Table 1.
Clinical characteristics for the study population (whole cohort and training and validation cohorts).
| Variables | Whole Cohort N = 154 |
Training Cohort N = 101 |
Validation Cohort N = 53 |
p-Value | Adjusted p-Value |
|---|---|---|---|---|---|
| Sex | 0.9 | >0.9 | |||
| Male | 80 (52%) | 53 (52%) | 27 (51%) | ||
| Female | 74 (48%) | 48 (48%) | 26 (49%) | ||
| Age, years | 62 (54, 68) | 62 (55, 68) | 61 (54, 67) | 0.6 | 0.9 |
| ≤60 | 66 (43%) | 42 (42%) | 25 (47%) | 0.5 | 0.8 |
| >60 | 87 (57%) | 59 (58%) | 28 (53%) | ||
| NA | 1 | 1 | 0 | ||
| Stage at diagnosis | 0.044 | 0.4 | |||
| Local | 70 (45%) | 40 (40%) | 30 (57%) | ||
| Metastatic | 84 (55%) | 61 (60%) | 23 (43%) | ||
| PDL1 status | >0.9 | >0.9 | |||
| Positive | 18 (30%) | 13 (30%) | 5 (29%) | ||
| Negative | 43 (70%) | 31 (70%) | 12 (71%) | ||
| NA | 93 | 57 | 36 | ||
| Surgery | 0.2 | 0.7 | |||
| No | 87 (56%) | 61 (60%) | 26 (49%) | ||
| Yes | 67 (44%) | 40 (40%) | 27 (51%) | ||
| Type of surgery | 0.2 | 0.7 | |||
| Curative | 60 (90%) | 34 (85%) | 26 (96%) | ||
| Palliative | 7 (10%) | 6 (15%) | 1 (3.7%) | ||
| Histology | >0.9 | >0.9 | |||
| Adenocarcinoma | 81 (53%) | 54 (53%) | 27 (51%) | ||
| Carcinoma | 55 (36%) | 35 (35%) | 20 (38%) | ||
| Other | 18 (12%) | 12 (12%) | 6 (11%) | ||
| Line of ICI | 0.5 | 0.8 | |||
| ≤2 | 101 (66%) | 68 (67%) | 33 (62%) | ||
| >2 | 53 (34%) | 33 (33%) | 20 (38%) | ||
| Number of cycles | 0.4 | 0.8 | |||
| ≤2 | 59 (38%) | 41 (41%) | 18 (34%) | ||
| >2 | 95 (62%) | 60 (59%) | 35 (66%) | ||
| Type of ICI | 0.5 | 0.8 | |||
| PD-1 | 93 (60%) | 61 (60%) | 32 (60%) | ||
| PD-L1 | 26 (17%) | 20 (20%) | 6 (11%) | ||
| PD-1/CTLA-4 | 4 (2.6%) | 3 (3.0%) | 1 (1.9%) | ||
| PD-L1/CTLA-4 | 27 (18%) | 15 (15%) | 12 (23%) | ||
| Other | 4 (2.6%) | 2 (2.0%) | 2 (3.8%) | ||
| WHO status at ICI | >0.9 | >0.9 | |||
| 0 | 55 (36%) | 36 (36%) | 19 (36%) | ||
| >0 | 98 (64%) | 64 (64%) | 34 (64%) | ||
| NA | 1 | 1 | 0 | ||
| Smoking status | 0.9 | >0.9 | |||
| Never smoker | 35 (29%) | 22 (28%) | 13 (30%) | ||
| Smoker | 87 (71%) | 56 (72%) | 31 (70%) | ||
| NA | 32 | 23 | 9 | ||
| Cerebral metastasis | 25 (16%) | 17 (17%) | 8 (15%) | 0.8 | >0.9 |
| NA | 1 | 0 | 1 | ||
| Liver metastasis | 47 (31%) | 35 (35%) | 12 (23%) | 0.14 | 0.7 |
| NA | 1 | 0 | 1 | ||
| Bone metastasis | 51 (33%) | 35 (35%) | 16 (31%) | 0.6 | 0.9 |
| NA | 1 | 0 | 1 | ||
| Lymph node metastasis | 106 (70%) | 65 (64%) | 41 (80%) | 0.042 | 0.4 |
| NA | 2 | 0 | 2 | ||
| Lung metastasis | 60 (42%) | 38 (39%) | 22 (47%) | 0.4 | 0.8 |
| NA | 10 | 4 | 6 | ||
| Pleuro-peritoneal metastasis | 58 (38%) | 42 (42%) | 16 (31%) | 0.2 | 0.7 |
| NA | 1 | 0 | 1 | ||
| Toxicity | 66 (43%) | 41 (41%) | 25 (47%) | 0.4 | 0.8 |
| Use of corticosteroids | 51 (33%) | 39 (39%) | 12 (23%) | 0.045 | 0.4 |
| RECIST | 0.3 | 0.8 | |||
| Progression | 115 (78%) | 71 (76%) | 44 (83%) | ||
| Response | 32 (22%) | 23 (24%) | 9 (17%) | ||
| NA | 7 | 7 | 0 | ||
| Cancer type | 0.2 | 0.7 | |||
| Breast | 13 (8%) | 12 (12%) | 1 (1.9%) | ||
| Colon | 19 (12%) | 12 (12%) | 7 (13%) | ||
| Lung | 55 (36%) | 36 (36%) | 19 (36%) | ||
| Other | 67 (44%) | 41 (41%) | 26 (49%) |
Continuous variables are described by median values and interquartile range (IQR). Categorical variables are described by number of observation and percentages (%). NA: Not Available; ICI: Immune Checkpoint Inhibitor; PD-1: Programmed cell Death protein 1; PD-L1: Programmed Death-Ligand 1; CTLA-4: Cytotoxic T Lymphocyte-Associated protein 4; WHO: World Health Organization.