Summary of patient baseline characteristics and clinical outcomes
| Overall (n=56) | Clinical benefit (n=30) | No clinical benefit (n=26) | P value | |
| Age, median (IQR) | 67 (58–73) | 67 (61–73) | 61 (57–74) | 0.2 |
| Gender | ||||
| Male | 40 (71%) | 23 (41%) | 17 (30%) | 0.4 |
| Female | 16 (27%) | 7 (13%) | 9 (16%) | |
| Histology | ||||
| Clear cell RCC | 47 (84%) | 26 (46%) | 21 (38%) | 0.6 |
| Non-clear cell RCC | 9 (16%) | 4 (7%) | 5 (9%) | |
| IMDC risk category | ||||
| Favorable | 20 (36%) | 13 (23%) | 7 (13%) | 0.3 |
| Intermediate | 28 (50%) | 12 (21%) | 16 (29%) | |
| Poor | 8 (14%) | 5 (9%) | 3 (5%) | |
| Treatment received | ||||
| Nivolumab monotherapy | 25 (45%) | 11 (20%) | 14 (25%) | 0.4 |
| Cabozantinib | 10 (18%) | 4 (7%) | 6 (11%) | |
| Nivolumab+Ipilimumab | 8 (14%) | 6 (11%) | 2 (4%) | |
| Sunitinib | 7 (13%) | 4 (7%) | 3 (5%) | |
| Lenvatinib/Everolimus | 5 (9%) | 4 (7%) | 1 (2%) | |
| Axitinib | 1 (2%) | 1 (2%) | 0 (0%) | |
| Line of therapy, median (IQR) | 2 (1–3) | 2 (1–3) | 2 (2–3) | 0.2 |
| Line of therapy | ||||
| First line | 11 (20%) | 8 (14%) | 3 (5%) | 0.3 |
| Second line | 26 (46%) | 13 (23%) | 13 (23%) | |
| Third line | 12 (21%) | 6 (11%) | 6 (11%) | |
| Further lines | 7 (13%) | 3 (5%) | 4 (7%) | |
| Best clinical response | ||||
| Partial response | 7 (13%) | 7 (13%) | 0 (0.0%) | <0.01 |
| Stable disease | 25 (45%) | 23 (41%) | 2 (4%) | |
| Progressive disease | 17 (30%) | 0 (0.0%) | 17 (30%) | |
| Toxicity-related discontinuation | 7 (13%) | 0 (0.0%) | 7 (13%) | |
| Progression-free survival, months, median (95% CI)* | 6.2 (2.9–10.4) | 13.9 (8.6–28.3) | 2.3 (2.0–2.6) | |
| Treatment-related toxicity | ||||
| Yes | 36 (64%) | 21 (38%) | 15 (27%) | 0.3 |
| No | 20 (36%) | 9 (16%) | 11 (20%) | |
*Kaplan-Meier method.
IMDC, International Metastatic Renal Cell Carcinoma Consortium; RCC, renal cell carcinoma.