New gene test can eliminate unnecessary chemotherapy for breast cancer

Breast cancer test: decision on chemotherapy remains difficult

Each year, around 75,000 women in Germany become ill with breast cancer. Breast cancer is the most common tumor in women in this country. For sufferers, the question usually arises as to whether chemotherapy is necessary. To answer this, biomarker tests are supposed to help. But apparently, such genetic tests do not provide clear insight.

Chemotherapy is not always useful

Around 75,000 women in Germany suffer from breast cancer each year. Many of them have to undergo chemotherapy with stressful side effects. But for a long time, health experts have pointed out that breast cancer does not always make sense.

Biomarker tests will help to find out if chemotherapy is useful in breast cancer patients. But these genetic tests bring according to research no clear insight. (Image: WavebreakMediaMicro / fotolia.com)

No clear knowledge gain

In fact, biomarker testing should help in deciding if chemotherapy is needed after breast cancer surgery. These can be used to measure the activity of genes in tumor tissue.

Such tests have been on the German market for years, in some cases the costs are covered by the health insurance companies.

In the coming year, the so-called Joint Federal Committee (G-BA) in Berlin wants to decide on a regulation for all legally insured women.

However, according to experts, such genetic tests according to the current state do not bring clear insight in the decision for or against chemotherapy.

Suitable for some patients

For the first time in its recently published oncology guideline "Interdisciplinary S3 guideline for the early detection, diagnosis, therapy and aftercare of breast cancer", the German Cancer Society is also addressing genetic testing for physicians.

Achim Wöckel, Director of the Department of Obstetrics and Gynecology at the University Hospital Würzburg said that they played an "increasingly important role" alongside the classic prognosis factors, according to a report by the dpa news agency.

"The guidelines advocate use in selected situations," says the expert.

Therefore, such a test could be useful in patients who can not make a reliable clinical decision on how to proceed after taking into account all other parameters and markers used as standard.

No clear benefit

However, the experts and organizations involved in the guideline came to a different conclusion than the Institute for Quality and Efficiency in Health Care (IQWiG) in Cologne.

According to the institute's report last year, which serves as the basis for the decision to reimburse the G-BA, there was "no indication for any of the biomarker tests available at that time that it could better identify those women who do not require chemotherapy than the standard tests "Says a press release.

A clear benefit of the tested test can not be said. On the one hand, the observation period of five years is too short: many distant metastases - ie metastases far away from the affected breast - do not appear until the following years.

"On the other hand, it is questionable whether one to two percent more deaths due to the recurrence and spread of the cancer due to a chemotherapy waiver are really insignificant," the institute wrote last year.

Decision support for patients

Because some tests are still pending, but the tests are "widely used by gynecologists and oncologists and promoted by manufacturers", the G-BA commissioned the IQWiG to provide a decision support, which has now been published.

This is aimed at women with early breast cancer who are not given a clear recommendation as to whether they should undergo additional supportive chemotherapy after the operation.

Because for every year about 20,000 patients in Germany, the conventional clinicopathological criteria, such as the size of the tumor or the lymph status, give a contradictory picture.

"The manufacturers of the biomarker tests promise to better recognize those patients who can do without chemotherapy," says the institute.

This is by no means proven by meaningful studies. "The way the results of the biomarker tests are communicated easily reflects a certainty that does not really exist," says the IQWiG.

To respond to uncertainties

According to the Institute, user tests have shown that the new booklet is able to convey the medical fundamentals in a comprehensible way.

"This also includes addressing the uncertainties," said Klaus Koch, head of the IQWiG health information department.

"The women understandably want a clear statement, whether a test is useful or not," said Koch.

"Instead, they have to learn that there is no reliable scientific evidence as to whether the new tests can actually predict their individual relapse risk more accurately. This situation, which is frustrating for some women, can at best begin to resolve written decision-making. "

Long-term studies necessary

According to Wöckel, the reason for the differing views in the new guideline and the IQWiG is that the institute did not take into account studies that were included in the evaluation of the guideline.

However, even there it became clear that a broad commitment would not be considered meaningful and that, first of all, it was important to pay attention to other clinical parameters.

Wöckel also pointed out that the follow-up period of five years was very short. "It's long-term studies and studies with a large number of women necessary," said the physician, according to dpa.

The S3 Guideline also stresses that "It is important that all experts see an urgent need for research for further investigation and clinical validation of gene expression testing."

A help among many

If a test suggests that there is no risk of recurrence or metastasis, and the cancer returns, the consequences for the woman are far greater than if the chemotherapy may have been done unnecessarily.

According to IQWiG, there are estimates that about two to three percent of chemotherapy leads to heart, kidney or other internal organ damage, even death.

Wöckel also pointed out in the dpa message on the psyche as a factor: "Many women only really feel cancer when they undergo chemo."

The treatment is not only associated with hair loss and fatigue, but often with stigmatization by others. "In the long term, however, chemotherapy probably only rarely harms," ​​says Wöckel.

According to him, patients currently often have great uncertainty. "Some people think that they will be struck by a test, others fear that they will be denied anything without a test," said the director of the gynecological clinic at the University Hospital Würzburg.

There is much more education needed. Neither the affected women nor the treating physicians should feel that a biomarker test is needed to make a good decision.

"That is clearly not so," said the physician, according to dpa. "Such a test can only be a contribution of many for a decision, an aid among many." (Ad)