Phase I trial of combination chemotherapy with gemcitabine, cisplatin, and S-1 in patients with advanced biliary tract cancer

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

DLT: Dose-limiting toxicities; Gr: Grade; NE: Not evaluable; PD: Progressive disease; PR: Partial response; SD: Stable disease.