Efficacy and safety of sintilimab combined with nab-paclitaxel plus S-1 for neoadjuvant treatment of locally advanced gastric cancer

Table 1 Baseline characteristics in group immune checkpoint inhibitor and group non-immune checkpoint inhibitor, n (%)

Variable	Group ICI (n = 53)	Group non-ICI (n = 29)	P value
Age (years)
≥ 65	31 (58.5)	12 (41.4)	0.138
< 65	22 (41.5)	17 (58.6)	-
Gender
Male	39 (73.6)	21 (72.4)	0.909
Female	14 (26.4)	8 (27.6)	-
ECOG
0-1	47 (88.7)	27 (93.1)	0.798
2	6 (13.3)	2 (6.9)	-
C-TNM
III	39 (73.6)	23 (79.3)	0.564
IVa	14 (26.4)	6 (20.7)	-
Tumor location
Upper	30 (56.6)	22 (75.9)	0.174
Middle	13 (24.5)	3 (10.3)	-
Lower	10 (18.9)	4 (13.8)	-
Differentiation degree
Poorly	22 (41.5)	16 (55.2)	0.236
Moderately-highly	31 (58.5)	13 (44.8)	-
Vascular tumor embolus	29 (54.7)	21 (72.4)	0.116
Nerve infiltration	29 (54.7)	22 (75.9)	0.059
Tumor size
> 5 cm	11 (20.8)	11 (37.9)	0.093
≤ 5 cm	42 (79.2)	18 (62.1)	-

ICI: Immune checkpoint inhibitor; ECOG: Eastern Cooperative Oncology Group; C-TNM: Tumor-node-metastasis.

Table 2 Radiological response in group immune checkpoint inhibitor and group non-immune checkpoint inhibitor, n (%)

Variable	Group A (n = 53)	Group B (n = 29)	P value
CR	7 (13.2)	0 (0.0)	0.048
PR	30 (56.6)	9 (31.0)	0.037
SD	15 (28.3)	18 (62.1)	0.004
PD	1 (1.9)	2 (6.7)	0.549
ORR	37 (69.8)	9 (31.0)	0.001
DCR	52 (98.1)	27 (93.1)	0.284

CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; ORR: Objective response rate; DCR: Disease control rate.

Table 3 Pathological evaluation of response in group immune checkpoint inhibitor and group non-immune checkpoint inhibitor, n (%)

Variable	Group ICI (n = 53)	Group non-ICI (n = 29)	P value
pCR	7 (13.2)	0 (0.0)	0.048
MPR	19 (35.8)	4 (13.8)	0.041
ypT0	8 (15.1)	0 (0.0)	0.046
ypN0	25 (47.2)	10 (34.5)	0.267
TRG1a	7 (13.2)	0 (0.0)	0.030
TRG1b	12 (22.6)	4 (13.8)	-
TRG2	23 (43.4)	14 (48.3)	-
TRG3	11 (20.8)	11 (39.7)	-

ICI: Immune checkpoint inhibitor; pCR: Pathologic complete response; MPR: Major pathologic response; ypT0: y pathological tumor stage 0; ypN0: y pathological node stage 0; TRG: Tumor regression grading.

Table 4 Perioperative treatment-related adverse events in group immune checkpoint inhibitor and group non-immune checkpoint inhibitor, n (%)

Variable	Group ICI (n = 53)						Group non-ICI (n = 29)
	0	I	II	III	V	Total	0	I	II	III	V	Total	P value
Leucopenia	38	9	2	2	2	15 (28.3)	22	3	2	1	1	7 (24.1)	0.684
Neutropenia	35	10	5	2	1	18 (34.0)	21	3	3	2	0	8 (27.6)	0.553
Anemia	40	9	3	1	0	13 (24.5)	24	2	3	0	0	5 (17.2)	0.446
Thrombocytopenia	51	1	1	0	0	2 (3.8)	29	0	0	0	0	0 (0.0)	0.537
Serum AST/ALT increase	38	10	2	2	1	15 (28.3)	21	6	2	0	0	8 (27.6)	0.945
Elevated bilirubin index	49	3	1	0	0	4 (7.5)	27	2	0	0	0	2 (6.9)	1.000
Electrolyte disturbance	46	6	0	1	0	7 (13.2)	27	2	0	0	0	2 (6.9)	0.614
Serum creatinine increase	50	3	0	0	0	3 (5.7)	29	0	0	0	0	0 (0.0)	0.490
Hyper- or hypothyroidism	46	3	2	0	0	5 (9.4)	29	0	0	0	0	0 (0.0)	0.221
Myocardial enzyme increase	49	4	0	0	0	4 (7.5)	29	0	0	0	0	0 (0.0)	0.327
Pneumonia	53	0	0	0	0	0 (0.0)	29	0	0	0	0	0 (0.0)	NA
Adrenocortical insufficiency	52	0	0	1	0	1 (1.9)	29	0	0	0	0	0 (0.0)	1.000
Nausea/vomiting	40	9	1	1	2	13 (24.5)	23	2	1	1	2	6 (20.7)	0.694
Grade 0	-	-	-	-	-	28 (52.8)	-	-	-	-	-	17 (58.6)	0.967
Grade I	-	-	-	-	-	8 (15.1)	-	-	-	-	-	4 (13.8)	-
Grade II	-	-	-	-	-	5 (9.4)	-	-	-	-	-	3 (10.3)	-
Grade III	-	-	-	-	-	6 (11.3)	-	-	-	-	-	2 (6.9)	-
Grade IV	-	-	-	-	-	6 (11.3)	-	-	-	-	-	3 (10.3)	-
Overall rate	-	-	-	-	-	25 (47.2)	-	-	-	-	-	12 (41.4)	0.614
Any grade	-	-	-	-	-	41 (77.4)	-	-	-	-	-	23 (82.8)	0.564

ICI: Immune checkpoint inhibitor; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase.