作者
Christoph Röllig,Michael Kramer,Christoph Schliemann,Jan‐Henrik Mikesch,Björn Steffen,Alwin Krämer,Richard Noppeney,Kerstin Schäfer‐Eckart,Stefan W. Krause,Mathias Hänel,Regina Herbst,Volker Kunzmann,Hermann Einsele,Edgar Jost,Tim H. Brümmendorf,Sebastian Scholl,Andreas Hochhaus,Andreas Neubauer,Kristina Sohlbach,Lars Fransecky,Martin Kaufmann,Dirk Niemann,Markus Schaich,Norbert Frickhofen,Alexander Kiani,Frank Heits,Ulrich Krümpelmann,Ulrich Kaiser,Johannes Kullmer,Maxi Wass,Friedrich Stölzel,Malte von Bonin,Jan Moritz Middeke,Christian Thiede,Johannes Schetelig,Wolfgang E. Berdel,Gerhard Ehninger,Claudia D. Baldus,Carsten Müller‐Tidow,Uwe Platzbecker,Hubert Serve,Martin Bornhäuser
摘要
Abstract In fit patients with newly diagnosed acute myeloid leukemia (AML), immediate treatment start is recommended due to the poor prognosis of untreated acute leukemia. We explored the relationship between time from diagnosis to treatment start (TDT) and prognosis in a large real-world data set from the German Study Alliance Leukemia–Acute Myeloid Leukemia (SAL-AML) registry. All registered non–acute promyelocytic leukemia patients with intensive induction treatment and a minimum 12 months of follow-up were selected (n = 2263). We analyzed influence of TDT on remission, early death, and overall survival (OS) in univariable analyses for each day of treatment delay, in groups of 0 to 5, 6 to 10, 11 to 15, and >15 days of TDT, adjusted for influence of established prognostic variables on outcomes. Median TDT was 3 days (interquartile range, 2-7). Unadjusted 2-year OS rates, stratified by TDT of 0 to 5, 6 to 10, 11 to 15, and >15 days, were 51%, 48%, 44%, and 50% (P = .211). In multivariable Cox regression analysis accounting for established prognostic variables, the TDT hazard ratio as a continuous variable was 1.00 (P = .617). In OS analyses, separately stratified for age ≤60 and >60 years and for high vs lower initial white blood cell count, no significant differences between TDT groups were observed. Our study suggests that TDT is not related to survival. As stratification in intensive first-line AML treatment evolves, TDT data suggest that it may be a feasible approach to wait for genetic and other laboratory test results so that clinically stable patients are assigned the best available treatment option. This trial was registered at www.clinicaltrials.gov as #NCT03188874.