Table 2.
Univariate and multivariate analyses for risk factors associated with the incidence of regorafenib-induced defined proteinuria.
| Univariate analysis | Multivariate analysis | |||
|---|---|---|---|---|
| Odds ratio (95% CI) | P-value | Odds ratio (95% CI) | P-value | |
|
Sex Male/female |
0.55 (0.25–1.24) | 0.15 | 0.48 (0.17–1.39) | 0.18 |
|
Age (years) ≥ 65/ < 65 |
1.62 (0.73–3.62) | 0.24 | Excluded | – |
|
Performance status (ECOG) 2/0 or 1 |
0.71 (0.12–4.04) | 0.70 | Excluded | – |
|
KRAS status Wild/Mutant |
1.24 (0.56–2.76) | 0.59 | Excluded | – |
|
BSA (m2) ≥ 1.6/ < 1.6 |
0.58 (0.26–1.29) | 0.178 | 0.66 (0.24–1.82) | 0.42 |
|
BMI (kg/m2) ≥ 25.0/ < 25.0 |
1.08 (0.434–2.66) | 0.87 | Excluded | – |
|
Anemia Present/Absent |
1.97 (0.73–5.29) | 0.181 | Excluded | – |
|
Thrombocytopenia Present/Absent |
0.73 (0.30–1.81) | 0.50 | Excluded | – |
|
Hypoalbuminemia Present/Absent |
1.56 (0.62–3.93) | 0.34 | Excluded | – |
|
Liver impairment Present/Absent |
Unable to calculate | – | Excluded | – |
|
Renal impairment Present/Absent |
1.56 (0.56–4.35) | 0.39 | Excluded | – |
|
Treatment line 2nd or 3rd/4th or later |
1.44 (0.56–3.67) | 0.45 | Excluded | – |
|
Dose reduction from treatment initiation Present/Absent |
0.96 (0.43–2.16) | 0.93 | Excluded | – |
|
Duration from last anti-VEGF treatment ≥ 28 days/ < 28 days |
1.67 (0.70–3.98) | 0.25 | Excluded | – |
|
Preexisting diabetes mellitus Present/Absent |
2.22 (0.65–7.57) | 0.20 | Excluded | – |
|
Preexisting hypertension Present/Absent |
1.36 (0.61–3.05) | 0.45 | Excluded | – |
|
Baseline calcium channel blocker use Present/Absent |
2.10 (0.91–4.88) | 0.08 | 1.56 (0.63–3.88) | 0.34 |
|
Baseline RASI use Present/Absent |
0.97 (0.42–2.22) | 0.94 | Excluded | – |
|
Preexisting proteinuria Present/Absent |
3.11 (1.34–7.21) | 0.008** | 3.76 (1.45–9.75) | 0.007** |
Liver impairment: grade ≥ 1 aspartate aminotransferase, alanine aminotransferase, total bilirubin elevation.
Renal impairment: estimated glomerular filtration rate < 60 mL/min/1.73 m2.
CI confidence interval, ECOG Eastern Cooperative Oncology Group, BSA body surface area, BMI body mass index, VEGF vascular endothelial growth factor, RASI renin-angiotensin system inhibitor (angiotensin receptor blocker and angiotensin-converting enzyme inhibitor).
**P < 0.01.