Cox proportional hazards model for AML-free survival and OS in patients randomized to lenalidomide: 6-month landmark analysis (safety population)
| . | Hazard ratio (95% CI) . | |||
|---|---|---|---|---|
| Univariate model . | Final model . | |||
| AML-free survival . | OS . | AML-free survival . | OS . | |
| Age, y* | 1.02 (1.00-1.05) | 1.03 (1.00-1.05) | 1.04 (1.01-1.06) | 1.04 (1.01-1.07) |
| P = .047 | P = .018 | P = .011 | P = .003 | |
| Time since diagnosis, y | 1.02 (0.97-1.08) | 1.02 (0.96-1.08) | — | — |
| P = .448 | P = .607 | |||
| Transfusion burden, units/8 wk* | 1.09 (1.01-1.17) | 1.10 (1.03-1.18) | 1.08 (1.00-1.16) | 1.09 (1.02-1.17) |
| P = .030 | P = .004 | P = .055 | P = .011 | |
| Bone marrow blasts, % | 1.04 (0.96-1.12) | 1.05 (0.97-1.13) | — | — |
| P = .335 | P = .233 | |||
| No. of cytopenias (2 or 3 vs 1) | 0.97 (0.57-1.64) | 0.95 (0.56-1.61) | — | — |
| P = .900 | P = .855 | |||
| Platelet count, × 109/L | 1.00 (1.00-1.00) | 1.00 (1.00-1.00) | — | — |
| P = .059 | P = .032 | |||
| ANC, × 109/L | 1.00 (0.91-1.09) | 1.00 (0.91-1.09) | — | — |
| P = .922 | P = .951 | |||
| Hemoglobin level, g/dL | 0.93 (0.70-1.23) | 0.95 (0.72-1.25) | — | — |
| P = .612 | P = .709 | |||
| del5q31 plus ≥ 1 additional abnormality vs isolated del5q31 | 1.47 (0.85-2.55) | 1.22 (0.70-2.14) | — | — |
| P = .169 | P = .485 | |||
| EPO level, 100 mIU/mL | 0.99 (0.97-1.01) | 0.99 (0.97-1.01) | — | — |
| P = .539 | P = .390 | |||
| Ferritin level, mol/L | 1.01 (1.00-1.02) | 1.01 (1.00-1.02) | 1.01 (1.00-1.02) | 1.01 (1.00-1.02) |
| P = .011 | P = .014 | P = .020 | P = .019 | |
| WPSS risk (High/Very high vs Low/Intermediate) | 1.40 (0.77-2.52) | 1.30 (0.73-2.33) | — | — |
| P = .271 | P = .377 | |||
| RBC-TI for ≥ 8 wk (yes vs no)* | 0.51 (0.30-0.85) | 0.47 (0.28-0.78) | 0.58 (0.33-0.99) | 0.53 (0.31-0.91) |
| P = .009 | P = .003 | P = .048 | P = .021 | |
| . | Hazard ratio (95% CI) . | |||
|---|---|---|---|---|
| Univariate model . | Final model . | |||
| AML-free survival . | OS . | AML-free survival . | OS . | |
| Age, y* | 1.02 (1.00-1.05) | 1.03 (1.00-1.05) | 1.04 (1.01-1.06) | 1.04 (1.01-1.07) |
| P = .047 | P = .018 | P = .011 | P = .003 | |
| Time since diagnosis, y | 1.02 (0.97-1.08) | 1.02 (0.96-1.08) | — | — |
| P = .448 | P = .607 | |||
| Transfusion burden, units/8 wk* | 1.09 (1.01-1.17) | 1.10 (1.03-1.18) | 1.08 (1.00-1.16) | 1.09 (1.02-1.17) |
| P = .030 | P = .004 | P = .055 | P = .011 | |
| Bone marrow blasts, % | 1.04 (0.96-1.12) | 1.05 (0.97-1.13) | — | — |
| P = .335 | P = .233 | |||
| No. of cytopenias (2 or 3 vs 1) | 0.97 (0.57-1.64) | 0.95 (0.56-1.61) | — | — |
| P = .900 | P = .855 | |||
| Platelet count, × 109/L | 1.00 (1.00-1.00) | 1.00 (1.00-1.00) | — | — |
| P = .059 | P = .032 | |||
| ANC, × 109/L | 1.00 (0.91-1.09) | 1.00 (0.91-1.09) | — | — |
| P = .922 | P = .951 | |||
| Hemoglobin level, g/dL | 0.93 (0.70-1.23) | 0.95 (0.72-1.25) | — | — |
| P = .612 | P = .709 | |||
| del5q31 plus ≥ 1 additional abnormality vs isolated del5q31 | 1.47 (0.85-2.55) | 1.22 (0.70-2.14) | — | — |
| P = .169 | P = .485 | |||
| EPO level, 100 mIU/mL | 0.99 (0.97-1.01) | 0.99 (0.97-1.01) | — | — |
| P = .539 | P = .390 | |||
| Ferritin level, mol/L | 1.01 (1.00-1.02) | 1.01 (1.00-1.02) | 1.01 (1.00-1.02) | 1.01 (1.00-1.02) |
| P = .011 | P = .014 | P = .020 | P = .019 | |
| WPSS risk (High/Very high vs Low/Intermediate) | 1.40 (0.77-2.52) | 1.30 (0.73-2.33) | — | — |
| P = .271 | P = .377 | |||
| RBC-TI for ≥ 8 wk (yes vs no)* | 0.51 (0.30-0.85) | 0.47 (0.28-0.78) | 0.58 (0.33-0.99) | 0.53 (0.31-0.91) |
| P = .009 | P = .003 | P = .048 | P = .021 | |
Variables are baseline except for RBC-TI for ≥ 8 weeks, which is a time-dependent covariate of the 6-month landmark analysis. Variables are continuous except for number of cytopenias, del5q31, WPSS, and RBC-TI for ≥ 8 weeks.
— indicates not significant; ANC, absolute neutrophil count; and WPSS, World Health Organization classification-based Prognostic Scoring System.
Statistically significant (P = .05) variables in the final model.