TY - JOUR
T1 - Venetoclax with decitabine vs intensive chemotherapy in acute myeloid leukemia
T2 - A propensity score matched analysis stratified by risk of treatment-related mortality
AU - Maiti, Abhishek
AU - Qiao, Wei
AU - Sasaki, Koji
AU - Ravandi, Farhad
AU - Kadia, Tapan M.
AU - Jabbour, Elias J.
AU - Daver, Naval G.
AU - Borthakur, Gautam
AU - Garcia-Manero, Guillermo
AU - Pierce, Sherry A.
AU - Montalbano, Kathryn S.
AU - Pemmaraju, Naveen
AU - Naqvi, Kiran
AU - Ohanian, Maro
AU - Short, Nicholas J.
AU - Alvarado, Yesid
AU - Takahashi, Koichi
AU - Yilmaz, Musa
AU - Jain, Nitin
AU - Kornblau, Steven M.
AU - Andreeff, Michael
AU - Bose, Prithviraj
AU - Ferrajoli, Alessandra
AU - Issa, Ghayas C.
AU - Masarova, Lucia
AU - Thompson, Philip A.
AU - Rausch, Caitlin R.
AU - Ning, Jing
AU - Kantarjian, Hagop M.
AU - DiNardo, Courtney D.
AU - Konopleva, Marina Y.
N1 - Funding Information:
FR: Research funding from Amgen, Bristol‐Myers Squibb, Merck, Seattle Genetics, Sunesis Pharmaceuticals, Honoraria from Amgen, Pfizer, Seattle Genetics, Sunesis Pharmaceuticals; Consulting or advisory role for Amgen, Seattle Genetics, Sunesis Pharmaceuticals.
Funding Information:
AM: Research funding from Celgene Corporation.
Funding Information:
We thank the patients and their caregivers; co-investigators, collaborators, and members of the study teams involved in these trials. We appreciate the comments and feedback from Dr. Elihu Estey, MD, and Dr. Ronald Walter, Seattle Cancer Care Alliance, during the initial conceptualization of this project and assistance with the treatment-related mortality score model. This study was supported in part by the MD Anderson Cancer Center Support Grant CA016672 from the National Cancer Institute, and Research Project Grant Program (R01CA235622) from the National Institutes of Health.
Funding Information:
We thank the patients and their caregivers; co‐investigators, collaborators, and members of the study teams involved in these trials. We appreciate the comments and feedback from Dr. Elihu Estey, MD, and Dr. Ronald Walter, Seattle Cancer Care Alliance, during the initial conceptualization of this project and assistance with the treatment‐related mortality score model. This study was supported in part by the MD Anderson Cancer Center Support Grant CA016672 from the National Cancer Institute, and Research Project Grant Program (R01CA235622) from the National Institutes of Health.
Funding Information:
EJJ: Consultancy Research funding from Takeda, BMS, Adaptive, Amgen, AbbVie, Pfizer, Cyclacel LTD.
Publisher Copyright:
© 2020 Wiley Periodicals LLC.
PY - 2021/3/1
Y1 - 2021/3/1
N2 - Hypomethylating agents (HMA) with venetoclax is a new standard for older/unfit patients with acute myeloid leukemia (AML). However, it is unknown how HMA with venetoclax compare to intensive chemotherapy (IC) in patients who are “fit” or “unfit” for IC. We compared outcomes of older patients with newly diagnosed AML receiving 10-day decitabine with venetoclax (DEC10-VEN) vs IC. DEC10-VEN consisted of daily venetoclax with decitabine 20 mg/m2 for 10 days for induction and decitabine for 5 days as consolidation. The IC cohort received regimens containing cytarabine ≥1 g/m2/d. A validated treatment-related mortality score (TRMS) was used to classify patients at high-risk or low-risk for TRM with IC. Propensity scores were used to match patients to minimize bias. Median age of the DEC10-VEN cohort (n = 85) was 72 years (range 63-89) and 28% patients were at high-risk of TRM with IC. The comparator IC group (n = 85) matched closely in terms of baseline characteristics. DEC10-VEN was associated with significantly higher CR/CRi compared to IC (81% vs 52%, P <.001), and lower rate of relapse (34% vs 56%, P =.01), 30-day mortality (1% vs 24%, P <.01), and longer overall survival (OS; 12.4 vs 4.5 months, HR = 0.48, 95%CI 0.29-0.79, P <.01). In patients at both at high-risk and low-risk of TRM, DEC10-VEN showed significantly higher CR/CRi, lower 30-day mortality, and longer OS compared to IC. Patients at both high-risk and low-risk of TRM had comparable outcomes with DEC10-VEN. In conclusion, DEC10-VEN offers better outcomes compared to intensive chemotherapy in older patients with newly diagnosed AML, particularly in those at high-risk of TRM.
AB - Hypomethylating agents (HMA) with venetoclax is a new standard for older/unfit patients with acute myeloid leukemia (AML). However, it is unknown how HMA with venetoclax compare to intensive chemotherapy (IC) in patients who are “fit” or “unfit” for IC. We compared outcomes of older patients with newly diagnosed AML receiving 10-day decitabine with venetoclax (DEC10-VEN) vs IC. DEC10-VEN consisted of daily venetoclax with decitabine 20 mg/m2 for 10 days for induction and decitabine for 5 days as consolidation. The IC cohort received regimens containing cytarabine ≥1 g/m2/d. A validated treatment-related mortality score (TRMS) was used to classify patients at high-risk or low-risk for TRM with IC. Propensity scores were used to match patients to minimize bias. Median age of the DEC10-VEN cohort (n = 85) was 72 years (range 63-89) and 28% patients were at high-risk of TRM with IC. The comparator IC group (n = 85) matched closely in terms of baseline characteristics. DEC10-VEN was associated with significantly higher CR/CRi compared to IC (81% vs 52%, P <.001), and lower rate of relapse (34% vs 56%, P =.01), 30-day mortality (1% vs 24%, P <.01), and longer overall survival (OS; 12.4 vs 4.5 months, HR = 0.48, 95%CI 0.29-0.79, P <.01). In patients at both at high-risk and low-risk of TRM, DEC10-VEN showed significantly higher CR/CRi, lower 30-day mortality, and longer OS compared to IC. Patients at both high-risk and low-risk of TRM had comparable outcomes with DEC10-VEN. In conclusion, DEC10-VEN offers better outcomes compared to intensive chemotherapy in older patients with newly diagnosed AML, particularly in those at high-risk of TRM.
UR - http://www.scopus.com/inward/record.url?scp=85099506537&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85099506537&partnerID=8YFLogxK
U2 - 10.1002/ajh.26061
DO - 10.1002/ajh.26061
M3 - Article
C2 - 33264443
AN - SCOPUS:85099506537
SN - 0361-8609
VL - 96
SP - 282
EP - 291
JO - American journal of hematology
JF - American journal of hematology
IS - 3
ER -