Table 1 Demographics and baseline characteristics (Phase 1 and 2)
From: Recombinant interleukin-21 plus sorafenib for metastatic renal cell carcinoma: a phase 1/2 study
Parameter, n (%) | Category/statistic | Phase 1 (N = 19) | Phase 2 (30 mcg/kg; N = 33) | |
|---|---|---|---|---|
Gender, n (%) | Male | 15 (79) | 26 (79) | |
Female | 4 (21) | 7 (21) | ||
Age in years, Median (range) |  | 63 (48–77) | 61 (46–75) | |
ECOG, n (%) | 0 | 15 (79) | 15 (45) | |
1 | 4 (21) | 18 (55) | ||
Prognostic risk category*, n (%) | Low risk | 12 (63) | 17 (52) | |
Intermediate risk | 7 (37) | 16 (48) | ||
Prior systemic treatment regimens for mRCC**, n (%) | 0 | 10 (53) | - | |
1 | 8 (42) | 25 (76) | ||
2 | 0 (0) | 8 (24) | ||
3 | 1 (5) | Â | ||
Agents used for prior systemic therapy**, n (%) | VEGFR-TKIs | Â | Â | |
| Â | Sunitinib | 4 (21) | 19 (58) | |
| Â | Pazopanib | Â | 1 (3) | |
| Â | Cediranib | Â | 1 (3) | |
mTOR Inhibitors | Â | Â | ||
| Â | Temsirolimus | Â | 5 (15) | |
| Â | Everolimus | Â | 2 (6) | |
Bevacizumab | Â | 3 (9) | ||
Immunotherapy | Â | Â | ||
| Â | IL-2 | 4 (21) | 11 (33) | |
| Â | Interferon | Â | 1 (3) | |
| Â | Vaccine | Â | 3 (9) | |
| Â | TLR-9 agonist | 1 (5) | Â | |
| Â | IL-2 gene therapy | 1 (5) | Â | |
Other | Â | Â | ||
| Â | Vinblastine | Â | 1 (3) | |
| Â | ABT-510 | 1 (5) | Â | |