Table 1 Baseline characteristics
HR070803 group (n = 149) | Placebo group (n = 149) | |
|---|---|---|
Age, years | 60 (52–66) | 59 (54–65) |
Male | 95 (63.8) | 93 (62.4) |
ECOG performance status | ||
0 | 25 (16.8) | 26 (17.5) |
1 | 124 (83.2) | 123 (82.6) |
Pancreatic tumor location | ||
Head | 60 (40.3) | 65 (43.6) |
Body | 6 (4.0) | 7 (4.7) |
Tail | 62 (41.6) | 59 (39.6) |
Multicentric | 21 (14.1) | 18 (12.1) |
Clinical TNM stage | ||
Stage II-III (locally advanced) | 5 (3.4) | 6 (4.0) |
Stage IV (metastatic) | 144 (96.6) | 142 (95.3) |
Site of metastatic lesions | ||
Liver | 110 (73.8) | 100 (67.1) |
Lung | 38 (25.5) | 40 (26.9) |
Lymph node, regional | 49 (32.9) | 44 (29.5) |
Lymph node, distant | 42 (28.2) | 55 (36.9) |
Peritoneum | 21 (14.1) | 12 (8.1) |
Other | 54 (36.2) | 55 (36.9) |
Number of metastatic sites | ||
0 | 1 (0.7) | 3 (2.0) |
1 | 40 (26.8) | 45 (30.2) |
2 | 58 (38.9) | 49 (32.9) |
3 | 33 (22.1) | 33 (22.1) |
≥ 4 | 17 (11.4) | 19 (12.8) |
UGT1A1 gene mutation | ||
UGT1A1*28 | 4 (2.7) | 5 (3.4) |
UGT1A1*6a | 2 (1.3) | 3 (2.0) |
CA19-9, U/mL | 267.3 (64.5–1523.5) | 503.8 (68.6–2056.0) |
Albumin | ||
< 40 g/L | 45 (30.2) | 46(30.9) |
≥ 40 g/L | 104 (69.8) | 103(69.1) |
Previous antitumor therapy | ||
Gemcitabine monotherapy | 27 (18.1) | 22 (14.8) |
Gemcitabine combination | 139 (93.3) | 137 (91.9) |
Fluorouracil-based | 15 (10.1) | 15 (10.1) |
Paclitaxel monotherapy | 3 (2.0) | 1 (0.7) |
Surgery for pancreatic cancer | 72 (48.3) | 68 (45.6) |
Duration since the diagnosis of the disease, months | 6.7 (4.5–9.9) | 6.9 (3.7–9.7) |
