TABLE II.
Univariate and multivariate analysis of overall survival in patients with and without baseline hypertension (HTN)
| Characteristic | Univariate | Multivariate | ||||
|---|---|---|---|---|---|---|
|
|
|
|||||
| HR | 95% CL | p Valuea | Adjusted HR | 95% CL | p Valueb | |
| Current or past diagnosis of HTN | 0.071 | 0.720 | ||||
| Yes | Reference | Reference | ||||
| No | 1.22 | 0.98, 1.51 | 1.05 | 0.80, 1.38 | ||
|
| ||||||
| Age group | 0.596 | Not in model | ||||
| <65 Years | Reference | |||||
| ≥65 Years | 1.05 | 0.87, 1.27 | ||||
|
| ||||||
| Sex | 0.107 | Not in model | ||||
| Women | Reference | |||||
| Men | 0.85 | 0.70, 1.04 | ||||
|
| ||||||
| ECOG PS | <0.0001 | |||||
| 0 | Reference | Reference | ||||
| 1 | 1.15 | 0.92, 1.45 | 1.25 | 0.94, 1.67 | 0.127 | |
| 2 | 2.51 | 1.93, 3.27 | 1.96 | 1.37, 2.80 | <0.0001 | |
|
| ||||||
| BMI group (kg/m2) | <0.0001 | |||||
| Low (<20) | Reference | Reference | ||||
| Normal (20–25) | 0.77 | 0.56, 1.05 | 0.86 | 0.54, 1.35 | 0.501 | |
| High (>25) | 0.54 | 0.40, 0.72 | 0.70 | 0.45, 1.10 | 0.123 | |
|
| ||||||
| Site of primary | 0.068 | |||||
| Colon only | Reference | Reference | ||||
| Rectum only | 0.83 | 0.66, 1.05 | 0.85 | 0.62, 1.17 | 0.323 | |
| Colon and rectum | 0.82 | 0.64, 1.05 | 0.77 | 0.55, 1.06 | 0.113 | |
|
| ||||||
| Dx-to-randomization group | <0.0001 | <0.0001 | ||||
| >2 Years | Reference | Reference | ||||
| <2 Years | 1.57 | 1.31, 1.90 | 1.66 | 1.30, 2.12 | ||
|
| ||||||
| Lactate dehydrogenase | <0.0001 | 0.026 | ||||
| ≤Upper limit of normal | Reference | Reference | ||||
| >Upper limit of normal | 1.99 | 1.56,2.53 | 1.42 | 1.04, 1.93 | ||
|
| ||||||
| Alkaline phosphatase | <0.0001 | <0.0001 | ||||
| ≤Upper limit of norma | Reference | Reference | ||||
| >Upper limit of normal | 2.16 | 1.73, 2.70 | 1.81 | 1.34, 2.44 | ||
|
| ||||||
| Hemoglobin | <0.0001 | <0.0001 | ||||
| Grade 0c | Reference | Reference | ||||
| ≥Grade 1c | 2.02 | 1.64, 2.48 | 1.79 | 1.38, 2.33 | ||
|
| ||||||
| Serum creatinine | 0.839 | Not in model | ||||
| Grade 0c | Reference | |||||
| ≥Grade 1c | 1.03 | 0.75, 1.42 | ||||
|
| ||||||
| Previous CTx drug classes | 0.192 | Not in model | ||||
| ≤2 | Reference | |||||
| >2 | 1.35 | 0.86, 2.11 | ||||
|
| ||||||
| KRAS status | 0.007 | 0.001 | ||||
| Wild type | Reference | Reference | ||||
| Mutated | 1.36 | 1.09, 1.70 | 1.51 | 1.18, 1.93 | ||
|
| ||||||
| Treatment | 0.004 | 0.045 | ||||
| BSC only | Reference | Reference | ||||
| Cetuximab and BSC | 0.76 | 0.63, 0.92 | 0.78 | 0.62, 0.99 | ||
a
Log-rank test.
b
Cox model using all factors reaching p ≤ 0.1 in the univariate analysis.
c
According to the Common Terminology Criteria for Adverse Events.
HR = hazard ratio; CL = confidence limits; ECOG PS = Eastern Cooperative Oncology Group performance status; BMI = body mass index; Dx = diagnosis; CTx = chemotherapy; BSC = best supportive care.