Phase II study of cisplatin, epirubicin, UFT, and leucovorin (PELUF) as first-line chemotherapy in metastatic gastric cancer

Figures & data

Table I.  Patient characteristics.

Characteristic	Value
Patients evaluable, n	39
Median age, years (range)	59.5 (31–76)
Sex, n (%)
Male	24 (62)
Female	15 (38)
ECOG performance status, n (%)
0	6 (15)
1	25 (64)
2	8 (21)
Status of primary tumor, n (%)
Unresected	31 (79)
Resected	8 (21)
Predominant site of disease, n (%)
Liver	15 (38)
Nodes	14 (36)
Peritoneum	4 (10)
Lung	5 (13)
Bone	1 (3)
Extent of disease, n (%)
Metastatic	32 (82)
Locally advanced	7 (18)
Patients with metastatic sites, n (%)
1 site	20 (51)
2 sites	14 (36)
≥ 3 sites	5 (13)

ECOG = Eastern Cooperative Oncology Group.

Figure 1.  Time to progression (TTP) in patients with metastatic gastric cancer treated with the combination of cisplatin, epirubicin, tegafur–uracil, and leucovorin (PELUF). TTP was analyzed according to the Kaplan-Meier method and was updated to August 30, 2005.

Figure 2.  Overall survival (OS) in patients with metastatic gastric cancer treated with the combination of cisplatin, epirubicin, tegafur–uracil, and leucovorin (PELUF). OS was analyzed according to the Kaplan-Meier method and was updated to August 30, 2005.

Table II.  Objective response following treatment with cisplatin and epirubicin plus UFT and leucovorin.

Response	No. of patients (%) (n = 39)
Complete response	2 (5)
Partial response	13 (33)
Stable disease	16 (41)
Progressive disease	8 (21)

UFT = tegafur–uracil.

Table III.  Grade 3/4 toxicity following treatment with cisplatin and epirubicin plus UFT and leucovorin.

	Cycles with toxicity, n (%) (n = 196)		Patients with toxicity, n (%) (n = 39)
Toxicity^a	Grade 3	Grade 4	Grade 3	Grade 4
Leukopenia	31 (16)	6 (3)	6 (15)	4 (10)
Neutropenia	27 (14)	6 (3)	4 (10)	4 (10)
Anemia	3 (1.5)	2 (1)	2 (5)	1 (3)
Thrombocytopenia	2 (1)	0 (0)	1 (3)	0 (0)
Diarrhea	12 (6)	0 (0)	3 (8)	0 (0)
Nausea/vomiting	15 (8)	0 (0)	3 (8)	0 (0)
Mucositis	7 (4)	0 (0)	2 (5)	0 (0)

^aNational Cancer Institute Common Toxicity Criteria version 2. UFT = tegafur–uracil.