6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy (141/150)
Language English Country United States Media electronic
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
34599139
PubMed Central
PMC8486817
DOI
10.1038/s41408-021-00555-8
PII: 10.1038/s41408-021-00555-8
Knihovny.cz E-resources
- MeSH
- Leukemia, Myeloid, Acute drug therapy mortality MeSH
- Double-Blind Method MeSH
- Middle Aged MeSH
- Humans MeSH
- Survival Rate MeSH
- Follow-Up Studies MeSH
- Disease-Free Survival MeSH
- Antineoplastic Combined Chemotherapy Protocols administration & dosage adverse effects MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
VIALE-C compared the safety and efficacy of venetoclax or placebo plus low-dose cytarabine (+LDAC) in patients with untreated AML ineligible for intensive chemotherapy. Overall, 211 patients were enrolled (n = 143, venetoclax; n = 68, placebo). At the primary analysis, the study did not meet its primary endpoint of a statistically significant improvement in overall survival (OS), however, ~60% of patients had been on study for ≤6-months. Here, we present an additional 6-months of follow-up of VIALE-C (median follow-up 17.5 months; range 0.1-23.5). Median OS was (venetoclax +LDAC vs. placebo +LDAC) 8.4 vs. 4.1 months (HR = 0.70, 95% CI 0.50,0.99; P = 0.040); a 30% reduction in the risk of death with venetoclax. Complete response (CR)/CR with incomplete hematologic recovery (CRi) rates were 48.3% vs. 13.2%. Transfusion independence rates (RBC) were 43% vs.19% and median event-free survival was 4.9 vs. 2.1 months (HR = 0.61; 95% CI 0.44,0.84; P = 0.002). These results represent improved efficacy over the primary analysis. Incidence of grade ≥3 adverse events were similar between study arms and overall safety profiles were comparable to the primary analysis. These data support venetoclax +LDAC as a frontline treatment option for patients with AML ineligible for intensive chemotherapy.This trial was registered at www.clinicaltrials.gov as #NCT03069352.
AbbVie Inc North Chicago IL USA
Almazov National Medical Research Center Saint Petersburg Russia
Centre Hospitalier Le Mans Le Mans France
Chinese Academy of Medical Sciences Tianjin China
CIBERONC Instituto Carlos 3 Madrid Spain
CIUSSS EMTL Installation Maisonneuve Rosemont Montreal QC Canada
Eastern Health and Monash University Melbourne VIC Australia
Evaggelismos General Hospital Athens Greece
George Papanicolaou General Hospital Thessalonica Greece
Heartlands Hospital Birmingham UK
Hospital Universitario y Politécnico La Fe Valencia Spain
Hubertus Wald University Cancer Center University Medical Center Hamburg Eppendorf Hamburg Germany
National and Kapodistrian University of Athens Medical School Laiko General Hospital Athens Greece
Netcare Pretoria East Hospital Moreletapark Pretoria South Africa
Norton Cancer Institute Louisville KY USA
Seoul National University Hospital Seoul South Korea
The Alfred Hospital and Monash University Melbourne VIC Australia
The University of Texas MD Anderson Cancer Center Houston TX USA
University of Fukui Hospital Fukui Japan
University of Pittsburgh Medical Center Cancer Center Pittsburgh PA USA
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ClinicalTrials.gov
NCT03069352
