Table 13. Phase II and III studies of gemcitabine.
| Reference | N | Regimen | RR | Median survival | Survival (at year) | Disease/line of treatment |
|---|---|---|---|---|---|---|
| Masters120 | 46 | G 1g/m2 d1, 8, 15 (q4/w) | 11.9% | 7.1 m | Not Rep | Ref |
| Rel | ||||||
| Hoang121 | 27 | G 1.25 g/m2 d1, 8 (q3/w) | 0% | 6.4 m | 25.4 at 1y | Ref |
| Rel | ||||||
| Van der Lee122 | 38 | G 1g/m2 d1, 8, 15 (q4/w) | 13% | 4 m | 3% (1y) | Ref |
| Cormier123 | 29 | G 1.25 g/m2 d1, 8, 15 (q4/w) | 27% | 12 m | 50% | First |
| ED | ||||||
| Vansteenkiste124 | 42 | G 1g/m2 d1, 8, 15 | 46% | 10.5 m | 37% (1y) | First |
| E 80 mg/m2 d8, 9, 10 (4/w) | ED | |||||
| Agelaki125 | 31 | G 1g/m2 d1, 8 and I 300 mg/m2 d8 (q3/w) | 10% | 6 m | 17% (1y) | Ref |
| Rel | ||||||
| LD and ED | ||||||
| Schuette126 | 35 | G 1g/m2 and I 100 mg/m2 d1, 8 (q3/w) | 17% | 5.8 m | 34% (1y) | Ref |
| Rel | ||||||
| Hainsworth127 | 28 | Vin 20 mg/m2 and Gem 1g/m2 d1, 8, 15 (q4/w) | 10% | 5 m | 17% (1y) | Rel |
| Ref | ||||||
| Rapti128 | 35 | Vin 25 mg/m2 and Gem 1.1g/m2 d1, 8 (q3/w) | 6% | 4.5 m | 42.6% | Pre-treated |
| at 6 m | ||||||
| Dudek129 | 16 | Vin 25 mg/m2 and Gem 1g/m2 d1, 8 (q3/w) | 6% | 5.4 m | NR | Pre-treated |
| Agelaki130 | 22 | G 1g/m2 d1, 8 and D 75 mg/m2 d8 (q3/w) | 0% | 3.3 m | 28% at 6 m | Ref |
| Rel | ||||||
| Hainsworth131 | 40 | G 8 g/m2 and D 30 mg/m2 d1, 8, 15 (q4/w) | 23% | 4 m | 14% (1y) | First |
| Poor PS | ||||||
| Elderly | ||||||
| ED | ||||||
| Lee132 | 241 | GC | 58% | 8.1 m | Not Rep | First |
| G 1.2 g/m2 d1, 8 and Carbo 5AUC d1 | ED and locally advanced | |||||
| PE | ||||||
| P 60 mg/m2 d1 and E 120 mg/m2 d1, E 100 mg d2, 3 | 63% | 8.2 m | Not Rep | |||
| De Marinis133 | 56 | P 70 mg/m2 d2 and E escalating and G 1 g/m2 d1, 8 | 72.2% | 10 m | 37.5 at 1y | First |
| De Marinis134 | 70 | PEG | 63% | 9.5 m | 50% (1y) | First |
| P 70 mg/m2 d2 and E 50 mg/m2 d1,8 and | CR=18.6% | 9% (2y) | ED and poor prognosis LD | |||
| G 1 g/m2 d1, 8 | ||||||
| PG | ||||||
| 70 | P 70 mg/m2 d1 and G 1.25 g/m2 d1, 8 (3/w) | 57% | 10 m | 48% (1y) | ||
| CR=4.3% | 7% (2y) |
G, gemcitabine; E, etoposide; Vin, vinorelbine; GC, gemcitabine, cisplatin; PE, cisplatin, etoposide; PEG, cisplatin, etoposide, gemcitabine; PG, cisplatin, gemcitabine; d, day; w, week.