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Epigenetic leukemia treatment can replace highly stressful chemotherapy in high-risk patients / Significantly fewer side effects than with chemotherapy / Publication in the journal Lancet Haematology

Acute myeloid leukemia (AML) is the most common form of acute blood cancer in adults. Until recently, chemotherapy followed by stem cell transplantation was the treatment of choice. Scientists at the Medical Center - University of Freiburg have now shown in the journal Lancet Haematology that "epigenetic" therapy with the active ingredient decitabine produces significantly fewer side effects with the same efficacy as chemotherapy. This means that it is also possible for older people who already have the disease and for whom intensive chemotherapy would be too stressful. The study was published on October 31, 2023.

"For many older AML patients, intensive chemotherapy is more of a burden on their health than a long-term help. With our study, we are showing that alternative therapy is gentler and just as safe," says study leader Prof. Dr. Michael Lübbert, Senior Physician at the Department of Medicine I at the Medical Center - University of Freiburg (Medical Director: Prof. Dr. Justus Duyster), explaining the need for a less aggressive form of therapy. "The treatment is so successful that epigenetically active drugs such as decitabine are already being used across the board for older AML patients," says Lübbert.

Gentle therapy without a long hospital stay

Acute myeloid leukemia occurs on average in 40 out of 100,000 people over the age of 70. Until now, AML patients have usually received intensive chemotherapy followed by a stem cell donation. This has also been successfully carried out for years at the Department of Medicine I at the Medical Center - University of Freiburg. However, because chemotherapy is often stressful, especially for older patients, a subsequent allogeneic blood stem cell transplant - and thus a cure - was often no longer possible.

In the current study, coordinated by the European Organization for Research and Treatment of Cancer (EORTC), a total of 606 patients were treated at 54 sites in nine European countries. The survival and quality of life of patients treated with decitabine or chemotherapy were compared. Unlike chemotherapy, decitabine does not destroy the cancer cells directly, but influences which genes are transcribed in the cancer cells. In this way, it prevents pathological proliferation. It was shown that survival was the same with both therapies, with stem cell transplantation even affecting more than half of the patients overall; however, the quality of life was significantly better with decitabine than with standard chemotherapy.

"With the better tolerated therapy, patients can often lead a normal life without stressful hospital stays. This is a very important goal for us, in addition to the cure," says Lübbert, who also heads the EORTC Leukemia Cooperative Group . The development of new epigenetic therapies and research into the corresponding fundamental biological processes is one of the research priorities of the Faculty of Medicine - University of Freiburg, for example in the DFG Collaborative Research Center 992, MEDEP.

The EORTC 1301 study (EudraCT number 2014-001486-27) was organized by the EORTC (Brussels) in collaboration with several other European study groups.

Original title of the study: 10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomized, controlled, phase 3 trial
DOI: 10.1016/S2352-3026(23)00273-9
Link to the study: https: //doi.org/10.1016/S2352-3026(23)00273-9