Table 1. Patients’ characteristics.
| DS arm ( n =56) | D arm ( n =49) | P-value | |
|---|---|---|---|
| Age, median (range) | 54.0 (20–72) | 52 (36–70) | 0.356 |
| Sex (N (%)) | |||
| Male | 40 (71.4) | 33 (67.3) | 0.650 |
| Female | 16 (28.6) | 16 (32.7) | |
| ECOG (N (%)) | |||
| 0 | 2 (3.6) | 3 (6.1) | 0.603 |
| 1 | 28 (85.7) | 43 (87.8) | |
| 2 | 6 (10.7) | 3 (6.1) | |
| Laboratory findings (median, range) | |||
| WBC | 6135 (2910–17 270) | 5900 (3110–12 170) | 0.352 |
| Haemoglobin | 10.9 (8.0–17.1) | 11.1 (8.4–15.5) | 0.529 |
| Platelet | 201 000 (75 000–495 000) | 187 000 (89000–497 000) | 0.094 |
| ANC | 3470 (1080–13 700) | 3500 (1390–9630) | 0.571 |
| Calcium | 9.0 (7.1–11.1) | 9.0 (7.7–10.5) | 0.138 |
| Creatinine | 0.8 (0.4–3.3) | 0.8 (0.6–6.4) | 0.312 |
| Total protein | 6.5 (3.9–7.8) | 6.6 (4.6–8.0) | 0.108 |
| Albumin | 4.0 (1.9–4.8) | 4.1 (2.4–4.9) | 0.484 |
| ALP | 80 (43–975) | 93 (45–1418) | 0.029 |
| AST | 19 (11–66) | 24 (10–58) | 0.980 |
| ALT | 14 (5–38) | 15 (5–49) | 0.804 |
| Total bilirubin | 0.5 (0.2–2.3) | 0.5 (0.2–1.6) | 0.063 |
| Site of metastases (N, (%)) | |||
| Liver | 0.081 | ||
| Yes | 24 (42.9) | 13 (26.5) | |
| No | 32 (57.1) | 36 (73.5) | |
| Lung | |||
| Yes | 5 (8.9) | 8 (16.3) | 0.251 |
| No | 51 (91.1) | 41 (83.7) | |
| Abdominal lymph nodes | 0.530 | ||
| Yes | 32 (57.1) | 25 (51.0) | |
| No | 24 (42.9) | 24 (49.0) | |
| Neck lymph nodes | |||
| Yes | 2 (3.6) | 2 (4.1) | 0.892 |
| No | 54 (96.4) | 47 (95.9) | |
| Peritoneal seeding | 0.124 | ||
| Yes | 17 (30.4) | 22 (44.9) | |
| No | 39 (69.6) | 27 (55.1) | |
| Bone | |||
| Yes | 3 (5.4) | 4 (8.2) | 0.565 |
| No | 53 (94.6) | 45 (91.8) | |
| Number of metastatic sites (N (%)) | |||
| 0 | 9 (16.1) | 2 (4.1) | |
| 1 | 23 (41.1) | 26 (53.1) | |
| 2 | 18 (32.1) | 15 (30.6) | |
| 3 | 6 (10.7) | 6 (12.2) | |
| Prior chemotherapy (N (%)) | |||
| Capecitabine+cisplatin | 74 (70.5%) | ||
| TS-1+cisplatin | 18 (17.1%) | ||
| Epirubicin+capecitabine+cisplatin | 6 (5.7%) | ||
| FOLFOX | 5 (4.8%) | ||
| TS-1+oxaliplatin | 2 (1.9%) | ||
Abbreviations: ALP=alkaline phosphatase; ALT=alanine aminotransferase; ANC=absolute neutrophil count; AST=aspartate aminotransferase; D=docetaxel monotherapy; DS=docetaxel+sunitinib; ECOG=Eastern Cooperative Oncology Group; FOLFOX=oxaliplatin, 5-fluorouracil, leucovorin; WBC=white blood corpuscles.