Perioperative cimetidine administration promotes peripheral blood lymphocytes and tumor infiltrating lymphocytes in patients with gastrointestinal cancer: Results of a randomized controlled clinical trial

Table 1 Clinico-pathological characteristics of 49 GI cancer patients

Parameters	Treatment group(n = 25)	Control group(n = 24)
Age (y)
Mean (range)	50 (25-73)	53 (27-78)
Gender
Male	13	16
Female	12	8
Tumor sites
Stomach	6	5
Colon	3	3
Rectum	16	16
Pathological types
Tubular adenocarcinoma	14	12
Papillary adenocarcinoma	3	3
Villous adenocarcinoma	2	1
Signet-ring-cell carcinoma	2	3
Mucous adenocarcinoma	4	5
TNM stages
I	3	5
II	7	9
III	9	6
IV	6	4
Tumor differentiation
Well differentiated	5	6
Moderately differentiated	8	7
Poorly differentiated	12	11

All the variables showed no statistically significant differences between the two groups (P > 0.05).

Table 2 Baseline values of lymphocyte subpopulations in pe-ripheral blood mononuclear cells of normal control, treatment and control groups (%, (^-χ±s)

Groups	n	CD3+	CD4+	CD8+	CD57+	CD4+/CD8+
Normal	20	67.1 ± 6.3	40.2 ± 5.1	27.7 ± 5.0	18.5 ± 2.31	1.49/0.24
control
Treatment	25	60.8 ± 6.3b	33.6 ± 4.2b	30.6 ± 5.2	14.8 ± 4.4a	1.15 ± 0.34b
Control	24	60.5 ± 4.6b	33.4 ± 3.7b	31.0 ± 3.9a	15.0 ± 2.8a	1.11 ± 0.25b

^aP < 0.05 vs normal control, ^bP < 0.01 vs normal control

Table 3 Changes of lymphocytes and NK cells in perioperative period (%, ^-χ±s)

Items Groups		Perioperative period
		A	B	C	D
CD3	Treatment	60.8 ± 6.3	63.0 ± 4.9d	60.3 ± 5.4a	64.2 ± 3.9d
	Control	60.5 ± 4.6	61.0 ± 2.7	56.2 ± 3.8bd	58.6 ± 4.0ab
CD4	Treatment	33.6 ± 4.2	36.3 ± 3.4a	32.8 ± 4.0d	36.6 ± 6.2d
	Control	33.4 ± 3.7	32.8 ± 3.3b	28.1 ± 3.4bd	30.4 ± 3.3ab
CD8	Treatment	30.6 ± 5.2	29.6 ± 4.3	31.1 ± 4.3	29.4 ± 3.6
	Control	31.0 ± 3.9	31.2 ± 4.8	32.9 ± 4.4a	32.1 ± 5.3
CD57+	Treatment	14.8 ± 4.4	15.7 ± 3.8	17.2 ± 3.7	21.1 ± 4.5b
	Control	15.0 ± 2.8	13.1 ± 2.5	14.2 ± 2.2b	15.6 ± 1.7b
CD4	Treatment	1.15 ± 0.34	1.25 ± 0.23a	1.08 ± 0.21d	1.27 ± 0.30d
/CD8	Control	1.11 ± 0.25	1.08 ± 0.22b	0.87 ± 0.17bd	0.98 ± 0.24ab

A: at admission, B: before operation, C: on the 2nd postopera-tive day, D: on the 10th postoperative day.

^aP < 0.05,

^dP < 0.01, B vs A, C vs B, D vs C;

^bP < 0.01 vs treatment group.

Table 4 TIL responses in treatment and control groups

Groups	SR		PR		Total	Rate (%)
	+++	++	+	+
Treatment	9	8	6	2	25	68b
Control	2	4	9	9	24	25
Total	23		26		49

SR = significant response, PR = poor response.

^bP < 0.01 vs control group, chi-square test.

Table 5 Comparison in TIL responses by TNM stages between control and treatment groups

TNM stages	Groups	Poor response	Significant response	Response rate (%)
I	Treatment	2	1	33
	Control	3	2	40
II	Treatment	3	4	57
	Control	6	3	33
III	Treatment	2	7	78a
	Control	5	1	17
IV	Treatment	1	5	83b
	Control	4	0	0

^aP < 0.05,

^bP < 0.01, vs control (Fisher’s exact test).