Univariate and multivariate analyses of baseline and relapse features as well as prior response and its duration on PRS
| Variable . | n/N (%) . | HR (95% CI) . | P* . | Cumulative R2 . |
|---|---|---|---|---|
| Univariate analysis | ||||
| Baseline: GEP high-risk | 15/71 (21) | 4.57 (2.28,9.15) | < .001 | — |
| Relapse: creatinine ≥ 2 mg/dL | 10/114 (9) | 2.83 (1.38,5.77) | .004 | — |
| Relapse: Hb < 10 g/dL | 21/112 (19) | 2.42 (1.40,4.18) | .002 | — |
| Relapse: LDH ≥ 190 U/L | 37/108 (34) | 1.30 (0.78,2.17) | .309 | — |
| Relapse: cytogenetic abnormalities | 72/106 (68) | 2.03 (1.16,3.54) | .013 | — |
| Relapse: GEP high-risk | 46/120 (38) | 4.01 (2.47,6.49) | < .001 | — |
| Relapse: GEP CD-1 | 5/104 (5) | 0.87 (0.21,3.56) | .844 | — |
| Relapse: GEP CD-2 | 6/104 (6) | 0.65 (0.23,1.81) | .412 | — |
| Relapse: GEP HY | 21/104 (20) | 0.37 (0.16,0.87) | .022 | — |
| Relapse: GEP MF | 5/104 (5) | 2.12 (0.85,5.32) | .109 | — |
| Relapse: GEP MS | 26/104 (25) | 1.11 (0.65,1.92) | .698 | — |
| Relapse: GEP MY | 9/104 (9) | 0.25 (0.06,1.02) | .054 | — |
| Relapse: GEP MF/MS/PR | 63/104 (61) | 3.01 (1.66,5.44) | < .001 | — |
| Relapse: TP53 deletion (TP53 < 727) | 24/106 (23) | 0.56 (0.30,1.05) | .072 | — |
| CR to initial therapy | 58/120 (48) | 1.13 (0.71,1.80) | .610 | — |
| PR duration ≥ 2 y | 62/120 (52) | 0.44 (0.27,0.72) | .001 | — |
| Randomization to thalidomide | 53/120 (44) | 1.56 (0.97,2.51) | .064 | — |
| Multivariate analysis with GEP | ||||
| Relapse: GEP high-risk | 38/104 (37) | 4.00 (2.38,6.73) | < .001 | 32.835 |
| Relapse: GEP HY | 21/104 (20) | 0.37 (0.16,0.87) | .022 | 40.821 |
| Multivariate analysis without GEP | ||||
| PR duration ≥ 2 y | 51/101 (50) | 0.51 (0.29,0.87) | .014 | 15.045 |
| Relapse: cytogenetic abnormalities | 69/101 (68) | 2.57 (1.41,4.70) | .002 | 24.322 |
| Relapse: creatinine ≥ 2 mg/dL | 9/101 (9) | 2.89 (1.31,6.40) | .009 | 31.399 |
| Variable . | n/N (%) . | HR (95% CI) . | P* . | Cumulative R2 . |
|---|---|---|---|---|
| Univariate analysis | ||||
| Baseline: GEP high-risk | 15/71 (21) | 4.57 (2.28,9.15) | < .001 | — |
| Relapse: creatinine ≥ 2 mg/dL | 10/114 (9) | 2.83 (1.38,5.77) | .004 | — |
| Relapse: Hb < 10 g/dL | 21/112 (19) | 2.42 (1.40,4.18) | .002 | — |
| Relapse: LDH ≥ 190 U/L | 37/108 (34) | 1.30 (0.78,2.17) | .309 | — |
| Relapse: cytogenetic abnormalities | 72/106 (68) | 2.03 (1.16,3.54) | .013 | — |
| Relapse: GEP high-risk | 46/120 (38) | 4.01 (2.47,6.49) | < .001 | — |
| Relapse: GEP CD-1 | 5/104 (5) | 0.87 (0.21,3.56) | .844 | — |
| Relapse: GEP CD-2 | 6/104 (6) | 0.65 (0.23,1.81) | .412 | — |
| Relapse: GEP HY | 21/104 (20) | 0.37 (0.16,0.87) | .022 | — |
| Relapse: GEP MF | 5/104 (5) | 2.12 (0.85,5.32) | .109 | — |
| Relapse: GEP MS | 26/104 (25) | 1.11 (0.65,1.92) | .698 | — |
| Relapse: GEP MY | 9/104 (9) | 0.25 (0.06,1.02) | .054 | — |
| Relapse: GEP MF/MS/PR | 63/104 (61) | 3.01 (1.66,5.44) | < .001 | — |
| Relapse: TP53 deletion (TP53 < 727) | 24/106 (23) | 0.56 (0.30,1.05) | .072 | — |
| CR to initial therapy | 58/120 (48) | 1.13 (0.71,1.80) | .610 | — |
| PR duration ≥ 2 y | 62/120 (52) | 0.44 (0.27,0.72) | .001 | — |
| Randomization to thalidomide | 53/120 (44) | 1.56 (0.97,2.51) | .064 | — |
| Multivariate analysis with GEP | ||||
| Relapse: GEP high-risk | 38/104 (37) | 4.00 (2.38,6.73) | < .001 | 32.835 |
| Relapse: GEP HY | 21/104 (20) | 0.37 (0.16,0.87) | .022 | 40.821 |
| Multivariate analysis without GEP | ||||
| PR duration ≥ 2 y | 51/101 (50) | 0.51 (0.29,0.87) | .014 | 15.045 |
| Relapse: cytogenetic abnormalities | 69/101 (68) | 2.57 (1.41,4.70) | .002 | 24.322 |
| Relapse: creatinine ≥ 2 mg/dL | 9/101 (9) | 2.89 (1.31,6.40) | .009 | 31.399 |
HR indicates hazard ratio; CI, confidence interval; and —, not applicable.
Variables considered for the multivariate model with GEP data were: baseline 70-gene defined high-risk, relapse: creatinine ≥ 2 mg/dL, relapse: Hb < 10 g/dL, relapse: platelets < 150 × 109/μL, relapse: cytogenetic abnormalities, relapse: 70-gene defined HiR, relapse: HY GEP molecular subgroup, relapse: MY GEP molecular subgroup, Relapse: MF/MS/PR GEP molecular subgroups, PR duration of at least 2 years. Variables considered for the multivariate model without GEP data were: relapse: β2-microglobulin ≥ 5.5 mg/L, relapse: creatinine ≥ 2 mg/dL, relapse: Hb < 10 g/dL, relapse: platelets < 150 × 109/μL, relapse: cytogenetic abnormalities and PR duration of at least 2 years.
P value from Wald χ2 test in Cox regression. NS2, multivariate results not statistically significant at .05 level. All univariate P values reported regardless of significance. Multivariate model uses stepwise selection with entry level 0.1 and variable remains if meets the 0.05 level. A multivariate P value greater than .05 indicates variable forced into model with significant variables chosen using stepwise selection.