Sunitinib added to FOLFIRI versus FOLFIRI in patients with chemorefractory advanced adenocarcinoma of the stomach or lower esophagus: a randomized, placebo-controlled phase II AIO trial with serum biomarker program

Table 1 Demographic, baseline and response characteristics in the ITT population and serum analysis subpopulation

Characteristic	ITT population				Serum analysis population
	Sunitinib		Placebo		Sunitinib		Placebo
	N	n (%)	N	n (%)	N	n (%)	N	n (%)
Number of patients	45	100	45	100	34	100	31	100
Age (years)
Mean (SD)	59 (11)		57 (11)		57 (12)		58 (12)
Median (Range)	62		57		60		60
Median (Range)	(37–76)		(28–84)		(37–76)		(28–84)
Gender
Male	33	73	30	67	25	74	18	58
Female	12	27	15	33	9	26	13	42
Karnofsky performance status
90–100 %	27	60	26	58	22	65	19	61
70–80 %	16	36	18	40	10	29	11	25
Not known	2	4	1	2	2	6	1	3
Histology: Adenocarcinoma of
Stomach	22	49	23	51	17	50	17	55
Cardia	23	51	20	44	17	50	14	45
Not known	0	0	2	4	0	0	0	0
Treatment lines before study entry
1	34	76	34	76	26	76	24	77
2	9	20	11	24	6	18	7	23
3	1	2	–	–	2	6	–	–
Not known	1	2	0	0	0	0	0	0
Screening pT-stadium
0	–	–	1	2	–	–	1	3
1	1	2	1	2	1	3	1	3
2	5	11	7	16	4	12	6	19
3	21	47	18	40	17	50	9	29
4	7	16	9	20	6	18	7	23
X	11	24	9	20	6	18	7	23
Screening pN-stadium
0	2	4	7	16	1	3	6	19
1	16	36	11	24	16	47	7	23
+	–	–	1	2	–	–	–	–
2	9	20	8	18	7	21	7	23
3	8	18	6	13	7	21	5	16
X	10	22	12	27	3	9	6	19
Screening pM-stadium
0	9	20	4	9	8	24	3	10
1	36	80	41	91	26	77	28	90
Best response
Complete response (CR)	–	–	5	11	–	–	4	13
Partial response (PR)	9	20	8	18	8	24	6	19
Stable disease (SD)	18	40	12	27	17	50	9	29
Progressive disease (PD)	14	31	16	36	8	24	12	39
Not evaluable	4	9	4	9	1	3	–	–
Objective response (CR + PR)	9	20	13	29	8	24	10	32
Tumor control rate (CR + PR + SD)	27	60	25	56	25	74	19	61

ISSN: 1471-2407