Treatment outcomes of chemotherapy between unresectable and recurrent biliary tract cancer

Table 1 Patient characteristics n (%)

	Unresectable(n = 55)	Recurrent(n = 10)	P value
Age (median, range)	68 (47-83)	70 (51-79)	0.43
Sex (male / female)	31/24	7/3	0.42
ECOG performance status			0.76
0	28 (51)	6 (60)
1	25 (45)	4 (40)
2-3	2 (4)	0
Primary biliary site			0.07
Gallbladder	26 (47)	4 (40)
Intrahepatic bile duct	20 (36)	2 (20)
Extrahepatic bile duct	9 (16)	3 (30)
Ampulla of Vater	0	1 (10)
Baseline sum of longest diameter(median, range, cm)	9 (1.0-31.9)	2.8 (1.2-16.0)	0.04

ECOG: Eastern Cooperative Oncology Group.

Table 2 Tumor response n (%)

	Unresectable(n = 55)	Recurrent(n = 10)	P value
Complete response	0	2 (20.0)
Partial response	14 (25.5)	2 (20.0)
Stable disease	29 (52.7)	3 (30.0)
Progressive disease	10 (18.2)	2 (20.0)
Not evaluable	2 (3.6)	1 (10.0)
Response rate	25.5%	40.0%	0.34
Disease control rate	78.2%	70.0%	0.57

ECOG: Eastern Cooperative Oncology Group.

Table 3 Drug administration

	Unresectable(n = 55)	Recurrent(n = 10)	P value
Treatment cycle
Median, range	4 (1-26)	7.5 (1-23)	0.15
Dose intensity (overall)
Gemcitabine	96.8%	83.5%	< 0.01
S-1	91.8%	75.9%	< 0.01
Dose intensity (first two cycles)
Gemcitabine	95.3%	89.4%	0.13
S-1	90.7%	78.9%	0.04

Table 4 Toxicity n (%)

	Unresectable(n = 55)		Recurrent(n = 10)
	All grades	Grade 3-4	All grades	Grade 3-4
Hematological
Leukopenia	33 (60)	16 (29)	9 (90)	2 (20)
Neutropenia	30 (55)	16 (29)	9 (90)	6 (60)
Anemia	41 (75)	9 (16)	7 (70)	1 (10)
Thrombocytopenia	25 (45)	9 (16)	5 (50)	0
Non-hematological
Nausea	12 (22)	1 (2)	4 (40)	0
Vomiting	3 (5)	0	2 (20)	0
Anorexia	19 (35)	2 (4)	4 (40)	0
Stomatitis	14 (25)	0	2 (20)	0
Diarrhea	7 (13)	0	0	0
Constipation	16 (29)	0	1 (10)	0
Pigmentation	12 (22)	0	3 (30)	0
Skin rash	10 (18)	3 (5)	2 (20)	0
Liver dysfunction	7 (13)	1 (2)	0	0