Myelodysplastic Syndromes
Conditions
Keywords
MDS
Brief summary
In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been evaluated the head to head comparison of two drugs. This study is a retrospective study to compare the efficacy of two drugs.
Detailed description
Among 300 MDS patient, 200 of them have been taking Azacitidine and 100 of them have been taking Decitabine. Medical chart of these patients will be reviewed to assess the efficacy and safety between two agents.
Interventions
None listed
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed MDS by bone marrow examination * Receiving azacitidine and decitabine as a first line chemotherapy * Adequate hepatic, cardiac, and renal function
Exclusion criteria
* Previously treated with another anti-cancer therapy due to MDS * Not available for clinical information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 6 months | Compare Azacitidine and Decitabine's treatment response rate in MDS patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 6 months | To compare hematologic improvement between Azacitidine and decitabine |
| Survival rate | 6 months | To compare survival rate between Azacitidine and decitabine |
| Number of participants with non-hematologic toxicities | 6 months | To compare toxicity between Azacitidine and decitabine |
| infection rate | 6 months | To compare infection rate between Azacitidine and decitabine |
Countries
South Korea
Outcome results
None listed