Clinical evaluation of sintilimab in conjunction with bevacizumab for advanced colorectal cancer with microsatellite stable-type after failure of first-line therapy

Table 1 Comparison of baseline data between the two groups, n (%)

Characteristic	Experimental group (n = 60)	Control group (n = 50)	P value
Gender			1.000
Male	36 (60.00)	30 (60.00)
Female	24 (40.00)	20 (40.00)
Age (years)	62.23 ± 7.49	61.20 ± 7.74	0.480
Clinical stage			0.366
Stage III	8 (13.30)	4 (8.00)
Stage IV	52 (86.70)	46 (92.00)
Stage IV			0.532
Hepatic metastases	48 (80.00)	43 (86.00)
Bone metastases	3 (5.00)	1 (1.66)
Pulmonary metastasis	1 (1.66)	1 (1.66)
Brain metastases	0 (0.00)	1 (1.66)
Degree of differentiation			0.091
Low differentiation	30 (50.00)	35 (70.00)
Moderate differentiation	22 (36.70)	10 (20.00)
High differentiation	8 (13.30)	5 (10.00)
BMI (kg/m2)	20.58 ± 2.03	20.17 ± 1.65	0.256
Colon tumor	36 (60.00)	25 (50.00)	0.293
Rectal tumor	24 (40.00)	25 (50.00)

BMI: Body mass index.

Table 2 Pre-treatment and post-treatment positive expression rates of cluster of differentiation 8 (+) T lymphocytes, tumor-associated macrophages, and cancer-associated fibroblasts in experimental participants and controls, n (%)

Characteristic	Experimental group (n = 60)	Control group (n = 50)	P value
CD8 (+) T lymphocytes
Pre-treatment	6 (10.00)	10 (20.00)	0.139
Post-treatment	30 (50.00)	15 (30.00)	0.033
TAMs
Pre-treatment	46 (76.70)	40 (80.00)	0.673
Post-treatment	14 (23.30)	30 (60.00)	0.001
CAFs
Pre-treatment	42 (70.00)	35 (70.00)	1.000
Post-treatment	14 (23.30)	25 (50.00)	0.003

CAFs: Cancer-associated fibroblasts; CD: Cluster of differentiation; TAMs: Tumor-associated macrophages.

Table 3 Therapeutic outcomes of the experimental participants and controls, n (%)

Characteristic	Experimental group (n = 60)	Control group (n = 50)	P value
CR	0	0	-
PR	16	5	0.023
SD	12	10	1.000
PD	32	35	0.073
ORR	16 (26.70)	5 (10.00)	0.023
DCR	28 (46.70)	15 (30.00)	0.073
PFS (months, mean ± SD)	5.04 ± 1.83	4.69 ± 1.30	0.247
mPFS (months)	5	4	-

CR: Complete remission; PR: Partial remission; SD: Stable disease; PD: Progressive disease; ORR: Objective response rate; DCR: Disease control rate; PFS: Progression-free survival; mPFS: Median progression-free survival.

Table 4 The incidence of drug-associated adverse events in experimental and control participants, n (%)

Characteristic	Experimental group (n = 60)	Control group (n = 50)	P value
Hypertension	3 (5.00)	0 (0.00)	0.054
I	2 (3.30)	0 (0.00)
II	1 (1.70)	0 (0.00)
Proteinuria	4 (6.70)	5 (10.00)	0.526
I	2 (3.35)	3 (6.00)
II	2 (3.35)	2 (4.00)
Gastrointestinal perforation	0 (0.00)	0 (0.00)	-
I	0 (0.00)	0 (0.00)
II	0 (0.00)	0 (0.00)
Bleeding	1 (1.70)	0 (0.00)	0.269
I	1 (1.70)	0 (0.00)
II	0 (0.00)	0 (0.00)
Arterial thrombosis	0 (0.00)	0 (0.00)	-
I	0 (0.00)	0 (0.00)
II	0 (0.00)	0 (0.00)
Thrombocytopenia	7 (11.70)	5 (10.00)	0.780
I	3 (5.00)	3 (6.00)
II	4 (6.70)	2 (4.00)
Pneumonia, nephritis, hepatitis, and endocrine disorders	0 (0.00)	0 (0.00)	-
I	0 (0.00)	0 (0.00)
II	0 (0.00)	0 (0.00)
Diarrhea and enteritis	3 (5.00)	2 (4.00)	0.801
I	2 (3.30)	2 (4.00)
II	1 (1.70)	0 (0.00)
Number of cases	18	12	0.525
I	10	8
II	8	4