Table 1. Baseline Characteristics of Patients With Extensive-Stage Small Cell Lung Cancer in the ASTRUM-005 Trial.
| Patients with extensive-stage small cell lung cancer, No. (%)a | ||
|---|---|---|
| Serplulimab (n = 389) | Placebo (n = 196) | |
| Age, median (range), y | 63 (28-76) | 62 (31-83) |
| Aged <65 y | 235 (60.4) | 119 (60.7) |
| Sex | ||
| Male | 317 (81.5) | 164 (83.7) |
| Female | 72 (18.5) | 32 (16.3) |
| Raceb | ||
| Asian | 262 (67.4) | 139 (70.9) |
| Non-Asianc | 127 (32.6) | 57 (29.1) |
| Eastern Cooperative Oncology Group Performance Status Scale scored | ||
| 0 (fully active) | 71 (18.3) | 32 (16.3) |
| 1 (restricted in physically strenuous activity but ambulatory) | 318 (81.7) | 164 (83.7) |
| Smoking history | ||
| Never | 81 (20.8) | 35 (17.9) |
| Current | 102 (26.2) | 48 (24.5) |
| Former | 206 (53.0) | 113 (57.7) |
| Size of target lesions, median (range), mm in diametere | 117.7 (13.8-323.7) | 120.5 (14.5-269.6) |
| Type of metastases | ||
| Brain | 50 (12.9) | 28 (14.3) |
| Liver | 99 (25.4) | 51 (26.0) |
| Programmed cell death ligand 1 expression level, No./total (%) | ||
| Tumor proportion score <1%f | 317/379 (83.6) | 152/186 (81.7) |
| Tumor proportion score ≥1%f | 62/379 (16.4) | 34/186 (18.3) |
| Previous cancer treatment | ||
| Chemotherapyg | 9 (2.3) | 3 (1.5) |
| Otherh | 1 (0.3) | 2 (1.0) |
Some of the data are expressed as median (range) as indicated in the rows.
Self-reported by the patients by selecting 1 or more racial designations (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White, or Other) or based on identity information provided by the patients.
All patients were White.
Scores range from 0 to 5 (higher scores indicate greater disability).
Measured using computed tomography or magnetic resonance imaging.
Not evaluable or no data for 20 patients (3.4%). This was mostly due to inappropriate sectioning or poor sample quality (insufficient evaluable cells).
There were 11 patients who had received treatment for limited-stage small cell lung cancer (treatment-free interval ≥6 months). One patient in the placebo group had received treatment for gastric cancer (>5 years ago).
Herbal or traditional Chinese medicine (2 in the placebo group) and the immunostimulant lentinan (1 in the serplulimab group).