Perioperative SOX plus sintilimab vs P-SOX and CAPOX in advanced gastric cancer: A real-world comparison

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

Variables1	Total (n = 323)	P-SOX (n = 148)	SOX + XDL (n = 101)	CAPOX (n = 74)	Statistic	P value
Age					χ² = 1.19	0.551
≤ 60	175 (54.18)	83 (56.08)	56 (55.45)	36 (48.65)
> 60	148 (45.82)	65 (43.92)	45 (44.55)	38 (51.35)
Sex					χ² = 2.67	0.263
Male	250 (77.40)	120 (81.08)	73 (72.28)	57 (77.03)
Female	73 (22.60)	28 (18.92)	28 (27.72)	17 (22.97)
ASA					χ² = 0.90	0.638
1 + 2	281 (87.00)	126 (85.14)	90 (89.11)	65 (87.84)
3	42 (13.00)	22 (14.86)	11 (10.89)	9 (12.16)
Differentiation					χ² = 0.69	0.953
Well	90 (27.86)	41 (27.70)	29 (28.71)	20 (27.03)
Moderate	94 (29.10)	43 (29.05)	27 (26.73)	24 (32.43)
Poorly	139 (43.03)	64 (43.24)	45 (44.55)	30 (40.54)
cT stage					χ² = 4.92	0.296
2	76 (23.53)	29 (19.59)	26 (25.74)	21 (28.38)
3	167 (51.70)	75 (50.68)	55 (54.46)	37 (50.00)
4	80 (24.77)	44 (29.73)	20 (19.80)	16 (21.62)
cN stage					χ² = 1.70	0.428
Negative	93 (28.79)	44 (29.73)	32 (31.68)	17 (22.97)
Positive	230 (71.21)	104 (70.27)	69 (68.32)	57 (77.03)
cTNM					χ² = 12.55	0.051
II	161 (49.85)	65 (43.92)	59 (58.42)	37 (50.00)
IIIA	32 (9.91)	19 (12.84)	7 (6.93)	6 (8.11)
IIIB	68 (21.05)	29 (19.59)	25 (24.75)	14 (18.92)
IIIC	62 (19.20)	35 (23.65)	10 (9.90)	17 (22.97)
RECIST1.1					χ² = 3.26	0.196
Ineffective	124 (38.39)	59 (39.86)	32 (31.68)	33 (44.59)
Effective	199 (61.61)	89 (60.14)	69 (68.32)	41 (55.41)
Lauren					χ² = 2.18	0.704
Diffuse	117 (36.22)	54 (36.49)	35 (34.65)	28 (37.84)
Mixed	150 (46.44)	64 (43.24)	51 (50.50)	35 (47.30)
Intestinal	56 (17.34)	30 (20.27)	15 (14.85)	11 (14.86)
Location					χ² = 2.03	0.730
Upper	80 (24.77)	32 (21.62)	27 (26.73)	21 (28.38)
Middle	129 (39.94)	59 (39.86)	40 (39.60)	30 (40.54)
Lower	114 (35.29)	57 (38.51)	34 (33.66)	23 (31.08)
TRG					χ² = 14.59	< 0.001
Ineffective	86 (26.63)	41 (27.70)	15 (14.85)	30 (40.54)
Effective	237 (73.37)	107 (72.30)	86 (85.15)	44 (59.46)
Tumor diameter					χ² = 2.27	0.686
≤ 2	126 (39.01)	55 (37.16)	39 (38.61)	32 (43.24)
2-5	133 (41.18)	59 (39.86)	45 (44.55)	29 (39.19)
≥ 5	64 (19.81)	34 (22.97)	17 (16.83)	13 (17.57)

¹Tumor location is classified as upper 1/3, middle 1/3, lower 1/3, diffuse tumor-node-metastasis staging according to the American Joint Committee on Cancer.

ASA: American Society of Anesthesiologists Score; RECIST: Response Evaluation Criteria in Solid Tumors; TRG: Tumor regression grade; cTNM: Clinical tumor-node-metastasis; P-SOX: Nab-paclitaxel plus oxaliplatin and S-1; SOX + XDL: Oxaliplatin plus S-1 combined with sintilimab; CAPOX: Capecitabine plus oxaliplatin.

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

Variables	Total (n = 323)	P-SOX (n = 148)	SOX + XDL (n = 101)	CAPOX (n = 74)	Statistic	P value
Nausea and vomiting					-2	0.5691
0	66 (20.43)	36 (24.32)	20 (19.80)	10 (13.51)
1	194 (60.06)	84 (56.76)	62 (61.39)	48 (64.86)
2	56 (17.34)	26 (17.57)	16 (15.84)	14 (18.92)
3	7 (2.17)	2 (1.35)	3 (2.97)	2 (2.70)
Liver toxicity					-2	0.966
0	275 (85.14)	124 (83.78)	88 (87.13)	63 (85.14)
1	44 (13.62)	22 (14.86)	12 (11.88)	10 (13.51)
2	4 (1.24)	2 (1.35)	1 (0.99)	1 (1.35)
Alopecia					χ² = 17.08	0.002
0	186 (57.59)	76 (51.35)	73 (72.28)	37 (50.00)
1	118 (36.53)	58 (39.19)	26 (25.74)	34 (45.95)
2	19 (5.88)	14 (9.46)	2 (1.98)	3 (4.05)
Peripheral sensory neuropathy					-2	0.944
0	160 (49.54)	73 (49.32)	47 (46.53)	40 (54.05)
1	133 (41.18)	61 (41.22)	43 (42.57)	29 (39.19)
2	26 (8.05)	12 (8.11)	9 (8.91)	5 (6.76)
3	4 (1.24)	2 (1.35)	2 (1.98)	0 (0.00)
Fewer neutrophils					-2	0.362
0	232 (71.83)	112 (75.68)	70 (69.31)	50 (67.57)
1	59 (18.27)	24 (16.22)	19 (18.81)	16 (21.62)
2	19 (5.88)	5 (3.38)	10 (9.90)	4 (5.41)
3	12 (3.72)	6 (4.05)	2 (1.98)	4 (5.41)
4	1 (0.31)	1 (0.68)	0 (0.00)	0 (0.00)
Fewer white blood cells					-2	0.455
0	209 (64.71)	100 (67.57)	63 (62.38)	46 (62.16)
1	73 (22.60)	27 (18.24)	29 (28.71)	17 (22.97)
2	28 (8.67)	12 (8.11)	8 (7.92)	8 (10.81)
3	9 (2.79)	6 (4.05)	1 (0.99)	2 (2.70)
4	4 (1.24)	3 (2.03)	0 (0.00)	1 (1.35)
Fewer platelets					-2	0.319
0	234 (72.45)	110 (74.32)	70 (69.31)	54 (72.97)
1	59 (18.27)	24 (16.22)	21 (20.79)	14 (18.92)
2	25 (7.74)	12 (8.11)	10 (9.90)	3 (4.05)
3	5 (1.55)	2 (1.35)	0 (0.00)	3 (4.05)
Anemia					χ² = 6.44	0.376
0	164 (50.77)	79 (53.38)	50 (49.50)	35 (47.30)
1	118 (36.53)	52 (35.14)	38 (37.62)	28 (37.84)
2	26 (8.05)	12 (8.11)	10 (9.90)	4 (5.41)
3	15 (4.64)	5 (3.38)	3 (2.97)	7 (9.46)

¹Simulated P value.

²Fisher exact.

P-SOX: Nab-paclitaxel plus oxaliplatin and S-1; SOX + XDL: Oxaliplatin plus S-1 combined with sintilimab; CAPOX: Capecitabine plus oxaliplatin.

Table 3 Results of univariate and multivariate Cox proportional hazards regression analyses

Variables	Univariate					Multivariate
	β	SE	Z	P value	HR (95%CI)	β	SE	Z	P value	HR (95%CI)
Age
≤ 60					1.00 (reference)					1.00 (reference)
> 60	-0.06	0.17	-0.33	0.739	0.95 (0.68-1.31)	0.22	0.18	1.22	0.222	1.24 (0.88-1.77)
ASA
1 + 2					1.00 (reference)					1.00 (reference)
3	-0.04	0.23	-0.15	0.878	0.97 (0.61-1.52)	-0.20	0.25	-0.81	0.420	0.82 (0.50-1.34)
Sex
Male					1.00 (reference)					1.00 (reference)
Female	-0.05	0.20	-0.26	0.797	0.95 (0.64-1.41)	0.14	0.22	0.64	0.522	1.15 (0.74-1.79)
Differentiation
Well					1.00 (reference)					1.00 (reference)
Moderate	0.64	0.25	2.57	0.010	1.89 (1.16-3.07)	0.29	0.28	1.04	0.298	1.33 (0.77-2.30)
Poorly	1.04	0.23	4.57	< 0.001	2.82 (1.81-4.41)	0.52	0.24	2.11	0.035	1.68 (1.04-2.71)
cT stage
2					1.00 (reference)					1.00 (reference)
3	0.11	0.21	0.53	0.598	1.12 (0.74-1.70)	-0.10	0.25	-0.41	0.680	0.90 (0.56-1.47)
4	0.70	0.23	3.04	0.002	2.02 (1.28-3.19)	-0.52	0.32	-1.62	0.105	0.60 (0.32-1.11)
cN stage
Negative					1.00 (reference)					1.00 (reference)
Positive	0.59	0.20	3.00	0.003	1.80 (1.23-2.64)	0.27	0.21	1.26	0.208	1.31 (0.86-2.00)
cTNM
II					1.00 (reference)					1.00 (reference)
IIIA	0.59	0.30	1.94	0.052	1.80 (0.99-3.25)	0.43	0.34	1.27	0.204	1.54 (0.79-2.99)
IIIB	1.10	0.21	5.19	< 0.001	3.00 (1.98-4.54)	1.13	0.24	4.71	< 0.001	3.09 (1.93-4.95)
IIIC	2.01	0.22	9.35	< 0.001	7.48 (4.91-11.40)	2.08	0.31	6.81	< 0.001	8.01 (4.40-14.59)
RECIST 1.1
Ineffective					1.00 (reference)					1.00 (reference)
Effective	-0.74	0.17	-4.43	< 0.001	0.48 (0.35-0.66)	-0.38	0.18	-2.12	0.034	0.68 (0.48-0.97)
Lauren
Diffuse					1.00 (reference)					1.00 (reference)
Mixed	-0.12	0.18	-0.64	0.520	0.89 (0.62-1.27)	0.02	0.20	0.07	0.941	1.02 (0.68-1.51)
Intestinal	-0.22	0.24	-0.92	0.356	0.80 (0.50-1.28)	-0.24	0.28	-0.85	0.397	0.79 (0.46-1.36)
Location
Upper					1.00 (reference)					1.00 (reference)
Middle	0.26	0.22	1.17	0.241	1.29 (0.84-1.99)	0.26	0.24	1.12	0.264	1.30 (0.82-2.07)
Lower	0.28	0.22	1.25	0.211	1.32 (0.86-2.03)	0.42	0.24	1.79	0.073	1.53 (0.96-2.43)
TRG
Ineffective					1.00 (reference)					1.00 (reference)
Effective	-0.84	0.17	-4.84	< 0.001	0.43 (0.31-0.60)	-0.73	0.20	-3.75	< 0.001	0.48 (0.33-0.70)
Tumor diameter
≤ 2					1.00 (reference)					1.00 (reference)
2-5	0.34	0.19	1.79	0.073	1.40 (0.97-2.03)	0.28	0.20	1.42	0.155	1.33 (0.90-1.97)
≥ 5	0.53	0.22	2.37	0.018	1.70 (1.10-2.63)	0.65	0.24	2.64	0.008	1.91 (1.18-3.08)

ASA: American Society of Anesthesiologists Score; RECIST: Response Evaluation Criteria in Solid Tumors; TRG: Tumor regression grade; cTNM: Clinical tumor-node-metastasis; HR: Hazards ratio; CI: Confidence interval.