Real-World Data on Osimertinib in Chinese Patients with Pretreated, EGFR T790M Mutation Positive, Advanced Non-Small Cell Lung Cancer: A Retrospective Study

Figures & data

Table 1 Baseline Clinical and Demographic Features of Patients

Characteristics	Patients (n=106)
	n	%
Age (years)
Median	60.7
Range	37–81
Sex
Male	37	34.9
Female	69	65.1
ECOG PS
0	18	17.0
1	63	59.4
2	25	23.6
Smoking status
Non-smoker	86	81.1
Former/current smoker	20	18.9
Histology
Adenocarcinoma	102	96.2
Others	4	3.8
Stage
IIIB	4	37.7
IV	102	96.3
Genotypes
T790M-positive
Exon 19del-positive	56	52.8
L858R-positive	50	47.2
Osimertinib treatment line
2nd	24	22.6
≥ 3nd	82	77.4
Prior EGFR‐TKI treatment
Gefitinib	42	39.6
Erlotinib	24	22.7
Icotinib	40	37.7
Osimertinib Treatment
Monotherapy	62	58.5
Osimertinib plus antiangiogenic	26	24.5
Osimertinib plus local radiotherapy	16	15.1
Osimertinib plus chemotherapy	2	1.9
PD sites prior to Osimertinib
Intracranial	28	26.4
Intrathoracic	23	21.7
Other	55	51.9

Abbreviations: EGFR, epidermal growth factor receptor; ECOG PS, Eastern cooperative oncology group performance score.

Table 2 Summary of Clinical Activity for Osimertinib

Types of Patients	Survival				Tumor Response
	PFS Months, 95% CI	P value	OS Months, 95% CI	P value	ORR %,	P value	DCR %,	P value
Overall population	12(10.5, 13.5)		27(19.6,34.4)		57.5		93.4
Treatment line
2nd (n=24)	11(9.0, 13.0)	0.799	27(20.3,33.7)	0.421	41.7	0.061	91.7	1.00
≥3rd (n=82)	12(8.9, 15.1)		Undefined		62.2		94.0
Genotype
T790M/exon19del (n=56)	11(9.2, 12.8)	0.833	Undefined	0.0273	60.7	0.308	96.4	0.348
T790M/L858R (n=50)	12(9.2, 14.8)		23(19.1,29.9)		54.0		90.0
CNS metastases
Yes (n=28)	11(8.0, 14.0)	0.373	15(6.9, 23.1)	0.0266	50.0	0.235	85.7	0.143
No (n=78)	12(10.3,13.7)		27(22, 32)		60.3		96.2
Smoking status
Never (n=86)	12(10.1, 13.9)	0.087	27(21.4,32.6)	0.155	61.6	0.066	94.2	0.858
Former/current (n=20)	10(7.4, 12.6)		18(13.9,22.1)		40.0		90.0
Age
≤61 (n=50)	11(9.5, 12.5)	0.401	Undefined	0.341	50.0	0.099	92.0	0.877
>61 (n=56)	13(11.2,14.8)		27(19.6,24.4)		64.3		94.6
Sex
Male (n=37)	12(10.3, 13.7)	0.309	18(14.6,21.4)	0.014	48.6	0.125	91.9	0.963
Female (n=69)	12(10.2, 13.8)		Undefined		62.3		94.2
Osimertinib treatment
Monotherapy (n=62)	11(9.9,12.1)	0.59	27(21.7,32.3)	0.88	53.2	0.474	88.7	0.099
Combined Anti-angiogenesis (n=26)	14 (11.2,16.8)		Undefined		61.5		100.0

Abbreviations: PFS, progression-free survival; OS, overall survival; CNS, central nervous system; ORR, objective response rate; DCR, disease control rate.

Figure 1 Progression-free Survival (PFS) in the overall population (A), in patients of T790M co-occurring with exon 19 deletion or L858R mutation (B), in patients with or without CNS metastasis (C), in patients with monotherapy or combined anti-antiangiogenesis therapy (D). Tick marks indicate censored observations.

Figure 2 Overall Survival (OS) in the overall population (A), in patients of T790M co-occurring with exon 19 deletion or L858R mutation (B), in patients with or without CNS metastasis (C), in patients with monotherapy or combined anti-antiangiogenesis therapy (D). Tick marks indicate censored observations.

Table 3 Adverse Events (n=106)

Type of AE	AE Grade				Total Report	Grade≥ 3
	1	2	3	4	No. of Patients (%)
Rash	7	0	0	0	7 (6.6)	0
Fatigue	5	0	0	0	5 (4.7)	0
Stomatitis	3	2	0	0	5 (4.7)	0
Dry skin	6	0	0	0	6 (5.7)	0
White blood cell decreased	7	0	0	1	7 (6.6)	1
Paronychia	3	0	0	0	3 (2.8)	0
Diarrhea	3	2	0	0	5 (4.7)	0
Anorexia	3	0	0	0	3 (2.8)	0
Constipation	3	2	0	0	5 (4.7)	0
Neutrophil count decreased	3	1	0	0	4 (3.8)	0
Nausea	1	0	0	0	1 (0.9)	0
Anemia	1	1	0	0	2 (1.9)	0
Vomiting	3	0	0	0	3 (2.8)	0
Cough	0	1	0	0	1 (0.9)	0
Headache	1	0	1	0	2 (1.9)	1
Dizziness	1	0	0	0	1 (0.9)	0
AST increased	3	0	0	0	3 (2.8)	0
ALT increased	3	0	0	0	3 (2.8)	0
Platelet count decreased	1	2	0	1	4 (3.8)	1
Palpitation	1	0	0	0	1 (0.9)	0
Pulmonary fibrosis	1	0	0	0	1 (0.9)	0