Table 1 Patient, disease and treatment characteristics
Characteristic | US (N = 68) | EU (N = 47) | |
|---|---|---|---|
Age in years, mean ± SD (range) | 40.9 ± 16.2 (19-83) | 37.9 ± 16.5 (18-74) | |
Female gender, N (%) | 33 (48.5) | 18 (38.3) | |
Race, N (%) | Caucasian/white | 54 (79.4) | 46 (97.9) |
Black | 10 (14.7) | 0 (0.0) | |
Other | 4 (5.9) | 1 (2.1) | |
BSA at baseline in m2, mean ± SD (range) | 1.94 ± 0.26 (1.42-2.53) | 1.85 ± 0.21 (1.41-2.28) | |
ECOG status, N (%) | 0 | 47 (69.1) | 30 (63.8) |
1 | 20 (29.4) | 14 (29.8) | |
2 | 1 (1.5) | 3 (6.4) | |
Disease stage 1, N (%) | I | 8 (12.1) 2 | 5 (10.6) |
II | 30 (45.5) 2 | 28 (59.6) | |
III | 23 (34.8) 2 | 8 (17.0) | |
IV | 5 (7.6) 2 | 6 (12.8) | |
Prior radiotherapy, N (%) | 6 (8.8) | 0 (0.0) | |
Baseline WBC in 103/mm3, mean ± SD; median | 9.4 ± 4.9; 7.8 | 9.5 ± 3.8; 8.4 | |
Baseline ANC in 103/mm3, mean ± SD; median | 6.5 ± 3.3; 5.3 2 | 7.2 ± 3.6; 6.6 | |
Diabetes, N (%) | 8 (11.8) | 0 (0.0) | |
Cardiac comorbidity, N (%) | 0 (0.0) | 2 (4.3) | |
Planned dose intensity in mg/m2/week, mean ± SD; median | |||
Bleomycin | 4.9 ± 0.9; 4.9 | 5.3 ± 1.2; 5.0 | |
Doxorubicin | 12.5 ± 1.9; 12.3 | 12.8 ± 2.7; 12.43 | |
Dacarbazine | 184.0 ± 29.5; 183.6 | 198.3 ± 50.2; 186.7 | |
Vinblastine | 3.0 ± 0.5; 2.9 | 3.2 ± 0.8; 3.0 | |
Planned cycle number, N (%) | ≤ 3 | 0 (0.0) | 2 (4.3) |
4-5 | 29 (42.6) | 16 (34.0) | |
6 | 38 (55.9) | 26 (55.3) | |
≥ 8 | 1 (1.5) | 3 (6.4) | |
Planned cycle length in days, N (%) | 14 | 7 (10.3) | 5 (10.6) |
21 | 5 (7.4) | 2 (4.3) | |
28 | 56 (82.4) | 40 (85.1) | |