Table 4.
Clinical trials of gemcitabine plus S‐1 (GS) therapy or gemcitabine plus cisplatin (GC) combination therapy for patients with advanced biliary tract cancer
| GS therapy | Gemcitabine (mg/m2) | S‐1 (mg/m2/day) | Cycle (days) | No. of patients | RR (%) | Median PFS (TTP), months | Median OS (months) | Grade 3/4 Neutropenia (%) | Grade 1–4 Nausea (%) | Grade 1–4 Vomiting (%) | Grade 1–4 Anorexia (%) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sasaki et al. | 1000 (days 1, 15) | 80 (days 1–14) | 28 | 35 | 34 | 5.9 | 11.6 | 34.0 | 26.0 | 9.0 | 23.0 |
| Kanai et al. | 1000 (days 1, 8) | 60 (days 1–14) | 21 | 25 | 30 | NA | 12.7 | 56.0 | 20.0 | 4.0 | 28.0 |
| Current study | 1000 (days 1, 8) | 60 (days 1–14) | 21 | 51 | 36 | 7.1 | 12.5 | 60.8 | 35.3 | 13.7 | 51.0 |
| GC therapy | Gemcitabine (mg/m2) | Cisplatin (mg/m2) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| BT22 (GC regimen) | 1000 (days 1, 8) | 25 (days 1, 8) | 21 | 42 | 20 | 5.8 | 11.2 | 56.1 | 68.3 | 48.8 | 80.5 |
| ABC‐02 (GC regimen) | 1000 (days 1, 8) | 25 (days 1, 8) | 21 | 204 | 26 | 8.0 | 11.7 | 25.3 | NA | NA | NA |
NA, not available; OS, overall survival; PFS, progression‐free survival; RR, response rate; TTP, time to progression.