Table 1.
Characteristics of the Patients at Baseline.
| Characteristic | Nivolumab plus Chemotherapy (N = 179) |
Chemotherapy Alone (N = 179) |
|---|---|---|
| Age | ||
| Median (range) — yr | 64 (41–82) | 65 (34–84) |
| Distribution — no. (%) | ||
| <65 yr | 93 (52.0) | 83 (46.4) |
| ≥65 yr | 86 (48.0) | 96 (53.6) |
| Sex — no. (%) | ||
| Male | 128 (71.5) | 127 (70.9) |
| Female | 51 (28.5) | 52 (29.1) |
| Geographic region — no. (%) | ||
| North America | 41 (22.9) | 50 (27.9) |
| Europe | 41 (22.9) | 25 (14.0) |
| Asia | 85 (47.5) | 92 (51.4) |
| Rest of the world* | 12 (6.7) | 12 (6.7) |
| ECOG performance-status score — no. (%)† | ||
| 0 | 124 (69.3) | 117 (65.4) |
| 1 | 55 (30.7) | 62 (34.6) |
| Disease stage — no. (%)‡ | ||
| IB or II | 65 (36.3) | 62 (34.6) |
| IIIA | 113 (63.1) | 115 (64.2) |
| Histologic type of tumor — no. (%) | ||
| Squamous | 87 (48.6) | 95 (53.1) |
| Nonsquamous | 92 (51.4) | 84 (46.9) |
| Smoking status — no. (%)§ | ||
| Never smoked | 19 (10.6) | 20 (11.2) |
| Current or former smoker | 160 (89.4) | 158 (88.3) |
| PD-L1 expression level — no. (%)¶ | ||
| Could not be evaluated | 12 (6.7) | 13 (7.3) |
| <1% | 78 (43.6) | 77 (43.0) |
| ≥1% | 89 (49.7) | 89 (49.7) |
| 1–49% | 51 (28.5) | 47 (26.3) |
| ≥50% | 38 (21.2) | 42 (23.5) |
| Tumor mutational burden — no. (%)∥ | ||
| Could not be evaluated or was not reported | 91 (50.8) | 89 (49.7) |
| <12.3 mutations per megabase | 49 (27.4) | 53 (29.6) |
| ≥12.3 mutations per megabase | 39 (21.8) | 37 (20.7) |
| Type of platinum therapy — no. (%) | ||
| Cisplatin | 124 (69.3) | 134 (74.9) |
| Carboplatin | 39 (21.8) | 33 (18.4) |
This category includes Argentina and Turkey only.
Eastern Cooperative Oncology Group (ECOG) performance-status scores range from 0 to 5, with higher scores indicating greater disability.
Data for disease stage are from case-report forms, with the TNM Classification of Malignant Tumors, 7th edition, used for classification. One patient in the chemotherapy-alone group had stage IA disease, and one patient in each group had stage IV disease.
One patient in the chemotherapy-alone group had unknown smoking status.
Percentages are based on the primary analysis population. The status of programmed death ligand 1 (PD-L1) expression was determined with the use of the PD-L1 IHC 28-8 pharmDx assay (Dako); patients with tumor tissue that could not be assessed for PD-L1 expression (≤10% of all the patients who underwent randomization) were stratified to the subgroup with a PD-L1 expression level of less than 1% at randomization.
Tumor mutational burden was not analyzed for patients in China, and these patients were included in the “not reported” category.