Table 1. Patients characteristics.
| Variable | Overall N = 35 | Non-irAEs group n = 23 | AE group n = 12 | p-value |
|---|---|---|---|---|
| Sex1 | 0.537 | |||
| Female | 15 (42.9) | 9 (39.1) | 6 (50) | |
| Male | 20 (57.1) | 14 (60.9) | 6 (50) | |
| Age2 (years) | 65.83 (7.12) | 65.87 (6.14) | 65.75 (9.02) | 0.565 |
| Histology1 | 0.011 | |||
| squamous | 19 (54.3) | 12 (52.2) | 7 (58.3) | |
| adenocarcinoma | 13 (37.1) | 11 (47.8) | 2 (16.7) | |
| not-otherwise-specified (NOS) | 3 (8.6) | 0 (0.0) | 3 (25.0) | |
| Age at NSCLC diagnosis2 | 64.29 (6,72) | 64.52 (5,82) | 63.83 (8,46) | 0.542 |
| Time from NSCLC diagnosis to initiation of nivolumab3 (months) | 12 (3–96) | 12 (3–39) | 13,5 (9–96) | 0.572 |
| Stage1 | 0.279 | |||
| IIIb | 16 (45.7) | 9 (39.1) | 7 (58.3) | |
| IV | 19 (54.3) | 14 (60.9) | 5 (41.7) | |
| EGFR mutation1 | 0.125 | |||
| no | 31 (88.6) | 19 (82.6) | 12 (100.0) | |
| yes | 4 (11.4) | 4 (17.4) | 0 (0.0) | |
| ALK rearrangment1 | >0.999 | |||
| no | 34 (97.1) | 22 (95.7) | 12 (100.0) | |
| yes | 1 (2.9) | 1 (4.3) | 0 (0.0) | |
| Bone metastasis1 | 0.380 | |||
| no | 28 (80.0) | 17 (73.9) | 11 (91.7) | |
| yes | 7 (20.0) | 6 (26.1) | 1 (8.3) | |
| Metastases to parenchymal organs1 | 0.434 | |||
| no | 25 (71.4) | 15 (65.2) | 10 (83.3) | |
| yes | 10 (28.6) | 8 (34.8) | 2 (16.7) | |
| Central nervous system metastases1 | >0.999 | |||
| no | 31 (88.6) | 20 (87.0) | 11 (91.7) | |
| yes | 4 (11.4) | 3 (13.0) | 1 (8.3) | |
| Current or previous smoker1 | 0.400 | |||
| no | 6 (17.1) | 5 (21.7) | 1 (8.3) | |
| yes | 29 (82.9) | 18 (78.3) | 11 (91.7) | |
| Pack years2 | 24.14 (14.73) | 22.61(15.58) | 27.08 (13.05) | 0.388 |
| Previous radiotherapy1 | 0.070 | |||
| no | 14 (40.0) | 12 (52.2) | 2 (16.7) | |
| yes | 21 (60.0) | 11 (47.8) | 10 (83.3) | |
| Line of treatment1 | 0.308 | |||
| 2 | 22 (62.9) | 12 (52.2) | 10 (83.3) | |
| 3 | 10 (28.6) | 8 (34.8) | 2 (16.7) | |
| 4 | 2 (5.7) | 2 (8.7) | 0 (0.0) | |
| 5 | 1 (2.9) | 1 (4.3) | 0(0.0) | |
| Patients with history of other cancers1 | ||||
| <5 years before immunotherapy | ||||
| no | 33 (94.3) | 22 (95.7) | 11 (91.7) | > 0.999 |
| yes | 2 (5.7) | 1 (4.3) | 1 (8.3) | |
| 5–10 years before immunotherapy | 0.343 | |||
| no | 34 (97.1) | 23 (100) | 11 (91.7) | |
| yes | 1 (2.9) | 0 (0.0) | 1 (8.3) | |
| >10 years before immunotherapy | > 0.999 | |||
| no | 33 (94.3) | 22 (95.7) | 11 (91.7) | |
| yes | 2 (5.7) | 1 (4.3) | 1 (8.3) | |
| % PD-L1 expresion1 | > 0.999 | |||
| PD-L1 ≥ 50 | 2 (12.5) | 1 (8.3) | 1 (25.0) | |
| PD-L1 1–49 | 5 (31.3) | 4 (33.3) | 1 (25.0) | |
| Unknown | 9 (56.3) | 7 (58.3) | 2 (50.0) | |
| Median total doses of nivolumab3, 4 | 5(1–76) | 4 (1–66) | 29 (3–76) | 0.009 |
| PFS (months)3, 5 | 2.5 (1.50–10.0) | 2 (1.50–2.50) | 9.0 (3.50–26.0) | 0.0214 |
| OS (months)5 | 36.0 (32.00–50.0) | 33.5 (20.0–40.50) | 54.5 (34.0–65.0) | 0.0953 |
| Reason for termination of treatment1 | 0.459 | |||
| Not applicable (ongoing treatment) | 3 (8.5) | 0 (0.0) | 3 (25.0) | |
| Disease progression | 29 (82.9) | 22 (95.7) | 7 (58.3) | |
| Adverse events | 2 (5.7) | 1 (4.3) | 1 (8.3) | |
| Other | 1 (2.9) | 0 (0.0) | 1 (8.3) |
M, mean; Me, median; SD, standard deviation
1 n (%)
2 mean (SD)
3 median (range minimum–maximum)
4 Mann–Whitney U test
5Kaplan-Meier analysis
AEs, adverse events; irAEs, immune-related adverse events; PFS, progression-free survival.