Phase II study of protracted irinotecan infusion and a low-dose cisplatin for metastatic gastric cancer

Table 1 Patient profile

	n	Site of metastases
Sex
Female	20	Lymph nodes	26
Male	11	Perigastric	6
PS		Para-aortic	6
0	21	Virchow’s	3
1	9	Neck	2
2	1	Mediastinum	1
Histology		Others	8
Intestinal	16	Liver	13
Diffuse	14	Peritoneal	3
Others	1	Skin	1
Prior chemotherapy		Lung	1
No	20	Ovary	2
Yes	11	Rectum	1

PS: Performance status.

Table 2 Response to therapy n (%)

	CR	PR	NC	PD	RR	95% CI
Overall	0	16 (52)	11 (35)	4 (13)	16 (52)	33-70
Prior chemotherapy
Yes	0	4 (36)	4 (27)	3 (27)	4 (36)	11-69
No	0	12 (60)	7 (35)	1 (5)	12 (60)	36-81
Liver	2 (15)	5 (39)	5 (39)	1 (8)	7 (54)
Lymph Nodes	2 (8)	12 (46)	12 (46)	0	14 (54)
Peritoneal	0	1 (33)	1 (33)	1 (33)	1 (33)
Ovary	0	0	1 (50)	1 (50)	0
Lung	0	1 (100)	0	0	1 (100)
Others	0	1 (50)	1 (50)	0	1 (50)

CR: Complete remission; PR: Partial response; NC: No change; PD: Progressive disease; RR: Response rate.

Table 3 Adverse reactions

	Grade (%)
	1	2	3	4
Hematologic
Leukopenia	1 (3)	14 (45)	8 (26)	3 (10)
Neutropenia	1 (3)	2 (6)	13 (42)	11 (35)
Thrombocytopenia	8 (25)	1 (3)	1 (3)	1 (3)
Anemia	5 (16)	13 (42)	7 (23)	2 (6)
Nonhematologic
Fatigue	3 (10)	0	0	0
Nausea	12 (39)	8 (26)	3 (10)	0
Diarrhea	9 (29)	4 (13)	1 (3)	0
Abdo pain	2 (6)	2 (6)	1 (3)	0
Alopecia	11 (35)	10 (30)	1 (3)	0
AST	1 (3)	0	0	0
T. bilirubin	1 (3)	0	0	0
Cr	8 (26)	0	0	0

Abdo pain: Abdominal pain.