PMID- 34350385
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210806
IS  - 2572-9241 (Electronic)
IS  - 2572-9241 (Linking)
VI  - 5
IP  - 8
DP  - 2021 Aug
TI  - Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for 
      Standard Induction Therapy: A Randomized, Phase 3 Trial.
PG  - e617
LID - 10.1097/HS9.0000000000000617 [doi]
LID - e617
AB  - In this phase 3 trial, older patients with acute myeloid leukemia ineligible for 
      intensive chemotherapy were randomized 2:1 to receive the polo-like kinase 
      inhibitor, volasertib (V; 350 mg intravenous on days 1 and 15 in 4-wk cycles), 
      combined with low-dose cytarabine (LDAC; 20 mg subcutaneous, twice daily, days 
      1-10; n = 444), or LDAC plus placebo (P; n = 222). Primary endpoint was objective 
      response rate (ORR); key secondary endpoint was overall survival (OS). Primary 
      ORR analysis at recruitment completion included patients randomized >/=5 months 
      beforehand; ORR was 25.2% for V+LDAC and 16.8% for P+LDAC (n = 371; odds ratio 
      1.66 [95% confidence interval (CI), 0.95-2.89]; P = 0.071). At final analysis 
      (>/=574 OS events), median OS was 5.6 months for V+LDAC and 6.5 months for P+LDAC 
      (n = 666; hazard ratio 0.97 [95% CI, 0.8-1.2]; P = 0.757). The most common 
      adverse events (AEs) were infections/infestations (grouped term; V+LDAC, 81.3%; 
      P+LDAC, 63.5%) and febrile neutropenia (V+LDAC, 60.4%; P+LDAC, 29.3%). Fatal AEs 
      occurred in 31.2% with V+LDAC versus 18.0% with P+LDAC, most commonly 
      infections/infestations (V+LDAC, 17.1%; P+LDAC, 6.3%). Lack of OS benefit with 
      V+LDAC versus P+LDAC may reflect increased early mortality with V+LDAC from 
      myelosuppression and infections.
CI  - Copyright (c) 2021 the Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the European Hematology Association.
FAU - Dohner, Hartmut
AU  - Dohner H
AD  - Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany.
FAU - Symeonidis, Argiris
AU  - Symeonidis A
AD  - Hematology Division, University Hospital, University of Patras Medical School, 
      Patras, Greece.
FAU - Deeren, Dries
AU  - Deeren D
AD  - AZ Delta, Roeselare, Belgium.
FAU - Demeter, Judit
AU  - Demeter J
AD  - Semmelweis University, Budapest, Hungary.
FAU - Sanz, Miguel A
AU  - Sanz MA
AD  - Department of Hematology, University Hospital La Fe, Valencia, Spain.
FAU - Anagnostopoulos, Achilles
AU  - Anagnostopoulos A
AD  - Hematology Department, General Hospital G. Papanikolaou, Thessaloniki, Greece.
FAU - Esteve, Jordi
AU  - Esteve J
AD  - Hospital Clinic de Barcelona, IDIBAPS, Barcelona, Spain.
FAU - Fiedler, Walter
AU  - Fiedler W
AD  - Department of Medicine II, University Medical Center, Hamburg-Eppendorf, Hamburg, 
      Germany.
FAU - Porkka, Kimmo
AU  - Porkka K
AD  - Department of Hematology, Helsinki University Hospital Cancer Center, Helsinki, 
      Finland.
FAU - Kim, Hee-Je
AU  - Kim HJ
AD  - Catholic Hematology Hospital, Seoul St. Mary's Hospital, College of Medicine, The 
      Catholic University of Korea, Seoul, South Korea.
FAU - Lee, Je-Hwan
AU  - Lee JH
AD  - Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
FAU - Usuki, Kensuke
AU  - Usuki K
AD  - NTT Medical Center Tokyo, Japan.
FAU - D'Ardia, Stefano
AU  - D'Ardia S
AD  - A.O. Citta della Salute e della Scienza, Torino, Italy.
FAU - Won Jung, Chul
AU  - Won Jung C
AD  - Samsung Medical Center, Seoul, South Korea.
FAU - Salamero, Olga
AU  - Salamero O
AD  - Hospital Vall d'Hebron/VHIO/UAB-Medicine, Barcelona, Spain.
FAU - Horst, Heinz-August
AU  - Horst HA
AD  - UKSH Campus Kiel, Kiel, Germany.
FAU - Recher, Christian
AU  - Recher C
AD  - Centre Hospitalier Universitaire de Toulouse, IUCT-Oncopole, Universite Paul 
      Sabatier Toulouse 3, Toulouse, France.
FAU - Rousselot, Philippe
AU  - Rousselot P
AD  - Centre Hospitalier de Versailles, University Versailles Saint-Quentin and Paris 
      Saclay, Le Chesnay, France.
FAU - Sandhu, Irwindeep
AU  - Sandhu I
AD  - Division of Hematology, Department of Medicine, University of Alberta, Edmonton, 
      AB, Canada.
FAU - Theunissen, Koen
AU  - Theunissen K
AD  - Jessa Ziekenhuis, Hasselt, Belgium.
FAU - Thol, Felicitas
AU  - Thol F
AD  - Medizinische Hochschule Hannover, Germany.
FAU - Dohner, Konstanze
AU  - Dohner K
AD  - Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany.
FAU - Teleanu, Veronica
AU  - Teleanu V
AD  - Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany.
FAU - DeAngelo, Daniel J
AU  - DeAngelo DJ
AD  - Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
FAU - Naoe, Tomoki
AU  - Naoe T
AD  - National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
FAU - Sekeres, Mikkael A
AU  - Sekeres MA
AD  - Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.
FAU - Belsack, Valerie
AU  - Belsack V
AD  - SCS Boehringer Ingelheim Comm.V, Brussels, Belgium.
FAU - Ge, Miaomiao
AU  - Ge M
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.
FAU - Taube, Tillmann
AU  - Taube T
AD  - Boehringer Ingelheim International GmbH, Biberach, Germany.
FAU - Ottmann, Oliver G
AU  - Ottmann OG
AD  - Goethe University, Frankfurt/Main, Germany.
LA  - eng
PT  - Journal Article
DEP - 20210802
PL  - United States
TA  - Hemasphere
JT  - HemaSphere
JID - 101740619
PMC - PMC8328241
EDAT- 2021/08/06 06:00
MHDA- 2021/08/06 06:01
PMCR- 2021/08/02
CRDT- 2021/08/05 06:32
PHST- 2020/12/15 00:00 [received]
PHST- 2021/06/09 00:00 [accepted]
PHST- 2021/08/05 06:32 [entrez]
PHST- 2021/08/06 06:00 [pubmed]
PHST- 2021/08/06 06:01 [medline]
PHST- 2021/08/02 00:00 [pmc-release]
AID - 10.1097/HS9.0000000000000617 [doi]
PST - epublish
SO  - Hemasphere. 2021 Aug 2;5(8):e617. doi: 10.1097/HS9.0000000000000617. eCollection 
      2021 Aug.