Copyright
©The Author(s) 2015.
World J Gastroenterol. May 21, 2015; 21(19): 5979-5984
Published online May 21, 2015. doi: 10.3748/wjg.v21.i19.5979
Published online May 21, 2015. doi: 10.3748/wjg.v21.i19.5979
Table 1 Doses and treatment schedules for each level
Gemcitabine | Cisplatin | S-1 (mg/d, Days 1-7, 15-21) | |||
(mg/m2, Days 1, 15) | BSA < 1.25 | 1.25 < BSA < 1.5 | BSA > 1.5 | ||
Level -1 | 800 | 20 | 60 | 80 | 100 |
Level 0 | 800 | 25 | 60 | 80 | 100 |
Level 1 | 1000 | 25 | 60 | 80 | 100 |
Level 2 | 1000 | 25 | 80 | 100 | 120 |
Table 2 Patient characteristics
Characteristic | n (%) |
Sex | |
Male | 10 (83) |
Female | 2 (17) |
Median age | 69 (range 44-77) |
Primary lesion | |
Intrahepatic | 2 (17) |
Extrahepatic | 3 (25) |
Gallbladder | 7 (58) |
Ampulla of vater | 0 (0) |
Disease status | |
Unresectable | 12 (100) |
Recurrent | 0 (0) |
Performance status (0/1) | 12/0 |
Biliary drainage | 6 (50) |
Median CEA (ng/mL) | 3 (range 1.1-33.4) |
Median CA19-9 (U/mL) | 156.5 (range 1.0- > 10000) |
Table 3 Dose-limiting toxicities at each level
Level | Age | Sex | Primary lesion | Biliary drainage | DLT | Response (RECIST) |
0 | 71 | M | Extrahepatic | Yes | None | PR |
0 | 73 | M | Extrahepatic | Yes | None | SD |
0 | 63 | F | Gallbladder | No | None | PD |
1 | 77 | M | Intrahepatic | Yes | Gr 4 febrile neutropenia and leucopenia, Gr 3 thrombocytopenia | PD |
1 | 67 | M | Gallbladder | Yes | None | NE |
1 | 64 | M | Gallbladder | No | None | SD |
1 | 70 | M | Extrahepatic | Yes | None | SD |
1 | 72 | M | Gallbladder | No | None | PR |
1 | 74 | M | Gallbladder | No | None | PR |
2 | 58 | M | Intrahepatic | No | None | PR |
2 | 68 | F | Gallbladder | No | None | SD |
2 | 44 | M | Gallbladder | Yes | None | PD |
Table 4 Hematologic adverse events during the first cycle
Level 0 | (n = 3) | Level 1 | (n = 6) | Level 2 | (n = 3) | |
Gr 1-2 | Gr 3-4 | Gr 1-2 | Gr 3-4 | Gr 1-2 | Gr 3-4 | |
Neutropenia | 0 | 0 | 0 | 1 | 0 | 1 |
Leucopenia | 1 | 0 | 2 | 1 | 1 | 0 |
Thrombocytopenia | 2 | 0 | 1 | 1 | 0 | 0 |
Anemia | 2 | 0 | 1 | 0 | 0 | 0 |
Febrile neutropenia | NA | 0 | NA | 1 | NA | 0 |
Table 5 Non-hematologic adverse events during the first cycle
Level 0 | (n = 3) | Level 1 | (n = 6) | Level 2 | (n = 3) | |
Gr 1-2 | Gr 3-4 | Gr 1-2 | Gr 3-4 | Gr 1-2 | Gr 3-4 | |
Anorexia | 2 | 0 | 1 | 0 | 2 | 0 |
Nausea | 1 | 0 | 1 | 0 | 0 | 0 |
Vomiting | 1 | 0 | 0 | 0 | 0 | 0 |
Fatigue | 0 | 0 | 0 | 0 | 2 | 0 |
Constipation | 1 | 0 | 1 | 0 | 0 | 0 |
Fever | 1 | 0 | 2 | 0 | 0 | 0 |
Biliary tract infection | NA | 3 | NA | 0 | NA | 1 |
Infections (others) | 0 | 0 | 0 | 2 | 0 | 0 |
AST | 3 | 0 | 2 | 0 | 0 | 0 |
ALT | 2 | 0 | 2 | 0 | 0 | 0 |
Hyperbilirubinemia | 2 | 0 | 1 | 0 | 1 | 0 |
Creatinine | 0 | 0 | 3 | 0 | 0 | 0 |
- Citation: Watanabe A, Kida M, Miyazawa S, Iwai T, Okuwaki K, Kaneko T, Yamauchi H, Takezawa M, Imaizumi H, Koizumi W. Phase I trial of combination chemotherapy with gemcitabine, cisplatin, and S-1 in patients with advanced biliary tract cancer. World J Gastroenterol 2015; 21(19): 5979-5984
- URL: https://www.wjgnet.com/1007-9327/full/v21/i19/5979.htm
- DOI: https://dx.doi.org/10.3748/wjg.v21.i19.5979