Outcomes in subgroups of thalidomide-exposed patients
| . | T1: Sensitive,* n = 124 . | T2: Relapsed,* n = 65 . | T3: Refractory,* n = 44 . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Len/Dex, n = 54 . | Placebo/Dex, n = 70 . | P† . | Len/Dex, n = 31 . | Placebo/Dex, n = 34 . | P† . | Len/Dex, n = 20 . | Placebo/Dex, n = 24 . | P† . | |
| Response, % | |||||||||
| Complete response | 11.1 | 1.4 | 6.5 | 2.9 | 5.0 | 0.0 | |||
| Very good partial response | 13.0 | 1.4 | 12.9 | 2.9 | 20.0 | 0.0 | |||
| Partial response | 40.7 | 14.3 | 22.6 | 0.0 | 25.0 | 20.8 | |||
| Overall response | 64.8 | 17.1 | < .001‡ | 41.9 | 5.9 | < .001‡ | 50.0 | 20.8 | .042‡ |
| Median response duration, mo (95% CI) | 13.4 (7.0 to NE) | 3.2 (2.3 to NE) | .009§ | 8.8 (5.3 to NE) | NE (8.6 to NE) | NS (P = .77) | NE (6.0 to NE) | 11.8 (5.1 to 12.5) | NS (P = .22) |
| (Responders only) | (n = 35) | (n = 12) | (n = 13) | (n = 2) | (n = 10) | (n = 5) | |||
| Median TTP, mo (95% CI) | 9.3 (5.6 to 18.0) | 4.6 (3.9 to 4.7) | < .001§ | 7.8 (5.6 to 12.1) | 3.7 (2.8 to 6.5) | .002§ | 7.2 (6.0 to NE) | 3.7 (2.1 to 8.4) | .007§ |
| % Progressed | 57.4 | 80.0 | 71.0 | 85.3 | 55.0 | 83.3 | |||
| Median PFS, mo (95% CI) | 9.3 (5.6 to 18.0) | 4.6 (3.9 to 4.7) | < .001§ | 7.8 (5.2 to 11.1) | 3.7 (2.8 to 6.5) | .002§ | 7.0 (4.9 to 16.9) | 3.7 (2.1 to 8.4) | .013§ |
| % Progressed/died | 57.4 | 80.0 | 74.2 | 88.2 | 60.0 | 83.3 | |||
| . | T1: Sensitive,* n = 124 . | T2: Relapsed,* n = 65 . | T3: Refractory,* n = 44 . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Len/Dex, n = 54 . | Placebo/Dex, n = 70 . | P† . | Len/Dex, n = 31 . | Placebo/Dex, n = 34 . | P† . | Len/Dex, n = 20 . | Placebo/Dex, n = 24 . | P† . | |
| Response, % | |||||||||
| Complete response | 11.1 | 1.4 | 6.5 | 2.9 | 5.0 | 0.0 | |||
| Very good partial response | 13.0 | 1.4 | 12.9 | 2.9 | 20.0 | 0.0 | |||
| Partial response | 40.7 | 14.3 | 22.6 | 0.0 | 25.0 | 20.8 | |||
| Overall response | 64.8 | 17.1 | < .001‡ | 41.9 | 5.9 | < .001‡ | 50.0 | 20.8 | .042‡ |
| Median response duration, mo (95% CI) | 13.4 (7.0 to NE) | 3.2 (2.3 to NE) | .009§ | 8.8 (5.3 to NE) | NE (8.6 to NE) | NS (P = .77) | NE (6.0 to NE) | 11.8 (5.1 to 12.5) | NS (P = .22) |
| (Responders only) | (n = 35) | (n = 12) | (n = 13) | (n = 2) | (n = 10) | (n = 5) | |||
| Median TTP, mo (95% CI) | 9.3 (5.6 to 18.0) | 4.6 (3.9 to 4.7) | < .001§ | 7.8 (5.6 to 12.1) | 3.7 (2.8 to 6.5) | .002§ | 7.2 (6.0 to NE) | 3.7 (2.1 to 8.4) | .007§ |
| % Progressed | 57.4 | 80.0 | 71.0 | 85.3 | 55.0 | 83.3 | |||
| Median PFS, mo (95% CI) | 9.3 (5.6 to 18.0) | 4.6 (3.9 to 4.7) | < .001§ | 7.8 (5.2 to 11.1) | 3.7 (2.8 to 6.5) | .002§ | 7.0 (4.9 to 16.9) | 3.7 (2.1 to 8.4) | .013§ |
| % Progressed/died | 57.4 | 80.0 | 74.2 | 88.2 | 60.0 | 83.3 | |||
All comparisons without adjustment or multiplicity.
CI indicates confidence interval; Dex, dexamethasone; Len, lenalidomide; NE, not estimable; NS, not significant; PFS, progression-free survival; and TTP, time to progression.
Thalidomide-exposed subgroups (T1-T3) based on their best response to, and final outcome after, prior thalidomide therapy (see ″Methods″).
P value is for comparison between lenalidomide plus dexamethasone versus dexamethasone alone.
Probability from continuity-corrected Pearson chi square tests.
Based on 2-sided log-rank tests for differences in survival distributions.