. PMID: 35226534.)

Authors underline: « Women who are considering having mammography screening should be counseled about the risk for unnecessary cancer treatment using this information."
Estimating that about 60% of the 280,000 cases of breast cancer diagnosed each year in the United States are discovered through mammography screening, eliminating overdiagnosis could save 25,000 women the cost and complications of unnecessary treatment.

"Substantial advances" in critical areas need to be made, according to the authors, including:
- Develop a better predictive capability to accurately identify tumors that will not progress
- Improve the accuracy of screening technologies to reduce the risk of overdiagnosis and improve the ability to detect breast cancer that has not been detected by mammography
-Implement prevention strategies to reduce the overall rate of breast cancer diagnosis, such as providing counseling on lifestyle changes and screening for genetic risk.

The authors of the editorial conclude: « Screening tests, whether for cancer or other conditions, can provide great benefit by detecting disease when it is more easily treatable. However, the risk of labeling millions of persons as having a disease without improving their outcomes is very real. For now, the key to navigating these tradeoffs remains open and effective physician–patient communication, rigorous evaluation of all proposed screening strategies, and continued investment in early detection research. We look forward to the day when making an early diagnosis always helps our patients achieve better outcomes. »

And the findings go beyond breast cancer screening.
"As screening and diagnostic testing continues to grow in clinical practice, the issue of overdiagnosis is being felt far beyond cancer screening. For some conditions, changing definitions have led patients to be labeled with a predisease state on the basis of a test result that was previously considered in the normal range. Although there are strong arguments in favor of early treatment to prevent long-term complications in many conditions, the reality is that, just as with cancer screening, there is little doubt that some patients diagnosed through a screening test would never have progressed and are likely to be receiving unnecessary treatment."

Comments and criticisms, opinion of Dr. V.Robert, statistician

1-A modeling study

The study remains a modeling study, which means that the results of a model depend on a chosen model and conditions of validity, at best unverifiable and at worst questionable. For example, the authors are obliged to consider that a breast cancer is either definitively non-evolving or inexorably evolving, with no possibility that the evolutionary status of cancer changes over time. It is not clear that things are that simple.

Another example is that the authors are obliged to build their model by considering that all progressive breast cancers evolve at the same rate and that this rate remains constant throughout the evolutionary period. In practice, there are most likely different distributions of progression rates for each type of breast cancer, and it is not clear that progression rates cannot vary over time.

2- The data on mortality from causes other than breast cancer used by the study do not seem well adapted.

On the one hand, after checking reference 25 of the study, which corresponds to the source of these data (Contribution of Breast Cancer to Overall Mortality for US Women): for a population of women aged 50 to 80 years, these data are not derived from direct measurements of mortality but from data estimated from projections (in other words, from models).

On the other hand, the data correspond to a cohort of women born in 1971. Since the median age of the women included in the study is 56 years, the cohort born in 1971 is adapted for the mortality of women included in 1971 + 56 = 2027. Or, if you prefer, the cohort adapted to have the mortality of women aged 56 in 2000-2018 should be born between 1944 and 1962. Whatever the reasoning, it is clear that the cohort considered to obtain the mortality data is too recent by at least a decade. This is not neutral since the tables in Reference 25 show a non-negligible decline in mortality over time.

3-The definition of screen-detected cancers is questionable.

Screen-detected cancers are considered to be those that meet the following two conditions: screening mammograms BI-RADS 3 to 5 + diagnosis of cancer within the next 12 months.
With criteria such as these, interval cancers are likely to be classified as screen-detected cancers (BI-RADS 3 + negative complementary examinations = screening showing no cancer; if a cancer occurs 11 months after the screening mammogram, it is an interval cancer, and yet it will be classified as a screened cancer). Even if these cases are not very frequent, they are part of the data used to adjust the parameters, and adjusting on "garbage in, garbage out" data can only give garbage results.

4- It is wrong to pretend that the study found that the overdiagnosis rate is 15%.

The reality is that the study shows that the overdiagnosis rate is somewhere between 9% and 27% (and any value within that range is possible, no more 15% than 9% or 27%).

Figure 3 from the study:

Depending on the age range, the percentage of overdiagnosis can vary up to 25% or even 32%.

Unfortunately, it is a very common mistake to take the result of a study (estimated rate from a sample) for the reality (real and unknown, rate in the population). And it is an even more common mistake to believe that the estimated rate is more likely to be close to the real rate than any other value in the confidence interval.

Conclusion

Based on such a study, we cannot arbitrarily consider that the debate on the frequency of overdiagnosis is closed, with a definitive frequency of 15%, as the study's authors would like.

On the other hand, the model may be interesting for answering questions about the evolution of the frequency of overdiagnosis as a function of the age of the women screened or about the evolution of the frequency of overdiagnosis as a function of the interval between two screening mammograms.    

Professor Alexandra Barrat of the University of Sydney, interviewed by Amanda Sheppeard, associate editor and reporter for Oncology Republic and The Medical Republic, said there are different methods for estimating the potential rate of overdiagnosis through breast cancer screening.
She said the study demonstrated the inevitability of overdiagnosis in screening for a number of cancers. "I think there is a need in the professional community for greater acceptance of what the evidence shows about breast cancer screening."
"We just need to recognize that this is inherent in a cancer screening program."

As a result, and beyond the evidence, according to A.Barrat, the study helped to underscore the importance of informed consent in breast cancer screening.

Conflicts of interests

Dr Ruth Etzioni - Individual investor and stock in Seno Medical  https://senomedical.com/clinical/product-applications

Seno’s first clinical product targets the diagnosis of breast cancer and will be used in addition to screening mammography, integrating opto-acoustics and ultrasound.

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.

Anatomopathology, possible uncertainties

Summary by Dr. C.Bour, 18 December 2021

Observation:

This case involves a 65-year-old woman who began mammograms at age 40 due to a family history of breast cancer (mother at age 80). She has already had biopsies, which revealed that she had a simple mastosis (benign condition of the breast, characterized by tension and pain in the breasts, as well as a "granular" consistency when palpating the breasts, in areas where the mammary gland is more present and dense).

A mammogram revealed two small foci of microcalcifications in one breast. A preliminary macrobiopsy was carried out, but it was unsuccessful due to difficulties in locating them. A few months later, a second macrobiopsy was performed.

The two biopsied sites revealed a carcinoma in situ (ductal carcinoma) and an "atypical hyperplasia" lesion. Due to the presence of two concomitant lesions, a complete mastectomy (complete removal) of the breast was recommended based on the pathology report.

Anatomopathology is not infallible

Breast biopsy samples can be difficult to analyze.

In a 2016 study published in the BMJ, American researchers assessed the effectiveness of 12 different strategies in reducing interpretation errors (second opinion requested for all samples, second opinion only in the case of atypia, or only in the case of the wish of the first pathologist or for first readers with less experience in breast pathology, etc...).

115 pathologists examined 240 breast biopsy specimens, one slide per case, and compared their observations to an expert consensus diagnosis.

This study revealed that pathologists who took part in the study disagreed with the expert panel's consensus about 25% of the time. Most of the disagreements were with specimens from difficult-to-interpret conditions, such as atypia, which occurs when cells appear abnormal but are not cancerous, and ductal carcinoma in situ (DCIS)

The conclusion of the study: except for invasive cancer cases where the second opinion rarely differs from the initial interpretation, ALL strategies requiring a second opinion improve diagnostic concordance and reduce misclassification rates of breast specimens from 24.7% to 18.1%, showing that variability in diagnosis is still only incompletely eliminated, especially for breast specimens with atypia.

A second opinion is thus recommended because it can mean the difference between a diagnosis of benign hyperplasia or carcinoma in situ, influencing surgical sanctions, the need for re-intervention, radiotherapy, and/or chemotherapy.

As a result, a second opinion can help patients make a therapeutic choice.

Why not propose a more systematic second reading of the biopsy?

In the case of a positive biopsy, the start of the disease is defined by this single examination of the tissue taken under the microscope (i.e., except for invasive cancer, where uncertainty is rarer) (histological diagnosis).

And it is astounding to note how, on the one hand, DCIS is considered a “stage 0” breast cancer with a very good prognosis, and how, on the other hand, the therapeutic sanctions for this DCIS and a fortiori for pre-cancerous lesions can be extremely aggressive, as aggressive as for a "true" invasive cancer.

The patient does not know the name of the person who read her biopsy; worse, she does not have the choice of the reader of her biopsy, the anatomopathologist, contrary to the choice she has for the general practitioner, the gynecologist, and even a surgeon if necessary.

This pathological anatomy report is never communicated to the patient, although it is strictly necessary and mandatory for treatment to begin. It determines the course of treatment and the therapeutic options available.

On the other hand, the pathology report is part of the patient's file and can thus be requested by the patient.

Recommendations for patients if carcinoma in situ or a borderline or atypical lesion is found.

First and foremost, don't panic; take your time. You have the following options:

1- Request that the biopsy results be sent to you physician.

2- In the event of a failure, request a complete copy of the medical file (mandatory within 8 days)

3- If you are unsuccessful, request that the Medical Council intervene to obtain it for you. You are the owner of the medical file.

4- With the result, it is legitimate to ask for a revision of the anatomopathology slides. You can even have the file re-examined by an expert (your general practitioner just has to ask for it).

5-It is also possible to ask for a second opinion from another surgeon, possibly located in another region.

The therapeutic choice can be discussed: a less aggressive intervention or even simply "careful monitoring," knowing that unfortunately in France, for the moment, very few practitioners are adept at this wait-and-see approach which is being studied in several large European trials, including the LORD trial which is still including patients.

Read here: https://www.dcisprecision.org/clinical-trials/lord/https://www.dcisprecision.org/clinical-trials/lord/

(-Since February 2019 are also accepted CIS grade II, in addition to grade I

-Since July 2020, the randomized trial has been transformed into a patient preference trial: women have the choice of the trial arm (either surveillance or conventional treatment)

Estrogen receptor and HER2 testing has been added before patients are enrolled in the trial to rule out high-grade lesions, to provide even greater safety in the trial

-There are now 28 sites open in the Netherlands, 6 in Belgium, and 15 sites will open in other countries (France, to come!)

Conclusion

An anatomopathological diagnosis should be reviewed and discussed by caregivers, rather than being accepted as a "gold standard" because it may trigger a series of aggressive treatments, the usefulness of which should be discussed with the patient.

Read more :

https://newsroom.uw.edu/story/second-opinions-notably-reduce-breast-biopsy-misdiagnoses

Website DCIS

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.


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Dual-energy angiomammography

November 27, C.Bour MD

Angiomammography is a recent technology that is not useful for screening but in diagnosing lesions and for particular indications.

We're talking about it because it's a technique you've probably heard of, and the French Health Authority recently examined it.

What is angiomammography?

This procedure combines mammography with the injection of a contrast agent to analyze contrasting lesions. It is possible to differentiate benign from malignant tumors based on the tumor's vascular behavior, specifically the emergence and subsequent fading of the vascular enhancement.

Dual-energy approach

After injecting the contrast agent into the patient, mammography is conducted with two incidences (one frontal and one oblique per breast) in two acquisitions, one low and one high energy, as is usual.

The glandular tissue and fat can be separated by recombining the images produced with these two acquisitions, leaving just the contrast of the lesions of interest apparent on the recombined images.

The end result is a type of mapping that allows for visualizing highly vascularized lesions such as cancers.

However, the dose delivered to the gland is higher due to the repetition of the acquisitions, once at low and once at high energy. The additional irradiation is approximately 1.2 times the usual dose for each image.

Why no indication in screening for women at high risk of breast cancer?

This technology is more irradiating than conventional mammography; MRI appears to be more suited because we usually want to limit irradiation in this at-risk population, for whom ionizing radiation is a potential factor in cancer induction.

What is the advantage of this technique compared to MRI?

It is quick to perform. Because the same incidences are used, it is simple to analyze the images and compare them to earlier mammograms (faces, obliques).

It is, however, irradiating and is not recommended for women who are at high risk of cancer. There is always the potential of allergy to the injected contrast products, even if it is low.

HAS (French Health Authority) recommendations

Angiomammography could be used in the following situations:

  • diagnostic impasses, to confirm the presence of a suspicious lesion or to rule out the presence of a lesion, although with necessary follow-up;
  • when contrast imaging is required:
    - locoregional extension assessment (tumor size and search for additional lesions);
    - evaluation of response to neoadjuvant chemotherapy;
    - tumor evaluation before neoadjuvant chemotherapy, but experts noted that breast MRI is currently the reference examination in this indication.

Two situations to be considered:

Angiomammography is recommended in the following situations where MRI is contraindicated:

  • diagnostic impasses;
  • locoregional extension assessment of cancer;
  • tumor evaluation before and after neoadjuvant chemotherapy.

In the absence of contraindications to MRI, angiomammography is recommended

  • In assessing locoregional extension or before/after neoadjuvant chemotherapy, for evaluating the tumor size, particularly for its perfect correspondence with the mammography images.

According to HAS, a quality control policy should be implemented to ensure optimal doses are always used and that the facilities are monitored.
More robust performance studies and meta-analyses are needed to confirm the diagnostic efficacy of angiomammography.

The HAS recommends conducting clinical research studies to confirm diagnostic performance data, to demonstrate the clinical usefulness of angiomammography, define its role in the diagnostic strategy, and determine its impact on therapeutic management (number of biopsies, the relevance of the surgical decision, rate of reinterventions, etc.).

References

https://www.edimark.fr/Front/frontpost/getfiles/24426.pdfhttps://www.has-sante.fr/jcms/p_3186760/fr/interet-de-l-angiomammographie-double-energie-dans-la-strategie-diagnostique-du-cancer-du-sein-rapport-d-evaluation

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.

October, the cruelest month?

Summary Dr. Cécile Bour, November 15, 2021

About an article published on October 15 in The New York Times by Holly Burns, a San Francisco area writer who was diagnosed with breast cancer 4 years ago.

Holly Burns shares her experience, which is similar to that of other cancer "survivors," and which remains poorly expressed during the annual Pink October: "October is National Breast Cancer Awareness Month and I am a person who’s had breast cancer, which means for me October is basically 31 days of low-key PTSD.”

Pink October as a trigger for an "anniversary reaction"

Kathleen Ashton, a psychologist at the Cleveland Clinic Breast Center in Ohio, also testifies in the article, "Some do enjoy the opportunity to raise awareness, but the majority of my patients find the month distressing."

For some patients and former patients, the month of Pink October acts as a red flag that is waved and brings everything to the surface, with the procession of trauma that has often accompanied the patient's journey, from the announcement to the treatment.

Deborah Serani, a psychologist and professor at Adelphi University in New York, explains that anxiety at a particular time may be triggered because of a phenomenon known as the "anniversary effect" or "anniversary reaction," a unique set of thoughts or feelings that arise around the anniversary of a significantly traumatic experience.

Thus, explains the psychologist, anything that reminds us of the traumatic event experienced can provoke this "anniversary reaction".

A gap between marketing and real life

This month can be particularly difficult for those whose cancer is progressive and has progressed. "It can feel like only the happy stories are presented," testifies a 40-year-old woman, Emma Fisher, with stage 4 metastatic breast cancer.

"It's hard to see campaigns where "everyone is laughing and smiling and having bake sales and doing fun runs," she says. "It makes me feel invisible, it's almost like metastatic patients are this dirty little secret in the breast cancer world, because nobody wants to portray breast cancer as a killer."

In the book IM-PATIENTE, Maëlle, the young woman with advanced cancer who testifies, says something similar: "the hospital is decorated in pink for a month, all the nice grannies knit their little pink squares, and we make a pretty ribbon around the hospital, well, okay. Sure. But during Pink October, what stories are we talking about? We always tell the same stories. We talk about these warriors who started their enterprise while undergoing chemo and who have three children after their surgery.
It's always the same story. Have we ever heard during Pink October about women having metastatic cancer? I don't think so. Because it's not pretty, it's not glamorous, we don't talk about it. that's unacceptable." (June 2018)

Bri Majsiak, co-founder of a non-profit organization for people affected by breast and gynecological cancers, says, "Breast cancer lasts 365 days a year, not 31."

How do you get through the month of October with peace of mind?

Psychologist Dr. Ashton (Cleveland Clinic Breast Center in Ohio) advises women affected by breast cancer to limit exposure to things they might experience as upsetting, which can mean taking a break from social media, unsubscribing from as many marketing emails as you can, not being afraid to set boundaries with loved ones who don't understand why ex-patients and patients might find this month very painful to live with, or sharing with other women who may be feeling the same way.

While friends and family may assume this is a month of celebration for survivors, they "need to understand that a serious personal illness like breast cancer is a traumatic experience," Dr. Serani said.

A Charleston psychotherapist, Ms. Ilderton, also advises against making the survivor you know a 'case study,' she whose friend emailed a group using her as an example of why a mammogram was a must.

Bri Masiak advises that for those who wish to support Pink October, they should look carefully at where the proceeds go and consider whether it would be better to donate to a more focused local organization, or one that is helpful to women during their treatment, for example.

Indeed, the destiny of the funds collected is often very opaque, the marketing budget can represent an important part, and the part really devoted "to the cause" is not known by the donors. The stated purpose of the fundraising is often "research".

But....what research? Do we wonder which studies have really been financed, what are the results, what are the concrete advances for women while we have been running for decades and yet breast cancer still kills, and this since the 90s, 11,000 to 12,000 women/year? This leaves us wondering about the real impact of these costly campaigns.

Conclusion

During this great annual pink barnum, not very useful and in reality not very informative for women, we should at least be aware that it can be a vector of distress and painful memories for some of us.

We hope that future Octobers will be less pink, more discreet and less festive, more educational and more interactive with all women, the healthy ones, the survivors and the heavily affected ones, for a better information on breast cancer, in a neutral and objective way.


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


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

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

November 5, 2021

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

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

Instrumentalization of fear

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

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

Awareness of all risks

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

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

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

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

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

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

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

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

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

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

Reducing the fear of dying from breast cancer

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

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

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

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

The right to choose AFTER adequate information

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

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

If there was only the fear of dying

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

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

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

A culture of understanding risk

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

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

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

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

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

References

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

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

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

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

(summary table of institutions using influence methods).

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


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

Increasing the importance of early clinical diagnosis

NOVEMBER 5, 2021 BY CANCER ROSE

A Lancet study

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

Concept of early clinical diagnosis

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

We therefore distinguish :

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

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

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

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

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

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

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

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

Reducing breast cancer mortality with less overdiagnosis

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

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

A serious alternative

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

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

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



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


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

Bad statistic of the month October

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

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

Translation by Cancer Rose, nov 5, 2021

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

Bad Statistic of the Month

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

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

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

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

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

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

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

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

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

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

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

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

Your contact for more information:

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

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

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

RWI - Leibniz Institute for Economic Research

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

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

Harding Center for Risk Literacy

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

University of Potsdam-Faculty of Health Sciences

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

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


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

INCa still outrageously dishonest and unethical

15th of October, 2021 

https://www.e-cancer.fr/Expertises-et-publications/Catalogue-des-publications/DEPLIANT-Depistage-des-cancers-du-sein.-Guide-pratique

In June 2021, the French National Cancer Institute (INCa) issued a new leaflet, in addition to the brochure published in 2017, sent to women one time for their first screening appointment at the age of 50. This new leaflet will be distributed to all women for the following appointments, beginning at the age of 52. 

here: PDF of the leaflet

 REMINDER: 

1) The 2015 citizen and scientific consultation [1] allowed for the expression of two scenarios: "Scenario 1: Termination of the organized screening program..."; "Scenario 2: Discontinuation of organized screening as it exists today [2],..." and the claim for women concerned by breast cancer screening to have "balanced and complete information." [3]

2) It took two years for the French National Cancer Institute to publish in 2017 a very insufficient brochure [4], barely mentioning the harms of screening (pain during the examination, overdiagnosis, etc.) but not detailing them, focusing mainly on the very meager benefits, which are advantageously put forward.

3) In an international study, INCa's lack of objective information and manipulative nature were questioned [5], as was already the case for the citizen and scientific consultation report.

Today, six years after the citizen consultation, INCa persists and signs.

The proof is this new leaflet, which will be included in future biennial invitations sent to women aged 52 and over.

Analysis

The poor informative content of this leaflet allows a rapid analysis: NONE of the adverse effects of screening are mentioned. 

Instead, it states:

"This early detection increases the chances of a cure: it allows 99 out of 100 women to be alive 5 years after diagnosis."

CAUTION: Being alive 5 years after a diagnosis does not imply that you have been "cured." 
What about this generously promoted survival? 
First and foremost, it would be more accurate to present the 5-year survival rates of 100 women who were screened and 100 who were not screened.

Here's an insightful article that explains what survival means and why it isn't a reliable indicator of screening effectiveness https://formindep.fr/cancer-des-chiffres-et-des-hommes/

This is what survival means:

 "Survival" measures the length of time the cancer is present or the length of time a patient lives with cancer, but it does not measure the longevity or life expectancy. 
Screening creates an optical illusion by anticipating the date of cancer onset by detecting it before any symptoms appear. While the result is the same, i.e., death regardless of the time of diagnosis, this creates the impression that the patient's life is being prolonged. In reality, screening does not affect t women's longevity; it simply shifts the "window of observation" in the disease's history.

A diagram from the WHO screening guide, page 47, illustrates this lead-time bias [6] :

Or in this diagram: [7]

"Lead-time bias occurs when screening finds cancer earlier than that cancer would have been diagnosed because of symptoms, but the earlier diagnosis does nothing to change the course of the disease" (National Institute of Cancer (NIH) USA).

To illustrate the situation differently, let's use an analogy: a train heading for Paris derails in Orleans at 3 p.m., causing the death of all passengers. If I boarded at Tours, I would have a survival of 30 minutes; if I boarded at Bordeaux, I would survive 2 hours. Artificially, we can say that people who boarded at Bordeaux have longer survival than those who boarded at Tours, even though they did the same thing: boarding the train at a given moment.

Thus, the extension of survival is the result of two phenomena: the efficacy of treatments that would extend the life of a cancer patient and the anticipation and detection of several lesions that would not have caused the death anyway. Nonetheless, not all over-diagnosed women die! As a result, there is an illusion of success in the case of breast cancer because we are diagnosing numerous lesions that would never have caused the death...

"Survival" is a poor indicator because it is used to describe something that it cannot: the effectiveness of screening.

The only indicators of the effectiveness of screening are the decrease in mortality and the reduction of advanced cancers. However, it is not enough to say: "THE EARLIER A BREAST CANCER IS SCREENED, THE GREATER THE CHANCES OF CURE," it is necessary to prove with data and the INCa, carefully omits this point in the leaflet...

Why is this leaflet outrageously dishonest and unethical?

1. Again, French women are not receiving the critical neutral information to which women in other countries are entitled. This is a serious breach of ethics.  Women citizens were indeed asking for easy-to-understand decision aids (pictograms). [8]

2. The information on the risks of screening is not directly available. The word "risk" is never even mentioned, which is a deceitful way to make this information as inaccessible as possible.

Indeed, we can read on one of the leaflet's pages, "To learn more, talk to your doctor or go to "cancersdusein.e-cancer.fr." 

If the woman invited to the screening wants to know the unfavorable effects, she must go to this website [9] and look for the section(s) dealing with these adverse effects herself. 

Overdiagnosis is never mentioned as a title on this website's home page; the risks of screening can be found by clicking on the inserts "the benefits and limits of screening" and "breast cancer screening, risk 0 or not?"

The word "limits" is misleading and not appropriate. In its French version of the guide, the WHO uses the term "effets nocifs" (in English: harms) of screening, which weighs against the benefits. [10]

For a woman to say that screening has limitations means that screening is not completely effective and that there are probably cancers that are missed. But this term does not imply that screening has risks.

3. Addressing citizens' requests does not mean that INCa can disseminate deliberately truncated, false, misleading, and incomplete information, embellishing the benefits and concealing the risks at the same time as the letter of invitation. This is yet another example of disregard for women who will never have access to the truthful information to which they are entitled.

4. This process, which is repeated every two years, is, of course, a strong incentive because of its repetition.

5. The initial brochure was incomplete and has not been modified since 2018 despite its shortcomings [4]. But at least it addressed the possibility of overdiagnosis. The 2017 brochure is aimed at women aged 50 who are invited to perform breast cancer screening for the first time. It is only sent for the first screening, so women who turned 50 before 2017, now aged 55 or older, have never received it and will have to rely on this misleading and incomplete leaflet issued in 2021.

6. This new leaflet is supposedly "based" on the 2017 brochure, misleading, as overdiagnosis is never mentioned.

7. The new leaflet says: "to know more, talk to your doctor or go to the website...". The general practitioner can certainly be contacted, but in reality, the woman makes an appointment directly with the radiology office, mainly because the information in the leaflet focuses all its communication on the benefits of screening, leaving the practitioner no opportunity to properly inform the patients before they go for mammography screening. In any case, what question would a woman ask her practitioner since the notion of "risk" does not appear anywhere in the brochure?

8. In the "key information" section, it is stated that mammography is "reliable." This information is again misleading since mammography exposes women to false positives (suspected cancers that are not confirmed) and false negatives (cancers that are hidden or develop between two mammograms and are, therefore, "missed" by screening).

Why is INCa so consistent in providing promotional information about mammography breast cancer screening? 

Why has INCa's biased promotional communication remained unchanged over the years? This is a question that everyone should ask.

Since the introduction of organized screening for breast cancer in 2004, scientific knowledge about mammography screening has advanced, but INCa's "communication" has not changed. INCa still presents screening as very beneficial to women, as it does in this leaflet, without mentioning what is debated in France and worldwide. The major benefit is still asserted even though it is increasingly being questioned.

Furthermore, many risks have been updated, but this brochure does not even use "risk," implying that they do not exist. The INCa replaces the term "risk" with "limit," which is never used in the scientific literature on the subject.

Why is this mode of communication being used? 

For all of its years, INCa has focused its communication on promoting breast cancer screening by mammography. This communication is very different from what is done in other countries. [8]

INCa's goal is not to correctly inform women about organized breast cancer screening by mammography but to intensify it to "win the European competition." And this is done blatantly, disregarding scientific knowledge on the subject. 

As proof: in its detailed report "Ten-year strategy 2021/2030 to fight cancer," we read INCa objectives on p20, "Achieve one million more screenings by 2025. It is up to us to exceed the coverage targets recommended at the European level in terms of screening and to join the leading group in terms of adherence (70% for the Organized Breast Cancer Screening ......., ". [11] 

The INCa appears to be only following orders from the authorities. On the other hand, citizens have the right to expect objective information from such a health authority rather than "propaganda." 

Why is it critical for citizens to have access to information that INCa does not provide?

INCa's role was defined at the time of its creation (article L1415-2 of the Public Health Code); it was given two contradictory missions: to inform (paragraph 3) and to promote screening (paragraph 6). 

"Informing" means providing unbiased information about the benefits and disadvantages of a public health system. "Promoting" means ensuring that the public is effectively influenced to adhere to it, which contradicts neutral information because it tends to conceal anything that dissuades people.

As a result, there is an irreconcilable incompatibility between these two missions, as well as a clear conflict of interest when, as with this unworthy leaflet, INCa can congratulate itself for responding to citizens' requests for information while ensuring that this information remains outrageously biased.

This is precisely what the INCa is doing with this brochure, which is akin to infantilizing women by maintaining them in ignorance, assuming their inability to make an independent choice.

According to a French publication, in order to increase screening participation, women who are called upon to undergo it should not be given information.[12]

Given this situation, doctors and patients will have to adapt and seek the information necessary for everyone to make informed decisions outside the communication of the French health authorities.

Example of a brochure

It is not surprising that this manipulative information comes from an institute that does not hesitate to label the scientific debate on screening as "Infox" or "Fake news." [13]

Our Cancer Rose collective began delivering more balanced information in a leaflet several years ago without any financial outlay. It is in A5 format, downloadable and foldable, and is intended for women and doctors to distribute to patients at the end of their consultation.

Our collective will make a point of informing the leaders of the INCa's International Scientific Council. We will notify international actors and groups fighting in many countries for women to be recognized as intelligent beings deserving of information to ensure their choices and autonomy in health matters within the framework of informed consent.

References


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

[2] page 132-133 du rapport https://cancer-rose.fr/wp-content/uploads/2019/07/depistage-cancer-sein-rapport-concertation-sept-2016.pdf

Two scenarios proposed, both contain the words "stopping screening".

[3] page 128 du rapport https://cancer-rose.fr/wp-content/uploads/2019/07/depistage-cancer-sein-rapport-concertation-sept-2016.pdf

[4] https://cancer-rose.fr/en/2021/01/01/critical-analysis-of-the-new-inca-information-booklet/

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

[6] https://apps.who.int/iris/handle/10665/330852?locale-attribute=en&

[7] https://www.cancer.gov/about-cancer/screening/research/what-screening-statistics-mean 

[8] https://cancer-rose.fr/en/2021/06/28/other-information-tools/

[9] https://cancersdusein.e-cancer.fr/

[10] https://apps.who.int/iris/handle/10665/330852

[11] https://solidarites-sante.gouv.fr/IMG/pdf/feuille_de_route_-_strategie_decennale_de_lutte_contre_les_cancers.pdf

[12] https://cancer-rose.fr/en/2021/01/24/objective-information-and-less-acceptance-of-screening-by-women/

[13] https://cancer-rose.fr/en/2021/07/13/the-national-institute-of-cancer-in-france-inca-relegates-the-question-of-the-benefit-risk-of-organized-breast-cancer-screening-to-the-fake-news-rubric/

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.

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