Allogeneic Stem Cell Transplantation Improves Survival in Patients with Acute Myeloid Leukemia Characterized by a High Allelic Ratio of Mutant FLT3-ITD

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Allogeneic Stem Cell Transplantation Improves Survival in Patients with Acute Myeloid Leukemia Characterized by a High Allelic Ratio of Mutant FLT3-ITD Anthony D. Ho, Johannes Schetelig, Tilmann Bochtler, Markus Schaich, Kerstin Schäfer-Eckart, Mathias Hänel, Wolf Rösler, Hermann Einsele, Martin Kaufmann, Hubert Serve, Wolfgang E. Berdel, Matthias Stelljes, Jiri Mayer, Albrecht Reichle, Claudia D. Baldus, Norbert Schmitz, Michael Kramer, Christoph Röllig, Martin Bornhäuser, Christian Thiede, Gerhard Ehninger Biology of Blood and Marrow Transplantation Volume 22, Issue 3, Pages 462-469 (March 2016) DOI: 10.1016/j.bbmt.2015.10.023 Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Consort flow diagram showing patient numbers according to randomization and FLT3-ITD ratio focusing on the transfer to alloHCT in first remission. Patients with an allelic ratio of mutant FLT3-ITD > .8 are denoted HRFLT3-ITD and the remaining FLT3-ITD+ patients denoted low ratio mutants (LRFLT3-ITD); auto HCT, autologous hematopoietic stem cell transplantation; Chemo PRT, chemotherapy-based postremission therapy. Biology of Blood and Marrow Transplantation 2016 22, 462-469DOI: (10.1016/j.bbmt.2015.10.023) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 EFS and OS by allelic ratio and type of consolidation therapy. We show Simon Makuch plots for OS (panels A and B) and EFS (panels C and D) for the 3-month landmark populations with the day of study enrollment as starting point. The 3-months landmark is shown by the gray bar. Patients who received allogeneic transplantation in first remission are represented by red lines and those who received postremission chemotherapy by black lines. Results for patients with HRFLT3-ITD AML are shown in panels A and C and with LRFLT3-ITD AML in panels B and D. The hazard ratios are derived from multivariable Cox regression models with alloHCT as time-dependent covariate. HR, hazard ratio (This Figure is available in color online at www.bbmt.org). Panel A: HR 0.3, 95%CI 0.16 to 0.7, P = .004. Panel B: HR 0.9, 95%CI 0.5 to 1.6, P = .6. Panel C: HR 0.4, 95%CI 0.16 to 0.9, P = .02. Panel D: HR 0.5, 95%CI 0.3 to 0.9, P = .04. Biology of Blood and Marrow Transplantation 2016 22, 462-469DOI: (10.1016/j.bbmt.2015.10.023) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 EFS and OS by allelic ratio, NPM1 mutations, and type of consolidation therapy. Simon Makuch plots for OS (top) and EFS (bottom) for the 3-month landmark populations with the day of study enrollment as starting point. Patients who received allogeneic transplantation in first remission are represented by red lines and those who received postremission chemotherapy by black lines. Results for patients with HRFLT3-ITD AML are shown by solid lines, patients with LRFLT3-ITD AML and wild-type NPM1 by broken lines, and patients with LRFLT3-ITD AML and concomitant NPM1 mutation by dotted lines. The 3-months landmark is shown by the gray bar. OS and EFS of patients who received alloHCT in first remission was significantly better compared with patients who received chemotherapy among patients with HRFLT3-ITD AML (P = .004 and P = .02, respectively) and patients with LRFLT3-ITD AML and wild-type NPM1 (P = .02 both endpoints) but not in patients with LRFLT3-ITD AML and concomitant NPM1 mutation (P = .2 and P = .6, respectively). This Figure is available in color online at www.bbmt.org. Biology of Blood and Marrow Transplantation 2016 22, 462-469DOI: (10.1016/j.bbmt.2015.10.023) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 Outcomes after allogeneic transplantation in first remission and more advanced stages. OS, CIR, and NRM after alloHCT in first remission (panels A and B) and in patients who experienced primary induction failure or relapse (panels C and D). Panels A and C show outcomes of patients with HRFLT3-ITD and panels B and D of patients with LRFLT3-ITD AML. Biology of Blood and Marrow Transplantation 2016 22, 462-469DOI: (10.1016/j.bbmt.2015.10.023) Copyright © 2016 American Society for Blood and Marrow Transplantation Terms and Conditions