A Retrospective Study of Ensartinib-Treated ALK-Positive Locally Advanced or Metastatic NSCLC Patients in China

Figures & data

Table 1. Patient demographics and clinical characteristics.

Characteristics	Total (n = 682), n (%)
Sex
Male	306 (44.9%)
Female	376 (55.1%)
Age
<65 years	515 (75.5%)
≥65 years	167 (24.5%)
Smoking history
Yes	34 (5.0%)
No	607 (89.0%)
Others	41 (6.0%)
ECOG performance status
0–1	587 (86.1%)
≥2	90 (13.2%)
Missing	5 (0.7%)
Tumor histology
Adenocarcinoma	623 (91.3%)
Squamous cell carcinoma	32 (4.7%)
Others/missing	27 (4.0%)
Tumor stage
IIIB–IIIC	74 (10.8%)
IV	585 (85.8%)
Others/missing	23 (3.4%)
Line of therapy
First line	210 (30.8%)
Second line	306 (44.9%)
Third line or multiple lines	2 (0.3%)
Others/missing	164 (24.0%)

ECOG: Eastern Cooperative Oncology Group.

Figure 1. Progression-free survival in all evaluable patients.

NE: Not estimable.

Figure 2. Progression-free survival curves according to line of treatment.

NE: Not estimable.

Figure 3. Forest plots for subgroup analysis of objective response rate with respect to stratification factors.

ECOG: Eastern Cooperative Oncology Group; ORR: Objective response rate.

Table 2. Treatment-related adverse events reported in ≥1% patients.

	Grade 1, n (%)	Grade 2, n (%)	Grade ≥3, n (%)	Unknown, n (%)	Total, n (%)
TRAE	113 (16.6%)	40 (5.8%)	7 (1.0%)	2 (0.3%)	162 (23.8%)
Rash	100 (14.7%)	35 (5.1%)	7 (1.0%)	2 (0.3%)	144 (21.1%)
Pruritus	22 (3.2%)	3 (0.4%)	1 (0.2%)	0	26 (3.8%)
Constipation	10 (1.4%)	4 (0.6%)	0	1 (0.2%)	15 (2.2%)
Facial edema	9 (1.3%)	0	0	0	9 (1.3%)
Vomiting	6 (0.8%)	1 (0.2%)	0	0	7 (1.0%)

TRAE: Treatment-related adverse event.

Table 3. Uni- and multivariate Cox regression analyses of independent prognostic factors for progression-free survival.

Variable	Progression-free survival (n = 30)
	Univariate analysis		Multivariate analysis
	HR (95% CI)	p-value	HR (95% CI)	p-value
Sex
Male	2.23 (1.06–4.66)	0.0295	1.78 (0.83–3.83)	0.1370
Female	1		1
Age
<65 years	1
≥65 years	0.58 (0.22–1.52)	0.2645
Smoking history
Yes	0.58 (0.14–2.42)	0.4457
No	1
ECOG performance status
0–1	1
≥2	0.92 (0.32–2.66)	0.8798
Tumor histology
Adenocarcinoma	1		1
Squamous cell carcinoma	6.95 (2.95–16.37)	<0.001	4.44 (1.75–11.26)	0.0017
Tumor stage
III	0.56 (0.13–2.35)	0.4193
IV	1
Line of therapy
First line	0.52 (0.22–1.23)	0.1326	0.71 (0.29–1.74)	0.4469
Second line	1		1
Others/missing	0.08 (0.01–0.55)	0.0013	0.10 (0.01–0.77)	0.0272

HR was determined with univariate Cox regression analysis, and p-value in univariate analysis was assessed by the Log rank test. Variables with a p-value <0.05 in the univariate analysis were included in multivariate logistic regression analysis, and HR and p-value in multivariate analysis were evaluated by Cox regression analysis.

ECOG: Eastern Cooperative Oncology Group; HR: Hazard ratio.

Data sharing statement

All data generated or analyzed during this study are available upon reasonable request from correspondence author.