Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy : A Randomized, Phase 3 Trial

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dc.contributor.author Dohner, Hartmut
dc.contributor.author Symeonidis, Argiris
dc.contributor.author Deeren, Dries
dc.contributor.author Demeter, Judit
dc.contributor.author Sanz, Miguel A.
dc.contributor.author Anagnostopoulos, Achilles
dc.contributor.author Esteve, Jordi
dc.contributor.author Fiedler, Walter
dc.contributor.author Porkka, Kimmo
dc.contributor.author Kim, Hee-Je
dc.contributor.author Lee, Je-Hwan
dc.contributor.author Usuki, Kensuke
dc.contributor.author D'Ardia, Stefano
dc.contributor.author Won Jung, Chul
dc.contributor.author Salamero, Olga
dc.contributor.author Horst, Heinz-August
dc.contributor.author Recher, Christian
dc.contributor.author Rousselot, Philippe
dc.contributor.author Sandhu, Irwindeep
dc.contributor.author Theunissen, Koen
dc.contributor.author Thol, Felicitas
dc.contributor.author Dohner, Konstanze
dc.contributor.author Teleanu, Veronica
dc.contributor.author DeAngelo, Daniel J.
dc.contributor.author Naoe, Tomoki
dc.contributor.author Sekeres, Mikkael A.
dc.contributor.author Belsack, Valerie
dc.contributor.author Ge, Miaomiao
dc.contributor.author Taube, Tillmann
dc.contributor.author Ottmann, Oliver G.
dc.date.accessioned 2021-09-28T05:46:01Z
dc.date.available 2021-09-28T05:46:01Z
dc.date.issued 2021-08
dc.identifier.citation Dohner , H , Symeonidis , A , Deeren , D , Demeter , J , Sanz , M A , Anagnostopoulos , A , Esteve , J , Fiedler , W , Porkka , K , Kim , H-J , Lee , J-H , Usuki , K , D'Ardia , S , Won Jung , C , Salamero , O , Horst , H-A , Recher , C , Rousselot , P , Sandhu , I , Theunissen , K , Thol , F , Dohner , K , Teleanu , V , DeAngelo , D J , Naoe , T , Sekeres , M A , Belsack , V , Ge , M , Taube , T & Ottmann , O G 2021 , ' Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy : A Randomized, Phase 3 Trial ' , Hemasphere , vol. 5 , no. 8 , 617 . https://doi.org/10.1097/HS9.0000000000000617
dc.identifier.other PURE: 168812802
dc.identifier.other PURE UUID: fc40d6b8-3854-42a4-9c17-c4ee048f0475
dc.identifier.other WOS: 000682773000010
dc.identifier.other ORCID: /0000-0003-4112-5902/work/100697243
dc.identifier.uri http://hdl.handle.net/10138/334645
dc.description.abstract 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. en
dc.format.extent 10
dc.language.iso eng
dc.relation.ispartof Hemasphere
dc.rights cc_by
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject KINASE INHIBITOR VOLASERTIB
dc.subject LOW-DOSE CYTARABINE
dc.subject BI 6727
dc.subject OPEN-LABEL
dc.subject RECOMMENDATIONS
dc.subject AZACITIDINE
dc.subject DECITABINE
dc.subject MANAGEMENT
dc.subject VENETOCLAX
dc.subject DIAGNOSIS
dc.subject 3122 Cancers
dc.title Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy : A Randomized, Phase 3 Trial en
dc.type Article
dc.contributor.organization HUS Comprehensive Cancer Center
dc.contributor.organization Department of Medicine
dc.contributor.organization Hematologian yksikkö
dc.contributor.organization Helsinki University Hospital Area
dc.description.reviewstatus Peer reviewed
dc.relation.doi https://doi.org/10.1097/HS9.0000000000000617
dc.relation.issn 2572-9241
dc.rights.accesslevel openAccess
dc.type.version publishedVersion

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