Table 3.
Univariate and multivariate PFS analyses. Univariate P values were computed by the log-rank test, multivariate P values by the Cox proportional hazards model
| Univariate analysis (N = 98) | Multivariate analysis (N = 96) | ||||||
|---|---|---|---|---|---|---|---|
| N | median PFS | 95%CI | P value | adjusted HR | 95%CI | P value | |
| Demographics | |||||||
| Gender | 0.016 | 0.0041 | |||||
| Male | 70 | 10.4 | [8.6; 14.7] | 1 | - | ||
| Female | 28 | 7.3 | |6.1; 11.0] | 2.1 | [1.3; 3.5] | ||
| Age | 0.19 | ||||||
| < median (61.6 years) | 49 | 8.0 | [6.6; 10.8] | ||||
| ≥ median (61.6 years) | 49 | 11.0 | [8.2; 17.1] | ||||
| Smoking status | 0.61 | ||||||
| Never | 43 | 8.7 | [7.2; 15.1] | ||||
| Former | 24 | 8.7 | [5.6; NR] | ||||
| Current | 19 | 8.2 | [4.1; 10.6] | ||||
| Disease characteristics | |||||||
| Histology | 0.17 | ||||||
| Clear cell carcinoma | 85 | 9.5 | [8.0; 11.8] | ||||
| Other | 13 | 5.6 | [4.0; NR] | ||||
| Fuhrman grades | 0.29 | ||||||
| I-II | 23 | 11.5 | [8.7; 17.6] | ||||
| III | 40 | 8.4 | [6.4; 11.3] | ||||
| IV | 16 | 13.2 | [9.0; NR] | ||||
| Nephrectomy | 0.63 | ||||||
| No | 12 | 6.1 | [4.3; NR] | ||||
| Yes | 86 | 9.3 | [8.0; 11.7] | ||||
| Axitinib treatment | |||||||
| Treatment line | 0.19 | ||||||
| 2nd-3rd line | 67 | 9.5 | [8.0; 13.2] | ||||
| 4th line and beyond | 31 | 7.4 | [5.4; 14.7] | ||||
| Baseline IMDC | 0.0026 | ||||||
| Favourable risk | 19 | 11.5 | [7.4; NR] | ||||
| Intermediate risk | 40 | 11.8 | [9.0; 16.7] | ||||
| Poor risk | 21 | 6.3 | [3.8; 9.3] | ||||
| Performance status | 0.00044 | <0.0001 | |||||
| 0 | 24 | 15.7 | [11.3; NR] | 1 | - | ||
| 1 | 54 | 8.7 | [7.2; 11.7] | 2.4 | [1.3; 4.4] | ||
| 2–3 | 18 | 6.3 | [3.6; 9.6] | 5.5 | [2.5; 11.9] | ||
| Anaemia | |||||||
| No | 48 | 8.8 | [8.7; 13.1] | 0.34 | |||
| Yes | 50 | 7.7 | [7.4; 10.6] | ||||
| BMI | 0.38 | ||||||
| < median (24.8 kg/m2) | 42 | 9.0 | [7.1; 11.8] | ||||
| ≥ median (24.8 kg/m2) | 43 | 8.9 | [6.6; 14.4] | ||||
| Adverse events | |||||||
| HbL increase (during first 3 mo.) | 0.0099 | ||||||
| < median (2.3 g/dL) | 49 | 7.4 | [6.1; 9.6] | ||||
| ≥ median (2.3 g/dL) | 49 | 11.7 | [9.3; 16.6] | ||||
| hBP (during treatment) | 0.0047 | ||||||
| No | 42 | 7.3 | [4.4; 9.3] | ||||
| Any grade | 56 | 11.2 | [8.9; 16.4] | ||||
| Composite factor: | |||||||
| HbL increase ≥2.3 g/dL and hBP | 0.00032 | 0.00048 | |||||
| None or only one | 63 | 7.4 | [6.2; 9.0] | 1 | - | ||
| Both | 35 | 14.7 | [10.8; 19.6] | 0.40 | [0.24; 0.68] | ||
NR not reached, 95%CI 95% confidence interval, IMDC International Metastatic Renal Cell Carcinoma Database Consortium, BMI body mass index, hBP high blood pressure, HbL haemoglobin level