Table 3.
Six-month landmark analyses of the MDS-003 and MDS-004 studies
| Outcome | MDS-003 study [20] |
MDS-004 studya [18] |
||
|---|---|---|---|---|
| Response | No response | P-value | Response versus no response P-value | |
| RBC-TI ≥8 weeks (IWG 2000 [23]) | ||||
| Median OS, years | 4.3 | 2.0 | <0.0001 | 0.0028 |
| Median AML-free survival, years | NA | NA | NA | 0.0085 |
| Median time to progression to AML, years | NR | 5.2 | 0.001 | NA |
| CyR | ||||
| Median OS, years | 4.9 | 3.1 | 0.010 | 0.0732 |
| Median time to progression to AML, years | NR | 3.8 | 0.002 | NA |
aOnly P-values were reported in the MDS-004 study.
AML, acute myeloid leukemia; CyR, cytogenetic response; IWG, International Working Group; LEN, lenalidomide; NA, not available; NR, not reached; OS, overall survival; RBC-TI, red blood cell transfusion independence.