Table 5.
Randomized clinical trials for unresectable biliary tract cancer
| n | Response rate | MST (months) GB/BD | P value | Study design | Evidence level | Author (year) | Reference | |
|---|---|---|---|---|---|---|---|---|
| 1) Oral 5-FU | 30 | 10% | 4.9/6.1 | NS | RCT | Level II | Falkson (1984) | 60 |
| 2) Oral 5-FU + Stz | 26 | 7.7% | 3.3/2.8 | |||||
| 3) Oral 5-FU + MeCCNU | 31 | 9.7% | 2.3/1.9 | |||||
| 1) Modified FAM | 35 (18)a | 4% | 6.2b | NS | RCT | Level II | Takada (1994) | 19 |
| 2) 5-FU | 36 (18)a | 0% | 6.0b | |||||
| 1) 5-FU + LV or FELV | 47 (18)a | 11% | 6.5 (6.5)b | 0.1 | RCT | Level II | Glimelius (1996) | 2 |
| 2) BSC | 43 (19)a | – | 2.5 (2.5)b | |||||
| 1) Modified FAM | 14 | – | 5.2/4.1 | NS | RCT | Level II | Takada (1998) | 3 |
| 2) Palliative surgery | 17 | – | 2.4/7.7 | |||||
| 1) MMC + gemcitabine | 25 | 20% | 6.7 | – | RCT | Level II | Kornek (2004) | 61 |
| 2) MMC + capecitabine | 26 | 31% | 9.3 | |||||
| 1) 5-FU | 29 | – | 5.0 | – | RCT | Level II | Ducreux (2005) | 62 |
| 2) 5-FU + FA + cisplatin | 29 | – | 8.0 | |||||
| 1) ECF | 27 | – | 9.0 | 0.72 | RCT | Level II | Rao (2005) | 63 |
| 2) FELV | 27 | – | 12.0 |
MST, median survival time; GB, gallbladder; BD, bile duct; Stz, streptozotocin; MeCCNU, methyl-CCNU; LV, levofolinic acid (lecovorin); BSC, best supportive care; MMC, mitomycin C; FA, folinic acid; FAM, 5-FU + adriamycin + MMC; FELV, 5-FU + etoposide + leucovorin; ECF, epirubicin + cisplatin + 5-FU
a The total number of patients in the study, including those with pancreatic cancer; numbers in parentheses, numbers of patients with biliary tract cancer
b The median overall survival time in all patients in the study, including those with pancreatic cancer; numbers in parentheses, median overall survival times in patients with biliary tract cancer