At the start of ELOS: Early activation of the body's own immune system could increase the chances of a cure for laryngeal cancer

People need the larynx to swallow and speak. Losing it always represents a serious cut in the quality of life for those affected.

Under the leadership of Leipzig University Hospital (UKL), the novel nationwide ELOS cancer study has now begun. ELOS stands for "European Laryngeal Organ Preservation Study". Together with a number of renowned head and neck tumour centres in Germany, the aim is to investigate how many patients can be spared a laryngectomy if chemotherapy and subsequent radiotherapy are combined and whether the result can even be improved by administering the immunotherapy drug "pembrolizumab".

The study is open to all patients with advanced laryngeal and pharyngeal (hypopharyngeal) cancer.

For about five years now, so-called immuno-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 previously only recurring cancers were treated with these drugs after standard therapy, it was also found that the early use of these immuno-checkpoint inhibitors before cancer surgery or radiotherapy can significantly improve the results. This principle is now to be tested in advanced laryngeal and pharyngeal cancer in a nationwide study at renowned head and neck cancer centres under the leadership of the Leipzig ENT University Hospital in order to spare patients the loss of an organ.

The study is called the "European Laryngeal Organ Preservation Study (ELOS)", as it was developed together with leading European centres following preliminary studies at the UKL ENT Clinic. The immunotherapeutic agent pembrolizumab, which is approved for activating the body's own cancer defences through the immune system, is being tested. It is used in combination with chemotherapy and radiotherapy. The principle of the new therapy is based on very early observation of the tumour's response to it in order to then continue treatment in a targeted manner. If the tumour does not respond to the new immunotherapy, any necessary surgery to cure it would be brought forward - in order to lose as little time as possible.

"We expect a significantly higher response rate with the new immunotherapy than with conventional chemotherapy to date," says Prof Dr Andreas Dietz, head of the study and Director of the Department of Otorhinolaryngology (ENT) at the UKL. "The early response rate is a first important signal for a good cancer cure with preservation of the larynx, which is so immensely important for swallowing and speaking," he explains. If the response is satisfactory, the remaining tumour tissue is then destroyed by radiotherapy. "We hope to see a high number of patients with not only a preserved larynx, but also with good swallowing and speech function," emphasises Prof. Dr Nils Nicolay, Director of the Clinic and Polyclinic for Radiotherapy at the UKL. And Prof. Dr Florian Lordick, spokesperson for the Central German Cancer Centre (CCCG), adds: "With the new immuno-checkpoint inhibitors, we have a completely new breed of cancer drugs that are much gentler and have fewer side effects than conventional chemotherapy."

Nine renowned centres are taking part

The very complex clinical trial was prepared over several years and underwent the new CETIS (Clinical Trials Information System) procedure of the European Medicines Agency (EMA) with the EU CT number 2022-502751-61-00, as required by the European Union. In addition to Leipzig, a total of nine renowned certified head and neck tumour centres from the university hospitals in Regensburg, Munich, Ulm, Würzburg, Mannheim, Cologne, Jena and the Potsdam Clinic are participating nationwide. "In order to provide statistically sound evidence of the significance of the new therapy, 140 patients will be included in the study," says Dr Gunnar Wichmann from Leipzig University ENT Clinic. The study started in February 2024. It is open to all patients with advanced laryngeal and pharyngeal (hypopharyngeal) cancer.

Press release of the "Leipzig University Hospital" from 15 February 2024