Table 2. Baseline characteristics of patients in the development and validation cohorts.
| |
Development data set (n=170) |
Validation data set (n=266) |
|
||||
|---|---|---|---|---|---|---|---|
| Median OS | n | (%) | Median OS | n | (%) | P-value | |
| Sex |
|
|
|
|
|
|
0.891 |
| Female | 11.6 | 45 | (27) | 19.1 | 72 | (27) | |
| Male |
22.4 |
125 |
(73) |
29.3 |
194 |
(73) |
|
| Nephrectomy |
|
|
|
|
|
|
<0.001 |
| No | 7.9 | 37 | (22) | 10.6 | 5 | (2) | |
| Yes |
22.3 |
133 |
(78) |
26.5 |
261 |
(98) |
|
| Previous IFNa |
|
|
|
|
|
|
<0.001 |
| No | 19.4 | 154 | (91) | 31.7 | 148 | (56) | |
| Yes |
22.3 |
16 |
(9) |
22.2 |
118 |
(44) |
|
| Time from initial diagnosis to sunitinib therapy |
|
|
|
|
|
|
<0.001 |
| ⩽12 months | 14.2 | 90 | (53) | 21 | 90 | (34) | |
| >12 months |
33.3 |
80 |
(47) |
28.8 |
176 |
(66) |
|
| Histology |
|
|
|
|
|
|
<0.001 |
| Clear Cell | 19.4 | 149 | (87) | 26.9 | 256 | (96) | |
| Other | 19.8 | 20 | (12) | 7.9 | 10 | (4) | |
| Missing |
- |
1 |
(1) |
|
0 |
(0) |
|
| Tumour grade |
|
|
|
|
|
|
0.199 |
| I | NR | 3 | (2) | 29.3 | 2 | (1) | |
| II | 28.8 | 44 | (26) | 40.2 | 53 | (20) | |
| III | 16.4 | 62 | (36) | 29 | 113 | (43) | |
| IV | 17.2 | 27 | (16) | 17.3 | 55 | (21) | |
| Missing |
|
34 |
(20) |
|
43 |
(16) |
|
| Neutrophils status |
|
|
|
|
|
|
0.615 |
| ⩽5000 | 24.7 | 66 | (39) | 34.4 | 130 | (49) | |
| >5000 | 15.1 | 64 | (38) | 18.8 | 113 | (43) | |
| Missing |
|
40 |
(23) |
|
23 |
(9) |
|
| Platelets status |
|
|
|
|
|
|
0.595 |
| ⩽400 | 22.3 | 118 | (69) | 29 | 217 | (82) | |
| >400 | 11.2 | 27 | (16) | 13.7 | 43 | (16) | |
| Missing |
|
25 |
(15) |
|
6 |
(2) |
|
| Karnofsky performance status |
|
|
|
|
|
|
0.086 |
| 0 | 36.7 | 96 | (57) | 37.2 | 160 | (60) | |
| 1 | 16.2 | 53 | (31) | 18.6 | 91 | (34) | |
| 2 | 6.4 | 16 | (9) | 6 | 10 | (4) | |
| 3 |
3.4 |
5 |
(3) |
13.6 |
5 |
(2) |
|
| Total number of metastatic sites |
|
|
|
|
|
|
<0.001 |
| 0–2 | 29 | 123 | (72) | 33 | 131 | (49) | |
| >2 |
7.9 |
47 |
(28) |
18.8 |
135 |
(51) |
|
| LDH |
|
|
|
|
|
|
<0.001 |
| Normal | 29.2 | 74 | (44) | 26.1 | 214 | (81) | |
| Abnormal | 13.9 | 50 | (29) | 23.6 | 35 | (13) | |
| Missing |
|
46 |
(27) |
|
17 |
(6) |
|
| Calcium |
|
|
|
|
|
|
0.537 |
| ⩽10 | 20.8 | 102 | (60) | 24.9 | 214 | (81) | |
| >10 | 9.8 | 18 | (10) | 26.9 | 31 | (12) | |
| Missing |
|
50 |
(30) |
|
21 |
(8) |
|
| Haemoglobin |
|
|
|
|
|
|
0.309 |
| ⩽13 for males, ⩽11.5 for females | 12 | 69 | (41) | 17.9 | 108 | (41) | |
| >13 for males, >11.5 for females | 29 | 77 | (45) | 30 | 149 | (56) | |
| Missing |
|
24 |
(14) |
|
9 |
(3) |
|
| Heng's risk classification |
|
|
|
|
|
|
<0.001 |
| Favourable | 37.4 | 16 | (9) | 40.2 | 53 | (20) | |
| Intermediate | 28.8 | 57 | (34) | 21 | 126 | (47) | |
| Poor | 11.2 | 32 | (19) | 13.6 | 48 | (18) | |
| Missing |
|
65 |
(38) |
|
39 |
(15) |
|
| Motzer's risk classification |
|
|
|
|
|
|
<0.001 |
| Favourable | NR | 16 | (9) | 38.1 | 59 | (22) | |
| Intermediate | 29.2 | 61 | (36) | 21 | 134 | (50) | |
| Poor | 11.6 | 37 | (22) | 13.6 | 44 | (17) | |
| Missing | 56 | (33) | 29 | (11) | |||
Abbreviations: IFN = interferon; LDH = lactate dehydrogenase; NR = not reached; OS = overall survival.