Table 3.
Univariate and multivariate analysis of relationships between baseline patient characteristics or early changes in biomarker concentrations and clinical outcome
| n* |
TTP |
OS |
|||||
|---|---|---|---|---|---|---|---|
| HR† | 95% CI | p | HR† | 95% CI | p | ||
|
Univariate analysis |
|
|
|
|
|
|
|
| Age (< 65 vs. ≥ 65 years) |
59/5 |
1.19 |
0.43-3.33 |
0.74 |
3.09 |
1.17-8.16 |
0.023 |
| Race (white vs. non-white) |
52/11 |
0.39 |
0.18-0.86 |
0.019 |
0.67 |
0.26-1.72 |
0.40 |
| ECOG performance status (0 vs. ≥ 1) |
24/40 |
1.20 |
0.70-2.04 |
0.53 |
1.58 |
0.78-3.21 |
0.21 |
| ER (+ vs. −) |
37/27 |
1.14 |
0.66-1.96 |
0.64 |
1.60 |
0.80-3.20 |
0.18 |
| PgR (+ vs. −) |
26/35 |
0.88 |
0.50-1.54 |
0.65 |
1.60 |
0.81-3.16 |
0.17 |
| HER2 (+ vs. −) |
12/48 |
0.74 |
0.38-1.45 |
0.38 |
0.70 |
0.29-1.69 |
0.43 |
| Triple-negative (yes vs. no) |
20/43 |
0.99 |
0.56-1.76 |
0.97 |
0.67 |
0.31-1.42 |
0.29 |
| Baseline sKIT (continuous‡) |
61 |
1.00 |
0.97-1.02 |
0.82 |
0.99 |
0.96-1.02 |
0.48 |
| Baseline VEGF-A (continuous‡) |
63 |
1.11 |
0.98-1.27 |
0.11 |
1.10 |
0.95-1.28 |
0.22 |
| Baseline sVEGFR-2 (continuous‡) |
62 |
0.99 |
0.89-1.10 |
0.83 |
0.91 |
0.80-1.03 |
0.15 |
| Baseline sVEGFR-3 (continuous‡) |
54 |
1.00 |
0.99-1.01 |
0.77 |
1.00 |
0.99-1.01 |
0.97 |
| sKIT change (≥ 48.6% vs. < 48.6%) |
30/31 |
4.36 |
2.38-7.97 |
< 0.0001 |
2.28 |
1.13-4.60 |
0.022 |
| VEGF-A change (≥ 89.4% vs. < 89.4%) |
31/30 |
1.71 |
0.99-2.96 |
0.054 |
2.25 |
1.09-4.65 |
0.029 |
| sVEGFR-2 change (≥ 55.8% vs. < 55.8%) |
31/30 |
1.14 |
0.67-1.94 |
0.63 |
1.37 |
0.68-2.74 |
0.37 |
| sVEGFR-3 change (≥ 52.8% vs. < 52.8%) |
28/27 |
1.39 |
0.79-2.45 |
0.26 |
1.66 |
0.79-3.52 |
0.18 |
| sKIT change (continuous‡) |
61 |
0.93 |
0.91-0.96 |
< 0.0001 |
0.94 |
0.92-0.97 |
< 0.0001 |
| VEGF-A change (continuous‡) |
61 |
0.99 |
0.97-1.01 |
0.21 |
0.98 |
0.96-1.00 |
0.042 |
| sVEGFR-2 change (continuous‡) |
61 |
1.00 |
0.98-1.02 |
0.95 |
0.99 |
0.97-1.01 |
0.45 |
| sVEGFR-3 change (continuous‡) |
55 |
0.99 |
0.98-1.01 |
0.38 |
0.98 |
0.96-1.00 |
0.051 |
|
Multivariate analysis of factors showing significance in univariate analysis§ | |||||||
| Model using categorical variables |
|
|
|
|
|
|
|
| Age (< 65 vs. ≥ 65 years) |
− |
− |
− |
− |
4.45 |
1.59-12.48 |
0.0045 |
| Race (white vs. non-white) |
− |
0.30 |
0.12-0.70 |
0.0055 |
− |
− |
− |
| sKIT change (≥ 48.6% vs. < 48.6%) |
− |
4.75 |
2.48-9.08 |
< 0.0001 |
2.69 |
1.29-5.64 |
0.0085 |
| VEGF-A change (≥ 89.4% vs. < 89.4%) |
− |
1.62 |
0.93-2.80 |
0.086 |
2.10 |
1.01-4.34 |
0.047 |
| Model using continuous variables |
|
|
|
|
|
|
|
| Age (continuous‡) |
− |
− |
− |
− |
1.05 |
1.00-1.09 |
0.047 |
| Race (white vs. non-white) |
− |
0.25 |
0.11-0.61 |
0.0021 |
− |
− |
− |
| sKIT change (continuous‡) | − | 0.92 | 0.90-0.95 | < 0.0001 | 0.94 | 0.92-0.97 | < 0.0001 |
CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; HR, hazard ratio; OS, overall survival; PgR, progesterone receptor; sKIT, soluble KIT; sVEGFR, soluble vascular endothelial growth factor receptor; TTP, time to tumor progression; VEGF, vascular endothelial growth factor.
*Number of patients analyzed in univariate analysis (for categorical variables, numbers for both groups are shown).
†For categorical variables, HR > 1 favors the first category and HR < 1 favors the second category; for continuous variables, HR > 1 favors the value when it decreases and HR < 1 favors the value when it increases.
‡Modeled as a continuous variable.
§n = 60 for the TTP models because race was unknown in one patient, and n = 61 for the OS models.