Capecitabine with radiation is an effective adjuvant therapy in gastric cancers

Table 1 Patient characteristics n (%)

	All patients (n = 108)	XRT (n = 33)	5FU-RT (n = 52)	Chemo alone (n = 23)	P-value1 for XRT vs
					5FU-RT	Chemo alone
Age (yr)
Median	60	64	57	56	0.0032	0.032
Inter-quartile range	49.5-66.0	57.7-68.8	48.0-63.7	49.3-65.7
Gender
Male	65 (60.2)	22 (66.7)	30 (57.7)	13 (56.5)	0.5	0.6
Female	43 (39.8)	11 (33.3)	22 (42.3)	10 (43.5)
ECOG
0	6 (5.6)	1 (3.0)	3 (5.8)	2 (8.7)	1.0	0.6
1	102 (94.4)	32 (97.0)	49 (94.2)	21 (91.3)
Helicobacter pylori status
Yes	36 (53.7)	16 (66.7)	15 (50.0)	5 (38.5)	0.3	0.2
No	31 (46.3)	8 (33.3)	15 (50.0)	8 (61.5)
Surgical margins
Positive	21 (19.4)	4 (12.1)	14 (26.9)	3 (13.0)	0.2	1.0
Negative	87 (80.6)	29 (87.9)	38 (73.1)	20 (87.0)
Stage
1 or 2	38 (35.2)	12 (36.4)	14 (26.9)	12 (52.2)	0.5	0.3
3 or 4	70 (64.8)	21 (63.6)	38 (73.1)	11 (47.8)
Grade
1 or 2	31 (28.7)	12 (36.4)	12 (23.1)	7 (30.4)	0.2	0.8
3	77 (71.3)	21 (63.6)	40 (76.9)	16 (69.6)
Albumin
< 30	12 (13.3)	4 (12.9)	4 (10.0)	4 (21.1)	0.7	0.5
≥ 30	78 (86.7)	27 (87.1)	36 (90.0)	15 (78.9)
CEA
Normal	50 (90.9)	17 (89.5)	24 (92.3)	9 (90.0)	1.0	1.0
High	5 (9.1)	2 (10.5)	2 (7.7)	1 (10.0)
Hemoglobin
< 10	26 (25.7)	8 (24.2)	14 (29.2)	4 (20.0)	0.8	1.0
≥ 10	75 (74.3)	25 (75.8)	34 (70.8)	16 (80.0)

¹All P-values calculated using Fisher’s exact test unless otherwise stated;

²P-value calculated using the Mann-Whitney U test. XRT: Capecitabine + radiation; 5FU-RT: 5-fluorouracil + radiation; ECOG: Eastern Cooperative Oncology Group status; CEA: Carcinoembryonic antigen.

Table 2 Recurrence-free survival and overall survival analysis

Variable	Categories/units	n	HR (95% CI)	P-value
Recurrence-free survival
Treatment	XRT	108	1
	5FU-RT		1.00 (0.508-1.959)	1.0
	Chemo only		1.05 (0.448-2.462)	0.9
Treatment	XRT	108	1
	5FU-RT		0.971 (0.477-1.966)	0.9
	Chemo only		1.031 (0.433-2.444)	0.9
Overall survival
Treatment	XRT	108	1
	5FU-RT		0.83 (0.411-1.681)	0.6
	Chemo only		1.13 (0.474-2.677)	0.8
Treatment	XRT	108	1
	5FU-RT		0.891 (0.428-1.856)	0.8
	Chemo only		1.191 (0.494-2.882)	0.7

¹Age-adjusted hazard ratio (HR). XRT: Capecitabine + radiation; 5FU-RT: 5-fluorouracil + radiation.

Table 3 Recurrence-free survival and overall survival analysis

Variable	Categories/units	Chemo alone		5FU-RT		XRT
		HR (95% CI)	P-value1	HR (95% CI)	P-value1	HR (95% CI)	P-value1
Recurrence-free survival
ECOG	0	1	0.9	1	1.0	E/N = 0/1	0.5
	1	0.92 (0.115-7.422)		1.01 (0.238-4.326)		NE
Gender	Male	1	0.9	1	0.2	1	0.5
	Female	0.91 (0.244-3.419)		1.58 (0.727-3.436)		0.65 (0.198-2.163)
Surgical margins	Positive	1	0.5	1	< 0.001	1	0.03
	Negative	0.51 (0.059-4.351)		0.16 (0.070-0.384)		0.27 (0.081-0.918)
Stage	1 or 2	1	0.1	1	0.2	1	0.06
	3 or 4	2.92 (0.724-11.773)		1.86 (0.749-4.633)		3.87 (0.853-17.586)
Grade of tumor	1, 2	1	0.3	1	0.09	1	0.3
	3	2.17 (0.444-10.636)		2.44 (0.836-7.099)		1.94 (0.515-7.288)
Overall survival
ECOG	0	1	0.8	1	0.9	E/N = 0/1	0.4
	1	0.78 (0.096-6.366)		0.95 (0.220-4.069)		NE
Gender	Male	1	1.0	1	0.2	8/22	0.7
	Female	1.02 (0.253-4.148)		1.63 (0.740-3.598)		0.78 (0.234-2.597)
Surgical margins	Positive	1	0.004	1	< 0.001	4/4	0.02
	Negative	0.10 (0.013-0.700)		0.26 (0.113-0.603)		0.25 (0.071-0.901)
Stage	1 or 2	1	0.2	1	0.1	2/12	0.06
	3 or 4	2.59 (0.646-10.412)		2.08 (0.778-5.557)		3.80 (0.829-17.397)
Grade of tumor	1, 2	1	0.4	1	0.06	3/12	0.4
	3	2.04 (0.418-9.944)		3.04 (0.903-10.239)		1.83 (0.482-6.980)

¹P -values were calculated using the Log-rank test. 5FU-RT: 5-fluorouracil + radiation; XRT: Capecitabine + radiation; ECOG: Eastern Cooperative Oncology Group status; E/N: Number of events/number of patients in the group; NE: Not estimable; HR: Hazard ratio.

Table 4 Subgroup analysis for overall and recurrence-free survival

Subgroup	Variable	Categories/units	n	Overall survival		Recurrence-free survival
				HR (95% CI)	P-value	HR (95% CI)	P-value
Surgical margins = positive	Treatment	Chemo alone	21	1		1
		5FU-RT/XRT		0.47 (0.100–2.191)	0.3	1.58 (0.206-12.154)	0.7
Stage T3/4	Treatment	Chemo alone	66	1		1
		5FU-RT/XRT		0.65 (0.294–1.454)	0.3	0.78 (0.352-1.709)	0.5
Node positive	Treatment	Chemo alone	94	1		1
		5FU-RT/XRT		0.92 (0.404–2.081)	0.8	1.10 (0.489-2.482)	0.8

5FU-RT: 5-fluorouracil + radiation; XRT: Capecitabine + radiation; HR: Hazard ratio.