作者
Dietrich W Beelen, Matthias Stelljes, Péter Reményi, Eva‐Maria Wagner‐Drouet, Peter Dreger, Wolfgang Bethge, Fabio Ciceri, Friedrich Stölzel, Christian Junghanß, Hélène Labussiere‐Wallet, Kerstin Schaefer‐Eckart, Goetz U Grigoleit, Christof Scheid, Francesca Patriarca, Alessandro Rambaldi, Dietger Niederwieser, Inken Hilgendorf, Domenico Russo, Gérard Socié, Ernst Holler, Bertram Glass, Jochen Casper, Gerald Wulf, Nadezda Basara, Maria Bieniaszewska, Gernot Stuhler, Mareike Verbeek, Ursula La Rocca, Jürgen Finke, Fabio Benedetti, Uwe Pichlmeier, Anja Klein, Joachim Baumgart, Miroslaw Markiewicz
发表日期
2022/8
期刊
American journal of hematology
卷号
97
期号
8
页码范围
1023-1034
出版商
John Wiley & Sons, Inc.
简介
The phase III study was designed to compare event‐free survival (EFS) after treosulfan‐based conditioning with a widely applied reduced‐intensity conditioning (RIC) busulfan regimen in older or comorbid patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT). A previously reported confirmatory interim analysis of the randomized clinical study including 476 patients demonstrated statistically significant noninferiority for treosulfan with clinically meaningful improvement in EFS. Here, the final study results and pre‐specified subgroup analyses of all 570 randomized patients with completed longer‐term follow‐up are presented. Patients presenting HCT‐specific comorbidity index >2 or aged ≥50 years were randomly assigned (1:1) to intravenous (IV) fludarabine with either treosulfan (30 g/m2 IV) or busulfan (6.4 mg/kg IV …
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DW Beelen, M Stelljes, P Reményi, EM Wagner‐Drouet… - American journal of hematology, 2022