Table 2.
Baseline patient characteristics
| CDD schedule sunitinib 25 mg/day | Schedule 2/2 sunitinib 25 mg/day | Schedule 2/2 sunitinib 37.5 mg/day | ||
|---|---|---|---|---|
| All patients (n = 4)a | All patients (n = 16)b,c | Patients with scirrhous-type disease (n = 7) | All patients (n = 6)d | |
| Gender, male, n (%) | 2 (50.0) | 13 (81.3) | 6 (85.7) | 4 (66.7) |
| Age, years | ||||
| Median | 63.0 | 60.0 | 57.0 | 60.5 |
| Range | 44–73 | 31–71 | 31–67 | 28–71 |
| ECOG performance status, n (%) | ||||
| 0 | 1 (25.0) | 7 (43.8) | 2 (28.6) | 3 (50.0) |
| 1 | 3 (75.0) | 9 (56.3) | 5 (71.4) | 3 (50.0) |
| Measurable disease, n (%) | 3 (75.0) | 11 (68.8) | 5 (71.4) | 4 (66.7) |
| Histology, n (%) | ||||
| Diffuse | 2 (50.0) | 9 (56.2) | 6 (85.7) | 2 (33.3) |
| Intestinal | 2 (50.0) | 7 (43.8) | 1 (14.3) | 3 (50.0) |
| Other | 0 (0) | 0 (0) | 0 (0) | 1e (16.7) |
| Prior surgery, n (%) | 1 (25.0) | 5 (31.3) | 1 (14.3) | 2 (33.3) |
| Prior systemic therapy, n (%) | ||||
| 0 | 2 (50.0) | 16 (100.0) | 7 (100.0) | 5 (83.3) |
| 1 | 2 (50.0) | 0 (0) | 0 (0) | 1 (16.7) |
| ≥2 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
CDD continuous daily dosing; ECOG Eastern Cooperative Oncology Group; Schedule 2/2 2 weeks on treatment followed by 2 weeks off treatment
aIncludes one patient with scirrhous-type disease
bIncludes 10 patients from the expansion cohort
cThe subject assigned to sunitinib 25 mg/day on Schedule 2/2 who mistakenly received sunitinib 12.5 mg/day was excluded from the efficacy analyses. At baseline, this patient had an ECOG performance status of 0, stage IV measurable intestinal disease, with 2 involved tumor sites (liver and lymph node) and no prior surgery or systemic therapy
dNo patients had scirrhous-type disease in this cohort
eThis patient had mucinous histology