Table 1.
Baseline and demographic data
| S-1 | Docetaxel | |
|---|---|---|
| N = 577 | N = 570 | |
| Sex | ||
| Male | 388 (67.2) | 381 (66.8) |
| Female | 189 (32.8) | 189 (33.2) |
| Age (years), median (range) | 62 (23−85) | 62 (28−82) |
| Body surface area (m2), median (range) | 1.670 (1.17–2.12) | 1.670 (1.21–2.30) |
| Previous chemotherapy regimens | ||
| 1 | 350 (60.7) | 357 (62.6) |
| 2 | 178 (30.8) | 169 (29.6) |
| 3 | 49 (8.5) | 44 (7.7) |
| ECOG performance status | ||
| 0 | 200 (34.7) | 207 (36.3) |
| 1 | 365 (63.3) | 350 (61.4) |
| 2 | 12 (2.1) | 13 (2.3) |
| Ethnicity | ||
| Japanese | 357 (61.9) | 358 (62.8) |
| Chinese | 193 (33.4) | 192 (33.7) |
| Korean | 1 (0.2) | 0 (0.0) |
| Taiwanese | 22 (3.8) | 16 (2.8) |
| Other | 4 (0.7) | 4 (0.7) |
| Previous EGFR TKI | ||
| No | 442 (76.6) | 440 (77.2) |
| Yes | 135 (23.4) | 130 (22.8) |
| Surgery | ||
| No | 470 (81.5) | 456 (80.0) |
| Yes | 107 (18.5) | 114 (20.0) |
| Radiation therapy | ||
| No | 358 (62.0) | 330 (57.9) |
| Yes | 219 (38.0) | 240 (42.1) |
| Histology type | ||
| Adenocarcinoma | 430 (74.5) | 431 (75.6) |
| Squamous cell carcinoma | 105 (18.2) | 97 (17.0) |
| Large cell carcinoma | 10 (1.7) | 7 (1.2) |
| Other | 31 (5.4) | 35 (6.1) |
| Unknown | 1 (0.2) | 0 (0.0) |
| Stage | ||
| IIIB | 48 (8.3) | 35 (6.1) |
| IV | 528 (91.5) | 535 (93.9) |
| Unknown | 1 (0.2) | 0 (0.0) |
| Smoking status | ||
| Ever | 395 (68.5) | 383 (67.2) |
| Never | 182 (31.5) | 187 (32.8) |
| EGFR mutation | ||
| Positive | 135 (23.4) | 130 (22.8) |
| Negative | 350 (60.7) | 347 (60.9) |
| Unknown | 92 (15.9) | 93 (16.3) |
| Target lesions | ||
| No | 80 (13.9) | 53 (9.3) |
| Yes | 496 (86.0) | 517 (90.7) |
| Unknown | 1 (0.2) | 0 (0.0) |
Data are n (%) unless otherwise specified.
ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; TKI, tyrosine kinase inhibitor.