Table 1.
Patient demographic and baseline characteristics-full analysis set
| Characteristics | Gefitinib plus anlotinib (n = 155) | Gefitinib plus placebo (n = 155) |
|---|---|---|
| Age, years | ||
| Median (range) | 59.0 (29.0–77.0) | 59.0 (32.0–76.0) |
| <65 | 119 (76.8) | 108 (69.7) |
| ≥65 | 36 (23.2) | 47 (30.3) |
| Male sex | 68 (43.9) | 67 (43.2) |
| ECOG performance status score | ||
| 0 | 19 (12.3) | 15 (9.7) |
| 1 | 130 (83.9) | 133 (85.8) |
| Unknown | 6 (3.4) | 7 (4.5) |
| Smoking status | ||
| Never smokers | 118 (76.1) | 121 (78.1) |
| Former smokers | 26 (16.8) | 24 (15.5) |
| Current smokers | 10 (6.5) | 9 (5.8) |
| Unknown | 1 (0.7) | 1 (0.7) |
| Stage of disease | ||
| IIIB | 10 (6.5) | 4 (2.6) |
| IV | 142 (91.6) | 148 (95.5) |
| Unknown | 3 (1.9) | 3 (1.9) |
| Tumor histologic subtypes | ||
| Adenocarcinoma | 153 (98.7) | 150 (96.8) |
| Others | 2 (1.3) | 5 (3.2) |
| Type of EGFR mutations | ||
| Exon 19 deletion | 80 (51.6) | 81 (52.3) |
| L858R | 75 (48.4) | 74 (47.7) |
| Metastatic sites | ||
| ≤2 | 54 (34.8) | 58 (37.4) |
| >2 | 101 (65.2) | 95 (61.3) |
| Unknown | 0 (0.0) | 2 (1.3) |
| Brain metastasis | ||
| Yes | 49 (31.6) | 50 (32.3) |
| No | 106 (68.3) | 105 (67.7) |
| Liver metastasis | ||
| Yes | 20 (12.9) | 22 (14.2) |
| No | 135 (87.1) | 133 (85.8) |
Data are expressed as number (%) unless otherwise indicated
Eastern Cooperative Oncology Group (ECOG) performance-status (PS) scores range from 0 to 5, with higher numbers indicating increasing impairment in activities of daily living
Definitions: Never smokers, defined as smoking <100 cigarettes/lifetime; former smokers, defined as abstinence from smoking for at least 15 years on the day before the start of therapy; current smokers, defined as smoking >100 cigarettes/lifetime, or smoking >100 cigarettes/lifetime but abstinence from smoking for less than one year on the day before the start of therapy