Randomized trial comparing standard vs sequential high-dose chemotherapy for inducing early CR in adult AML by Renato Bassan, Tamara Intermesoli, Arianna.

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Presentation transcript:

Randomized trial comparing standard vs sequential high-dose chemotherapy for inducing early CR in adult AML by Renato Bassan, Tamara Intermesoli, Arianna Masciulli, Chiara Pavoni, Cristina Boschini, Giacomo Gianfaldoni, Filippo Marmont, Irene Cavattoni, Daniele Mattei, Elisabetta Terruzzi, Lorella De Paoli, Chiara Cattaneo, Erika Borlenghi, Fabio Ciceri, Massimo Bernardi, Anna M. Scattolin, Elisabetta Todisco, Leonardo Campiotti, Paolo Corradini, Agostino Cortelezzi, Dario Ferrero, Pamela Zanghì, Elena Oldani, Orietta Spinelli, Ernesta Audisio, Sergio Cortelazzo, Alberto Bosi, Brunangelo Falini, Enrico M. Pogliani, and Alessandro Rambaldi BloodAdv Volume 3(7):1103-1117 April 9, 2019 © 2019 by The American Society of Hematology

Renato Bassan et al. Blood Adv 2019;3:1103-1117 © 2019 by The American Society of Hematology

Design of the Northern Italy Leukemia Group AML trial 02/06. Design of the Northern Italy Leukemia Group AML trial 02/06. ICE was compared with sHD induction chemotherapy. After a common 2-step CR induction and early consolidation phase, patients received 1 of 2 types of final consolidation, depending on risk. Patients at HR received allogeneic HSCT. Patients at SR, 65 years of age or younger, and mobilizing blood stem cells underwent a second randomization to either standard BU-CY-conditioned autologous HSCT or up to 3 repetitive blood stem cell-supported HD courses, denoted “A20” after the cumulative cytarabine (arabinosylcytosine, A) dose of 20 g/m2. SR patients unable to proceed to HD consolidation could receive allogeneic HSCT, and HR patients unable to receive HSCT could undergo HD consolidation. Patients older than 65 years and/or not mobilizing blood stem cells underwent 1 to 2 additional age-adapted ID consolidation courses, denoted “A15,” “A10,” or “A8” after the cumulative cytarabine dose (dashed line). Renato Bassan et al. Blood Adv 2019;3:1103-1117 © 2019 by The American Society of Hematology

CONSORT diagram illustrating patient selection, study flow, successive treatment steps, and patient outcome, according to the randomization group. CONSORT diagram illustrating patient selection, study flow, successive treatment steps, and patient outcome, according to the randomization group. APL, acute promyelocytic leukemia; ED, early death; NR, nonresponder; TKI, tyrosine-kinase inhibitor. Renato Bassan et al. Blood Adv 2019;3:1103-1117 © 2019 by The American Society of Hematology

Kaplan-Meier survival analyses, according to the randomization group. Kaplan-Meier survival analyses, according to the randomization group. (A) OS. (B) Event-free survival (EFS). (C) RFS. (D) Cumulative incidence of relapse (CIR). Renato Bassan et al. Blood Adv 2019;3:1103-1117 © 2019 by The American Society of Hematology

Forest plot of study groups. Forest plot of study groups. Effects of treatments on CR and OS, according to the main patient and disease characteristics. Renato Bassan et al. Blood Adv 2019;3:1103-1117 © 2019 by The American Society of Hematology