No long-term survival benefit with sustained-release 5-fluorouracil implants in patients with stages II and III gastric cancer

Table 1 Clinicopathological characteristics of different gastric cancer group

	SR group (n = 148)	NSR group (n =161)	P value
Age (yr)	57.15 ± 10.71	59.27 ± 11.52	0.2917
Gender, n (%)			0.781
Male	106 (71.6)	113 (70.2)
Female	42 (28.4)	48 (29.8)
BMI (kg/m2)	23.97 ± 3.591	23.68 ± 3.488	0.9716
Neoadjuvant therapy, n (%)			0.52
Yes	29 (19.6)	27 (16.8)
No	119 (80.4)	134 (83.2)
Cardiovascular disease, n (%)			0.503
Yes	32 (21.6)	40 (24.8)
No	116 (78.4)	121 (75.2)
Diabetes, n (%)			0.093
Yes	10 (6.8)	20 (12.4)
No	138 (93.2)	141 (87.6)
T stage, n (%)			0.699
T1 and T2	23 (15.5)	21 (13.0)
T3 and T4	96 (64.9)	113 (70.2)
yp T1 and T2	5 (3.4)	3 (1.9)
yp T3 and T4	24 (16.2)	24 (14.9)
N stage, n (%)			0.533
N0 and N1	44 (29.7)	51 (31.7)
N2 and N3	75 (50.7)	83 (51.6)
yp N0 and yp N1	11 (7.4)	15 (9.3)
yp N2 and yp N3	18 (12.2)	12 (7.5)
M stage, n (%)			> 0.999
M0	148 (100.00)	161 (100)
TNM stage, n (%)			0.91
Stage II	57 (38.5)	61 (37.9)
Stage III	91 (61.5)	100 (62.1)
Borrmann classification, n (%)			0.207
Superficial type	3 (2.0)	1 (0.6)
Type I	10 (6.8)	9 (5.6)
Type II	41 (27.7)	36 (22.4)
Type III	73 (49.3)	78 (48.4)
Type IV	2 (1.4)	9 (5.6)
NA	19 (12.8)	28 (17.4)
Lauren classification, n (%)			0.782
Intestinal type	42 (28.4)	48 (29.8)
Diffuse type	64 (43.2)	69 (42.9)
Mixed type	34 (23.0)	39 (24.2)
NA	8 (5.4)	5 (3.1)
Differentiation, n (%)			0.666
Low	88 (59.5)	91 (56.5)
Low-medium	36 (24.3)	39 (24.2)
Medium	19 (12.8)	26 (16.1)
Medium-high and high	2 (1.4)	4 (2.5)
NA	3 (2.0)	1 (0.6)
Nerve invasion, n (%)			0.26
Yes	73 (49.3)	92 (57.1)
No	24 (16.2)	27 (16.8)
NA	51 (34.5)	42 (26.1)
Vascular tumor thrombus, n (%)			0.23
Yes	57 (38.5)	57 (38.5)
No	40 (27.0)	54 (33.5)
NA	51 (34.5)	42 (26.1)
Pathological classification, n (%)			0.481
Signet-ring cell carcinoma	45 (30.4)	55 (34.2)
Another adenocarcinoma	103 (69.6)	106 (65.8)
Resection type, n (%)			0.057
Total gastrectomy	53 (35.8)	54 (33.5)
Proximal gastrectomy	7 (4.7)	20 (12.4)
Distal gastrectomy	88 (59.5)	87 (54.0)
R0 resection	148 (100.00)	161 (100)	> 0.999
Resected lymph nodes number	39.21 ± 14.13	35.73 ± 13.53	0.0145
Positive lymph nodes number	7.393 ± 8.864	6.856 ± 9.743	0.2319

SR: Sustained-release; NSR: Not sustained-release; BMI: Body mass index; NA: Not available.

Table 2 Postoperative complications in patients

	SR group (n = 148), n (%)	NSR group (n = 161), n (%)	P value
Pulmonary infection	3 (2.0)	6 (3.8)	0.583
Anastomotic fistula	6 (4.0)	6 (3.8)	0.882
Postoperative bleeding	1 (0.7)	3 (1.9)	0.675
Abdominal infection	3 (2.0)	9 (5.6)	0.105
Intestinal obstruction	3 (2.0)	1 (0.6)	0.556

SR: Sustained-release; NSR: Not sustained-release.

Table 3 Univariate and multivariate Cox analysis of patients

	Univariate analysis			Multivariate analysis
Characteristics	HR	95%CI	P value	HR	95%CI	P value
Gender
Male	Reference
Female	1.058	0.712-1.572	0.781
Age, yr
< 60	Reference
≥ 60	1.03	0.717-1.481	0.872
Neoadjuvant therapy
No	Reference
Yes	2.188	1.448-3.306	< 0.001	2.118	1.194-3.759	0.01
BMI
Normal < 24	Reference
Abnormal ≥ 24	0.752	0.516-1.098	0.14
Cardiovascular disease
No	Reference
Yes	0.943	0.606-1.467	0.794
Diabetes
No	Reference
Yes	0.891	0.479-1.658	0.715
Drug administration
No	Reference
Yes	1.052	0.731-1.513	0.786
Resection type
Total gastrectomy	Reference
Partial gastrectomy	0.558	0.387-0.804	0.002	0.663	0.428-1.027	0.066
Borrmann classification
Superficial type, Type I and II	Reference
Type III and IV	2.203	1.378-3.522	0.001	1.562	0.951-2.566	0.078
Lauren classification
Intestinal type	Reference
Others	1.158	0.762-1.762	0.492
Differentiation type
Low	Reference
Others	0.874	0.535-1.430	0.593
TNM stage
Stage II	Reference
Stage III	3.12	1.977-4.926	< 0.001	1.315	0.561-3.084	0.528
T stage
T1 and T2	Reference
T3 and T4	3.382	1.649-6.937	0.001	1.9	0.777-4.645	0.159
N stage
N0 and N1	Reference
N2 and N3	2.516	1.636-3.869	< 0.001	2.224	1.082-4.572	0.03
Signet-ring cell carcinoma
Yes	Reference
No	1.188	0.736-1.916	0.481
Nerve invasion
No	Reference
Yes	1.703	0.938-3.093	0.08
Vascular tumor thrombus
No	Reference
Yes	1.099	0.701-1.722	0.681

HR: Hazard ratio; CI: Confidence interval; BMI: Body mass index.