Efficacy and safety of cord blood-derived dendritic cells plus cytokine-induced killer cells combined with chemotherapy in the treatment of patients with advanced gastric cancer: a randomized Phase II study

Figures & data

Figure 1 Morphological characteristics of immune cells.

Notes: (A) Morphology of CB mononuclear cells. (B) Morphology of mature CB-DC. (C) Morphology of CB-DC-CIK.
Abbreviations: CB, cord blood; DC, dendritic cells; CB-DC-CIK, cord blood-derived dendritic cells and cytokine-induced killer cells.

Figure 2 The proliferation rate of CD3⁺ (A) and CD3⁺CD56⁺ (B) subsets and the changes in CB-DC and CB-DC-CIK cell phenotypes over different culture times (C and D).

Abbreviations: CB, cord blood; DC, dendritic cells; CB-DC-CIK, cord blood-derived dendritic cells and cytokine-induced killer cells.

Figure 3 Cytotoxicity of different numbers of CB-DC-CIK against the gastric cancer cell lines SGC7901 (A) and BGC823 (B) was tested by CCK-8 assay. *P<0.05, **P<0.01.

Abbreviations: CB-DC-CIK, cord blood-derived dendritic cells and cytokine-induced killer cells; E:T, effector cells:target cells.

Table 1 Expression of cytokines, including IFN-γ, TNF-α, and IL-2, of CB-DC-CIK after in vitro culture for 8 and 15 days

Culture time (days)	Cytokines (pg/mL)
	IFN-γ	TNF-α	IL-2
8 days	568.5±129.5	58.5±15.7	623.8±161.5
15 days	998.4±187.2*	123.3±25.9*	1,178.8±257.8*

Note:

* P<0.05, cultured for 15 days compared with 8 days.

Abbreviation: CB-DC-CIK, cord blood-derived dendritic cells and cytokine-induced killer cells.

Table 2 Clinical characteristics of the patients with advanced gastric cancer in the two groups

Characteristic	Total (n=28)	Control (n=15)	Experimental (n=13)	χ^2	P-value
Sex				0.346	0.686
Male	20	10	10
Female	8	5	3
Age (years)				0.185	0.718
<60	12	7	5
>60	16	8	8
Tumor site				0.428	0.689
Gastric cardia	19	11	8
Gastric body	9	4	5
Histologic differentiation				0.597	0.476
Moderately differentiated	10	7	8
Poorly differentiated	18	8	5
Tumor stage				0.712	0.460
III	19	8	9
IV	9	7	4
Chemotherapy regimen				0.038	1.000
FOLFOX4	22	12	10
DCF	6	3	3

Abbreviations: DCF, docetaxel, cisplatin, 5-florouracil; FOLFOX4, folinic acid, fluorouracil, oxaliplatin.

Table 3 Comparison of the ORR and DCR between the two groups

Group	ORR		DCR		CR	PR	SD	PD
	N	%	N	%
Exp (n=13)	5	38.5	11	84.6	0	5	6	2
Con (n=15)	3	20	10	66.7	0	3	7	5
χ^2	1.122		1.154
P-value	0.410		0.396

Abbreviations: ORR, overall response rate; DCR, disease control rate; CR, cytotoxicity rate; PR, partial response; SD, stable disease; PD, progressive disease; Exp, experimental; Con, control.

Figure 4 Kaplan–Meier estimates for OS and DFS for patients in the two groups (A and B), 1- and 2-year OS and the DFS rate in the two groups (C and D).

Abbreviations: OS, overall survival; DFS, disease-free survival.

Table 4 Tumor markers including CEA, CA199, and CA724 in the two groups (mean ± sd, %)

Group	CEA (ng/mL)	CA199 (ng/mL)	CA724 (ng/mL)
Exp (n=13)
Pretherapy	23.7±15.8	47.2±32.5	22.5±14.6
Posttherapy	13.6±10.2*,**	28.9±18.2*,**	16.4±11.3*,**
Con (n=15)
Pretherapy	22.6±14.1	46.8±33.6	24.1±15.2
Posttherapy	18.5±12.3*	35.6±22.7*	20.3±13.6*

Notes:

* P<0.05, comparisons between pretherapy and posttherapy in each group.

** P<0.05, posttherapy comparisons between the two groups.

Abbreviations: Exp, experimental; Con, control; sd, standard deviation.

Table 5 T lymphocyte subsets in the two groups (mean ± sd, %)

Group	CD3^+	CD4^+	CD8^+	CD4^+/CD8^+	CD^‒CD56^+	CD3^+CD56^+
Exp (n=13)
Pretherapy	61.3±10.6	30.3±6.3	29.6±6.1	1.03±0.21	9.6±2.6	3.2±1.8
Posttherapy	65.2±11.5	36.1±7.5*,**	28.2±6.3	1.33±0.28*,**	14.6±3.3*,**	6.3±2.3*,**
Con (n=15)
Pretherapy	60.8±10.3	29.8±5.9	28.9±6.5	1.03±0.20	9.4±2.3	3.3±1.9
Posttherapy	60.2±10.8	29.2±5.2	29.6±7.3	0.97±0.19	9.7±2.5	3.1±1.8

Notes:

* P<0.05, comparisons between pretherapy and posttherapy in each group.

** P<0.05, posttherapy comparisons between the two groups.

Abbreviations: Exp, experimental; Con, control; sd, standard deviation.

Table 6 Expression of cytokines including IFN-γ, TNF-α, and IL-2 in the two groups (mean ± sd, %)

Group	IFN-γ (pg/mL)	TNF-α (pg/mL)	IL-2 (pg/mL)
Exp (n=13)
Pretherapy	18.2±5.8	28.2±8.3	42.1±12.6
Posttherapy	45.4±13.7*,**	39.5±12.7*,**	84.2±23.7*,**
Con (n=15)
Pretherapy	18.5±6.1	27.8±7.9	43.7±13.9
Posttherapy	17.8±5.9	28.3±7.4	41.9±14.1

Notes:

* P<0.05, comparisons between pretherapy and posttherapy in each group.

** P<0.05, posttherapy comparisons between the two groups.

Abbreviations: Exp, experimental; Con, control; sd, standard deviation.

Table 7 Comparison of the adverse effects between the two groups

Group	Nausea and vomiting		Thrombocytopenia		Neutropenia		Diarrhea		Fever
	No	%	No	%	No	%	No	%	No	%
Exp (n=13)	4	30.8	3	23.1	2	15.4	2	15.4	5	38.5
Con (n=15)	10	66.7	5	33.3	4	26.7	3	20.0	1	6.7
χ^2	3.462		0.346		0.508		0.098		4.032
P-value	0.128		0.686		0.655		1.000		0.069

Abbreviations: Exp, experimental; Con, control.