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10-DAY DECITABINE VS. CONVENTIONAL CHEMOTHERAPY ('3+7') FOLLOWED BY ALLOGRAFTING (HSCT) IN AML PATIENTS ≥60 YEARS: A RANDOMIZED PHASE III STUDY OF THE EORTC LEUKEMIA GROUP, GIMEMA, CELG, AND GMDS-SG
Author(s): ,
Michael Lübbert
Affiliations:
Department of Hematology, Oncology and Stem Cell Transplantation, Faculty of Medicine, University Medical Center Freiburg,University of Freiburg,Freiburg,Allemagne;Department of Hematology, Oncology and Stem Cell Transplantation, Faculty of Medicine, University Medical Center Freiburg,University of Freiburg,Freiburg,Deutschland;Department of Hematology, Oncology and Stem Cell Transplantation, Facu
,
Pierre Wijermans
Affiliations:
Department of Hematology,Haga Teaching Hospital,The Hague,Pays-bas;Department of Hematology,Haga Teaching Hospital,The Hague,Niederlande;Department of Hematology,Haga Teaching Hospital,The Hague,Paesi Bassi;Department of Hematology,Haga Teaching Hospital,The Hague,Netherland;Department of Hematology,Haga Teaching Hospital,The Hague,Países Bajos;Department of Hematology,Haga Teaching Hospital,The H
,
Michal Kicinski
Affiliations:
EORTC Headquarters,Brussels,Belgique;EORTC Headquarters,Brussels,Belgien;EORTC Headquarters,Brussels,Belgio;EORTC Headquarters,Brussels,Belgium;EORTC Headquarters,Brussels,Bélgica;EORTC Headquarters,Brussels,België;EORTC Headquarters,Brussels,Bélgica;EORTC Headquarters,Brussels,Belgium;EORTC Headquarters,Brussels,Belgien
,
Sylvain Chantepie
Affiliations:
Institut d'Hématologie de Basse Normandie,Centre Hospitalo-Universitaire de Caen,Caen,France;Institut d'Hématologie de Basse Normandie,Centre Hospitalo-Universitaire de Caen,Caen,Frankreich;Institut d'Hématologie de Basse Normandie,Centre Hospitalo-Universitaire de Caen,Caen,Francia;Institut d'Hématologie de Basse Normandie,Centre Hospitalo-Universitaire de Caen,Caen,France;Institut d'Hématologie
,
Walter van der Velden
Affiliations:
Department of Hematology,Radboud University Medical Centre,Nijmegen,Pays-bas;Department of Hematology,Radboud University Medical Centre,Nijmegen,Niederlande;Department of Hematology,Radboud University Medical Centre,Nijmegen,Paesi Bassi;Department of Hematology,Radboud University Medical Centre,Nijmegen,Netherland;Department of Hematology,Radboud University Medical Centre,Nijmegen,Países Bajos;Dep
,
Richard Noppeney
Affiliations:
Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Allemagne;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Deutschland;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Germania;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Germany;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Alemania;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Duitsland;Klinik
,
Laimonas Griskevicius
Affiliations:
Department of Hematology, Oncology and Transfusion Medicine Center,Vilnius University Hospital Santaros Klinikos, Vilnius University,Vilnius,Lituanie;Department of Hematology, Oncology and Transfusion Medicine Center,Vilnius University Hospital Santaros Klinikos, Vilnius University,Vilnius,Litauen;Department of Hematology, Oncology and Transfusion Medicine Center,Vilnius University Hospital Santar
,
Andreas Neubauer
Affiliations:
Department of Internal Medicine, Hematology, Oncology and Immunology,Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg,Marburg,Allemagne;Department of Internal Medicine, Hematology, Oncology and Immunology,Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg,Marburg,Deutschland;Department of Internal Medicine, Hematology, Oncol
,
Martina Crysandt
Affiliations:
Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty,Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD),Aachen,Allemagne;Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Faculty,Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD),Aachen,Deutschland;Department of Hemato
,
Radovan Vrhovac
Affiliations:
Department of Haematology,University Hospital Centre Zagreb,Zagreb,Croatie;Department of Haematology,University Hospital Centre Zagreb,Zagreb,Kroatien;Department of Haematology,University Hospital Centre Zagreb,Zagreb,Croazia;Department of Haematology,University Hospital Centre Zagreb,Zagreb,克罗地亚;Department of Haematology,University Hospital Centre Zagreb,Zagreb,Croacia;Department of Haematology,U
,
Mario Luppi
Affiliations:
Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto,University of Modena and Reggio Emilia, Azienda Ospedaliera Universitaria,Modena,Italie;Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto,University of Modena and Reggio Emilia, Azienda Ospedaliera Universitaria,Modena,Italien;Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e d
,
Stephan Fuhrmann
Affiliations:
Department of Hematology and Oncology,HELIOS Hospital Berlin-Buch,Berlin,Allemagne;Department of Hematology and Oncology,HELIOS Hospital Berlin-Buch,Berlin,Deutschland;Department of Hematology and Oncology,HELIOS Hospital Berlin-Buch,Berlin,Germania;Department of Hematology and Oncology,HELIOS Hospital Berlin-Buch,Berlin,Germany;Department of Hematology and Oncology,HELIOS Hospital Berlin-Buch,Ber
,
Ernesta Audisio
Affiliations:
SC Ematologia Città della Salute e della Scienza Torino,Torino,Italie;SC Ematologia Città della Salute e della Scienza Torino,Torino,Italien;SC Ematologia Città della Salute e della Scienza Torino,Torino,Italia;SC Ematologia Città della Salute e della Scienza Torino,Torino,Italy;SC Ematologia Città della Salute e della Scienza Torino,Torino,Italia;SC Ematologia Città della Salute e della Scienza T
,
Anna Candoni
Affiliations:
Clinica Ematologica Azienda Sanitaria Universitaria Integrata di Udine,Udine,Italie;Clinica Ematologica Azienda Sanitaria Universitaria Integrata di Udine,Udine,Italien;Clinica Ematologica Azienda Sanitaria Universitaria Integrata di Udine,Udine,Italia;Clinica Ematologica Azienda Sanitaria Universitaria Integrata di Udine,Udine,Italy;Clinica Ematologica Azienda Sanitaria Universitaria Integrata di
,
Ollivier Legrand
Affiliations:
Service d'Hématologie Clinique et de Thérapie cellulaire,Hôpital Saint Antoine, APHP,Paris,France;Service d'Hématologie Clinique et de Thérapie cellulaire,Hôpital Saint Antoine, APHP,Paris,Frankreich;Service d'Hématologie Clinique et de Thérapie cellulaire,Hôpital Saint Antoine, APHP,Paris,Francia;Service d'Hématologie Clinique et de Thérapie cellulaire,Hôpital Saint Antoine, APHP,Paris,France;Ser
,
Robin Foà
Affiliations:
Ematologia, Dipartimento di Medicina Traslazionale e di Precisione,"Sapienza" Università di Roma,Rome,Italie;Ematologia, Dipartimento di Medicina Traslazionale e di Precisione,"Sapienza" Università di Roma,Rome,Italien;Ematologia, Dipartimento di Medicina Traslazionale e di Precisione,"Sapienza" Università di Roma,Rome,Italia;Ematologia, Dipartimento di Medicina Traslazionale e di Precisione,"Sapi
,
Gianluca Gaidano
Affiliations:
Division of Hematology, Department of Translational Medicine,Università del Piemonte Orientale and Azienda Ospedaliero-Universitaria Maggiore della Carità,Novara,Italie;Division of Hematology, Department of Translational Medicine,Università del Piemonte Orientale and Azienda Ospedaliero-Universitaria Maggiore della Carità,Novara,Italien;Division of Hematology, Department of Translational Medicine,
,
Danielle van Lammeren-Venema
Affiliations:
Department of Hematology,Haga Teaching Hospital,The Hague,Pays-bas;Department of Hematology,Haga Teaching Hospital,The Hague,Niederlande;Department of Hematology,Haga Teaching Hospital,The Hague,Paesi Bassi;Department of Hematology,Haga Teaching Hospital,The Hague,Netherland;Department of Hematology,Haga Teaching Hospital,The Hague,Países Bajos;Department of Hematology,Haga Teaching Hospital,The H
,
Eduardus F.M. Posthuma
Affiliations:
Department of Internal Medicine,Reinier de Graaf Hospital,Delft,Pays-bas;Department of Internal Medicine,Reinier de Graaf Hospital,Delft,Niederlande;Department of Internal Medicine,Reinier de Graaf Hospital,Delft,Paesi Bassi;Department of Internal Medicine,Reinier de Graaf Hospital,Delft,Netherland;Department of Internal Medicine,Reinier de Graaf Hospital,Delft,Países Bajos;Department of Internal
,
Mels Hoogendoorn
Affiliations:
Department of Hematology,Medical Center Leeuwarden,Leeuwarden,Pays-bas;Department of Hematology,Medical Center Leeuwarden,Leeuwarden,Niederlande;Department of Hematology,Medical Center Leeuwarden,Leeuwarden,Paesi Bassi;Department of Hematology,Medical Center Leeuwarden,Leeuwarden,Netherland;Department of Hematology,Medical Center Leeuwarden,Leeuwarden,Países Bajos;Department of Hematology,Medical
,
Anne Giraut
Affiliations:
EORTC Headquarters,Brussels,Belgique;EORTC Headquarters,Brussels,Belgien;EORTC Headquarters,Brussels,Belgio;EORTC Headquarters,Brussels,Belgium;EORTC Headquarters,Brussels,Bélgica;EORTC Headquarters,Brussels,België;EORTC Headquarters,Brussels,Bélgica;EORTC Headquarters,Brussels,Belgium;EORTC Headquarters,Brussels,Belgien
,
Marian Stevens-Kroef
Affiliations:
Radboud University Medical Center,Nijmegen,Pays-bas;Radboud University Medical Center,Nijmegen,Niederlande;Radboud University Medical Center,Nijmegen,Paesi Bassi;Radboud University Medical Center,Nijmegen,Netherland;Radboud University Medical Center,Nijmegen,Países Bajos;Radboud University Medical Center,Nijmegen,Nederland;Radboud University Medical Center,Nijmegen,Holanda;Radboud University Medic
,
Joop H. Jansen
Affiliations:
Dept laboratory Medicine, Lab Hematology,Radboud University Medical Center,Nijmegen,Pays-bas;Dept laboratory Medicine, Lab Hematology,Radboud University Medical Center,Nijmegen,Niederlande;Dept laboratory Medicine, Lab Hematology,Radboud University Medical Center,Nijmegen,Paesi Bassi;Dept laboratory Medicine, Lab Hematology,Radboud University Medical Center,Nijmegen,Netherland;Dept laboratory Medi
,
Emanuele Ammatuna
Affiliations:
University Medical Center Groningen,Groningen,Pays-bas;University Medical Center Groningen,Groningen,Niederlande;University Medical Center Groningen,Groningen,Paesi Bassi;University Medical Center Groningen,Groningen,Netherland;University Medical Center Groningen,Groningen,Países Bajos;University Medical Center Groningen,Groningen,Nederland;University Medical Center Groningen,Groningen,Holanda;Uni
,
Jean-Pierre Vilque
Affiliations:
Institut d'Hématologie de Basse Normandie,Centre Hospitalo-Universitaire de Caen,Caen,France;Institut d'Hématologie de Basse Normandie,Centre Hospitalo-Universitaire de Caen,Caen,Frankreich;Institut d'Hématologie de Basse Normandie,Centre Hospitalo-Universitaire de Caen,Caen,Francia;Institut d'Hématologie de Basse Normandie,Centre Hospitalo-Universitaire de Caen,Caen,France;Institut d'Hématologie
,
Ralph Wäsch
Affiliations:
Department of Hematology, Oncology and Stem Cell Transplantation, Faculty of Medicine, University Medical Center Freiburg,University of Freiburg,Freiburg,Allemagne;Department of Hematology, Oncology and Stem Cell Transplantation, Faculty of Medicine, University Medical Center Freiburg,University of Freiburg,Freiburg,Deutschland;Department of Hematology, Oncology and Stem Cell Transplantation, Facu
,
Heiko Becker
Affiliations:
Department of Hematology, Oncology and Stem Cell Transplantation, Faculty of Medicine, University Medical Center Freiburg,University of Freiburg,Freiburg,Allemagne;Department of Hematology, Oncology and Stem Cell Transplantation, Faculty of Medicine, University Medical Center Freiburg,University of Freiburg,Freiburg,Deutschland;Department of Hematology, Oncology and Stem Cell Transplantation, Facu
,
Nicole Blijlevens
Affiliations:
Department of Hematology,Radboud University Medical Centre,Nijmegen,Pays-bas;Department of Hematology,Radboud University Medical Centre,Nijmegen,Niederlande;Department of Hematology,Radboud University Medical Centre,Nijmegen,Paesi Bassi;Department of Hematology,Radboud University Medical Centre,Nijmegen,Netherland;Department of Hematology,Radboud University Medical Centre,Nijmegen,Países Bajos;Dep
,
Ulrich Dührsen
Affiliations:
Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Allemagne;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Deutschland;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Germania;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Germany;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Alemania;Klinik für Hämatologie,Universitätsklinikum Essen,Essen,Duitsland;Klinik
,
Frédéric Baron
Affiliations:
University of Liège,Liège,Belgique;University of Liège,Liège,Belgien;University of Liège,Liège,Belgio;University of Liège,Liège,Belgium;University of Liège,Liège,Bélgica;University of Liège,Liège,België;University of Liège,Liège,Bélgica;University of Liège,Liège,Belgium;University of Liège,Liège,Belgien
,
Stefan Suciu
Affiliations:
EORTC Headquarters,Brussels,Belgique;EORTC Headquarters,Brussels,Belgien;EORTC Headquarters,Brussels,Belgio;EORTC Headquarters,Brussels,Belgium;EORTC Headquarters,Brussels,Bélgica;EORTC Headquarters,Brussels,België;EORTC Headquarters,Brussels,Bélgica;EORTC Headquarters,Brussels,Belgium;EORTC Headquarters,Brussels,Belgien
,
Sergio Amadori
Affiliations:
Department of Biomedicine and Prevention,University of Rome Tor Vergata,Rome,Italie;Department of Biomedicine and Prevention,University of Rome Tor Vergata,Rome,Italien;Department of Biomedicine and Prevention,University of Rome Tor Vergata,Rome,Italia;Department of Biomedicine and Prevention,University of Rome Tor Vergata,Rome,Italy;Department of Biomedicine and Prevention,University of Rome Tor
,
Adriano Venditti
Affiliations:
Department of Biomedicine and Prevention,University of Rome Tor Vergata,Rome,Italie;Department of Biomedicine and Prevention,University of Rome Tor Vergata,Rome,Italien;Department of Biomedicine and Prevention,University of Rome Tor Vergata,Rome,Italia;Department of Biomedicine and Prevention,University of Rome Tor Vergata,Rome,Italy;Department of Biomedicine and Prevention,University of Rome Tor
Gerwin Huls
Affiliations:
University Medical Center Groningen,Groningen,Pays-bas;University Medical Center Groningen,Groningen,Niederlande;University Medical Center Groningen,Groningen,Paesi Bassi;University Medical Center Groningen,Groningen,Netherland;University Medical Center Groningen,Groningen,Países Bajos;University Medical Center Groningen,Groningen,Nederland;University Medical Center Groningen,Groningen,Holanda;Uni
(Abstract release date: 05/12/22) EHA Library. Lübbert M. 06/11/22; 356989; S125
Prof. Michael Lübbert
Prof. Michael Lübbert
Contributions
Abstract
Presentation during EHA2022: All Oral presentations will be presented between Friday, June 10 and Sunday, June 12 and will be accessible for on-demand viewing from Monday, June 20 until Monday, August 15, 2022 on the Congress platform.

Abstract: S125

Type: Oral Presentation

Session title: Novel insights into AML treatment

Background

Older, fit AML patients (pts) treated with induction chemotherapy (IC) have poor long-term survival unless HSCT is performed. DNA-hypomethylating agents have become the backbone of AML therapy in pts unfit for IC. Promising outcomes have been reported for the 10-day decitabine (DEC) schedule, suggesting it may be a better treatment prior to HSCT as compared to IC.

Aims

To compare efficacy and safety of 10-day DEC followed by allografting to IC followed by allografting in older fit AML pts.

Methods

This was an international open-label randomized phase III trial (NCT02172872). Key inclusion criteria were newly diagnosed AML, age >60 years, eligible for IC, WHO performance status 0-2. DEC was administered 10 days consecutively in cycle 1 (20 mg/m2), 10 or 5 days in subsequent cycles (depending on bone marrow blast clearance at day 28). IC treatment was daunorubicin 60 mg/m2 x 3 days, cytarabine 200 mg/m2 x 7 days, followed by 1-3 additional chemotherapy cycles. Pts who had an HLA-matched donor and at least stable disease were encouraged to undergo HSCT after >1 treatment cycle. Pts from the DEC arm not receiving HSCT could continue DEC treatment. The primary endpoint was overall survival (OS). Pts were randomized 1:1, stratified by de novo AML vs. secondary AML, age (60-64 vs 65-70 vs >70 yrs), and institution. The statistical design aimed to detect a hazard ratio (HR) for OS of 0.75 (HR<1 indicates longer survival for DEC), requiring 441 deaths (one-sided alpha 0.025, 85% power). Due to the slow accumulation of deaths, the final analysis was performed with a clinical cut-off (CCO) date June 30, 2021, following the Data Monitoring Committee recommendation.

Results

Between 12/2014 and 8/2019, 606 pts were randomized, 303 in each arm. Median follow-up was 4.0 yrs. Median age was 68 yrs (range 60-81), 34% of pts were 70 yrs old and 57% were male, 21% and 32% had good and adverse ELN 2017 risk profile, respectively. A median of 3 DEC cycles (Q1-3: 2-5) and 2 IC cycles (Q1-3: 1-2) were administered. The CR/CRi rate was 48% with DEC and 61% with IC. HSCT as part of the protocol was performed in 122 pts (40%, 30 of them not in CR/CRi) from the DEC and 118 (39%, 11 of them not in CR/CRi) from the IC arm, and in 52% in both arms at any time. By the CCO, 423 deaths occurred. The OS was not significantly different between DEC and IC groups (HR=1.04, 95% confidence interval [CI]: 0.86-1.26; 2-sided p=0.68). The median OS was 15 months (95% CI: 13-18) in the DEC and 18 months (95% CI: 14-22) in the IC group. The OS rates (%) after 1, 2, 3 and 4 years for the DEC and IC groups were 58 vs 59, 38 vs 40, 30 vs 33, and 26 vs 30, respectively. In age subgroups, the estimated HR for OS for DEC vs IC was 1.34 (99% CI: 0.79-2.28) for pts aged 60-64, 1.14 (99% CI: 0.77-1.69) for pts aged 65-69, and 0.84 (99% CI: 0.55-1.26) for pts aged >70 yrs (p-value for trend: 0.058). Notable differences in the incidence of grade 3-5 adverse events (%) reported (before HSCT) were: febrile neutropenia (37% for DEC vs 57% for IC), decrease in platelets (24% for DEC vs 32 % for IC), oral mucositis (2% for DEC vs 10% for IC), diarrhea (1% for DEC vs 8% for IC), decrease in neutrophils (19% for DEC vs 13% for IC). The 30-day mortality rate was 3.6% for DEC and 6.4% for IC. The incidence of grade 5 treatment-related adverse events after HSCT was comparable in both treatment arms (25% for DEC and 22% for IC).

Conclusion

Treatment with DEC resulted in a similar OS and HSCT rate but a better safety profile compared to IC in older AML pts 60 yrs, eligible for IC.

Keyword(s): Allogeneic hematopoietic stem cell transplant, AML, Clinical trial, Decitabine

Presentation during EHA2022: All Oral presentations will be presented between Friday, June 10 and Sunday, June 12 and will be accessible for on-demand viewing from Monday, June 20 until Monday, August 15, 2022 on the Congress platform.

Abstract: S125

Type: Oral Presentation

Session title: Novel insights into AML treatment

Background

Older, fit AML patients (pts) treated with induction chemotherapy (IC) have poor long-term survival unless HSCT is performed. DNA-hypomethylating agents have become the backbone of AML therapy in pts unfit for IC. Promising outcomes have been reported for the 10-day decitabine (DEC) schedule, suggesting it may be a better treatment prior to HSCT as compared to IC.

Aims

To compare efficacy and safety of 10-day DEC followed by allografting to IC followed by allografting in older fit AML pts.

Methods

This was an international open-label randomized phase III trial (NCT02172872). Key inclusion criteria were newly diagnosed AML, age >60 years, eligible for IC, WHO performance status 0-2. DEC was administered 10 days consecutively in cycle 1 (20 mg/m2), 10 or 5 days in subsequent cycles (depending on bone marrow blast clearance at day 28). IC treatment was daunorubicin 60 mg/m2 x 3 days, cytarabine 200 mg/m2 x 7 days, followed by 1-3 additional chemotherapy cycles. Pts who had an HLA-matched donor and at least stable disease were encouraged to undergo HSCT after >1 treatment cycle. Pts from the DEC arm not receiving HSCT could continue DEC treatment. The primary endpoint was overall survival (OS). Pts were randomized 1:1, stratified by de novo AML vs. secondary AML, age (60-64 vs 65-70 vs >70 yrs), and institution. The statistical design aimed to detect a hazard ratio (HR) for OS of 0.75 (HR<1 indicates longer survival for DEC), requiring 441 deaths (one-sided alpha 0.025, 85% power). Due to the slow accumulation of deaths, the final analysis was performed with a clinical cut-off (CCO) date June 30, 2021, following the Data Monitoring Committee recommendation.

Results

Between 12/2014 and 8/2019, 606 pts were randomized, 303 in each arm. Median follow-up was 4.0 yrs. Median age was 68 yrs (range 60-81), 34% of pts were 70 yrs old and 57% were male, 21% and 32% had good and adverse ELN 2017 risk profile, respectively. A median of 3 DEC cycles (Q1-3: 2-5) and 2 IC cycles (Q1-3: 1-2) were administered. The CR/CRi rate was 48% with DEC and 61% with IC. HSCT as part of the protocol was performed in 122 pts (40%, 30 of them not in CR/CRi) from the DEC and 118 (39%, 11 of them not in CR/CRi) from the IC arm, and in 52% in both arms at any time. By the CCO, 423 deaths occurred. The OS was not significantly different between DEC and IC groups (HR=1.04, 95% confidence interval [CI]: 0.86-1.26; 2-sided p=0.68). The median OS was 15 months (95% CI: 13-18) in the DEC and 18 months (95% CI: 14-22) in the IC group. The OS rates (%) after 1, 2, 3 and 4 years for the DEC and IC groups were 58 vs 59, 38 vs 40, 30 vs 33, and 26 vs 30, respectively. In age subgroups, the estimated HR for OS for DEC vs IC was 1.34 (99% CI: 0.79-2.28) for pts aged 60-64, 1.14 (99% CI: 0.77-1.69) for pts aged 65-69, and 0.84 (99% CI: 0.55-1.26) for pts aged >70 yrs (p-value for trend: 0.058). Notable differences in the incidence of grade 3-5 adverse events (%) reported (before HSCT) were: febrile neutropenia (37% for DEC vs 57% for IC), decrease in platelets (24% for DEC vs 32 % for IC), oral mucositis (2% for DEC vs 10% for IC), diarrhea (1% for DEC vs 8% for IC), decrease in neutrophils (19% for DEC vs 13% for IC). The 30-day mortality rate was 3.6% for DEC and 6.4% for IC. The incidence of grade 5 treatment-related adverse events after HSCT was comparable in both treatment arms (25% for DEC and 22% for IC).

Conclusion

Treatment with DEC resulted in a similar OS and HSCT rate but a better safety profile compared to IC in older AML pts 60 yrs, eligible for IC.

Keyword(s): Allogeneic hematopoietic stem cell transplant, AML, Clinical trial, Decitabine

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