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

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Pysyväisosoite

http://hdl.handle.net/10138/334645

Lähdeviite

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

Julkaisun nimi: Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy : A Randomized, Phase 3 Trial
Tekijä: Dohner, Hartmut; Symeonidis, Argiris; Deeren, Dries; Demeter, Judit; Sanz, Miguel A.; Anagnostopoulos, Achilles; Esteve, Jordi; Fiedler, Walter; Porkka, Kimmo; Kim, Hee-Je; Lee, Je-Hwan; Usuki, Kensuke; D'Ardia, Stefano; Won Jung, Chul; Salamero, Olga; Horst, Heinz-August; Recher, Christian; Rousselot, Philippe; Sandhu, Irwindeep; Theunissen, Koen; Thol, Felicitas; Dohner, Konstanze; Teleanu, Veronica; DeAngelo, Daniel J.; Naoe, Tomoki; Sekeres, Mikkael A.; Belsack, Valerie; Ge, Miaomiao; Taube, Tillmann; Ottmann, Oliver G.
Tekijän organisaatio: HUS Comprehensive Cancer Center
Department of Medicine
Hematologian yksikkö
Helsinki University Hospital Area
Päiväys: 2021-08
Kieli: eng
Sivumäärä: 10
Kuuluu julkaisusarjaan: Hemasphere
ISSN: 2572-9241
DOI-tunniste: https://doi.org/10.1097/HS9.0000000000000617
URI: http://hdl.handle.net/10138/334645
Tiivistelmä: 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.
Avainsanat: KINASE INHIBITOR VOLASERTIB
LOW-DOSE CYTARABINE
BI 6727
OPEN-LABEL
RECOMMENDATIONS
AZACITIDINE
DECITABINE
MANAGEMENT
VENETOCLAX
DIAGNOSIS
3122 Cancers
Vertaisarvioitu: Kyllä
Tekijänoikeustiedot: cc_by
Pääsyrajoitteet: openAccess
Rinnakkaistallennettu versio: publishedVersion


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