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

Standard

Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial. / Döhner, 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; Döhner, Konstanze; Teleanu, Veronica; DeAngelo, Daniel J; Naoe, Tomoki; Sekeres, Mikkael A; Belsack, Valerie; Ge, Miaomiao; Taube, Tillmann; Ottmann, Oliver G.

In: HEMASPHERE, Vol. 5, No. 8, 08.2021, p. e617.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Döhner, H, Symeonidis, A, Deeren, D, Demeter, J, Sanz, MA, 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, Döhner, K, Teleanu, V, DeAngelo, DJ, Naoe, T, Sekeres, MA, Belsack, V, Ge, M, Taube, T & Ottmann, OG 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, pp. e617. https://doi.org/10.1097/HS9.0000000000000617

APA

Döhner, 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., ... Ottmann, O. G. (2021). Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial. HEMASPHERE, 5(8), e617. https://doi.org/10.1097/HS9.0000000000000617

Vancouver

Döhner H, Symeonidis A, Deeren D, Demeter J, Sanz MA, Anagnostopoulos A et al. Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial. HEMASPHERE. 2021 Aug;5(8):e617. https://doi.org/10.1097/HS9.0000000000000617

Bibtex

@article{8c014a203cdd44f3a4d962efde1c6351,
title = "Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial",
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.",
author = "Hartmut D{\"o}hner and Argiris Symeonidis and Dries Deeren and Judit Demeter and Sanz, {Miguel A} and Achilles Anagnostopoulos and Jordi Esteve and Walter Fiedler and Kimmo Porkka and Hee-Je Kim and Je-Hwan Lee and Kensuke Usuki and Stefano D'Ardia and {Won Jung}, Chul and Olga Salamero and Heinz-August Horst and Christian Recher and Philippe Rousselot and Irwindeep Sandhu and Koen Theunissen and Felicitas Thol and Konstanze D{\"o}hner and Veronica Teleanu and DeAngelo, {Daniel J} and Tomoki Naoe and Sekeres, {Mikkael A} and Valerie Belsack and Miaomiao Ge and Tillmann Taube and Ottmann, {Oliver G}",
note = "Copyright {\textcopyright} 2021 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association.",
year = "2021",
month = aug,
doi = "10.1097/HS9.0000000000000617",
language = "English",
volume = "5",
pages = "e617",
journal = "HEMASPHERE",
issn = "2572-9241",
publisher = "Wolters Kluwer Health",
number = "8",

}

RIS

TY - JOUR

T1 - Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial

AU - Döhner, Hartmut

AU - Symeonidis, Argiris

AU - Deeren, Dries

AU - Demeter, Judit

AU - Sanz, Miguel A

AU - Anagnostopoulos, Achilles

AU - Esteve, Jordi

AU - Fiedler, Walter

AU - Porkka, Kimmo

AU - Kim, Hee-Je

AU - Lee, Je-Hwan

AU - Usuki, Kensuke

AU - D'Ardia, Stefano

AU - Won Jung, Chul

AU - Salamero, Olga

AU - Horst, Heinz-August

AU - Recher, Christian

AU - Rousselot, Philippe

AU - Sandhu, Irwindeep

AU - Theunissen, Koen

AU - Thol, Felicitas

AU - Döhner, Konstanze

AU - Teleanu, Veronica

AU - DeAngelo, Daniel J

AU - Naoe, Tomoki

AU - Sekeres, Mikkael A

AU - Belsack, Valerie

AU - Ge, Miaomiao

AU - Taube, Tillmann

AU - Ottmann, Oliver G

N1 - Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association.

PY - 2021/8

Y1 - 2021/8

N2 - 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.

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.

U2 - 10.1097/HS9.0000000000000617

DO - 10.1097/HS9.0000000000000617

M3 - SCORING: Journal article

C2 - 34350385

VL - 5

SP - e617

JO - HEMASPHERE

JF - HEMASPHERE

SN - 2572-9241

IS - 8

ER -