TABLE 1.
Patients baseline characteristics in FAS
| Characteristics | Sintilimab arm(n = 145) | Docetaxel arm(n = 135) |
|---|---|---|
| Sex, n (%) | ||
| Male | 136 (93.8) | 122 (90.4) |
| Female | 9 (6.2) | 13 (9.6) |
| Age (years) | ||
| Mean ± SD | 60.6 ± 8.2 | 59.5 ± 8.4 |
| Median (min, max) | 61.0 (38.0, 74.0) | 60.0 (34.0, 75.0) |
| > 60, n (%) | 84 (57.9) | 65 (48.1) |
| ≤ 60, n (%) | 61 (42.1) | 70 (51.9) |
| Ethnicity, n (%) | ||
| Han | 141 (97.2) | 129 (95.6) |
| Others | 4 (2.8) | 6 (4.4) |
| BMI (kg/m2) | ||
| Mean ± SD | 23.1 ± 3.1 | 23.6 ± 3.4 |
| Median (min, max) | 22.9 (15.0, 30.8) | 23.5 (17.4, 34.1) |
| ECOG PS, n (%) | ||
| 0 | 35 (24.1) | 31 (23.0) |
| 1 | 110 (75.9) | 104 (77.0) |
| PD‐L1 expression, n (%) | ||
| TPS < 1% | 27 (42.9) | 27 (52.9) |
| TPS ≥ 1% | 36 (57.1) | 24 (47.1) |
| Missing data | 82 | 84 |
| Smoking status, n (%) | ||
| Current smoker/quitted | 130 (89.7) | 108 (80.0) |
| Non‐smoker | 15 (10.3) | 27 (20.0) |
| Disease conditions, n (%) | ||
| Locally advanced | 28 (19.3) | 26 (19.3) |
| Metastatic | 117 (80.7) | 109 (80.7) |
| Brain metastases, n (%) | ||
| Yes | 12 (12.0) | 10 (10.8) |
| No | 88 (88.0) | 83 (89.2) |
| Missing data | 45 | 42 |
| Liver metastases, n (%) | ||
| Yes | 17 (11.7) | 15 (11.2) |
| No | 128 (88.3) | 119 (88.8) |
| Missing data | 0 | 1 |
| Staging, n (%) | ||
| Stage IIIB | 21 (14.5) | 17 (12.6) |
| Stage IIIC | 7 (4.8) | 9 (6.7) |
| Stage IVA | 69 (47.6) | 64 (47.4) |
| Stage IVB | 48 (33.1) | 45 (33.3) |
| Prior systemic chemotherapy | 145 (100.0) | 135 (100.0) |
| Paclitaxel‐based chemotherapy | 54 (37.2) | 44 (32.6) |
| Response to prior chemotherapy * | ||
| Complete or partial response | 37 (25.5) | 39 (28.9) |
| Stable disease | 59 (40.7) | 50 (37.0) |
| Progressive disease | 33 (22.8) | 37 (27.4) |
| Not evaluable or unknown | 37 (25.5) | 45 (33.3) |
| Time since prior treatment (months) # , median (95% CI) | 2.7 (1.4‐5.5) | 2.0 (1.2‐6.2) |
*
Patients’ response to any chemotherapy, including prior neoadjuvant therapy, adjuvant therapy or first‐line chemotherapy were recorded. Therefore, the data was not equal to 145 (sintilimab arm) or 135 (docetaxel arm).
#
Defined as the time from the last dose of prior chemotherapy to randomization.
Abbreviations: FAS: full analysis set; SD: standard deviation; BMI: body mass index; ECOG: Eastern Cooperative Oncology Group; PS: performance status; PD‐L1: programmed cell death‐ligand 1; TPS: tumor proportional score; CI: confidence interval.