Programmed cell death 1 inhibitor sintilimab plus S-1 and gemcitabine for liver metastatic pancreatic ductal adenocarcinoma

Table 1 Patient characteristics, n

Characteristics	Combination group	Chemotherapy group
Age (years)
Median	54	56
Range	45-70	48-68
Gender
Male	18	15
Female	14	19
Performance status
0	26	27
1	6	7
Number of liver metastases
1-3	22	25
> 3	10	09

Table 2 Summary of tumor response and survival outcomes according to Response Evaluation Criteria in Solid Tumors 1.0 Criteria, n (%)

Outcomes	Combination group (n = 32)	Chemotherapy group (n = 32)	P value
Best tumor response
Complete response	0 (0)	0 (0)
Partial response	10 (31.3)	7 (20.6)	> 0.05
Stable disease	19 (59.4)	18 (52.9)	> 0.05
Progressive disease	3 (9.4)	9 (26.5)	> 0.05
Objective response rate	10 (31.3)	7 (20.6)	> 0.05
Disease control rate	29 (90.6)	25 (73.5)	> 0.05
Median OS, months (95%CI)	18.8 ± 2.6 (16.2-21.4)	10.3 ± 2.3 (8-12.6)	< 0.05
Median PFS, months (95%CI)	9.6 ± 3.1 (6.5-12.7)	5.4 ± 2.2 (3.3-7.7)	< 0.05

OS: Overall survival; CI: Confidence interval; PFS: Progression-free survival.

Table 3 Adverse events occurring in the two groups, n

	Combination group, grade 1	Combination group, grade 2	Combination group, grade 3	Combination group, grade 4	Chemotherapy group, grade 1	Chemotherapy group, grade 2	Chemotherapy group, grade 3	Chemotherapy group, grade 4
Leukopenia	14	10	5	1	12	9	3	1
Fatigue	15	9	2	0	17	8	2	0
Anemia	16	6	1	0	14	7	1	0
Nausea	22	11	1	0	21	12	1	0
Anorexia	13	8	0	0	12	9	0	0