Table 1. Baseline Characteristics of the Study Population (n = 44).

From: Relationship between Programmed Cell Death Protein Ligand 1 Expression and Immune-related Adverse Events in Non-small-cell Lung Cancer Patients Treated with Pembrolizumab

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]
Table 2. Categorization of irAEs in Patient Cohort.

From: Relationship between Programmed Cell Death Protein Ligand 1 Expression and Immune-related Adverse Events in Non-small-cell Lung Cancer Patients Treated with Pembrolizumab

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
Table 3. Characteristics of Patients with irAEs (irAE Group) and without irAEs (Non-irAE Group) (n = 44)a.

From: Relationship between Programmed Cell Death Protein Ligand 1 Expression and Immune-related Adverse Events in Non-small-cell Lung Cancer Patients Treated with Pembrolizumab

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 - - -
Table 4. Comparison of the Development of irAEs and Severe irAEsa in Patients with High PD-L1 Expression Based on Primary Therapy and Secondary Therapy or More (n = 27)b.

From: Relationship between Programmed Cell Death Protein Ligand 1 Expression and Immune-related Adverse Events in Non-small-cell Lung Cancer Patients Treated with Pembrolizumab

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
Table 5. Comparison of the Development of irAEs and Severe irAEsa in Previously-treated Patients Based on High and Low PD-L1 Expression (n = 22)b.

From: Relationship between Programmed Cell Death Protein Ligand 1 Expression and Immune-related Adverse Events in Non-small-cell Lung Cancer Patients Treated with Pembrolizumab

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
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