Skip to main content

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

From: 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

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
(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
  1. SD standard deviation