Clinical features affecting efficacy of immune checkpoint inhibitors in pretreated patients with advanced NSCLC: a Danish nationwide real-world study

Figures & data

Table 1. Baseline characteristics.

Baseline characteristics	n (%)
All patients	840 (100)
Sex
Male	432 (51)
Female	408 (49)
Age, median; range	68; 22−89
Age
<75 years	677 (81)
≥75 years	163 (19)
ECOG PS
0	182 (22)
1	479 (57)
≥2	158 (19)
Missing	21 (2)
Charlson Comorbidity Index Score (CCIS)
0 (no)	332 (40)
1 (mild)	207 (25)
2 (moderate)	154 (18)
≥3 (severe)	147 (17)
Smoking status
Current	238 (28)
Former	535 (64)
Never	46 (6)
Unknown	21 (2)
TNM stage
III	116 (14)
IV	724 (86)
Metastatic sites^a
Brain	95 (11)
Bone	221 (26)
Liver	133 (16)
Adrenal	127 (15)
Distant lymph nodes	233 (28)
NSCLC histopathology
Adenocarcinoma	485 (58)
Squamous cell carcinoma	303 (36)
Other^b	52 (6)
EGFR mutation
No	537 (64)
Yes	25 (3)
Unknown	278 (33)
PD-L1 status
Negative	72 (9)
≥1% and < 50%	233 (28)
≥50%	290 (35)
Unknown	245 (29)

^aPatients may be registered with more than one metastatic site.

^b‘Other’ includes NSCLC NOS (not otherwise specified) and adenosquamous carcinoma.

n: number of patients; ECOG PS: Eastern Cooperative Oncology Group performance status; NA: not available; TNM: tumor-node-metastasis classification of malignant tumors; NSCLC: non-small cell lung cancer; EGFR: epidermal growth factor receptor; PD-L1: programmed death-ligand 1.

Table 2. ICI treatment characteristics.

Treatment characteristics	n (%)
All patients	840 (100)
Treatment line
2	536 (64)
3	205 (24)
4	68 (8)
≥5	31 (4)
Treatment
Nivolumab	444 (53)
Pembrolizumab	396 (47)
Median number of ICI cycles^a; range
Nivolumab	6; 1–64
Pembrolizumab	6; 1–37
ICI treatment duration^a;
Median days; range	98; 1–961
mTTD months; 95% CI	3.2; 2.8–3.6
Ongoing ICI treatment^b	10 (1)
ICI discontinuation due to^c:
PD	461 (56)
Poor PS	126 (15)
irAEs^d	179 (22)
Pneumonitis	47 (6)
Hepatitis	19 (2)
Skin toxicity	27 (3)
Endocrinopathy	15 (2)
Diarrhea/colitis	40 (5)
Other toxicity	51 (6)
irAEs only^e	150 (18)
Other reasons^f	145 (17)
Hospitalization due to irAEs	135 (16)
Death due to irAEs	8 (1)

^aPatients with ongoing ICI treatment (n = 10) not included.

^bAt date of censoring.

^cEach patient could be registered with more than one cause of treatment-discontinuation.

^dEach patient could be registered with more than one type of irAE as a cause of treatment-discontinuation.

^eProportion of patients with irAE as the only cause of treatment discontinuation.

^f‘Other reasons’ are not specified irAEs.

n: number of patients; ICI: immune checkpoint inhibitor; mTTD: median time to treatment discontinuation; PD: progressive disease; PS: performance status; irAEs: immune-related adverse events.

Table 3. Overall and progression-free survival according to sex and performance status.

Survival	mOS months (95% CI)	mPFS months (95% CI)	one-year OS rate % (95% CI)	Two-year OS rate % (95% CI)
All patients	12.2 (10.8–13.8)	5.2 (4.5–5.9)	50 (47–54)	30 (27–33)
Male	10.0 (9.0–11.7)	4.4 (3.7–5.3)	44 (40–49)	25 (21–30)
Female	15.1 (13.4–17.2)	6.4 (5.2–8.1)	57 (53–62)	34 (30–39)
PS 0–1	15.3 (13.5–16.8)	6.3 (5.4–7.5)	57 (53–61)	35 (31–38)
PS ≥2	4.5 (3.2–5.7)	2.0 (1.7–2.6)	26 (20–34)	11 (7–17)

mOS: median overall survival; mPFS: median progression-free survival; CI: confidence interval; PS: performance status.

Figure 1. OS stratified by ECOG PS, sex and histopathology, liver metastases and bone metastases. OS: overall survival; ECOG PS: Eastern Cooperative Oncology Group performance status; F: female; M: male; A: adenocarcinoma; S: squamous cell carcinoma.

Figure 2. Weighted multivariable Cox regression analysis, with forest plots showing average hazard ratios (HR). CI: confidence interval; ECOG PS: Eastern Cooperative Oncology Group performance status; CCIS: Charlson Comorbidity Index Score; NSCLC: non-small cell lung cancer; EGFR: epidermal growth factor receptor; PD-L1: programmed death-ligand 1

Data availability statement

The study data may be available on request from the corresponding author, Mette T Mouritzen. The data are not publicly available due to the General Data Protection Regulation.