Table 1. Baseline patient characteristics.
| Characteristics | Total (n = 160) | Experimental arm Nimotuzumab+ Gefitinib (n = 80) |
Control arm Gefitinib (n = 80) |
P |
|---|---|---|---|---|
| n (%) | n (%) | n (%) | ||
| Age, years | 0.80 | |||
| Median | 63 | 63 | 63 | |
| Range | 31-84 | 31-84 | 37-83 | |
| Sex | 0.41 | |||
| Male | 102 (63.8%) | 54 (67.5%) | 48 (60.0%) | |
| Female | 58 (36.2%) | 26 (32.5%) | 32 (40.0%) | |
| ECOG performance status | 0.13 | |||
| 0 | 77 (49.7%) | 41 (52.6%) | 36 (46.8%) | |
| 1 | 75 (48.4%) | 34 (43.6%) | 41 (53.2%) | |
| 2 | 3 (1.9%) | 3(3.8%) | 0 (0%) | |
| Smoking | 0.40 | |||
| Never/light smoker | 56 (35.0%) | 25 (31.2%) | 31 (38.8%) | |
| Ever smoker | 104 (65%) | 55 (68.8%) | 49 (61.2%) | |
| Histology | 0.56 | |||
| Adenocarcinoma | 106 (66.2%) | 53 (66.2%) | 53 (66.2%) | |
| Non-adenocarcinoma | 54 (33.8%) | 27 (33.8%) | 27 (33.8%) | |
| Brain metastasis | 0.65 | |||
| Yes | 30 (18.8%) | 16 (20.0%) | 14 (17.5%) | |
| EGFR mutation | 0.36 | |||
| Positive | 31 (19.4%) | 11 (13.8%) | 20 (25.0%) | |
| Exon19 del | 14 (8.8%) | 3 (3.8%) | 11 (13.8%) | |
| Exon21 L858R | 11 (6.9%) | 7 (8.8%) | 4 (5.0%) | |
| Other† | 6 (3.8%) | 1 (1.2%) | 5 (6.3%) | |
| Negative | 84 (52.5%) | 39 (48.8%) | 38 (47.5%) | |
| Not evaluable | 45 (26.9%) | 29 (36.2%) | 27 (33.8%) | |
| KRAS mutation | 0.59 | |||
| Positive | 7 (4.3%) | 5 (6.2%) | 2 (2.5%) | |
| Negative | 70 (43.8%) | 36 (45.0%) | 34 (42.5%) | |
| Unknown | 83 (51.9%) | 39 (48.8%) | 44 (55.0%) | |
| Previous first-line therapy | 0.68 | |||
| Platinum + paclitaxel | 77 (49.0%) | 38 (48.1%) | 39 (50.0%) | |
| Platinum + gemcitabine | 41 (26.1%) | 22 (27.8%) | 19 (24.4%) | |
| Platinum + pemetrexed | 35 (22.3%) | 16 (20.3%) | 19 (24.4%) | |
| Other | 4 (2.5%) | 3 (3.8%) | 1 (1.3%) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; †These six patients had in three exon 18 mutation (G719X) and three exon20 insertion mutation.