A phase II study of oxaliplatin with low dose leucovorin and bolus and continuous infusion 5-fluorouracil (modified FOLFOX-4) as first line therapy for patients with advanced gastric cancer

Figures & data

Table I.  Patient characteristics.

	No. of patients	%
Total number of patients	45
Sex
Male	30	66.7
Female	15	33.3
Age
Median	56
Range	31–76
Performance status (ECOG)
0–1	33	73.3
2	12	26.7
Hemoglobin
≥ 12 g/dl	23	51.1
< 12 g/dl	22	48.9
Carcinoembryonic antigen (CEA)
< 5 ng/ml	26	57.8
≥ 5 ng/ml	17	37.8
Unchecked	2	4.4
Previous operation
Curative	22	48.9
Adjuvant chemotherapy	11	24.4
Adjuvant chemoradiotherapy	3	6.7
None	8	17.8
Palliative	10	22.2
None	13	28.9
Previous exposure to 5-fluorouracil
Yes	12	26.7
No	33	73.3
No. of organ involved
1	28	62.2
2	13	28.9
≥ 3	4	8.8
Organ involved (multiple involved)
Peritoneum	20	44.4
Lymph node	16	35.6
Liver	15	33.3
Lung	5	11.1
Bone	3	6.7
Ovary	3	6.7
Colon	2	4.4
Pancreas	1	2.2

Figure 1.  Time to progression of treatment.

Figure 2.  Overall survival of treatment.

Table II.  Toxicity of treatment.

	NCI-CTC^‡ grade (%)
	1	2	3	4
Hematologic (n = 247)*
Anemia	52 (21.1)	46 (18.6)	1 (0.4)
Neutropenia	42 (17)	33 (13.4)	8 (3.2)	19 (7.7)
Thrombocytopenia	13 (5.3)	10 (4)	3 (1.2)
Febrile neutropenia				12 (4.8)
Non-hematologic (n = 45)^†
Nausea/vomiting		9 (20)	2 (4.4)
Diarrhea		1 (2.2)	1 (2.2)
Mucositis		3 (6.7)
Neuropathy^§	3 (6.7)	3 (6.7)

^*per cycle.

^†per person, maximum toxicity of each patient.

^‡National Cancer Institute-Common Toxicity Criteria.

^§According to an oxaliplatin-specific scale.

Table III.  Prognostic factors.

		TTP^†		OS^†
	Response^* (CR + PR)	Univariate	Multivariate	Univariate	Multivariate
Sex (male)	0.752	.9881	NS	.0531	NS
Age ≥ 60	0.739	.0002	0.001	.2061	NS
Performance 2	0.329	.4950	NS	.5172	NS
CEA ≥ 5 ng/ml	0.127	.0150	0.002	.0316	NS
Hemoglobin < 12 g/dl	0.661	.1818	NS	.6099	NS
Initially metastasis	0.768	.3472	NS	.1786	NS
Palliative surgery	0.529	.6080	NS	.0537	NS
Previous 5-FU use	0.685	.9174	NS	.2409	NS
Previous chemoradiation	0.883	.7967	NS	.4310	NS
Organ involvement ≥ 3	0.889	.9894	NS	.3244	NS

^*Fischer's exact test.

^†Kaplan-Meier and Cox Regression Analysis.

CR: Complete Response, PR: Partial Response, CEA: carcinoembryonic antigen, 5-FU: 5-fluorouracil.

Table IV.  Comparison of Efficacy and Toxicity of 1^st line FOLFOX in AGC.

Study	Louvet et al [16]: FOLFOX-6	De Vita et al [21]: FOLFOX-4	Oh et al: m FOLFOX-4
No. of patients	49	61	45
Efficacy
Response rate (%)	45	38	50
Median TTP (months)	6.2	7.1	7.7
Median OS (months)	8.6	11.2	11.2
Toxicity NCI-CTC G I-II/III–IV (%)
Neutropenia	30/38	23/36	20/11
Anemia	80/11	37/10	40/0.4
Vomiting	43/0	19/2	20/4.4
Diarrhea	39/4	23/5	2.2/2.2
Mucositis	34/9	11/2	6.7/0
Neuropathy^§	66/21	26/5	13/0

AGC: Advanced gastric cancer, TTP: Time to progression, OS: Overall survival, NCI-CTC G: National Cancer Institute-Common Toxicity Criteria Grade.