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. Author manuscript; available in PMC: 2023 Jan 17.
Published in final edited form as: N Engl J Med. 2022 Apr 11;386(21):1973–1985. doi: 10.1056/NEJMoa2202170

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.

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