Treatment and outcomes comparison between control and lenalidomide remission induction
| . | Control induction therapy . | Lenalidomide induction therapy . | Logistic/Cox regression* . | ||
|---|---|---|---|---|---|
| OR/HR . | 95% CI . | P . | |||
| Total no. of patients | 392 (100) | 388 (100) | |||
| Treatment | |||||
| Remission induction | |||||
| Cycle 1 | 391 (100) | 386 (99) | |||
| Cycle 2 | 340 (87) | 326 (84) | |||
| Consolidation therapy after CR/CRi | 279 (71) | 254 (65) | |||
| Cycle 3 | 25 (6) | 34 (9) | |||
| Auto-SCT | 94 (24) | 76 (20) | |||
| Allo-SCT | 160 (41) | 144 (37) | |||
| Outcomes | |||||
| CR/CRi after induction | 340 (87) | 319 (82) | 0.71 | 0.48-1.05 | .08 |
| Early CR/CRi (attained before remission induction cycle 2) | 276 (70) | 254 (65) | |||
| Early death | |||||
| Death within 30 days | 11 (3) | 18 (5) | |||
| Death within 60 days | 20 (5) | 26 (7) | |||
| At 4 years (% ± SE): | |||||
| EFS† | 44 ± 3 | 44 ± 3 | 0.99 | 0.82-1.20 | .96 |
| OS† | 54 ± 3 | 54 ± 3 | 0.98 | 0.79-1.21 | .83 |
| RFS† | |||||
| RFS | 49 ± 3 | 51 ± 3 | 0.95 | 0.77-1.18 | .66 |
| Relapse | 39 ± 3 | 36 ± 3 | |||
| Death | 12 ± 2 | 13 ± 2 | |||
| MRD negativity after cycle 2‡ | 167 (78) | 161 (77) | 0.92 | 0.59-1.46 | .73 |
| . | Control induction therapy . | Lenalidomide induction therapy . | Logistic/Cox regression* . | ||
|---|---|---|---|---|---|
| OR/HR . | 95% CI . | P . | |||
| Total no. of patients | 392 (100) | 388 (100) | |||
| Treatment | |||||
| Remission induction | |||||
| Cycle 1 | 391 (100) | 386 (99) | |||
| Cycle 2 | 340 (87) | 326 (84) | |||
| Consolidation therapy after CR/CRi | 279 (71) | 254 (65) | |||
| Cycle 3 | 25 (6) | 34 (9) | |||
| Auto-SCT | 94 (24) | 76 (20) | |||
| Allo-SCT | 160 (41) | 144 (37) | |||
| Outcomes | |||||
| CR/CRi after induction | 340 (87) | 319 (82) | 0.71 | 0.48-1.05 | .08 |
| Early CR/CRi (attained before remission induction cycle 2) | 276 (70) | 254 (65) | |||
| Early death | |||||
| Death within 30 days | 11 (3) | 18 (5) | |||
| Death within 60 days | 20 (5) | 26 (7) | |||
| At 4 years (% ± SE): | |||||
| EFS† | 44 ± 3 | 44 ± 3 | 0.99 | 0.82-1.20 | .96 |
| OS† | 54 ± 3 | 54 ± 3 | 0.98 | 0.79-1.21 | .83 |
| RFS† | |||||
| RFS | 49 ± 3 | 51 ± 3 | 0.95 | 0.77-1.18 | .66 |
| Relapse | 39 ± 3 | 36 ± 3 | |||
| Death | 12 ± 2 | 13 ± 2 | |||
| MRD negativity after cycle 2‡ | 167 (78) | 161 (77) | 0.92 | 0.59-1.46 | .73 |
All data are n (%) unless otherwise indicated. OR is estimated for CR/CRi after induction and for MRD negativity rate after cycle 2. HR applies to EFS, OS, and RFS.
Logistic/Cox regression included induction treatment arm and diagnostic subgroup (AML or RAEB) as covariates.
Percentages are actuarial 4-year probabilities.
MRD negativity rate is evaluated relative to 424 patients with evaluable MRD after induction cycle 2 (214 in the control arm and 210 in the lenalidomide arm).