Thursday, February 9, 2023

First clinical trial challenges international standard of blood cancer treatment

The results of this trial suggest that adult patients with relapsed or refractory AML should undergo stem cell transplantation as soon as possible. Read this report of Hitansha Tagra…

The challenge given to the international standard of treatment of blood cancer

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acute myeloid leukemia The standard approach to treatment in AML is to attempt complete remission before stem cell transplant. Complete remission means that tests, physical exams and scans show that all signs of your cancer are gone. But this is now being challenged by the results of clinical trials conducted by DKMS. The results of this trial suggest that adult patients with relapsed or refractory AML should undergo stem cell transplantation as soon as possible.

Contrary to earlier assumptions, the results of this trial suggest that complete remission before transplant does not increase survival chances, but also unnecessarily increases chemotherapy, associated side effects and hospitalization. This important conclusion has been drawn by researchers from the University Hospital Carl Gustav Carus Dresden and the National Center for Tumor Diseases Dresden (NCT/UCC).

Dr. Schetelig, Head of the Department of Stem Cell Transplantation at the University Hospital Dresden (Germany) and Head of the DKMS Clinical Trials Unit, Professor Dr Schetelig at the annual meeting of the American Society of Hematology (ASH) in New Orleans, USA on 11 December, the world’s largest hematology congress Presented its results. This study was supported by the Study Alliance Leukemia (SAL), the Cooperative German Transplant Study Group and the Münster University Hospital.

Adult patients with non-favorable AML who respond poorly after initial induction therapy or who have relapsed are usually offered allogeneic stem cell transplantation as a treatment. An important step before this life saving therapy is to achieve complete remission through high dose chemotherapy.

Standard treatment for high-risk AML patients

The goal of this trial, conducted under the leadership of Professor Shetlig, was to transplant patients as soon as possible. Because of this the trial was named ASAP. The team of researchers collected data of 281 patients with an average age of 61 years who were divided into two groups. As per standard practice, one group was treated with long-term chemotherapy before stem cell transplant to achieve complete remission. The second group received their transplant after only a 12-day conditioning period without achieving complete remission prior to transplant. The only requirement for stem cell transplantation was the availability of a matching allogeneic donor.

Trial results clear

The common practice of complete remission before transplantation does not show any benefit. In addition, patients with the second alternative method not only achieved the same results, but also benefited from fewer side effects by not undergoing prolonged high-dose chemotherapy, and their average hospital stay was only halved. Professor Schetelig said, “The results of our clinical trial challenge the international standard of leukemia therapy and were quite surprising even for us. They suggest that if an HLA-compatible stem cell donor is available, the transplant should occur as soon as possible, even if leukemia cells are still present in the patient’s body.” In addition, these results emphasize the need to find a donor early, possibly at the time of diagnosis but after receiving genetic reports that demonstrate a non-favourable risk profile for AML.

Patients around the world could benefit

Even with intensive chemotherapy, complete remission can be achieved in only 50% of patients. If this treatment is unsuccessful, then most patients are given a second intensive chemotherapy, depending on their health status along with its side effects. Prompt transplant without attempting complete remission could not only reduce side effects and reduce the length of hospital stay but also allow more patients to access this life-saving therapy.

Professor Schetelig explained, “This is particularly true for countries with less comprehensive health care, where stem cell transplants are often not performed for reasons of cost, even after failed complete remissions. Eliminating this costly method could open the way for stem cell transplants for most AML patients worldwide, which in many cases are the only way to cure them.”

Click here to read in English.

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