Table 3.
Association of Demographics and Baseline Clinical Characteristics with OS by Univariate and Multivariate Analyses (n=33)
| Factors | n | Overall Survival Median (95% CI) (Months) | p-value* | Overall Survival Hazard Ratio (95% CI) Univariate Analysis# | p-value^ | Overall Survival Hazard Ratio (95% CI) Multivariable Analysis# | p-value^ |
|---|---|---|---|---|---|---|---|
| Age at Study Entry | 0.030 | 0.043 | 0.022 | ||||
| <75 | 23 | 20.3 (8.5, 51.6+) | 1.00 | 1.00 | |||
| ≥75 | 10 | 9.5 (1.5, 15.1) | 2.41 (1.06, 5.48) | 3.34 (1.25, 8.97) | |||
| Gender | 0.13 | 0.12 | 0.018 | ||||
| Female | 11 | 25.3 (9.5, 51.6+) | 1.00 | 1.00 | |||
| Male | 22 | 8.5 (3.3, 20.3) | 1.94 (0.81, 4.63) | 3.30 (1.20, 9.02) | |||
| ECOG Performance Status at Study Entry | 0.69 | 0.69 | |||||
| 0 | 8 | 17.3 (0.9, 30.1+) | 1.00 | ||||
| 1 or 2 | 25 | 12.1 (8.5, 21.6) | 1.22 (0.45, 3.29) | ||||
| Diagnosis | 0.033 | 0.046 | 0.45 | ||||
| MDS | 30 | 16.4 (9.5, 27.3) | 1.00 | 1.00 | |||
| CMML | 3 | 2.1 (0.9, 15.1) | 3.61 (1.02, 12.69) | 0.55 (0.11, 2.72) | |||
| IPSS-R Prognostic Score for MDS at Study Entry (n=30) | 0.83 | 0.83 | |||||
| Intermediate Risk Score > 3 and <=4.5) | 11 | 21.6 (2.5, 46.2+) | 1.00 | ||||
| High or Very High (Risk Score > 4.5) | 19@ | 12.1 (8.2, 35.0) | (1.11 (0.44, 2.76) | ||||
| Diagnosis and IPSS-R | 0.10 | 0.21 | |||||
| MDS – Intermediate Risk | 11 | 21.6 (2.5, 46.2+) | 1.00 | ||||
| MDS - High or Very High Risk | 19@ | 12.1 (8.2, 35.0) | 1.11 (0.45, 2.77) | ||||
| CMML | 3 | 2.1 (0.9, 15.1) | 3.86 (0.96, 15.48) | ||||
| Disease Status at Study Entry | 0.50 | 0.51 | |||||
| Refractory Disease | 23 | 17.3 (8.2, 35.0) | 1.00 | ||||
| Relapsed Disease | 10 | 10.5 (4.0, 21.6) | 1.34 (0.57, 3.18) | ||||
| Baseline Bone Marrow Blasts (IHC) | 0.74 | 0.73 | |||||
| ≤ 2.0% | 6 | 10.5 (2.5, 46.2+) | 1.00 | ||||
| 2.1% - 5.0% | 10 | 16.4 (1.5, 51.6+) | 1.31 (0.34, 5.12) | ||||
| >5% | 16 | 9.8 (8.5, 27.3) | 1.60 (0.45, 5.65) | ||||
| Number of Prior Chemotherapy Regimens | 0.11 | 0.12 | 0.019 | ||||
| 1 | 18 | 21.6 (8.5, 51.6+) | 1.00 | 1.00 | |||
| > 1 | 15 | 9.5 (2.1, 17.3) | 1.92 (0.85, 4.32) | 3.29 (1.24, 8.74) |
*
p-value based on logrank test
^
p-value based on likelihood ratio test from Cox proportional hazards model. All variables with p≤0.20 on univariate analysis (age at study entry, gender, diagnosis, and the number of prior chemotherapy regimens) were included in the model for multivariable analysis
#
Hazard ratio 1.0 is the reference group.