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Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study

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Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study. / Wei, Andrew H; Strickland, Stephen A; Hou, Jing-Zhou; Fiedler, Walter; Lin, Tara L; Walter, Roland B; Enjeti, Anoop; Tiong, Ing Soo; Savona, Michael; Lee, Sangmin; Chyla, Brenda; Popovic, Relja; Salem, Ahmed Hamed; Agarwal, Suresh; Xu, Tu; Fakouhi, Kaffa M; Humerickhouse, Rod; Hong, Wan-Jen; Hayslip, John; Roboz, Gail J.

in: J CLIN ONCOL, Jahrgang 37, Nr. 15, 20.05.2019, S. 1277-1284.

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

Harvard

Wei, AH, Strickland, SA, Hou, J-Z, Fiedler, W, Lin, TL, Walter, RB, Enjeti, A, Tiong, IS, Savona, M, Lee, S, Chyla, B, Popovic, R, Salem, AH, Agarwal, S, Xu, T, Fakouhi, KM, Humerickhouse, R, Hong, W-J, Hayslip, J & Roboz, GJ 2019, 'Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study', J CLIN ONCOL, Jg. 37, Nr. 15, S. 1277-1284. https://doi.org/10.1200/JCO.18.01600

APA

Wei, A. H., Strickland, S. A., Hou, J-Z., Fiedler, W., Lin, T. L., Walter, R. B., Enjeti, A., Tiong, I. S., Savona, M., Lee, S., Chyla, B., Popovic, R., Salem, A. H., Agarwal, S., Xu, T., Fakouhi, K. M., Humerickhouse, R., Hong, W-J., Hayslip, J., & Roboz, G. J. (2019). Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study. J CLIN ONCOL, 37(15), 1277-1284. https://doi.org/10.1200/JCO.18.01600

Vancouver

Wei AH, Strickland SA, Hou J-Z, Fiedler W, Lin TL, Walter RB et al. Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study. J CLIN ONCOL. 2019 Mai 20;37(15):1277-1284. https://doi.org/10.1200/JCO.18.01600

Bibtex

@article{c4577512100d4f0e8a1603bf5d17fb7a,
title = "Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study",
abstract = "PURPOSE: Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. An international phase Ib/II study evaluated the safety and preliminary efficacy of venetoclax, a selective B-cell leukemia/lymphoma-2 inhibitor, together with low-dose cytarabine (LDAC) in older adults with AML.PATIENTS AND METHODS: Adults 60 years or older with previously untreated AML ineligible for intensive chemotherapy were enrolled. Prior treatment of myelodysplastic syndrome, including hypomethylating agents (HMA), was permitted. Eighty-two patients were treated at the recommended phase II dose: venetoclax 600 mg per day orally in 28-day cycles, with LDAC (20 mg/m2 per day) administered subcutaneously on days 1 to 10. Key end points were tolerability, safety, response rates, duration of response (DOR), and overall survival (OS).RESULTS: Median age was 74 years (range, 63 to 90 years), 49% had secondary AML, 29% had prior HMA treatment, and 32% had poor-risk cytogenetic features. Common grade 3 or greater adverse events were febrile neutropenia (42%), thrombocytopenia (38%), and WBC count decreased (34%). Early (30-day) mortality was 6%. Fifty-four percent achieved complete remission (CR)/CR with incomplete blood count recovery (median time to first response, 1.4 months). The median OS was 10.1 months (95% CI, 5.7 to 14.2), and median DOR was 8.1 months (95% CI, 5.3 to 14.9 months). Among patients without prior HMA exposure, CR/CR with incomplete blood count recovery was achieved in 62%, median DOR was 14.8 months (95% CI, 5.5 months to not reached), and median OS was 13.5 months (95% CI, 7.0 to 18.4 months).CONCLUSION: Venetoclax plus LDAC has a manageable safety profile, producing rapid and durable remissions in older adults with AML ineligible for intensive chemotherapy. High remission rate and low early mortality combined with rapid and durable remission make venetoclax and LDAC an attractive and novel treatment for older adults not suitable for intensive chemotherapy.",
keywords = "Journal Article",
author = "Wei, {Andrew H} and Strickland, {Stephen A} and Jing-Zhou Hou and Walter Fiedler and Lin, {Tara L} and Walter, {Roland B} and Anoop Enjeti and Tiong, {Ing Soo} and Michael Savona and Sangmin Lee and Brenda Chyla and Relja Popovic and Salem, {Ahmed Hamed} and Suresh Agarwal and Tu Xu and Fakouhi, {Kaffa M} and Rod Humerickhouse and Wan-Jen Hong and John Hayslip and Roboz, {Gail J}",
year = "2019",
month = may,
day = "20",
doi = "10.1200/JCO.18.01600",
language = "English",
volume = "37",
pages = "1277--1284",
journal = "J CLIN ONCOL",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "15",

}

RIS

TY - JOUR

T1 - Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study

AU - Wei, Andrew H

AU - Strickland, Stephen A

AU - Hou, Jing-Zhou

AU - Fiedler, Walter

AU - Lin, Tara L

AU - Walter, Roland B

AU - Enjeti, Anoop

AU - Tiong, Ing Soo

AU - Savona, Michael

AU - Lee, Sangmin

AU - Chyla, Brenda

AU - Popovic, Relja

AU - Salem, Ahmed Hamed

AU - Agarwal, Suresh

AU - Xu, Tu

AU - Fakouhi, Kaffa M

AU - Humerickhouse, Rod

AU - Hong, Wan-Jen

AU - Hayslip, John

AU - Roboz, Gail J

PY - 2019/5/20

Y1 - 2019/5/20

N2 - PURPOSE: Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. An international phase Ib/II study evaluated the safety and preliminary efficacy of venetoclax, a selective B-cell leukemia/lymphoma-2 inhibitor, together with low-dose cytarabine (LDAC) in older adults with AML.PATIENTS AND METHODS: Adults 60 years or older with previously untreated AML ineligible for intensive chemotherapy were enrolled. Prior treatment of myelodysplastic syndrome, including hypomethylating agents (HMA), was permitted. Eighty-two patients were treated at the recommended phase II dose: venetoclax 600 mg per day orally in 28-day cycles, with LDAC (20 mg/m2 per day) administered subcutaneously on days 1 to 10. Key end points were tolerability, safety, response rates, duration of response (DOR), and overall survival (OS).RESULTS: Median age was 74 years (range, 63 to 90 years), 49% had secondary AML, 29% had prior HMA treatment, and 32% had poor-risk cytogenetic features. Common grade 3 or greater adverse events were febrile neutropenia (42%), thrombocytopenia (38%), and WBC count decreased (34%). Early (30-day) mortality was 6%. Fifty-four percent achieved complete remission (CR)/CR with incomplete blood count recovery (median time to first response, 1.4 months). The median OS was 10.1 months (95% CI, 5.7 to 14.2), and median DOR was 8.1 months (95% CI, 5.3 to 14.9 months). Among patients without prior HMA exposure, CR/CR with incomplete blood count recovery was achieved in 62%, median DOR was 14.8 months (95% CI, 5.5 months to not reached), and median OS was 13.5 months (95% CI, 7.0 to 18.4 months).CONCLUSION: Venetoclax plus LDAC has a manageable safety profile, producing rapid and durable remissions in older adults with AML ineligible for intensive chemotherapy. High remission rate and low early mortality combined with rapid and durable remission make venetoclax and LDAC an attractive and novel treatment for older adults not suitable for intensive chemotherapy.

AB - PURPOSE: Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. An international phase Ib/II study evaluated the safety and preliminary efficacy of venetoclax, a selective B-cell leukemia/lymphoma-2 inhibitor, together with low-dose cytarabine (LDAC) in older adults with AML.PATIENTS AND METHODS: Adults 60 years or older with previously untreated AML ineligible for intensive chemotherapy were enrolled. Prior treatment of myelodysplastic syndrome, including hypomethylating agents (HMA), was permitted. Eighty-two patients were treated at the recommended phase II dose: venetoclax 600 mg per day orally in 28-day cycles, with LDAC (20 mg/m2 per day) administered subcutaneously on days 1 to 10. Key end points were tolerability, safety, response rates, duration of response (DOR), and overall survival (OS).RESULTS: Median age was 74 years (range, 63 to 90 years), 49% had secondary AML, 29% had prior HMA treatment, and 32% had poor-risk cytogenetic features. Common grade 3 or greater adverse events were febrile neutropenia (42%), thrombocytopenia (38%), and WBC count decreased (34%). Early (30-day) mortality was 6%. Fifty-four percent achieved complete remission (CR)/CR with incomplete blood count recovery (median time to first response, 1.4 months). The median OS was 10.1 months (95% CI, 5.7 to 14.2), and median DOR was 8.1 months (95% CI, 5.3 to 14.9 months). Among patients without prior HMA exposure, CR/CR with incomplete blood count recovery was achieved in 62%, median DOR was 14.8 months (95% CI, 5.5 months to not reached), and median OS was 13.5 months (95% CI, 7.0 to 18.4 months).CONCLUSION: Venetoclax plus LDAC has a manageable safety profile, producing rapid and durable remissions in older adults with AML ineligible for intensive chemotherapy. High remission rate and low early mortality combined with rapid and durable remission make venetoclax and LDAC an attractive and novel treatment for older adults not suitable for intensive chemotherapy.

KW - Journal Article

U2 - 10.1200/JCO.18.01600

DO - 10.1200/JCO.18.01600

M3 - SCORING: Journal article

C2 - 30892988

VL - 37

SP - 1277

EP - 1284

JO - J CLIN ONCOL

JF - J CLIN ONCOL

SN - 0732-183X

IS - 15

ER -