Table 1.
Patients’ characteristics.
| All patients n = 118 |
First-line IO-IO n = 73 |
First-line IO-TKI n = 45 |
P | |
|---|---|---|---|---|
| Age at the time of second-line cabozantinib initiation, median (range) | 67 (37–87) | 67 (37–87) | 67 (42–80) | 0.7500 |
| Sex | ||||
| Male | 93 (79%) | 55 (75%) | 38 (84%) | 0.2398 |
| Female | 25 (21%) | 18 (25%) | 7 (16%) | |
| Nephrectomy | ||||
| Positive | 71 (60%) | 40 (55%) | 31 (69%) | 0.1287 |
| Negative | 47 (40%) | 33 (45%) | 14 (31%) | |
| Histology | ||||
| Clear cell | 90 (76%) | 54 (74%) | 36 (80%) | 0.0555 |
| Non-clear cell | 22 (19%) | 18 (25%) | 4 (9%) | |
| Unknown | 6 (5%) | 1 (1%) | 5 (11%) | |
| Sarcomatoid change | ||||
| Present | 12 (10%) | 7 (10%) | 5 (11%) | 0.7791 |
| Absent | 96 (81%) | 60 (82%) | 36 (80%) | |
| Unknown | 10 (9%) | 6 (8%) | 4 (9%) | |
| IMDC risk at the time of first-line therapy | ||||
| Favorable | 15 (13%) | 6 (8%) | 9 (20%) | 0.4035# |
| Intermediate | 64 (54%) | 41 (56%) | 23 (51%) | |
| Poor | 37 (31%) | 25 (34%) | 12 (27%) | |
| Unknown | 2 (2%) | 1 (3%) | 1 (2%) | |
| IMDC risk at the time of second-line therapy | ||||
| Favorable | 12 (10%) | 2 (3%) | 10 (22%) | 0.2145# |
| Intermediate | 72 (61%) | 47 (64%) | 25 (56%) | |
| Poor | 34 (29%) | 24 (33%) | 10 (22%) | |
| Unknown | 0 (0%) | 0 (0%) | 0 (0%) | |
| BOR for first-line therapy | ||||
| CR | 2 (2%) | 2 (3%) | 0 (0%) | 0.1184† |
| PR | 37 (31%) | 18 (25%) | 19 (42%) | |
| SD | 48 (41%) | 31 (42%) | 17 (38%) | |
| PD | 29 (25%) | 20 (27%) | 9 (20%) | |
| NE | 2 (2%) | 2 (3%) | 0 (0%) | |
| Reason for first-line therapy discontinuation | ||||
| PD | 91 (77%) | 58 (79%) | 33 (73%) | 0.4421 |
| AE | 27 (23%) | 15 (21%) | 12 (27%) | |
| Duration between first-line and second-line therapy (months), median (range) | 6.7 (0.7–48.3) | 7.8 (0.7–37.6) | 6.4 (1.4–48.3) | 0.3336 |
| Metastatic organ at the start of second-line therapy | ||||
| Lungs | 74 (63%) | 48 (66%) | 26 (58%) | |
| Liver | 26 (22%) | 15 (21%) | 11 (24%) | |
| Bone | 36 (31%) | 20 (27%) | 16 (36%) | |
| Brain | 6 (5%) | 3 (4%) | 3 (7%) | |
| Median observation period from the initiation of second-line therapy (months) | 10.5 | 10.5 | 10.5 | 0.3257 |
IMDC International Metastatic RCC Database Consortium, BOR Best overall response, CR complete response, PR partial response, SD stable disease, PD progressive disease, NE not evaluable, AE adverse event, IO immuno-oncology, TKI tyrosine kinase inhibitor.
#Poor vs. favorable/intermediate.
†CR/PR vs. SD/PD.