Idarubicin-transarterial chemoembolization combined with gemcitabine plus cisplatin for unresectable intrahepatic cholangiocarcinoma

Table 1 The half maximal inhibitory concentration values of 10 anticancer drugs for two cholangiocarcinoma cell lines, mean ± SD

	Cholangiocarcinoma cell line
Antitumor drugs	RBE	HuCC-T1
5-FU	4.99 ± 2.92	0.30 ± 0.24
Gemcitabine	3.15 ± 0.58	7.23 ± 3.12
Lobaplatin	0.049 ± 0.009	0.062 ± 0.006
Oxaliplatin	0.054 ± 0.028	0.076 ± 0.014
Idarubicin	0.00072 ± 0.00082	0.00023 ± 0.00005
Doxorubicin	0.35 ± 1.13	0.0015 ± 0.0005
Epirubicin	0.0055 ± 0.0075	0.0088 ± 0.0069
Irinotecan	0.50 ± 0.13	0.65 ± 0.15
Cisplatin	0.029 ± 0.007	0.030 ± 0.008
Raltitrexed

5-FU: 5-fluorouracil.

Table 2 The cytotoxicity index values of 10 anticancer drugs for two cholangiocarcinoma cell lines, mean ± SD

	Cholangiocarcinoma cell line
Antitumor drugs	RBE	HuCC-T1
5-FU	19.51 ± 17.02	223.61 ± 194.21
Gemcitabine	11.79 ± 3.76	3.93 ± 0.93
Lobaplatin	206.93 ± 34.33	160.32 ± 35.81
Oxaliplatin	95.63 ± 31.13	62.26 ± 25.04
Idarubicin	1715.32 ± 743.62	6517.36 ± 4924.53
Doxorubicin	10.75 ± 7.97	1697.96 ± 740.25
Epirubicin	441.10 ± 283.93	238.35 ± 139.13
Irinotecan	40.44 ± 10.32	32.51 ± 8.29
Cisplatin	32.53 ± 6.76	38.03 ± 19.38
Raltitrexed

5-FU: 5-fluorouracil.

Table 3 Baseline demographic and clinical characteristics of the patients, mean ± SE/n (%)

Characteristics	Total (n = 50)	GemCis group (n = 31)	GemCis + IDA-TACE group (n = 19)	P value
Age, years, median (IQR)	56.5 (48.0-63.0)	57.0 (48.0-63.0)	56.0 (48.0-63.0)	0.976
Gender
Male	30 (60.0)	18 (58.1)	12 (63.2)	0.721
Female	20 (40.0)	13 (41.9)	7 (36.8)
ECOG performance status
0	16 (32.0)	9 (29.0)	7 (36.8)	0.566
1	34 (68.0)	22 (71.0)	12 (63.2)
Nodules
Single	23 (46.0)	15 (48.4)	8 (42.1)	0.665
Multiple	27 (54.0)	16 (51.6)	11 (57.9)
AJCC stage
I	6 (12.0)	4 (12.9)	2 (10.5)	0.951
II	11 (22.0)	7 (22.6)	4 (21.1)
III	17 (34.0)	11 (35.5)	6 (31.6)
IV	16 (32.0)	9 (29.0)	7 (36.8)
Largest nodule
≤ 5	28 (56.0)	19 (61.3)	9 (47.4)	0.336
> 5	22 (44.0)	12 (38.7)	10 (52.6)
Child-Pugh class
A	43 (86.0)	25 (80.6)	18 (94.7)	0.229
B	7 (14.0)	6 (19.4)	1 (5.3)
Extrahepatic spread
Absent	17 (34.0)	11 (35.5)	6 (31.6)	0.900
Present
Single metastasis	24 (48.0)	15 (48.4)	9 (47.4)
Multiple metastases	9 (18.0)	5 (16.1)	4 (21.1)
CA199, U/mL
≤ 37	12 (24.0)	6 (19.4)	6 (31.6)	0.496
> 37	38 (76.0)	25 (80.6)	13 (68.4)
CA125, U/mL
≤ 35	27 (54.0)	15 (48.4)	12 (63.2)	0.309
> 35	23 (46.0)	16 (51.6)	7 (36.8)
TBIL, μmol/mL, median (IQR)	11.2 (7.5-21.6)	11.2 (7.6-48.5)	10.3 (7.2-19.6)	0.556
Albumin, g/L	41.3 ± 6.4	42.0 ± 7.5	40.1 ± 4.1	0.302
RBC, × 109/L	4.4 ± 0.8	4.4 ± 0.9	4.3 ± 0.8	0.770
WBC, × 109/L	7.45 ± 3.1	7.7 ± 2.9	7.0 ± 3.4	0.454
Platelet, × 109/L	216.8 ± 82.1	229.8 ± 89.5	195.6 ± 66.2	0.156
PT, seconds	13.3 ± 1.2	13.4 ± 1.2	13.1 ± 1.2	0.537

IDA: Idarubicin; GemCis: Gemcitabine and cisplatin; TACE: Transarterial chemoembolization; ECOG: Eastern cooperative oncology group; AJCC: American Joint Committee on Cancer; RBC: Red blood cells; WBC: White blood cells; IQR: Interquartile range; CA: Carbohydrate antigen; TBIL: Total bilirubin; PT: Prothrombin Time.

Table 4 Safety profiles and adverse events, n (%)

Adverse event	Any grade group			Grades 3-4 group
	GemCis group (n = 31)	GemCis + IDA-TACE group (n = 19)	P value	GemCis group (n = 31)	GemCis + IDA-TACE group (n = 19)	P value
Nausea and vomiting	13 (42.9)	14 (73.7)	0.029	0 (0)	1 (5.3)	0.380
Abdominal pain	6 (19.4)	15 (78.9)	< 0.001	2 (6.5)	5 (26.3)	0.049
Myelosuppression	11 (35.5)	8 (42.1)	0.640	6 (19.4)	4 (21.1)	1.000
Fever	7 (22.6)	10 (52.6)	0.029	4 (12.9)	5 (26.3)	0.273
Fatigue	3 (9.7)	4 (21.1)	0.404	0 (0)	0 (0)	1.000
Infections	5 (16.1)	6 (31.6)	0.293	1 (3.2)	2 (10.5)	0.549
Ascites	6 (19.4)	3 (15.8)	1.000	2 (6.5)	1 (5.3)	1.000
Elevated transaminases	9 (29.0)	12 (63.2)	0.018	4 (12.9)	8 (42.1)	0.038
Hyperbilirubinemia	4 (12.9)	8 (42.1)	0.038	0 (0)	1 (5.3)	0.380

IDA: Idarubicin; GemCis: Gemcitabine and cisplatin; TACE: Transarterial chemoembolization.