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EBMT 2021 | FORUM: TBI versus chemotherapy conditioning in pediatric ALL

Tayfun Güngör, MD, University Children’s Hospital Zurich, Zurich, Switzerland, shares an update on the prospective Phase III FORUM study (NCT01949129) investigating total body irradiation (TBI) versus chemotherapy conditioning before hematopoietic stem cell transplantation in pediatric patients with acute lymphoblastic leukemia (ALL). In this trial, 417 patients with ALL were randomized to receive either TBI with etoposide or chemotherapy conditioning with fludarabine, thiotepa, and either busulfan or treosulfan. At a median follow-up of two years, overall survival was significantly higher following TBI versus chemotherapy conditioning. This interview took place during the 47th Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT) 2021.

Transcript (edited for clarity)

As a transplanter, we should be really happy on prospective studies in the transplant area, because it’s not so easy to perform prospective studies. And this is a prospective study, which randomized patients with pediatric ALL, about four years, total body irradiation which is the standard treatment, versus chemotherapy because we know that total body irradiation in children is even though very efficient, and leukemia, especially lymphatic leukemias has a lot of side effects like secondary tumors emerging in up to 10% of these irradiated children...

As a transplanter, we should be really happy on prospective studies in the transplant area, because it’s not so easy to perform prospective studies. And this is a prospective study, which randomized patients with pediatric ALL, about four years, total body irradiation which is the standard treatment, versus chemotherapy because we know that total body irradiation in children is even though very efficient, and leukemia, especially lymphatic leukemias has a lot of side effects like secondary tumors emerging in up to 10% of these irradiated children. And we wanted to find a solution or an alternative for total body radiation. I said we, but I’m only part of this multicenter trial, which is initiated by Professor Peters in Vienna, but I’m the principal investigator in Switzerland. We had already participated in a study before in 2003, a CTs trial, where we had also involved more than 25 patients.

And this paper now shows or showed quite clearly that chemotherapy is, at least the chemotherapy that was used in this trial, busulfan-thiotepa-fludarabine or treosulfan-thiotepa-fludarabine is inferior to total body irradiation and VP16 as a conditioning treatment, since the relapse rate is much higher. So, therefore it became quite clear, also statistically, that at the moment, there is no alternative to TBI, at least in terms of being as efficient as possible in, in using the relapse-free survival.

But I hope very much that other therapies will be able to come up treatments, perhaps other combinations of chemotherapies or combinations of chemotherapies and antibodies and other components to replace total body irradiation, the conditioning regimen of acute lymphoblastic leukemia in children.

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Disclosures

Dr Tayfun Güngör, MD, has participated in advisory boards for Jazz Pharmaceuticals and Novartis.

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