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Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: phase 3 randomized placebo-controlled trial

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Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: phase 3 randomized placebo-controlled trial. / Wei, Andrew Henry; Montesinos, Pau; Ivanov, Vladimir; DiNardo, Courtney D; Novak, Jan; Laribi, Kamel; Kim, Inho; Stevens, Don; Fiedler, Walter; Pagoni, Maria; Samoilova, Olga; Hu, Yu; Anagnostopoulos, Achilles; Bergeron, Julie; Hou, Jing-Zhou; Murthy, Vidhya; Yamauchi, Takahiro; McDonald, Andrew Bruce; Chyla, Brenda; Gopalakrishnan, Sathej; Jiang, Qi; Mendes, Wellington L; Hayslip, John; Panayiotidis, Panayiotis.

in: BLOOD, Jahrgang 135, Nr. 24, 11.06.2020, S. 2137-2145.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Wei, AH, Montesinos, P, Ivanov, V, DiNardo, CD, Novak, J, Laribi, K, Kim, I, Stevens, D, Fiedler, W, Pagoni, M, Samoilova, O, Hu, Y, Anagnostopoulos, A, Bergeron, J, Hou, J-Z, Murthy, V, Yamauchi, T, McDonald, AB, Chyla, B, Gopalakrishnan, S, Jiang, Q, Mendes, WL, Hayslip, J & Panayiotidis, P 2020, 'Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: phase 3 randomized placebo-controlled trial', BLOOD, Jg. 135, Nr. 24, S. 2137-2145. https://doi.org/10.1182/blood.2020004856

APA

Wei, A. H., Montesinos, P., Ivanov, V., DiNardo, C. D., Novak, J., Laribi, K., Kim, I., Stevens, D., Fiedler, W., Pagoni, M., Samoilova, O., Hu, Y., Anagnostopoulos, A., Bergeron, J., Hou, J-Z., Murthy, V., Yamauchi, T., McDonald, A. B., Chyla, B., ... Panayiotidis, P. (2020). Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: phase 3 randomized placebo-controlled trial. BLOOD, 135(24), 2137-2145. https://doi.org/10.1182/blood.2020004856

Vancouver

Wei AH, Montesinos P, Ivanov V, DiNardo CD, Novak J, Laribi K et al. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: phase 3 randomized placebo-controlled trial. BLOOD. 2020 Jun 11;135(24):2137-2145. https://doi.org/10.1182/blood.2020004856

Bibtex

@article{4eeec868e4f946d796937e3d102f6c36,
title = "Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: phase 3 randomized placebo-controlled trial",
abstract = "Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Adults age ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in this international phase 3 randomized double-blind placebo-controlled trial. Patients (N = 211) were randomized 2:1 to venetoclax (n = 143) or placebo (n = 68) in 28-day cycles, plus low-dose cytarabine (LDAC) on days 1 to 10. Primary end point was overall survival (OS); secondary end points included response rate, transfusion independence, and event-free survival. Median age was 76 years (range, 36-93 years), 38% had secondary AML, and 20% had received prior hypomethylating agent treatment. Planned primary analysis showed a 25% reduction in risk of death with venetoclax plus LDAC vs LDAC alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.52-1.07; P = .11), although not statistically significant; median OS was 7.2 vs 4.1 months, respectively. Unplanned analysis with additional 6-month follow-up demonstrated median OS of 8.4 months for the venetoclax arm (HR, 0.70; 95% CI, 0.50-0.98; P = .04). Complete remission (CR) plus CR with incomplete blood count recovery rates were 48% and 13% for venetoclax plus LDAC and LDAC alone, respectively. Key grade ≥3 adverse events (venetoclax vs LDAC alone) were febrile neutropenia (32% vs 29%), neutropenia (47% vs 16%), and thrombocytopenia (45% vs 37%). Venetoclax plus LDAC demonstrates clinically meaningful improvement in remission rate and OS vs LDAC alone, with a manageable safety profile. Results confirm venetoclax plus LDAC as an important frontline treatment for AML patients unfit for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT03069352.",
author = "Wei, {Andrew Henry} and Pau Montesinos and Vladimir Ivanov and DiNardo, {Courtney D} and Jan Novak and Kamel Laribi and Inho Kim and Don Stevens and Walter Fiedler and Maria Pagoni and Olga Samoilova and Yu Hu and Achilles Anagnostopoulos and Julie Bergeron and Jing-Zhou Hou and Vidhya Murthy and Takahiro Yamauchi and McDonald, {Andrew Bruce} and Brenda Chyla and Sathej Gopalakrishnan and Qi Jiang and Mendes, {Wellington L} and John Hayslip and Panayiotis Panayiotidis",
note = "{\textcopyright} 2020 by The American Society of Hematology.",
year = "2020",
month = jun,
day = "11",
doi = "10.1182/blood.2020004856",
language = "English",
volume = "135",
pages = "2137--2145",
journal = "BLOOD",
issn = "0006-4971",
publisher = "American Society of Hematology",
number = "24",

}

RIS

TY - JOUR

T1 - Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: phase 3 randomized placebo-controlled trial

AU - Wei, Andrew Henry

AU - Montesinos, Pau

AU - Ivanov, Vladimir

AU - DiNardo, Courtney D

AU - Novak, Jan

AU - Laribi, Kamel

AU - Kim, Inho

AU - Stevens, Don

AU - Fiedler, Walter

AU - Pagoni, Maria

AU - Samoilova, Olga

AU - Hu, Yu

AU - Anagnostopoulos, Achilles

AU - Bergeron, Julie

AU - Hou, Jing-Zhou

AU - Murthy, Vidhya

AU - Yamauchi, Takahiro

AU - McDonald, Andrew Bruce

AU - Chyla, Brenda

AU - Gopalakrishnan, Sathej

AU - Jiang, Qi

AU - Mendes, Wellington L

AU - Hayslip, John

AU - Panayiotidis, Panayiotis

N1 - © 2020 by The American Society of Hematology.

PY - 2020/6/11

Y1 - 2020/6/11

N2 - Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Adults age ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in this international phase 3 randomized double-blind placebo-controlled trial. Patients (N = 211) were randomized 2:1 to venetoclax (n = 143) or placebo (n = 68) in 28-day cycles, plus low-dose cytarabine (LDAC) on days 1 to 10. Primary end point was overall survival (OS); secondary end points included response rate, transfusion independence, and event-free survival. Median age was 76 years (range, 36-93 years), 38% had secondary AML, and 20% had received prior hypomethylating agent treatment. Planned primary analysis showed a 25% reduction in risk of death with venetoclax plus LDAC vs LDAC alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.52-1.07; P = .11), although not statistically significant; median OS was 7.2 vs 4.1 months, respectively. Unplanned analysis with additional 6-month follow-up demonstrated median OS of 8.4 months for the venetoclax arm (HR, 0.70; 95% CI, 0.50-0.98; P = .04). Complete remission (CR) plus CR with incomplete blood count recovery rates were 48% and 13% for venetoclax plus LDAC and LDAC alone, respectively. Key grade ≥3 adverse events (venetoclax vs LDAC alone) were febrile neutropenia (32% vs 29%), neutropenia (47% vs 16%), and thrombocytopenia (45% vs 37%). Venetoclax plus LDAC demonstrates clinically meaningful improvement in remission rate and OS vs LDAC alone, with a manageable safety profile. Results confirm venetoclax plus LDAC as an important frontline treatment for AML patients unfit for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT03069352.

AB - Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Adults age ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in this international phase 3 randomized double-blind placebo-controlled trial. Patients (N = 211) were randomized 2:1 to venetoclax (n = 143) or placebo (n = 68) in 28-day cycles, plus low-dose cytarabine (LDAC) on days 1 to 10. Primary end point was overall survival (OS); secondary end points included response rate, transfusion independence, and event-free survival. Median age was 76 years (range, 36-93 years), 38% had secondary AML, and 20% had received prior hypomethylating agent treatment. Planned primary analysis showed a 25% reduction in risk of death with venetoclax plus LDAC vs LDAC alone (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.52-1.07; P = .11), although not statistically significant; median OS was 7.2 vs 4.1 months, respectively. Unplanned analysis with additional 6-month follow-up demonstrated median OS of 8.4 months for the venetoclax arm (HR, 0.70; 95% CI, 0.50-0.98; P = .04). Complete remission (CR) plus CR with incomplete blood count recovery rates were 48% and 13% for venetoclax plus LDAC and LDAC alone, respectively. Key grade ≥3 adverse events (venetoclax vs LDAC alone) were febrile neutropenia (32% vs 29%), neutropenia (47% vs 16%), and thrombocytopenia (45% vs 37%). Venetoclax plus LDAC demonstrates clinically meaningful improvement in remission rate and OS vs LDAC alone, with a manageable safety profile. Results confirm venetoclax plus LDAC as an important frontline treatment for AML patients unfit for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT03069352.

U2 - 10.1182/blood.2020004856

DO - 10.1182/blood.2020004856

M3 - SCORING: Journal article

C2 - 32219442

VL - 135

SP - 2137

EP - 2145

JO - BLOOD

JF - BLOOD

SN - 0006-4971

IS - 24

ER -