Hepatic artery infusion with raltitrexed or 5-fluorouracil for colorectal cancer liver metastasis

Table 1 Summary of patient baseline characteristics

	Overall cohort (n = 42)	TOMOX (n = 18)	FOLFOX (n = 24)	P value
Gender				0.700
Male	29	13	16
Female	13	5	8
Age at first TACE (yr)	59 ± 10.7	60 ± 9.1	58 ± 11.8	0.473
Primary tumor site				0.601
Right hemicolon	10	5	5
Left hemicolon	32	19	13
Time to liver metastasis				0.508
Synchronous	28	11	17
Metachronous	14	7	7
Primary tumor grade				0.639
Poor	6	3	3
Well to moderate	36	15	21
Genetic condition				0.459
KRAS mutation	8	5	3
KRAS wild type	21	8	13
Unknown	13	5	8
Extrahepatic metastasis				0.927
Present	27	12	15
Absent	15	6	9
Combined with other local treatments				0.209
Yes	10	6	4
No	32	12	20

Table 2 Response evaluation n (%)

Response	Treatment group		P value
	FOLFOX (n = 24)	TOMOX (n = 18)
Partial response	7 (29.2)	2 (11.1)	0.158
Stable disease	14 (58.3)	11 (61.1)	0.856
Progressive disease	3 (12.5)	5 (27.8)	0.734

Table 3 Predictors of overall survival

Factor	Univariate analysis
	HR	95%CI	P value
TOMOX/FOLFOX	0.877	0.410-1.876	0.736
Male sex	0.915	0.411-2.035	0.827
Age (> 60/60 yr)	0.758	0.353-1.627	0.477
Histology (poor/well and moderate)	1.768	0.686-4.554	0.238
Primary tumor site (left/right hemicolon)	0.715	0.285-1.797	0.476
Serum CA19-9 (high/normal)	1.725	0.803-3.706	0.162
Serum CA72-4 (high/normal)	1.325	0.536-3.278	0.542
Serum CEA (high/normal)	1.339	0.463-3.873	0.590
Extrahepatic metastasis (present/absent)	1.220	0.550-2.706	0.624
Time to liver metastasis (synchronous/metachronous)	1.281	0.560-2.932	0.558
Response to TACE			0.047
PD	1.000	1.000
SD	0.275	0.081-0.931
PR	0.272	0.095-0.783

Table 4 Observed toxicity according to common terminology criteria for adverse events grading n (%)

Adverse event	TOMOX (n = 18)		FOLFOX (n = 24)		P value
	All grade	Severe	All grade	Severe
Hematological
Anemia	7 (39)		11 (46)		0.212
Leucopenia	3 (16)		12 (50)	1 (4)	0.026
Neutropenia	1 (5)		6 (25)	1 (4)	0.094
Thrombocytopenia	8 (44)		13 (54)	3 (12)	0.533
Nonhematological
Elevation of liver enzymes	18 (100)	9 (50)	19 (79)	7 (29)	0.039
Elevation of bilirubin	17 (94)	3 (17)	23 (95)	4 (17)	0.834
Nausea/vomiting	14 (78)		17 (71)		0.839
Asthenia	13 (72)		12 (50)		0.414
Neuropathy	5 (28)		7 (29)	1 (4)	0.921
Pain	14 (78)	7 (39)	19 (79)	13 (54)	0.914
Fever	6 (33)		11 (46)		0.558