Table IV.
Multivariate analysis of clinical outcomes on total therapy 2 (TT2) (both arms) according to pretreatment variables inclusive of gene expression profiling (GEP)-defined risk category.
| Overall survival | Event-free survival | CR duration | ||||||
|---|---|---|---|---|---|---|---|---|
| 70 gene-defined GEP high-risk | 44/334 (13%) | 2.93 (1.84, 4.68) | <0.001 | 2.47 (1.77, 3.45) | <0.001 | 20/174 (11%) | 2.59 (1.41, 4.76) | 0.002 |
| Cytogenetic abnormalities | 108/334 (32%) | 1.93 (1.31, 2.86) | <0.001 | NS2 | NS2 | NS2 | NS2 | |
| Creatinine ≥2.0 mg/dl | 37/334 (11%) | 1.72 (1.05, 2.81) | 0.033 | 1.78 (1.25, 2.54) | 0.001 | NS2 | NS2 | |
| LDH ≥190 U/l | 114/334 (34%) | 1.59 (1.08, 2.35) | 0.019 | 1.37 (1.09, 1.74) | 0.008 | NS2 | NS2 | |
| Randomization to thalidomide | 166/334 (50%) | NS2 | NS2 | 0.75 (0.60, 0.93) | 0.008 | NS2 | NS2 |
Results given as Hazard Ratio (95% confidence intervals) P-value from Wald chi-square test in Cox regression.
NS2 – Multivariate results not statistically significant at 0.05 level.
Multivariate model uses stepwise selection with entry level 0.1 and variable remains if it meets the 0.05 level.
Other variables considered for OS and EFS: age, Hb, CRP, albumin and B2M; for CR duration: creatinine, B2M and cytogenetic abnormalities.