Efficacy and safety of nivolumab plus chemotherapy in patients with advanced gastric cancer with massive ascites

Table 1 Patients’ characteristics, n (%)

		All (n = 124)	HAB (n = 26)	LAB (n = 98)	P value
Age (years)	Median (range)	70 (23-87)	71.5 (38-86)	70 (23-87)	0.9211
Sex	Male	82 (66)	14 (54)	68 (69)	0.1641
PS	0	44 (35)	1 (4)	43 (44)	< 0.0001
	1	60 (48)	16 (62)	44 (45)
	2 or 3	20 (16)	9 (35)	11 (11)
Location	Esophago-gastric junction	20 (16)	1 (4)	19 (19)	0.0716
	Gastric	104 (84)	25 (96)	79 (81)
Gastrectomy	Yes	34 (27)	5 (19)	29 (30)	0.3345
Pathology	Diffuse type	75 (60)	24 (92)	51 (52)	0.0009
Number of metastatic organs	2 or more	62 (50)	15 (58)	47 (48)	0.5086
Liver metastasis	Yes	38 (31)	4 (15)	34 (35)	0.0921
Peritoneum dissemination	Yes	75 (60)	25 (96)	50 (51)	< 0.0001
Ascites	Yes	47 (38)	26 (100)	21 (21)	< 0.0001
High ascites burden	Yes	26 (21)	26 (100)	0	< 0.0001
Regimen	SOX	67 (54)	8 (31)	59 (60)	0.0037
	FOLFOX	51 (41)	18 (69)	33 (34)
	CAPOX	6 (5)	0	6 (6)
PD-L1 CPS	Less than 1	24 (19)	10 (38)	14 (14)	0.0082
	1 ≤ CPS < 5	36 (29)	6 (23)	29 (30)
	5 or more	45 (36)	5 (19)	41 (42)
	Unknown	19 (15)	5 (19)	14 (14)
MSI	MSI-high	5 (4)	0	5 (5)	0.3489
	MSS	74 (60)	18 (69)	56 (57)
	Unknown	45 (36)	8 (31)	37 (38)
CLDN 18.2	Positive	14 (11)	4 (15)	10 (10)	0.0767
	Negative	29 (23)	2 (8)	27 (28)
	Unknown	81 (65)	20 (77)	61 (62)

PS: Performance status; CPS: Combined positive score; MSI: Micro satellite instability; MSS: Microsatellite stable; HAB: High ascites burden; LAB: Low ascites burden.

Table 2 Response rate and disease control rate of patients with evaluable lesions

	Total (n = 124)	HAB (n = 26)	LAB (n = 98)	P value
Best overall response
Complete response	2	0	2
Partial response	48	8	40
Stable disease	49	10	39
Progressive disease	19	6	13
Not evaluated	6	2	4
Objective response rate (%)	42.3	33.3	44.9	0.3615
Disease control rate (%)	83.9	75.0	86.2	0.2152
Improvement of ascites (%)	59.6	61.5	57.1	0.7745

HAB: High ascites burden; LAB: Low ascites burden.

Table 3 Adverse events, n (%)

	All (n = 124)		HAB (n = 26)		LAB (n = 98)		P value
	All	Grade 3 or more	All	Grade 3 or more	All	Grade 3 or more	All	Grade 3 or more
	111 (90)	51 (41)	23 (88)	14 (54)	88 (90)	37 (38)	1.000	0.179
Neutropenia	44 (35)	30 (24)	12 (46)	12 (46)	32 (33)	18 (18)	0.258	0.010
Anaemia	18 (15)	7 (6)	4 (15)	3 (12)	14 (14)	4 (4)	0.546	0.159
Low platelet	17 (14)	6 (5)	3 (12)	2 (8)	14 (14)	4 (4)	1.000	0.281
Nausea	30 (24)	2 (2)	5 (19)	0	25 (26)	2 (2)	0.794	1.000
Fatigue	42 (34)	1 (1)	6 (23)	0	36 (37)	1 (1)	0.246	1.000
Anorexia	34 (27)	5 (4)	6 (23)	1 (4)	28 (29)	4 (4)	0.631	1.000
Peripheral sensory neuropathy	49 (40)	1 (1)	6 (23)	0	43 (44)	1 (1)	0.014	1.000
Stomatitis	6 (5)	0	0	0	6 (6)	0	0.342	-
Diarrhoea	20 (16)	3 (2)	2 (8)	1 (4)	18 (18)	2 (2)	0.240	1.000
Constipation	11 (9)	0	0	0	11 (11)	0	0.118	-
Oedema	6 (5)	0	0	0	6 (6)	0	0.583	-
Allergy	9 (7)	7 (6)	1 (4)	1 (4)	8 (8)	6 (6)	0.201	0.342
Dysgeusia	10 (8)	0	2 (8)	0	8 (8)	0	0.714	-
Infection	10 (8)	4 (3)	3 (12)	2 (8)	7 (7)	2 (2)	0.395	0.281
Hand-foot syndrome	5 (4)	0	0	0	5 (5)	0	0.583	-

HAB: High ascites burden; LAB: Low ascites burden.

Table 4 Immune related adverse events, n (%)

	All (n = 124)		HAB (n = 26)		LAB (n = 98)		P value
	All	Grade 3 or more	All	Grade 3 or more	All	Grade 3 or more	All	Grade 3 or more
Any adverse event	45 (36)	12 (10)	6 (23)	2 (8)	39 (40)	10 (10)	0.168	1.000
Skin reaction	16 (13)	0	0	0	16 (16)	0	0.023	-
Hypothyroidism	7 (6)	0	1 (4)	0	6 (6)	0	1.000	-
Adrenal insufficiency	5 (4)	2 (2)	0	0	5 (5)	2 (2)	0.583	1.000
Hypopituitary function	2 (2)	0	0	0	2 (2)	0	1.000	-
Pneumonitis	9 (7)	3 (2)	4 (15)	1 (4)	5 (5)	2 (2)	0.091	0.510
Colitis	6 (5)	2 (2)	0	0	6 (6)	2 (2)	0.342	0.579
Hepatitis	2 (2)	2 (2)	0	0	2 (2)	2 (2)	1.000	1.000
Nephritis	2 (2)	1 (1)	1 (4)	0	1 (1)	1 (1)	0.377	1.000
Myositis	1 (1)	1 (1)	0	0	1 (1)	1 (1)	1.000	1.000
Polymyalgia	1 (1)	0	0	0	1 (1)	0	1.000	-
Arthritis	1 (1)	0	0	0	1 (1)	0	1.000	-
Cholangitis	1 (1)	1 (1)	1 (4)	1 (4)	0	0	1.000	1.000

HAB: High ascites burden; LAB: Low ascites burden.