Table 1.
Characteristics of patients with advanced biliary tract cancer who participated in the randomized phase II study of gemcitabine plus S‐1 combination therapy (GS) versus S‐1 alone
| GS (n = 51) | S‐1 (n = 50) | Total | |
|---|---|---|---|
| Age (years) | |||
| Median (range) | 66.0 (39–78) | 62.5 (49–79) | |
| Gender, n (%) | |||
| Male | 27 (52.9) | 28 (56.0) | 55 |
| Female | 24 (47.1) | 22 (44.0) | 46 |
| PS, n (%) | |||
| 0 | 39 (76.5) | 37 (74.0) | 76 |
| 1 | 12 (23.5) | 13 (26.0) | 25 |
| Target lesion, n (%) | |||
| Present | 44 (86.3) | 46 (92.0) | 90 |
| Absent | 7 (13.7) | 4 (8.0) | 11 |
| Primary tumor, n (%) | |||
| IHBD | 20 (39.2) | 15 (30.0) | 35 |
| EHBD | 9 (17.6) | 11 (22.0) | 20 |
| GB | 19 (37.3) | 19 (38.0) | 38 |
| AV | 3 (5.9) | 5 (10.0) | 8 |
| Stage, n (%) | |||
| II or III | 8 (15.7) | 7 (14.0) | 15 |
| IV | 29 (56.9) | 32 (64.0) | 61 |
| Recurrent | 14 (27.5) | 11 (22.0) | 25 |
| Biliary drainage, n (%) | |||
| − | 32 (62.7) | 31 (62.0) | 63 |
| + | 19 (37.3) | 19 (38.0) | 38 |
AV, ampulla of Vater; EHBD, extrahepatic biliary duct; GB, gallbladder; IHBD, intrahepatic biliary duct; PS, performance status.