Outcomes in thalidomide-naive and thalidomide-exposed patients
| . | No prior exposure to thalidomide . | Prior exposure to thalidomide . | ||||
|---|---|---|---|---|---|---|
| Len/Dex, n = 226 . | Placebo/Dex, n = 204 . | P* . | Len/Dex, n = 127 . | Placebo/Dex, n = 147 . | P* . | |
| Response, % | ||||||
| Complete response | 19.0† | 2.5 | 7.9† | 1.4 | ||
| Very good partial response | 19.5 | 4.4 | 13.4 | 0.7 | ||
| Partial response | 26.1 | 20.6 | 32.3 | 12.2 | ||
| Overall response | 64.6† | 27.5‡ | < .001§ | 53.5† | 14.3‡ | < .001§ |
| Median response duration, mo (95% CI) | 16.2 (12.1 to NE) | 7.9 (5.1 to 11.9) | .003‖ | 13.4 (8.5 to NE) | 5.1 (3.2 to 11.8) | .004‖ |
| (responders only) | (n = 146) | (n = 56) | (n = 68) | (n = 21) | ||
| Median TTP, mo (95% CI) | 13.9 (11.1 to 18.5)† | 4.7 (4.7 to 5.6)‡ | < .001‖ | 8.4 (6.7 to 11.1)† | 4.6 (3.7 to 4.7)‡ | < .001‖ |
| % Progressed | 43.4 | 77.0 | 59.8 | 79.6 | ||
| Median PFS, mo (95% CI) | 13.2 (10.2 to 15.3)† | 4.7 (4.6 to 5.4) | < .001‖ | 8.4 (6.5 to 10.3)† | 4.6 (3.7 to 4.7) | < .001‖ |
| % Progressed/died | 48.2 | 80.4 | 62.2 | 80.3 | ||
| Median overall survival, mo (95% CI) | 36.1 (32.8 to NE) | 32.0 (26.4 to NE) | .04‖ | 33.3 (25.8 to NE) | 28.7 (20.6 to 36.8) | NS (P = .23) |
| % Died | 39.8 | 49.5 | 48.8 | 53.7 | ||
| . | No prior exposure to thalidomide . | Prior exposure to thalidomide . | ||||
|---|---|---|---|---|---|---|
| Len/Dex, n = 226 . | Placebo/Dex, n = 204 . | P* . | Len/Dex, n = 127 . | Placebo/Dex, n = 147 . | P* . | |
| Response, % | ||||||
| Complete response | 19.0† | 2.5 | 7.9† | 1.4 | ||
| Very good partial response | 19.5 | 4.4 | 13.4 | 0.7 | ||
| Partial response | 26.1 | 20.6 | 32.3 | 12.2 | ||
| Overall response | 64.6† | 27.5‡ | < .001§ | 53.5† | 14.3‡ | < .001§ |
| Median response duration, mo (95% CI) | 16.2 (12.1 to NE) | 7.9 (5.1 to 11.9) | .003‖ | 13.4 (8.5 to NE) | 5.1 (3.2 to 11.8) | .004‖ |
| (responders only) | (n = 146) | (n = 56) | (n = 68) | (n = 21) | ||
| Median TTP, mo (95% CI) | 13.9 (11.1 to 18.5)† | 4.7 (4.7 to 5.6)‡ | < .001‖ | 8.4 (6.7 to 11.1)† | 4.6 (3.7 to 4.7)‡ | < .001‖ |
| % Progressed | 43.4 | 77.0 | 59.8 | 79.6 | ||
| Median PFS, mo (95% CI) | 13.2 (10.2 to 15.3)† | 4.7 (4.6 to 5.4) | < .001‖ | 8.4 (6.5 to 10.3)† | 4.6 (3.7 to 4.7) | < .001‖ |
| % Progressed/died | 48.2 | 80.4 | 62.2 | 80.3 | ||
| Median overall survival, mo (95% CI) | 36.1 (32.8 to NE) | 32.0 (26.4 to NE) | .04‖ | 33.3 (25.8 to NE) | 28.7 (20.6 to 36.8) | NS (P = .23) |
| % Died | 39.8 | 49.5 | 48.8 | 53.7 | ||
All comparisons without adjustment for multiplicity.
CI indicates confidence interval; Dex, dexamethasone; Len, lenalidomide; NE, not estimable; NS, not significant; PFS, progression-free survival; and TTP, time to progression.
P value is for comparison between lenalidomide plus dexamethasone versus dexamethasone alone.
P value less than .05 for patients receiving lenalidomide plus dexamethasone is for comparison between no prior versus prior exposure to thalidomide.
P value less than .05 for patients receiving dexamethasone alone is for comparison between no prior versus prior exposure to thalidomide.
Probability from continuity-corrected Pearson chi square tests.
Based on 2-sided log-rank tests for differences in survival distributions.