Application of sintilimab combined with anlotinib hydrochloride in the clinical treatment of microsatellite stable colorectal cancer

Table 1 Comparison of basic data between the two groups

Item		Observation group, n = 46	Control group, n = 46	χ2	P value
Sex	Male	24 (52.17)	25 (54.35)	0.044	0.834
	Female	22 (47.83)	21 (45.65)
Age in yr		58.34 ± 3.28	58.54 ± 3.49	0.283	0.778
Pathological type	Colon cancer	33 (71.74)	31 (67.39)	0.205	0.650
	Rectal cancer	13 (28.26)	15 (32.61)
Differentiation degree	Low differentiation	41 (89.13)	37 (80.43)	0.494	0.482
	Moderate to high differentiation	5 (10.87)	7 (15.22)
TNM stage	Stage III	34 (73.91)	32 (69.57)	0.215	0.643
	Stage IV	12 (26.09)	14 (30.43)
Distant metastasis	Hepatic metastasis	2 (4.35)	1 (2.17)	0.000	1.0001
	Pulmonary metastasis	1 (2.17)	0 (0.00)	0.000	1.0001
	Pelvic metastasis	1 (2.17)	1 (2.17)	0.511	0.4751

¹The use of continuity correction, which is applied in χ²tests when the expected frequency is less than or equal to 5 to perform a continuity-corrected test. Data are n (%) or mean ± SD.

Table 2 Comparison of short-term efficacy

Indicator	Observation group, n = 46	Control group, n = 46	χ2	P value
Complete response	11 (23.91)	5 (10.87)
Partial response	24 (52.17)	18 (39.13)
Stable disease	7 (15.22)	20 (43.48)
Disease progression	4 (8.70)	3 (6.52)
Overall response	35 (76.09)	23 (50.00)	6.718	0.010

Data are n (%).

Table 3 Comparison of serum carcinoembryonic antigen, carbohydrate antigen 199, and carbohydrate antigen 125 levels

Indicators	Time	Observation group, n = 46	Control group, n = 46	t	P value
CEA in ng/mL	Before treatment	119.16 ± 18.54	120.06 ± 18.91	0.230	0.818
	After treatment	52.17 ± 7.401	71.24 ± 10.221	110.250	0.000
CA199 in IU/mL	Before treatment	120.16 ± 20.41	120.55 ± 20.59	0.091	0.928
	After treatment	51.37 ± 10.221	62.47 ± 14.041	4.335	0.000
CA125 in U/mL	Before treatment	247.56 ± 25.47	246.91 ± 25.21	0.123	0.902
	After treatment	69.14 ± 10.091	88.15 ± 14.531	7.288	0.000

¹Denotes a comparison with the pre-treatment values. Data are mean ± SD. CA: Carbohydrate antigen; CEA: Carcinoembryonic antigen.

Table 4 Comparison of the levels of T lymphocyte subsets

Indicators	Time	Observation group, n = 46	Control group, n = 46	t	P value
CD4+ in %	Before treatment	28.40 ± 2.46	28.35 ± 2.50	0.097	0.923
	After treatment	36.45 ± 5.511	32.21 ± 4.011	4.220	0.000
CD8+ in %	Before treatment	27.26 ± 2.36	27.35 ± 2.47	0.179	0.859
	After treatment	21.32 ± 1.101	24.20 ± 1.541	10.321	0.000
CD4+/CD8+ in %	Before treatment	1.04 ± 0.44	1.03 ± 0.47	0.123	0.902
	After treatment	1.71 ± 0.581	1.33 ± 0.521	3.309	0.001

¹Denotes a comparison with the pretreatment values. Data are mean ± SD.

Table 5 Comparison of life quality

Indicators	Time	Observation group, n = 46	Control group, n = 46	t	P value
Functional domains	Before treatment	35.12 ± 4.06	35.40 ± 4.57	0.311	0.757
	After treatment	42.10 ± 6.061	39.11 ± 5.741	2.430	0.017
Symptom domains	Before treatment	17.52 ± 3.24	17.06 ± 3.00	0.707	0.482
	After treatment	10.42 ± 1.571	14.20 ± 2.171	9.572	0.000
General health status/quality of life domains	Before treatment	7.52 ± 0.85	7.23 ± 0.89	1.598	0.114
	After treatment	11.54 ± 1.471	9.24 ± 1.031	8.691	0.000
Individual item measurements	Before treatment	17.41 ± 2.09	17.26 ± 2.47	0.314	0.754
	After treatment	13.02 ± 1.221	15.05 ± 1.541	7.008	0.000

¹Denotes a comparison with the pre-treatment values. Data are mean scores ± SD.

Table 6 Comparison of the incidence of adverse events between the two groups during the treatment period

Indicators	Observation group, n = 46	Control group, n = 46	χ2	P value
Fever	1 (2.317)	1 (2.17)
Fatigue	2 (4.35)	1 (2.17)
Dizziness/headache	2 (4.35)	2 (4.35)
Decreased appetite	2 (4.35)	1 (2.17)
Diarrhea	2 (4.35)	1 (2.17)
Total incidence	9 (19.57)	7 (15.22)	0.302	0.582

Data are n (%).