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Breast Cancer: After surgery, chemotherapy - or not?  December 2016

By Christina Sartori

In determining whether chemotherapy is necessary after a breast cancer operation, biomarker tests could help. The Institute for Quality and Efficiency has now analyzed their usefulness and published the results on Monday (05.12.2016).

For some women with breast cancer, the question arises after the operation: Now a chemotherapy - or rather not? In many cases, the doctor can give a clear recommendation depending on clinical factors such as age of the woman, size and shape of the tumor, and state of the lymph nodes: if these clinical factors give a certain risk that the cancer might return in a few years, then He will advise his patient to chemotherapy - otherwise not.

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In some cases, however, the clinical factors do not give a clear picture. It is then necessary to balance the side effects of chemotherapy and the risk of tumors occurring in the near future, so-called recurrences. In this situation, biomarker tests could help to analyze the genes or proteins of cancer cells. But how reliable the testimony of such biomarker tests is, was hitherto unclear.

The Iqwig examines the benefits of biomarker tests

The Institute for Quality and Efficiency in Health Care (Iqwig) has analyzed studies that have examined the utility of three biomarker tests over the last few years: MammaPrint, EndoPredict and Oncotype DX.

The results are poor: Only for the MammaPrint test, the scientists of Iqwig found a study that meets their requirements, so they do not make any statement about EndoPredict and Oncotyp DX [due to the exclusion of studies].

And to the MammaPrint test, they base their assessment on a single study. The conclusion: There is no clear advantage of the biomarker test MammaPrint. On the one hand, the study has only been running for five years. However, breast cancer can also return after more than 5 years, so these are preliminary results. The results will be more important after ten years of observation.

Surgery in a patient with breast cancer.  After surgery, chemotherapy?

On the other hand, the study showed that in the group of 1,000 women who failed chemotherapy for the biomarker test, there were 21 additional recurrences and 11 additional deaths from the group of women who had chemotherapy. "According to the authors, the differences are so small that they can spare chemotherapy for women," says Stefan Lange, Deputy Head of Iqwig. But he himself sees this differently: "I would like to discuss this more closely with the affected women and experts."

Each patient is concerned about survival

Prof. Dr. Stefan Wiemann, Head of the Department of Molecular Genome Analysis at the German Cancer Research Center in Heidelberg, will be able to understand the concerns regarding the biomarker test MammaPrint: "The test would lead to incorrect decisions not to perform chemotherapy, ultimately leading to serious consequences For each individual patient, it is a question of personal survival, and the negative side effects of chemotherapy are usually accepted rather than the possibility of dying due to a non-performed treatment. "

However, Prof. Wiemann estimates the benefit of the biomarker test Oncotyp DX differently than the Iqwig: "The Oncotype DX test has shown the efficacy or the benefit for the therapy decision in a number of studies and is therefore also recognized by several relevant Societies. "

Side effects of chemotherapy -- or cancer return

 So there is currently no undebated conclusion on the topic biomarker test.

For affected women, this means that if the results of the biomarker test are not followed by chemotherapy after surgery, there is little risk that the test was wrong. If they are to be as safe as possible, they can do chemotherapy with all their side effects, although this may be superfluous. "The side effects of chemotherapy can also be serious, so they should also be included in the overall review," says Dr. Stefanie Seltmann from the German Cancer Research Center in Heidelberg. "Not all, but some chemotherapies can have serious consequences, Such as the fatigue syndrome, depression, or even heart or kidney damage. "

 Decision on the cost

Up to now, such biomarker tests, which cost several hundred to a thousand euros, are paid in Germany only by the German statutory health insurance companies in individual cases.[*]

This would only change if the joint federal committee of the (G-BA [**]), the highest decision-making body of the joint self-administration of doctors, hospitals and health insurance funds in Germany would oblige the [100 regional] health insurance funds to reimburse a biomarker test in general. It is difficult to predict how the G-BA will decide - but it is probable that this decision is expected in a year at the earliest. [***]

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[*] Most Germans are covered by one of about a regional insurance plans, which are closely regulated in terms of coverage rules that are set by a national body rather than by the plan.  

[**] G-BA doesn't have a ready equivalent in the US.  It might be a bit like the CMS agency using NCDs and thousands of pages of policymaking to regulate the 10 Medicare contractors, but that is not an exact analogy.   However, unlike CMS, it controls about 90% of the insurance plans.     

[***]  Sounds like the IQWiG assessment is contributory to, but not directly binding on, the G-BA.