Characteristics | Chemotherapy + PD-1/L1 | Chemotherapy alone | P value |
---|---|---|---|
Number | 190 | 102 | |
Gender, n (%) | 0.728 | ||
Male | 163 (85.8%) | 89 (87.3%) | |
Female | 27 (14.2%) | 13 (12.7%) | |
Age(years), mean ± sd | 60.437 ± 7.8359 | 61.99 ± 11.686 | 0.230 |
Baseline ECOG PS, n (%) | 0.201 | ||
1 | 140 (73.7%) | 82 (80.4%) | |
0 | 50 (26.3%) | 20 (19.6%) | |
Disease status at trial entry, n (%) | < 0.001 | ||
Metastatic | 77 (40.5%) | 63 (61.8%) | |
Unresectable advanced | 46 (24.2%) | 31 (30.4%) | |
Recurrent, distant | 38 (20%) | 3 (2.9%) | |
Recurrent, locoregional | 29 (15.3%) | 5 (4.9%) | |
Hepatic Metastases, n (%) | 0.046 | ||
NO | 163 (85.8%) | 78 (76.5%) | |
YES | 27 (14.2%) | 24 (23.5%) | |
Pulmonary Metastases, n (%) | 0.316 | ||
NO | 149 (78.4%) | 85 (83.3%) | |
YES | 41 (21.6%) | 17 (16.7%) | |
Bone Metastases, n (%) | 0.143 | ||
NO | 180 (94.7%) | 92 (90.2%) | |
YES | 10 (5.3%) | 10 (9.8%) | |
Site, n (%) | 0.061 | ||
Lower | 61 (32.1%) | 38 (37.3%) | |
Middle | 67 (35.3%) | 36 (35.3%) | |
Cervical | 10 (5.3%) | 2 (2%) | |
Upper | 36 (18.9%) | 10 (9.8%) | |
Multiple | 16 (8.4%) | 16 (15.7%) | |
Baseline clinical stage (AJCC 8th), n (%) | 0.223 | ||
IV | 164 (86.3%) | 93 (91.2%) | |
III | 26 (13.7%) | 9 (8.8%) | |
Histological grade, n (%) | 0.267 | ||
Well or moderately differentiated | 97 (51.1%) | 59 (57.8%) | |
Poorly differentiated or undifferentiated | 93 (48.9%) | 43 (42.2%) | |
Chemotherapy regimen of the study treatment, n (%) | 0.117 | ||
Platinum + Fluorouracil | 46 (24.2%) | 27 (26.5%) | |
Platinum + Paclitaxel | 120 (63.2%) | 68 (66.7%) | |
Fluorouracil + Irinotecan | 7 (3.7%) | 1 (1%) | |
Irinotecan | 4 (2.1%) | 0 (0%) | |
Fluorouracil | 6 (3.2%) | 0 (0%) | |
Paclitaxel | 5 (2.6%) | 2 (2%) | |
Others | 2 (1.1%) | 4 (3.9%) | |
Chemotherapy in postprogression stage, n (%) | 0.357 | ||
Paclitaxel | 8 (21.6%) | 2 (10.5%) | |
Fluorouracil + Irinotecan | 17 (45.9%) | 10 (52.6%) | |
Platinum + Paclitaxel | 2 (5.4%) | 0 (0%) | |
Irinotecan | 5 (13.5%) | 4 (21.1%) | |
Fluorouracil | 2 (5.4%) | 3 (15.8%) | |
Others | 3 (8.1%) | 0 (0%) | |
Continuing immunotherapy or immunotherapy in postprogression stage, n (%) | 0.452 | ||
Toripolimab | 9 (25.7%) | 4 (44.4%) | |
Sintilimab | 17 (48.6%) | 2 (22.2%) | |
Camrelizumab | 4 (11.4%) | 2 (22.2%) | |
Nivolumab | 3 (8.6%) | 0 (0%) | |
Tislelizumab | 1 (2.9%) | 1 (11.1%) | |
Pembrolizumab | 1 (2.9%) | 0 (0%) |