Table 3.
Characteristics of 168 mRCC Patients Included in the PK/PD Analyses
| Covariates | n |
|---|---|
| Age, years | |
| Median (range) | 60 (34–85) |
| Gender, (%) | |
| Male | 120 (71) |
| Female | 48 (29) |
| Prior therapy, (%) | |
| Cytokine-refractory | 114 (68) |
| Sorafenib-refractory | 54 (32) |
| ECOG PS, (%) | |
| 0 | 109 (65) |
| 1 | 59 (35) |
| Hemoglobin, g/dLa | |
| Median (range) | 12.4 (1.1–17.9) |
| ≤ 13 for male, ≤ 11.5 for female (%) | 89 (53) |
| >13 for male, >11.5 for female (%) | 79 (47) |
| Corrected serum calcium, mg/dLa | |
| Median (range) | 9.4 (8.4–13.1) |
| <10 (%) | 145 (86) |
| ≥ 10 (%) | 23 (14) |
| AUC, hxng/mLa,b | |
| Median (range) | 375 (32.8–1,728) |
| <300c (%) | 63 (38) |
| ≥300 (%) | 105 (62) |
| dBP, mm Hga,d | |
| Median (range) | 90 (58–116)e |
| <90 (%) | 80 (48)f |
| ≥90 (%) | 88 (52)g |
AUC, area under the plasma concentration–time curve; dBP, diastolic blood pressure; ECOG PS, Eastern Cooperative Oncology Group performance status; mRCC, metastatic renal cell carcinoma; PK/PD, pharmacokinetics/pharmacodynamics.
Of the 178 mRCC patients, 2 patients were missing hemoglobin, 3 were missing calcium, 2 were missing dBP, and 5 were missing AUC.
AUC at the end of 4 weeks of study treatment.
Total daily AUC correlated with the maximum reduction in blood flow and permeability was determined to be reached at ~300 hxng/mL (based on Figures 3 and 4 in the previous study evaluating axitinib exposure and blood flow23).
Maximum post-baseline dBP within the first 8 weeks.
Median baseline dBP for all patients was 76 mm Hg (range 55–96.5).
Median baseline dBP for patients with post-baseline dBP <90 mm Hg was 71.3 mm Hg (range 55–96).
Median baseline dBP for patients with post-baseline dBP ≥90 mm Hg was 80 mm Hg (range 56–96.5).