Table 1.
Characteristics of the Patients.
| All patients | Non-CS group | Pre-CS group | Post-CS group | p-value | ||
|---|---|---|---|---|---|---|
| n = 109 | n = 64 | n = 12 | n = 33 | |||
| Gender, n (%) | Male | 80 (73) | 44 (69) | 11 (92) | 25 (76) | 0.24a) |
| Female | 29 (27) | 20 (31) | 1 (8) | 8 (24) | ||
| Age, years, median (quartile) | 67 (60, 73) | 67 (60, 73) | 63 (57, 67) | 67 (61, 72) | 0.31b) | |
| Smoking history, n (%) | Never smokers | 14 (13) | 12 (19) | 0 (0) | 2 (6) | 0.08a) |
| Former smokers | 95 (87) | 52 (81) | 12 (100) | 31 (94) | ||
| Histological subtypes, n (%) | Non-squamous | 67 (62) | 40 (63) | 8 (67) | 19 (58) | 0.86a) |
| Squamous | 42 (38) | 24 (37) | 4 (33) | 14 (42) | ||
| EGFR mutation status, n (%) | EX19del / L858R | 3 (3) / 2 (2) | 3 (5) / 1 (2) | 0 (0) / 0 (0) | 0 (0) / 1 (3) | 0.89a) |
| Wild type | 61 (56) | 34 (53) | 8 (67) | 19 (58) | ||
| Not inspected | 43 (39) | 26 (40) | 4 (33) | 13 (39) | ||
| Stage, n (%) | Ⅲ A / Ⅲ B | 23 (21) / 13 (12) | 10 (16) / 6 (9) | 1 (8) / 3 (25) | 12 (36) / 4 (12) | 0.05a) |
| Ⅳ / Recurrent | 54 (50) / 19 (17) | 38 (59) / 10 (16) | 6 (50) / 2 (17) | 10 (30) / 7 (22) | ||
| ECOG-PS at first cycle of nivolumab, n (%) | 0, 1 | 96 (88) | 56 (88) | 10 (83) | 30 (91) | 0.77a) |
| ≧2 | 13 (12) | 8 (12) | 2 (17) | 3 (9) | ||
| Number of lines of nivolumab, n (%) | 2 | 30 (28) | 20 (31) | 1 (8) | 9 (27) | 0.58a) |
| ≧3 | 79 (72) | 44 (69) | 11 (92) | 24 (73) | ||
| CNS metastasis at diagnosis, n (%) | YES | 13 (12) | 9 (14) | 3 (25) | 1 (3) | 0.10a) |
| NO | 96 (88) | 55 (86) | 9 (75) | 32 (97) | ||
| Number of nivolumab cycle, median (quartile) | 6 (4, 11) | 7 (4, 12) | 4 (2, 4) | 8 (6, 11) | <0.01b)* | |
a) Dunnett test, b) Kruskal-Wallis test, *p < 0.05, non-CS vs pre-CS. EGFR, epidermal growth factor receptor; ECOG PS, Eastern Cooperative Oncology Group performance status; CNS, central nervous system; non-CS, not systemically administered corticosteroids; post-CS, systemic corticosteroid administration initiated during nivolumab treatment; pre-CS, systemic corticosteroid administration before the first cycle of nivolumab administration.