Characteristic | Observation n = 155 | Gemcitabine n = 154 | Erlotinib n = 155 |
---|---|---|---|
Median age (range, years) | 59.8 (37–72) | 57.9 (29–71) | 56.4 (36–71) |
Gender, n (%) | |||
Male | 113 (72.9) | 113 (73.4) | 113 (72.9) |
Female | 42 (27.1) | 41 (26.6) | 42 (27.1) |
ECOG PS at inclusion, n (%) | |||
0 | 78 (50.3) | 73 (47.4) | 81 (52.3) |
1 | 77 (49.7) | 81 (52.6) | 74 (47.7) |
ECOG PS at randomization, n (%) | |||
0 | 68 (44.2) | 61 (40.1) | 58 (37.9) |
1 | 81 (52.6) | 82 (53.9) | 85 (55.6) |
2 | 4 (2.6) | 7 (4.6) | 8 (5.2) |
3 | 1 (0.6) | 2 (1.3) | 2 (1.3) |
Unknown | 1 (0.6) | 2 (1.3) | 2 (1.3) |
Stage, n (%) | |||
IIIB | 14 (9.2) | 14 (9.3) | 11 (7.4) |
IV | 139 (90.8) | 137 (90.7) | 137 (92.6) |
Unknown | 2 (1.3) | 3 (1.9) | 7 (4.5) |
Brain metastases, n (%) | 1 (0.6) | 5 (3.2) | 2 (1.3) |
Smoking status, n (%) | |||
Current and former smokers | 143 (92.3) | 137 (89) | 138 (89.0) |
Never smoker* | 12 (7.7) | 17 (11.0) | 17 (11) |
Histology, n (%) | |||
Adenocarcinoma | 103 (66.5) | 101 (65.6) | 97 (62.6) |
Squamous cell carcinoma | 30 (19.4) | 34 (22.1) | 27 (17.4) |
Unknown | 22 (14.2) | 19 (12.3) | 31 (20) |
Response to induction chemotherapy, n (%) | |||
Objective response | 82 (52.9) | 81 (52.6) | 82 (52.9) |
Stable disease | 73 (47.1) | 73 (47.4) | 73 (47.1) |