Comparison of efficacy and safety of nab-paclitaxel and oxaliplatin + S-1 and standard S-1 and oxaliplatin chemotherapy regimens for treatment of gastric cancer

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

Variables	Total (n = 219)	P-SOX (n = 149)	SOX (n = 70)	Z	P value
Age				2.674	0.102
≤ 60	142 (64.8)	102 (68.5)	40 (57.1)
> 60	77 (35.2)	47 (31.5)	30 (42.9)
Sex				0.514	0.473
Male	184 (84)	127 (85.2)	57 (81.4)
Female	35 (16)	22 (14.8)	13 (18.6)
BMI				0.278	0.598
18.5–24	140 (63.9)	97 (65.1)	43 (61.4)
< 18.5 or > 24	79 (36.1)	52 (34.9)	27 (38.6)
ASA				0.168	0.681
1+2	178 (81.3)	120 (80.5)	58 (82.9)
3	41 (18.7)	29 (19.5)	12 (17.1)
RECIST 1.1				1.906	0.167
Ineffective	104 (47.5)	66 (44.3)	38 (54.3)
Effective	115 (52.5)	83 (55.7)	32 (45.7)
TRG				1.324	0.250
Effective	128 (58.4)	91 (61.1)	37 (52.9)
Ineffective	91 (41.6)	58 (38.9)	33 (47.1)
Tumor location				0.260	0.878
Lower	76 (34.7)	51 (34.2)	25 (35.7)
Upper	69 (31.5)	46 (30.9)	23 (32.9)
Middle	74 (33.8)	52 (34.9)	22 (31.4)
Differentiation				1.883	0.390
Poorly	101 (46.1)	64 (43)	37 (52.9)
Moderate	72 (32.9)	52 (34.9)	20 (28.6)
Well	46 (21)	33 (22.1)	13 (18.6)
cT stage				0.384	0.825
2	60 (27.4)	42 (28.2)	18 (25.7)
3	117 (53.4)	80 (53.7)	37 (52.9)
4	42 (19.2)	27 (18.1)	15 (21.4)
cN stage				0.155	0.694
Negative	76 (34.7)	53 (35.6)	23 (32.9)
Positive	143 (65.3)	96 (64.4)	47 (67.1)
cTNM1				1.170	0.557
II	120 (54.8)	83 (55.7)	37 (52.9)
III	52 (23.7)	37 (24.8)	15 (21.4)
IV	47 (21.5)	29 (19.5)	18 (25.7)
Tumor diameter				2.196	0.333
≤ 2	55 (25.1)	33 (22.1)	22 (31.4)
2-5	91 (41.6)	64 (43)	27 (38.6)
≥ 5	73 (33.3)	52 (34.9)	21 (30)
Laurnen				3.274	0.195
Enteric	42 (19.2)	29 (19.5)	13 (18.6)
Mixed type	98 (44.7)	72 (48.3)	26 (37.1)
Diffuse	79 (36.1)	48 (32.2)	31 (44.3)

¹Tumor 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; BMI, body mass index; RECIST: Response Evaluation Criteria in Solid Tumors; TRG: Tumor Regression Grade; P-SOX: Nab-paclitaxel and oxaliplatin + S-1; SOX: Standard S-1 and oxaliplatin.

Table 2 Side effects associated with nab-paclitaxel and oxaliplatin + S-1 and standard S-1 and oxaliplatin treatment, n (%)

Variables	Total (n = 219)	P-SOX (n = 149)	SOX (n = 70)	P value
Fewer neutrophils				0.598
0	168 (77.4)	115 (77.2)	53 (77.9)
1	37 (17.1)	24 (16.1)	13 (19.1)
2	2 (0.9)	1 (0.7)	1 (1.5)
3	6 (2.8)	5 (3.4)	1 (1.5)
4	4 (1.8)	4 (2.7)	0 (0)
Fewer white blood cells				0.418
0	141 (64.4)	95 (63.8)	46 (65.7)
1	50 (22.8)	33 (22.1)	17 (24.3)
2	18 (8.2)	13 (8.7)	5 (7.1)
3	9 (4.1)	8 (5.4)	1 (1.4)
4	1 (0.5)	0 (0)	1 (1.4)
Fewer platelets				0.985
0	158 (72.1)	106 (71.1)	52 (74.3)
1	49 (22.4)	34 (22.8)	15 (21.4)
2	7 (3.2)	5 (3.4)	2 (2.9)
3	5 (2.3)	4 (2.7)	1 (1.4)
Anemia				0.415
0	146 (66.7)	102 (68.5)	44 (62.9)
1	56 (25.6)	35 (23.5)	21 (30)
2	13 (5.9)	8 (5.4)	5 (7.1)
3	4 (1.8)	4 (2.7)	0 (0)
Nausea and vomiting				0.856
0	48 (21.9)	33 (22.1)	15 (21.4)
1	123 (56.2)	81 (54.4)	42 (60)
2	43 (19.6)	31 (20.8)	12 (17.1)
3	5 (2.3)	4 (2.7)	1 (1.4)
Live toxicity				0.057
0	168 (76.7)	113 (75.8)	55 (78.6)
1	40 (18.3)	25 (16.8)	15 (21.4)
2	11 (5)	11 (7.4)	0 (0)
alopecia				0.013
0	82 (37.4)	46 (30.9)	36 (51.4)
1	114 (52.1)	85 (57)	29 (41.4)
2	23 (10.5)	18 (12.1)	5 (7.1)
Peripheral sensory neuropathy				0.052
0	94 (42.9)	58 (38.9)	36 (51.4)
1	87 (39.7)	59 (39.6)	28 (40)
2	35 (16)	30 (20.1)	5 (7.1)
3	3 (1.4)	2 (1.3)	1 (1.4)

PSOX: Nab-paclitaxel and oxaliplatin + S-1; SOX: Standard S-1 and oxaliplatin.

Table 3 Single-factor Cox regression analysis

Variable	Z	HR (95%CI)	P value
Age
≤ 60		Reference
> 60	0.853	1.247 (0.751-2.069)	0.393
Sex
Male		Reference
Female	-0.350	0.882 (0.437-1.782)	0.727
BMI
18.5–24		Reference
< 18.5 or > 24	0.333	1.089 (0.659-1.799)	0.739
ASA
1+2		Reference
3	-0.192	0.941 (0.503-1.758)	0.848
RECIST 1.1
Ineffective		Reference
Effective	-3.803	0.379 (0.230-0.625)	< 0.001
TRG
Effective		Reference
Ineffective	3.329	2.278 (1.403-3.698)	0.001
Tumor location
Lower		Reference
Upper	-1.622	0.579 (0.300-1.120)	0.105
Middle	0.996	1.319 (0.765-2.277)	0.319
Differentiation
Poorly		Reference
Moderate	-0.752	0.819 (0.487-1.378)	0.452
Well	-2.555	0.365 (0.168-0.791)	0.011
cT stage
2		Reference
3	1.105	1.432 (0.757-2.707)	0.269
4	3.594	3.721 (1.817-7.618)	< 0.001
cN stage
Negative		Reference
Positive	2.097	1.786 (1.039-3.072)	0.036
cTNM
II		Reference
III	2.132	1.935 (1.055-3.550)	0.033
IV	4.508	3.724 (2.103-6.597)	< 0.001
Tumor diameter
≤ 2		Reference
2-5	2.178	2.503 (1.096-5.715)	0.029
≥ 5	3.061	3.619 (1.588-8.248)	0.002
Laurnen
Enteric		Reference
Mixed type	-0.276	0.906 (0.447-1.833)	0.783
Diffuse	1.506	1.705 (0.852-3.415)	0.132

BMI: Body mass index; RECIST: Response Evaluation Criteria in Solid Tumors; TRG: Tumor Regression Grade; HR: Hazard ratio.

Table 4 Multi-factor Cox regression analysis

Variable	Z	HR (95%CI)	P value
RECIST 1.1
Ineffective		Reference
Effective	-2.544	0.507 (0.300-0.856)	0.011
TRG
Effective		Reference
Ineffective	2.518	1.949 (1.159-3.276)	0.012
Differentiation
Poorly		Reference
Moderate	-1.624	0.628 (0.358-1.101)	0.104
Well	-2.010	0.443 (0.200-0.980)	0.044
cT stage
2		Reference
3	1.263	1.520 (0.794-2.909)	0.206
4	1.834	2.041 (0.952-4.376)	0.067
cN stage
Negative		Reference
Positive	1.725	1.645 (0.934-2.895)	0.085
cTNM
II		Reference
III	1.383	1.575 (0.827-2.997)	0.167
IV	3.338	3.015 (1.577- 5.765)	0.001
Tumor diameter
≤ 2		Reference
2-5	2.131	2.503 (1.077-5.819)	0.033
≥ 5	2.736	3.281 (1.401-7.685)	0.006

RECIST: Response Evaluation Criteria in Solid Tumors; TRG: Tumor Regression Grade; HR: Hazard ratio.