| |
Overall
|
Starting dose
|
Starting dose
|
|---|
|
320 mg/m2
|
≤280 mg/m2
|
|---|
| |
n = 77
|
n = 37
|
n = 40 *
|
|
Female
|
14 (18.2 %)
|
6 (16.2 %)
|
8 (20.0 %)
|
|
Male
|
63 (81.1 %)
|
31 (83.3 %)
|
32 (80.0 %)
|
|
Median age in years (range)
|
67 (39–80)
|
66 (39–77)
|
70 (51–80)
|
|
≥70 y
|
32 (41.6 %)
|
12 (32.4 %)
|
20 (50.0 %)
|
|
ECOG PS
| | | |
|
0
|
35 (45.5 %)
|
18 (48.6 %)
|
17 (42.5 %)
|
|
1
|
42 (54.5 %)
|
19 (51.4 %)
|
23 (57.5 %)
|
|
Visceral involvement
|
46 (59.7 %)
|
23 (62.2 %)
|
23 (57.5 %)
|
|
Liver metastases†
|
17 (22.1 %)
|
6 (16.2 %)
|
11 (27.5 %)
|
|
TFPC < 6 months‡
|
45 (58.4 %)
|
19 (51.4 %)
|
26 (65.0 %)
|
|
Mean Hb in g/dL§
|
11.2
|
11.6
|
10.9
|
|
Hb < 10 g/dL§
|
13 (16.9 %)
|
5 (13.5 %)
|
8 (20.0 %)
|
- ECOG: Eastern Cooperative Oncology Group; PS: performance status; TFPC: time from prior chemotherapy; Hb: hemoglobin
- *n(280 mg/m2) = 30; n(<280 mg/m2) = 10
- †information missing for 4 patients in the 320 mg/m2 group and 8 patients in the ≤ 280 mg/m2 group
- ‡information missing for 6 patients in the 320 mg/m2 group and 2 patients in the ≤ 280 mg/m2 group
- §information missing for 6 patients in the 320 mg/m2 group and 2 patients in the ≤ 280 mg/m2 group; ITT: intent-to-treat
