Table 1.
Baseline demographics and clinical characteristics
| ILIXA/SUN (n = 56) | SUN (n = 30) | |
|---|---|---|
| Gender, n (%) | ||
| Male | 43 (76.8) | 21 (70) |
| Female | 13 (23.2) | 9 (30) |
| Age (yr) | ||
| Median | 63 | 64 |
| Range | 41–76 | 49–86 |
| Ethnic origin, n (%) | ||
| Caucasian | 55 (98.2) | 28 (93.3) |
| Unknown | 1 (1.8) | 2 (6.7) |
| ECOG performance status (screening), n (%) | ||
| 0 | 33 (58.9) | 17 (56.6) |
| 1 | 23 (41.1) | 12 (40) |
| 2 | 0 (0) | 1 (3.3) |
| Time from diagnosis to screening (mo) | 0.6 | 0.8 |
| Tumor type, n (%) | ||
| RCC histology | 51 (91.1) | 27 (90.0) |
| RCC with clear cell component | 49 (87.5) | 25 (83.3) |
| RCC without clear cell component | 1 (1.8)a | 0 (0) |
| Non-RCC histology | 1 (1.8)b | 1 (3.3)c |
| Clinical and radiological RCC/no nephrectomy due to rapid progression/no histology | 4 (7.1) | 2 (6.7) |
| IMDC risk category, n (%) | ||
| Intermediate | 40 (71.4) | 22 (73.3) |
| Poor | 16 (28.6) | 8 (26.6) |
ECOG = Eastern Cooperative Oncology Group; ILIXA = ilixadencel; IMDC = International Metastatic Renal Cell Carcinoma Database Consortium; RCC = renal cell carcinoma; SUN = sunitinib.
a
Chromophobe RCC.
b
Sarcoma.
c
Urothelial cancer.