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At the start of ELOS: Early activation of the body's immune system could increase the chances of recovery from throat cancer

Leipzig ENT University Clinic is leading a nationwide scientific study to preserve the larynx through the use of immune checkpoint inhibitors

Humans need the larynx to swallow and speak. Losing it always represents a serious impact on the quality of life for those affected.

The nationwide new cancer study ELOS has now begun under the direction of the Leipzig University Hospital (UKL). ELOS stands for “European Laryngeal Organ Preservation Study”. Together with a number of renowned head and neck tumor centers in Germany, the aim is to investigate how many patients can be spared a laryngectomy if prior chemotherapy and subsequent radiation treatment are combined and whether the result is improved by administering the immunotherapy drug. Pembrolizumab” can even be improved.

The study is open to all those affected by advanced larynx and pharynx (hypopharynx) cancer.

For around five years, so-called immune checkpoint inhibitors, i.e. drugs that activate the body's own immune system against cancer, have found their way into cancer therapy in the head and neck area. While so far only recurrent cancers have been treated with it after standard therapy, it has also been found that the early use of these immune checkpoint inhibitors before cancer surgery or cancer radiation can significantly improve the results. This principle is now to be tested in advanced larynx and pharynx cancer in a nationwide study at renowned head and neck cancer centers under the leadership of the Leipzig ENT University Hospital in order to spare patients the loss of the organ.

The study is called the “European Laryngeal Organ Preservation Study (ELOS)” because it was developed together with top European centers following preliminary studies by the UKL ENT Clinic. The immunotherapy drug pembrolizumab is being tested, which is approved to activate the body's own cancer defenses through the immune system. It is used in combination with chemotherapy and radiation therapy. The principle of the new therapy is based on the very early observation of the response to the same in order to then continue treatment in a targeted manner. If the tumor does not respond to the new immunotherapy, an operation that is necessary to cure it would be preferred - in order to waste as little time as possible.

“We expect a significantly higher response rate with the new immunotherapy than with conventional chemotherapy,” says Prof. Dr. Andreas Dietz, study leader and director of the clinic and polyclinic for ear, nose and throat medicine (ENT) at the UKL. “The early response rate is an important first signal for good cancer healing with preservation of the larynx, which is so important for swallowing and speaking,” he explains. If the response is satisfactory, the remaining tumor tissue is then destroyed using radiation therapy. “We hope for a large number of patients with not only a preserved larynx, but also with good swallowing and speaking functions,” emphasizes Prof. Dr. Nils Nicolay, Director of the Clinic and Polyclinic for Radiation Therapy at UKL. And Prof. Dr. Florian Lordick, spokesman for the Central German Cancer Center (CCCG), adds: “With the new immune checkpoint inhibitors, we have a completely new guard of cancer drugs that are significantly gentler and have fewer side effects than conventional chemotherapy.”

Nine renowned centers are taking part

The very complex clinical study was prepared over several years and went through the new CETIS (Clinical Trials Information System) procedure required by the European Union from the “European Medicines Agency (EMA) with the EU-CT number 2022-502751-61-00 . In addition to Leipzig, a total of nine renowned, certified head and neck tumor centers from the University Hospitals Regensburg, Munich, Ulm, Würzburg, Mannheim, Cologne, Jena and the Potsdam Clinic are taking part nationwide. “In order to be able to demonstrate the significance of the new therapy statistically, 140 patients will be included in the study,” says Dr. Gunnar Wichmann from the ENT University Clinic Leipzig. The study started in February 2024. It is open to all patients with advanced larynx and pharyngeal (hypopharynx) cancer.

Press release from the “University Hospital Leipzig” from February 15.02.2024, XNUMX

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