TABLE 1.
Demographics and baseline disease characteristics (Japan intent‐to‐treat population) a
| Characteristic |
Pembrolizumab + Chemo N = 35 |
Placebo + Chemo N = 22 |
|---|---|---|
| Age | ||
| Median (range), years | 54 (26–82) | 50 (33–78) |
| ≥65 years | 9 (26) | 5 (23) |
| ECOG performance status | ||
| 0 | 29 (83) | 16 (73) |
| 1 | 6 (17) | 6 (27) |
| Disease stage at initial diagnosis b | ||
| I | 8 (23) | 4 (18) |
| II | 13 (37) | 1 (5) |
| IIIA | 1 (3) | 2 (9) |
| IIIB | 2 (6) | 1 (5) |
| IVB | 11 (31) | 14 (64) |
| Disease status at trial entry | ||
| Metastatic c | 4 (11) | 10 (46) |
| Persistent or recurrent with distant metastases | 24 (69) | 9 (41) |
| Persistent or recurrent without distant metastases | 7 (20) | 3 (14) |
| Histologic type | ||
| Adenocarcinoma | 6 (17) | 5 (23) |
| Adenosquamous carcinoma | 2 (6) | 1 (5) |
| Squamous cell carcinoma | 27 (77) | 16 (73) |
| PD‐L1 combined positive score | ||
| <1 | 5 (14) | 1 (5) |
| 1 to <10 | 15 (43) | 11 (50) |
| ≥10 | 15 (43) | 10 (46) |
| Previous therapy | ||
| Chemoradiotherapy and surgery | 6 (17) | 1 (5) |
| Radiotherapy and surgery | 2 (6) | 1 (5) |
| Chemoradiotherapy only | 17 (49) | 9 (41) |
| Radiotherapy only | 2 (6) | 1 (5) |
| Surgery only | 4 (11) | 0 |
| None | 4 (11) | 10 (45) |
| Bevacizumab use during the trial | ||
| Yes | 22 (63) | 17 (77) |
| No | 13 (37) | 5 (23) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; PD‐L1, programmed death ligand 1.
a
Data are presented as n (%) unless specified otherwise.
b
Stage at initial diagnosis determined using FIGO 2009/NCCN 2017 criteria.
c
Metastatic includes patients with paraaortic lymph node involvement.