Back to Search
Start Over
Azacitidine and venetoclax in previously untreated acute myeloid leukemia
- Source :
- The New England journal of medicine, Vol. 383, no. 7, p. 617-629 (2020)
- Publication Year :
- 2020
- Publisher :
- Massachussetts Medical Society, 2020.
-
Abstract
- BACKGROUND: Older patients with acute myeloid leukemia (AML) have a dismal prognosis, even after treatment with a hypomethylating agent. Azacitidine added to venetoclax had promising efficacy in a previous phase 1b study. METHODS: We randomly assigned previously untreated patients with confirmed AML who were ineligible for standard induction therapy because of coexisting conditions, because they were 75 years of age or older, or both to azacitidine plus either venetoclax or placebo. All patients received a standard dose of azacitidine (75 mg per square meter of body-surface area subcutaneously or intravenously on days 1 through 7 every 28-day cycle); venetoclax (target dose, 400 mg) or matching placebo was administered orally, once daily, in 28-day cycles. The primary end point was overall survival. RESULTS: The intention-to-treat population included 431 patients (286 in the azacitidine-venetoclax group and 145 in the azacitidine-placebo [control] group). The median age was 76 years in both groups (range, 49 to 91). At a median follow-up of 20.5 months, the median overall survival was 14.7 months in the azacitidine-venetoclax group and 9.6 months in the control group (hazard ratio for death, 0.66; 95% confidence interval, 0.52 to 0.85; P
- Subjects :
- Oncology
Myeloid
Male
endocrine system diseases
Kaplan-Meier Estimate
030204 cardiovascular system & hematology
chemistry.chemical_compound
0302 clinical medicine
Older patients
Recurrence
hemic and lymphatic diseases
Antineoplastic Combined Chemotherapy Protocols
80 and over
Medicine
030212 general & internal medicine
Aged
Aged, 80 and over
Azacitidine
Bridged Bicyclo Compounds, Heterocyclic
Double-Blind Method
Female
Follow-Up Studies
Humans
Intention to Treat Analysis
Leukemia, Myeloid, Acute
Leukopenia
Middle Aged
Pneumonia
Remission Induction
Sulfonamides
Thrombocytopenia
Leukemia
Heterocyclic
Myeloid leukemia
General Medicine
3. Good health
medicine.anatomical_structure
After treatment
medicine.drug
medicine.medical_specialty
Acute
03 medical and health sciences
Bridged Bicyclo Compounds
Internal medicine
neoplasms
business.industry
Venetoclax
medicine.disease
Hypomethylating agent
chemistry
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- The New England journal of medicine, Vol. 383, no. 7, p. 617-629 (2020)
- Accession number :
- edsair.doi.dedup.....eab46dd5ad180457ee2330bae17d0598