Table 1.
Baseline patient characteristics (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) | |
| Median age, years (range) | 61.0 (55–69) | 58.0 (41–72) | 53.0 (43–57) | 59.5 (49–77) | 59.0 (36–72) | 62.5 (59–80) | 56.0 (46–59) |
| Male/female (n) | 3/1 | 5/4 | 3/2 | 6/6 | 8/1 | 5/3 | 4/2 |
| ECOG PS, n (%) | |||||||
| 0 | 1 (25.0) | 1 (11.1) | 1 (20.0) | 1 (8.3) | 1 (11.1) | 5 (62.5) | 1 (16.7) |
| 1 | 3 (75.0) | 8 (88.9) | 4 (80.0) | 11 (91.7) | 8 (88.9) | 3 (37.5) | 5 (83.3) |
| Primary tumor type, n (%) | |||||||
| Breast | – | – | – | – | – | – | 1 (16.7) |
| CRC | 1 (25.0) | 3 (33.3) | 5 (100.0) | 2 (16.7) | 2 (22.2) | – | 1 (16.7) |
| Gastric | – | – | – | – | 1 (11.1) | 1 (12.5) | – |
| Head and neck | 1 (25.0) | – | – | 1 (8.3) | – | – | – |
| Hepatobiliary | – | 1 (11.1) | – | – | 1 (11.1) | – | – |
| Melanoma | 1 (25.0) | – | – | – | – | – | – |
| NSCLC | 1 (25.0) | – | – | – | – | – | – |
| Ovarian | – | 2 (22.2) | – | – | – | – | – |
| Pancreatic | – | 2 (22.2) | – | 5 (41.7) | 2 (22.2) | 3 (37.5) | 2 (33.3) |
| Other | – | 1 (11.1) | – | 4 (33.3) | 3 (33.3) | 4 (50.0) | 2 (33.3) |
| Prior therapy, n (%) | |||||||
| Radiotherapy | 1 (25.0) | 2 (22.2) | 0 | 1 (8.3) | 5 (55.6) | 2 (25.0) | 2 (33.3) |
| Immunotherapy | 1 (25.0) | 2 (22.2) | 1 (20.0) | 0 | 0 | 1 (12.5) | 0 |
| Chemotherapy | |||||||
| Neoadjuvant | 0 | 0 | 0 | 0 | 2 (22.2) | 0 | 0 |
| Adjuvant | 2 (50.0) | 4 (44.4) | 0 | 0 | 0 | 1 (12.5) | 3 (50.0) |
| Advanced | 4 (100.0) | 8 (88.9) | 5 (100.0) | 8 (66.7) | 5 (55.6) | 3 (37.5) | 4 (66.7) |
| Prior systemic therapy, n (%) | |||||||
| Bevacizumab | 3 (75.0) | 2 (22.2) | 3 (60.0) | 2 (16.7) | 2 (22.2) | 0 | 2 (33.3) |
| Capecitabine | 1 (25.0) | 3 (33.3) | 2 (40.0) | 1 (8.3) | 3 (33.3) | 2 (25.0) | 2 (33.3) |
| 5-fluorouracil | 1 (25.0) | 3 (33.3) | 3 (60.0) | 2 (16.7) | 3 (33.3) | 1 (12.5) | 1 (16.7) |
| Irinotecan | 1 (25.0) | 3 (33.3) | 3 (60.0) | 1 (8.3) | 3 (33.3) | 0 | 1 (16.7) |
| Oxaliplatin | 1 (25.0) | 3 (33.3) | 2 (40.0) | 2 (16.7) | 1 (11.1) | 1 (12.5) | 2 (33.3) |
CDD continuous daily dosing, CRC colorectal cancer, ECOG PS Eastern Cooperative Oncology Group performance status, ITT intention-to-treat, NSCLC non-small cell lung cancer