Table 1 Patient demographics and baseline characteristics (safety population)
Characteristic | Cohort 1 (n = 23) | Cohort 2 (n = 22) | Cohort 3 (n = 24) | P a |
|---|---|---|---|---|
Mean age, years (SD) | 47 (10) | 50 (10) | 45 (12) | 0.27 |
Male, n (%) | 22 (96) | 19 (86) | 20 (83) | 0.39 |
WHO histopathological grade, n (%) | 0.77 | |||
Grade I | 2 (9) | 2 (9) | 1 (4) | |
Grade II | 0 | 0 | 0 | |
Grade III | 21 (91) | 20 (91) | 23 (96) | |
Current or past smoker, n (%) | 13 (57) | 15 (68) | 14 (58) | 0.69 |
Alcohol use, n (%) | 19 (83) | 18 (82) | 19 (79) | 0.95 |
Metastatic sites, n (%) | ||||
Lung | 8 (35) | 5 (22) | 7 (29) | 0.67 |
Liver | 8 (35) | 10 (45) | 13 (54) | 0.41 |
Bone | 13 (57) | 12 (55) | 12 (50) | 0.90 |
Distant lymph nodes | 7 (30) | 7 (32) | 4 (17) | 0.43 |
Multiple sites | 10 (44) | 10 (46) | 10 (42) | 0.97 |
Prior chemotherapy, n (%) | ||||
Any chemotherapy | 16 (70) | 15 (68) | 20 (83) | 0.43 |
Paclitaxel | 5 (21) | 4 (27) | 9 (45) | 0.49 |
Treatment history, n (%) | 0.07 | |||
Failed 1st-line chemotherapy | 15 (65) | 10 (46) | 12 (50) | |
Recurrence after curative treatment | 1 (4) | 6 (27) | 9 (38) | |
Treatment-naïve | 7 (30) | 6 (27) | 3 (13) | |
Median cycles of prior lines of chemotherapy (range) | 5 (1 to 14) | 5 (2 to 8) | 4 (1 to 10) | 0.75 |
Mean time since last chemotherapy, months (SD) | 4 (4) | 7 (11) | 7 (8) | 0.40 |
Prior radiotherapy, n (%) | 10 (44) | 11 (50) | 17 (71) | 0.143 |