Table 4.
Demographic and disease characteristics of the patients included in the independent pharmacokinetics cohort*
| Characteristic | PPI users, n = 21 (42%) | PPI nonusers, n = 29 (58%) | p value |
|---|---|---|---|
| Age, median (range), yr | 58 (40–79) | 57 (22–73) | .748 |
| Male gender, n (%) | 17 (80.9) | 23 (79.3) | .354 |
| Histology, n (%) | |||
| Clear cell RCC | 17 (80.9) | 21 (72.4) | .068 |
| Nonclear cell RCC | 4 (19.1) | 8 (27.6) | |
| Cabozantinib line of treatment, n (%) | .130 | ||
| First and second line | 5 (23.3) | 8 (27.6) | |
| Third line and beyond | 16 (76.7) | 21 (72.4) | |
| Median duration of treatment, wk | 26.7 | 39.6 | .794 |
| Cabozantinib dose intensity b /blood draw, n (%), mg per day | .117 | ||
| 20 | 1 (3.1) | 4 (8) | |
| 28.57 | 7 (21.9) | 4 (8) | |
| 30 | 0 | 1 (2) | |
| 35.71 | 0 | 1 (2) | |
| 40 | 17 (53 ) | 14 (28) | |
| 42.85 | 3 (9.4) | 8 (16) | |
| 50 | 0 | 1 (2) | |
| 60 | 3 (9.4) | 13 (26) |
a
16 patients are included in both the clinical study set and the pharmacokinetic cohort.
b
Cumulative cabozantinib dose received in the previous 4 weeks divided by 28.
Abbreviations: IMDC, International Metastatic RCC Database Consortium; PPI, proton pump users; RCC, renal cell carcinoma.