Characteristics | Valuea, n (%) | |
---|---|---|
Age, years, median [range] | 68 [31–83] | |
Sex (male) | 31 (70.5%) | |
ECOG PS at time of pembrolizumab monotherapyb | ||
0 | 31 (70.5%) | |
1 | 10 (22.7%) | |
2 | 3 (6.8%) | |
Smoking status | ||
Current smoker or ever smoked | 35 (79.5%) | |
Never smoked | 9 (20.4%) | |
Pathological subtype | ||
Squamous cell carcinoma | 17 (38.6%) | |
Non-squamous NSCLC | 27 (61.4%) | |
PD-L1 expression | ||
≥ 50% (high) | 27 (61.4%) | |
1–49% (low) | 17 (38.6%) | |
EGFR status in non-squamous NSCLC | ||
Mutant | 3 (6.8%) | |
Number of prior chemotherapy regimens | ||
0 | 22 (50%) | |
1 | 13 (29.5%) | |
≥ 2 | 9 (20.5%) | |
Development of irAEs | 31 (70.5%) | |
Development of severe irAEs | 10 (22.7%) | |
Onset of irAEs, weeks, median [range] | 3.3 [0–28] |
n (%) | Grade of irAEs, n 1/2/3/4/5 |
|
---|---|---|
Skin reaction | 18 (40.9%) | 14/1/3/0/0 |
Pneumonitis | 10 (22.7%) | 0/5/4/0/1 |
Infusion reaction | 8 (18.2%) | 5/3/0/0/0 |
Hepatitis | 4 (9.1%) | 2/0/1/1/0 |
Thyroid dysfunction | 4 (9.1%) | 4/0/0/0/0 |
Microhematuria | 2 (4.5%) | 2/0/0/0/0 |
Myocarditis | 1 (2.3%) | 0/0/0/1/0 |
Pancreatitis | 1 (2.3%) | 0/0/1/0/0 |
Enteritis | 1 (2.3%) | 0/1/0/0/0 |
Eye symptom | 1 (2.3%) | 1/0/0/0/0 |
Myositis/peripheral neuropathy | 0 (0%) | 0/0/0/0/0 |
Variables | Univariate analysis | Multivariate analysis | |||||
---|---|---|---|---|---|---|---|
irAE groupb (n = 31) |
non-irAE groupc (n = 13) |
P | Odds rate | 95% CI | Ph | ||
Sex (male), n (%) | 22 (71.0%) | 9 (69.2%) | 1.0f | - | - | - | |
Age, years, median [range] | 68 [37–83] | 71 [31–80] | 0.77g | - | - | - | |
Pathological subtype | |||||||
Squamous cell carcinoma, n (%) | 13 (41.9%) | 4 (30.8%) | 0.74f | - | - | - | |
Non-squamous NSCLC, n (%) | 18 (58.0%) | 9 (69.2%) | |||||
Smoking (ex, current), n (%) | 26 (83.9%) | 9 (69.2%) | 0.41f | - | - | - | |
ECOG PS 0, n (%) | 25 (80.6%) | 6 (46.1%) | 0.033f | 4.4 | 0.85–22.8 | 0.076 | |
Primary treatment, n (%) | 20 (64.5%) | 2 (15.3%) | 0.007f | - | - | - | |
High PD-L1 expression, n (%) | 24 (77.4%) | 3 (23.1%) | 0.002f | 11 | 2.1–54.4 | 0.004 | |
Best response, n CR/PR/SD/PD | 0/16/14/1 | 0/2/5/6 | - | - | - | ||
Response rate, n (%)d | 16 (51.6%) | 2 (15.4%) | 0.043f | - | - | - | |
Disease control rate, n (%)e | 30 (96.8%) | 7 (53.8%) | 0.001f | - | - | - |
Primary therapy (n = 22) |
Second therapy or more (n = 5) |
Pc | |
---|---|---|---|
irAEs, n (%) | 20 (90.9%) | 4 (80.0%) | 0.47 |
Severe irAEs, n (%) | 6 (27.3%) | 2 (40.0%) | 0.62 |
High PD-L1 expression (n = 5) |
Low PD-L1 expression (n = 17) |
Pc | |
---|---|---|---|
irAEs, n (%) | 4 (80.0%) | 7 (41.2%) | 0.31 |
Severe irAEs, n (%) | 2 (40.0%) | 2 (11.7%) | 0.21 |