Table 2.
Overall Study Population stratified by type of first-line immune combination and gender. The percentages refer to the total number of males (1352) and females (475) included in this study
| Characteristics | IO + IO | p value | IO + TKI | p value | ||
|---|---|---|---|---|---|---|
| Males No. (%) |
Females No. (%) |
Males No. (%) |
Females No. (%) |
|||
| Total patients | 538 (40) | 184 (39) | 0.885 | 814 (60) | 291 (61) | 0.885 |
| Age < 50y | 65 (5) | 26 (5) | 1.000 | 115 (9) | 34 (7) | 0.603 |
| Age > 70y | 156 (12) | 64 (13) | 0.831 | 236 (17) | 85 (18) | 0.853 |
| Clear cell histology | 480 (36) | 161 (34) | 0.767 | 690 (51) | 247 (52) | 0.888 |
| Sarcomatoid differentiation | 101 (7) | 45 (9) | 0.969 | 79 (6) | 49 (10) | 0.298 |
| Metastatic at diagnosis | 333 (25) | 118 (25) | 1.000 | 425 (31) | 158 (33) | 0.762 |
| Previous nephrectomy | 345 (26) | 114 (24) | 0.744 | 536 (40) | 184 (39) | 0.885 |
|
No. of metastatic sites > 2 |
154 (11) | 48 (10) | 0.818 | 242 (18) | 88 (19) | 0.856 |
| Site of metastasis, individual | ||||||
| Lung | 403 (30) | 120 (25) | 0.430 | 544 (40) | 184 (39) | 0.885 |
| Lymph node | 181 (13) | 65 (14) | 0.837 | 264 (20) | 104 (22) | 0.729 |
| Liver | 95 (7) | 35 (7) | 1.000 | 130 (10) | 63 (13) | 0.507 |
| Bone | 177 (13) | 52 (11) | 0.664 | 274 (20) | 100 (21) | 0.861 |
| Brain | 39 (3) | 17 (4) | 0.701 | 49 (4) | 24 (5) | 0.734 |
| IMDC Prognostic Risk Group | ||||||
| Favorable | 0 (0) | 0 (0) | 1.000 | 194 (14) | 65 (14) | 1.000 |
| Intermediate | 390 (29) | 126 (27) | 0.732 | 462 (34) | 161 (34) | 1.000 |
| Poor | 148 (11) | 58 (12) | 0.825 | 158 (12) | 65 (13) | 0.831 |
| NLR ≥ 4 | 176 (13) | 55 (12) | 0.831 | 214 (16) | 88 (19) | 0.578 |
| BMI ≥ 25 | 374 (28) | 102 (21) | 0.251 | 525 (39) | 153 (32) | 0.302 |
|
First-line therapy Nivolumab plus ipilimumab Pembrolizumab plus axitinib Nivolumab plus Cabozantinib Pembrolizumab plus lenvatinib |
538 (40) – – – |
183 (39) – – – |
0.885 – – – |
– 601 (45) 153 (11) 60 (4) |
– 208 (44) 53 (11) 31 (7) |
– 0.887 1.000 0.353 |
|
Second-line therapy Cabozantinib Sunitinib Lenvatinib plus Everolimus Nivolumab Everolimus Clinical trials |
123 (9) 57 (4) 5 (< 1) 3 (< 1) 0 (0) 18 (1) |
39 (9) 22 (5) 1 (< 1) 2 (< 1) 2 (< 1) 5 (1) |
- |
148 (11) 39 (3) 10 (< 1) 3 (< 1) 4 (< 1) 28 (2) |
67 (14) 11 (2) 0 (0) 2 (< 1) 1 (< 1) 12 (3) |
– |
BMI, Body Mass Index; NLR, Neutrophil-to-Lymphocyte Ratio