Phase I study of short-time oxaliplatin, capecitabine and epirubicin (EXE) as first line therapy in patients with non-resectable gastric cancer

Figures & data

Table I.  Dose escalation scheme

Dose level	Number of patients	Epirubicin mg/m^2	Oxaliplatin mg/m^2	Capecitabine mg/m^2	Number of DLT
I	3 (+3*)	50	85	500×2	0
II	3 (+5*)	50	100	500×2	0
III	3 + 3 (+1*)	50	115	500×2	1
IV	3 + 3 (+4*)	50	130	500×2	2
V	0	50	130	625×2

*We had no standard treatment for these patients, and therefore additional patients were offered therapy at the actual dose level while waiting for the first included patients to complete their first cycle.

Table II.  Patient characteristics at baseline

Characteristic	n
Age, years
Median	61
Range	39–75
Sex
Female	5
Male	26
WHO performance status
0	16
1	13
2	2
Location
Cardia	20
Corpus	11
Status of primary tumour
R0 resection	5
R2 resection	3
No surgery	23
Prior adjuvant therapy	0
Predominant site of disease
Liver	14
Local	6
Lung	4
Nodes	3
Peritoneum	4
No. of organs involved
1	13
2	14
≥ 3	4
Increased alkaline phosphatase
(>300 U/l)	7
Increased platelets
(>400×109/l)	11
Increased ALAT
(>40 U/l)	5
Increased WBC
(>10×109/l)	5

Table III.  Grade 2–4 toxicity after 1^st cycle of EXE, (n = 31)

	Grade 2	Grade 3	Grade 4
Toxicity	n	n	n
Diarrhea	1	0	0
Nausea/vomiting	4	0	0
Neuropathy	1	0	0
Infection (without neutropenia)	0	1	0
Febrile neutropenia	0	0	1
Neutropenia (without fever)	0	1	0

Table IV.  Worst toxicity after median 6 cycles of EXE

	Grade 2	Grade 3	Grade 4
	n (%)	n (%)	n (%)
Hematologic toxicity
Neutropenia	4 (31)	3 (10)	2 (6)
Thrombocytopenia	0	1 (3)	0
Infection (no neutropenia)	1 (3)	2 (6)	0
Febrile neutropenia	0	0	1 (3)
Nonhematologic toxicity
Diarrhea	6 (19)	1 (3)	0
PPE	6 (19)	2 (6)	0
Nausea	6 (19)	1 (3)	0
Vomiting	7 (23)	1 (3)	0
Neuropathy	7 (23)	1 (3)	0

Figure 1.  Time to progression and overall survival