SOX plus sintilimab vs P-SOX vs SOX as neoadjuvant therapy in advanced gastric cancer: Efficacy and safety

Table 1 Basic patient characteristics and short-term efficacy, n (%)

Variables	Total (n = 299)	P-SOX (n = 118)	SOX (n = 100)	SOX + XDL (n = 81)	P value
Age					0.451
≤ 60	164 (54.8)	69 (58.5)	50 (50)	45 (55.6)
> 60	135 (45.2)	49 (41.5)	50 (50)	36 (44.4)
Gender					0.056
Male	240 (80.3)	102 (86.4)	79 (79)	59 (72.8)
Female	59 (19.7)	16 (13.6)	21 (21)	22 (27.2)
ASA					0.666
1 + 2	261 (87.3)	102 (86.4)	86 (86)	73 (90.1)
3	38 (12.7)	16 (13.6)	14 (14)	8 (9.9)
Differentiation					0.238
Well	82 (27.4)	33 (28)	28 (28)	21 (25.9)
Moderate	80 (26.8)	25 (21.2)	34 (34)	21 (25.9)
Poorly	137 (45.8)	60 (50.8)	38 (38)	39 (48.1)
cT stage					0.264
2	71 (23.7)	26 (22)	26 (26)	19 (23.5)
3	155 (51.8)	56 (47.5)	51 (51)	48 (59.3)
4	73 (24.4)	36 (30.5)	23 (23)	14 (17.3)
cN stage					0.066
Negative	92 (30.8)	41 (34.7)	22 (22)	29 (35.8)
Positive	207 (69.2)	77 (65.3)	78 (78)	52 (64.2)
cTNM					0.083
II	148 (49.5)	56 (47.5)	47 (47)	45 (55.6)
IIIA	28 (9.4)	13 (11)	11 (11)	4 (4.9)
IIIB	62 (20.7)	22 (18.6)	17 (17)	23 (28.4)
IIIC	61 (20.4)	27 (22.9)	25 (25)	9 (11.1)
RECIST 1.1					0.099
Ineffective	117 (39.1)	48 (40.7)	45 (45)	24 (29.6)
Effective	182 (60.9)	70 (59.3)	55 (55)	57 (70.4)
Lauren					0.616
Diffuse	107 (35.8)	42 (35.6)	39 (39)	26 (32.1)
Mixed	141 (47.2)	58 (49.2)	41 (41)	42 (51.9)
Intestinal	51 (17.1)	18 (15.3)	20 (20)	13 (16)
Tumor location					0.955
Upper	75 (25.1)	29 (24.6)	26 (26)	20 (24.7)
Middle	116 (38.8)	44 (37.3)	41 (41)	31 (38.3)
Lower	108 (36.1)	45 (38.1)	33 (33)	30 (37)
TRG					0.320
Effective	262 (87.6)	104 (88.1)	84 (84)	74 (91.4)
Ineffective	37 (12.4)	14 (11.9)	16 (16)	7 (8.6)
Tumor diameter					0.152
≤ 2	156 (52.2)	55 (46.6)	57 (57)	44 (54.3)
2-5	79 (26.4)	29 (24.6)	26 (26)	24 (29.6)
≥ 5	64 (21.4)	34 (28.8)	17 (17)	13 (16)

Tumor location is classified as upper 1/3, middle 1/3, lower 1/3, diffuse TNM staging according to the American Cancer Consortium. ASA: American Society of Anesthesiologists Score; RECIST: Response Evaluation Criteria in Solid Tumors; TRG: Tumor regression grade; XDL: Sintilimab.

Table 2 Side effects associated with three groups treatment, n (%)

Variables	Total (n = 299)	P-SOX (n = 118)	SOX (n = 100)	SOX + XDL (n = 81)	P value
Nausea and vomiting					0.786
0	63 (21.1)	24 (20.3)	20 (20)	19 (23.5)
1	171 (57.2)	65 (55.1)	62 (62)	44 (54.3)
2	58 (19.4)	27 (22.9)	16 (16)	15 (18.5)
3	7 (2.3)	2 (1.7)	2 (2)	3 (3.7)
Liver toxicity					0.912
0	254 (84.9)	100 (84.7)	83 (83)	71 (87.7)
1	39 (13)	15 (12.7)	15 (15)	9 (11.1)
2	6 (2)	3 (2.5)	2 (2)	1 (1.2)
Alopecia					0.009
0	178 (59.5)	64 (54.2)	53 (53)	61 (75.3)
1	107 (35.8)	46 (39)	42 (42)	19 (23.5)
2	14 (4.7)	8 (6.8)	5 (5)	1 (1.2)
Peripheral sensory neuropathy					0.426
0	143 (47.8)	51 (43.2)	54 (54)	38 (46.9)
1	124 (41.5)	50 (42.4)	40 (40)	34 (42)
2	27 (9)	15 (12.7)	5 (5)	7 (8.6)
3	5 (1.7)	2 (1.7)	1 (1)	2 (2.5)
Fewer neutrophils					0.231
0	218 (72.9)	88 (74.6)	70 (70)	60 (74.1)
1	52 (17.4)	23 (19.5)	17 (17)	12 (14.8)
2	18 (6)	3 (2.5)	7 (7)	8 (9.9)
3	10 (3.3)	3 (2.5)	6 (6)	1 (1.2)
4	1 (0.3)	1 (0.8)	0 (0)	0 (0)
Fewer white blood cells					0.838
0	196 (65.6)	80 (67.8)	65 (65)	51 (63)
1	66 (22.1)	23 (19.5)	21 (21)	22 (27.2)
2	26 (8.7)	9 (7.6)	10 (10)	7 (8.6)
3	7 (2.3)	3 (2.5)	3 (3)	1 (1.2)
4	4 (1.3)	3 (2.5)	1 (1)	0 (0)
Fewer platelets					0.457
0	215 (71.9)	87 (73.7)	72 (72)	56 (69.1)
1	54 (18.1)	19 (16.1)	20 (20)	15 (18.5)
2	25 (8.4)	10 (8.5)	5 (5)	10 (12.3)
3	5 (1.7)	2 (1.7)	3 (3)	0 (0)
Anemia					0.794
0	152 (50.8)	63 (53.4)	49 (49)	40 (49.4)
1	106 (35.5)	39 (33.1)	37 (37)	30 (37)
2	26 (8.7)	10 (8.5)	7 (7)	9 (11.1)
3	15 (5)	6 (5.1)	7 (7)	2 (2.5)

XDL: Sintilimab.

Table 3 Single-factor Cox regression analysis

Variable	Z	HR (95%CI)	P value
Age
≤ 60		Reference
> 60	1.059	1.189 (0.863, 1.638)	0.290
Gender
Male		Reference
Female	1.286	1.285 (0.877, 1.883)	0.198
ASA
1 + 2		Reference
3	1.184	1.292 (0.846, 1.973)	0.236
Differentiation
Well		Reference
Moderate	1.511	1.469 (0.892, 2.420)	0.131
Poorly	4.465	2.614 (1.714, 3.986)	< 0.001
cT stage
2		Reference
3	-0.739	0.853 (0.561, 1.299)	0.460
4	3.075	2.049 (1.297, 3.237)	0.002
cN stage
Negative		Reference
Positive	4.551	2.417 (1.653, 3.535)	< 0.001
cTNM
II		Reference
IIIA	1.560	1.750 (0.866, 3.533)	0.119
IIIB	5.165	2.915 (1.942, 4.374)	< 0.001
IIIC	7.878	5.049 (3.375, 7.554)	< 0.001
RECIST 1.1
Ineffective		Reference
Effective	-3.636	0.550 (0.398, 0.759)	< 0.001
Lauren
Diffuse		Reference
Mixed	-1.152	0.811 (0.569, 1.158)	0.249
Intestinal	-0.203	0.953 (0.600, 1.514)	0.839
Tumor location
Upper		Reference
Middle	0.741	1.163 (0.780, 1.736)	0.459
Lower	-0.093	0.981 (0.654, 1.471)	0.926
TRG
Ineffective		Reference
Effective	3.110	2.084 (1.312, 3.310)	0.002
Tumor diameter
≤ 2		Reference
2-5	3.658	2.026 (1.388, 2.958)	< 0.001
≥ 5	5.225	2.922 (1.954, 4.368)	< 0.001

ASA: American Society of Anesthesiologists Score; RECIST: Response Evaluation Criteria in Solid Tumors; TRG: Tumor regression grade.

Table 4 Multi-factor Cox regression analysis

Variable	Z	HR (95%CI)	P value
Differentiation
Well		Reference
Moderate	1.573	1.516 (0.903, 2.545)	0.116
Poorly	2.678	1.848 (1.179, 2.896)	0.007
cN stage
Negative		Reference
Positive	2.872	1.794 (1.204, 2.672)	0.004
cTNM
II		Reference
IIIA	1.100	1.493 (0.731, 3.048)	0.271
IIIB	4.213	2.477 (1.625, 3.778)	< 0.001
IIIC	5.834	3.750 (2.405, 5.846)	< 0.001
RECIST 1.1
Ineffective		Reference
Effective	-3.259	0.574 (0.411, 0.802)	0.001
TRG
Ineffective		Reference
Effective	2.580	2.008 (1.182, 3.410)	0.010
Tumor diameter
≤ 2		Reference
2-5	3.453	1.974 (1.342, 2.903)	0.001
≥ 5	5.282	3.145 (2.056, 4.811)	< 0.001

RECIST: Response Evaluation Criteria in Solid Tumors; TRG: Tumor regression grade.