Research Do Lymph Nodes Always Have to Get Out of Breast Cancer?

In breast cancer, it is now standard therapy to also remove the lymph nodes. A large-scale study will now find out if there are other treatment options. More than 6,000 patients will be involved in the study.

A groundbreaking study on breast cancer has started with the first patient. For the INSEMA study (INSEMA stands for "Intergroup sentinel mamma"), several study groups are working together under the direction of the University of Rostock. In the end, nearly 6000 patients with early breast cancer and a planned breast-conserving surgery from Germany will be involved in about 130 study centers and about 800 patients in Austria.

Large-scale study should investigate whether the previous therapy needs to be adjusted. Image: Eskymaks-fotolia

The researchers are investigating whether the surgery will be able to do without a previously customary measure. So far, the so-called guardian lymph node in the armpit is removed during the procedure. "We are investigating whether the omission of this measure is oncologically safe and the complications in the operation can be reduced," says study leader Prof. Toralf Reimer, Senior Physician of the University Gynecological Clinic in Rostock.

The fact that breast cancer patients who have been diagnosed by palpation and ultrasound at the time of diagnosis by palpation and ultrasound to lose the lymph nodes, often has long-lasting negative consequences for some women. This can cause lymphedema, pain or numbness in the arm; the quality of life deteriorates. "In addition, without the lymph node surgery, the risk of a recurrence of a tumor in the armpit of the affected side seems to be very low. This is shown by earlier, smaller studies with several years of follow-up ", says Reimer and has a good explanation for this:" The lymph node tumor cells are treated by the now very effective postoperative therapy, ie chemo, hormone therapy and the radiation of the rest of the breast. "

So, if the breast carcinoma is up to five centimeters in size and the incidence of the armpit and planned breast-conserving therapy is normal, can the lymph nodes be removed? One of the key questions the study should answer. "In the end, survival without disease is evaluated," said the study director.

The current data suggest that there will be no relevant difference between the two treatment arms: "At present, we can not detect a tumor cell infiltration of the guardian lymph nodes in at least 70% of the cases of a patient who has an inconspicuous underarm sensation before surgery. "This high percentage of patients does not need the surgery in the armpit anyway. "In addition, no study has yet shown that lymph node removal with unremarkable pre-op palpation provided patients with breast cancer survival benefit," says Reimer.

The INSEMA study, with a total funding of 4.588 million euros, is one of the largest study projects funded by the German Cancer Aid. The responsibility for carrying out the study lies with the University Medical Center Rostock.

In order to be able to record and evaluate the large number of data to be expected, data management is handled in cooperation with GBG Forschungs GmbH in Neu-Isenburg. The German Breast Group (GBG) is an academic research group active since 2003 to conduct breast cancer studies nationally and internationally. Thanks to the expertise of the GBG, a continuous data collection over the planned study duration of nine years is guaranteed.

"We may be able to spare some of our breast cancer patients surgery on the armpits and removal of lymph nodes with the same prognosis," hopes Prof. Bernd Gerber, deputy study director in Rostock. The study also covers factors such as quality of life, surgical complications and metastasis. In addition, the actual radiation dose is evaluated as part of the whole-breast post-irradiation. So the cooperation with the radiation therapists in the respective breast centers is an important interface for the data quality. (Pm)