Table 1.
Baseline demographic characteristics (intent-to-treat population)
| Characteristic | TAS-114/S-1 (n = 64) |
S-1 (n = 64) |
|---|---|---|
| Age (years), median | 65.5 | 64.0 |
| Age group, n (%) | ||
| < 65 years | 28 (43.8) | 33 (51.6) |
| ≥ 65 years | 36 (56.3) | 31 (48.4) |
| Sex, n (%) | ||
| Male | 41 (64.1) | 48 (75.0) |
| Female | 23 (35.9) | 16 (25.0) |
| Region, n (%) | ||
| Western | 34 (53.1) | 34 (53.1) |
| Asian | 30 (46.9) | 30 (46.9) |
| ECOG PS, n (%) | ||
| 0 | 12 (18.8) | 17 (26.6) |
| 1 | 52 (81.3) | 47 (73.4) |
| Histology subtype, n (%) | ||
| Squamous cell carcinoma | 14 (21.9) | 14 (21.9) |
| Adenocarcinoma | 48 (75.0) | 48 (75.0) |
| Large cell carcinoma | 0 | 1 (1.6) |
| Carcinoid tumor | 1 (1.6) | 0 |
| Other | 1 (1.6) | 1 (1.6) |
| EGFR mutation status, n (%) | ||
| Positive | 7 (10.9) | 12 (18.8) |
| Negative | 46 (71.9) | 38 (59.4) |
| Unknown | 11 (17.2) | 14 (21.9) |
| ALK translocation status, n (%) | ||
| Positive | 2 (3.1) | 0 |
| Negative | 44 (68.8) | 43 (67.2) |
| Unknown | 18 (28.1) | 21 (32.8) |
| Brain metastases, n (%) | 6 (9.4) | 7 (11.0) |
| Number of prior systemic regimens, n (%) | ||
| 1 | 0 | 0 |
| 2 | 24 (37.5) | 19 (29.7) |
| 3 | 19 (29.7) | 17 (26.6) |
| 4 | 14 (21.9) | 15 (23.4) |
| ≥ 5 | 7 (10.9) | 13 (20.3) |
| Main prior systemic anti-cancer agent, n (%) | ||
| Platinum | 64 (100) | 64 (100) |
| PD-1/PD-L1 antibodies | 46 (71.9) | 49 (76.6) |
| Pemetrexed | 48 (75.0) | 47 (73.4) |
| Docetaxel | 33 (51.6) | 38 (59.4) |
| EGFR-TKI | 7 (11.0) | 11 (17.2) |
| ALK-TKI | 2 (3.1) | 0 |
ALK, anaplastic lymphoma kinase; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; PD-1, programmed death 1; PD-L1, programmed death ligand 1; TKI, tyrosine kinase inhibitor