Table 2.
Efficacy Outcomes According to Renal Function
| No. of Patients (%) | |||
|---|---|---|---|
| Outcome | Mild or No RI: CLCr ≥60 mL/min | Moderate RI: CLCr ≥30 mL/min to <60 mL/min | Severe RI: CLCr <30 mL/min |
| Total no. of patients | 243 | 82 | 16 |
| Response | |||
| Overall response | 156 (64) | 46 (56) | 8 (50) |
| Complete response | 38 (16) | 13 (16) | 1 (6) |
| Very good partial response | 45 (19) | 9 (11) | 5 (31) |
| Partial response | 73 (30) | 24 (29) | 2 (13) |
| Stable disease | 69 (28) | 28 (34) | 5 (31) |
| Progressive disease | 5 (2) | 3 (4) | 0 |
| Response not evaluablea | 13 (5) | 5 (6) | 3 (19) |
| Efficacy, mo | |||
| Median time to progression | 12.0 | 11.1 | 7.8 |
| Median PFS | 11.1 | 9.5 | 7.8 |
| Median OS | 38.9 | 29.0b | 18.4b |
RI indicates renal impairment; CLCr, creatinine clearance; PFS, progression-free survival; OS, overall survival.
a
P = .006 versus patients with mild or no RI.
b
Including patients who did not have any response assessment data at the data cutoff point or whose only assessment was “response not evaluable.”