Table 2.
Exposure to sunitinib, 5-fluorouracil, leucovorin, and oxaliplatin (ITT population)
| Sunitinib Schedule 2/2 | Sunitinib Schedule 4/2 | Sunitinib CDD schedule | |||||
|---|---|---|---|---|---|---|---|
|
|
|
|
|||||
| 37.5 mg/day (n = 4) | 50 mg/day (n = 9) | 50 mg/day CRC expansion (n = 5) | 37.5 mg/day (n = 12) | 50 mg/day (n = 9) | 25 mg/day (n = 8) | 37.5 mg/day (n = 6) | |
| Sunitinib | |||||||
| Median number of cycles started (range) | 4 (2–4) | 4 (1–4) | 4 (1–4) | 1 (1–2) | 2 (1–2) | 3 (1–4) | 3 (1–4) |
| Median duration of treatment (range)a, days | 113 (65–147) | 126 (28–166) | 119 (28–160) | 42 (42–112) | 91 (42–106) | 97 (28–133) | 88 (28–147) |
| Patients with treatment interruption (missed dose), n (%) | 1 (25.0) | 4 (44.4) | 2 (40.0) | 8 (66.7) | 6 (66.7) | 8 (100.0) | 6 (100.0) |
| Patients with dose reductions, n (%) | 0 | 3 (33.3) | 2 (40.0) | 2 (16.7) | 4 (44.4) | 1 (12.5) | 3 (50.0) |
| Median average daily dose (mg) | 37.5 | 50.0 | 50.0 | 37.5 | 50.0 | 25.0 | 35.0 |
| 5-fluorouracil | |||||||
| Median number of cycles started (range)b | 5 (3–8) | 8 (2–8) | 8 (1–8) | 3 (1–6) | 5 (2–7) | 5 (1–8) | 4 (1–8) |
| Patients with dosing interruption, n (%) | 0 | 1 (11.1) | 0 | 0 | 0 | 0 | 0 |
| Leucovorin | |||||||
| Median number of cycles started (range)b | 5 (3–8) | 8 (2–8) | 8 (1–8) | 3 (1–6) | 5 (2–7) | 5 (1–8) | 4 (1–8) |
| Patients with dosing interruption, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Oxaliplatin | |||||||
| Median number of cycles started (range)b | 5 (3–8) | 7 (2–8) | 8 (1–8) | 3 (1–6) | 5 (2–7) | 5 (1–8) | 4 (1–8) |
| Patients with dosing interruption, n (%) | 0 | 1 (11.1) | 0 | 0 | 0 | 0 | 0 |
CDD continuous daily dosing, CRC colorectal cancer, ITT intention-to-treat
a
The time period starting from date of first dose and ending at either the termination date or 2 weeks after last dose (whichever was earliest)
b
Considered to be administered in any cycle if a patient received at least one dose in that cycle