Multicenter randomized study on Me-CCNU, 5-FU and ADM vs ACNU, 5-FU and ADM for treatment of advanced gastric cancer

Table 1 General data of evaluable patients in Groups A and B

Parameter	Group A	Group B
No. of cases	47	46
Sex, M	36	32
Sex, F	11	14
Age (yr), -40	4	7
41-50	9	4
51-60	8	14
61-70	16	17
71-80	10	4
Performance status grade 1	1	0
Performance status grade 2	5	11
Performance status grade 3	5	5
Performance status grade 4	35	26
Unclear	1	4
Histology
Papillary adenocarcinoma	3	1
Tubular adenocarcinoma 1	4	8
Tubular adenocarcinoma 2	17	12
Low differentiated adenocarcinoma	13	8
Mucocellular carcinoma	2	1
Signet ring cell carcinoma	0	2
Others	8	14

Table 2 Courses of treatment in Groups A and B patients

Groups	No. of courses								Total
	1	2	3	4	5	6	7	8
Group A	16	20	5	2	0	1	0	0	47
Group B	8	23	6	2	0	0	1	1	46

Table 3 Data on partial remission cases

Case No.	Group	Sex	Age	Performance status	Pathohistology	No. of courses	Effective site
22	B	M	54	4	Tubular adenocarcinoma	4	Liver
35	B	M	46	4	Tubular adenocarcinoma	3	Stomach
45	B	M	65	4	Low differentiated adenocarcinoma	7	Liver
67	B	F	60	4	Low differentiated adenocarcinoma	4	Spleen
71	B	F	66	3	Tubular adenocarcinoma	3	Stomach
82	B	F	72	2	Low differentiated adenocarcinoma	2	Liver spleen
83	B	M	74	4	Tubular adenocarcinoma	8	Stomach
100	B	M	65	4	Tubular adenocarcinoma	3	Liver

Table 4 Anti-tumor effect in Group A and B patients

Group	A	B
Partial response (%)	0 (0)	8 (17.4)
No change (moderate response)	16 (1)	17 (2)
Progressive lesion	31	21
95% reliability	0, 6.2%	6.4%, 28.4%
Fisher’s test	P > 0.01	P > 0.01
Median survival time	108 d	112 d
Average course	1.9	2.3

Table 5 Adverse effects in Group A and B patients

	Group A		Group B
	Cases	%	Cases	%
Loss of appetite	3	6.5	4	8.7
Nausea	3	6.5	3	6.5
Vomiting	9	19.6	8	17.4
Fatigue	1	2.2	1	2.2
Muscular disability	4	8.7	3	8.7
Alopecia	4	8.7	3	6.5
Fever	1	2.2	2	4.3
EKG abnormality	1	2.2	1	2.2
Leukopenia	2	4.3	5	10.9
Decrease of hemoglobin	1	2.2	0	0.0