Efficacy and Safety of First-Generation EGFR-TKIs Combined with Chemotherapy for Treatment-Naïve Advanced Non-Small-Cell Lung Cancer Patients Harboring Sensitive EGFR Mutations: A Single-Center, Open-Label, Single-Arm, Phase II Clinical Trial

Figures & data

Table 1 Clinical Responses to First-Generation EGFR-TKIs Combined with Chemotherapy in Advanced NSCLC Patients Harboring EGFR Mutations by Demographic and Clinical Characteristics

Characteristics		No. of Cases (%)	Objective Response Rate (%)	P	Median PFS (Months, 95% CI)	P	Median OS (Months, 95% CI)	P
Overall		21	76.2	‒	15 (10.56‒19.45)	‒	26 (24.52‒27.48)	‒
Gender	Male	10 (47.6)	60	0.149	12 (7.45‒16.56)	0.242	26 (21.35‒30.65)	0.576
	Female	11 (52.4)	90.9		15 (6.37‒23.63)		25 (22.84‒27.16)
Age (years)	≤60	16 (76.2)	75	1	15 (8.47‒21.53)	0.09	25 (23.04‒26.96)	0.946
	>60	5 (23.8)	80		9 (4.76‒13.29)		26 (23.85‒28.15)
Subtype of EGFR mutation	19 del	10 (47.6)	50	0.012	12 (2.70‒27.30)	0.281	26 (19.80‒32.2)	0.876
	L858R	11 (52.4)	100		15 (8.5‒21.47)		25 (22.84‒27.16)
Brain metastasis	Yes	6 (28.6)	100	0.149	17 (13.8‒20.20)	0.828	25 (19.4‒30.6)	0.788
	No	15 (71.4)	66.7		12 (8.28‒15.72)		26 (23.85‒28.15)
Depth of response	<50%	9 (42.9)			12 (9.08‒14.92)	0.166	26 (23.08‒28.92)	0.992
	≥50%	12 (57.1)			15 (6.51‒23.49)		25 (22.74‒27.63)

Figure 1 Maximum tumor change from baseline by the best overall response, as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, each bar represents the maximum change in the sum of the diameters of the target lesions of an individual patient.

Figure 2 Kaplan-Meier estimates of survival. (A) Progression-free survival; (B) overall survival; (C) comparison of progression-free survival between advanced NSCLC patients harboring EGFR 19del and L858R mutations; (D) comparison of overall survival between advanced NSCLC patients harboring EGFR 19del and L858R mutations.

Table 2 Toxicities During the Treatment with First-Generation EGFR-TKIs in Combination with Chemotherapy in Advanced NSCLC Patients Harboring EGFR Mutations

Adverse Event	No. Subjects with Treatment-Related Toxicity					Overall Incidence of Toxicity (%)	Incidence of Grade 3/4 Toxicity (%)
	Grade 0	Grade 1	Grade 2	Grade 3	Grade 4
Leukopenia	7	5	9	0	0	66.7	0
Neutropenia	4	8	7	2	0	81	9.5
Thrombocytopenia	20	1	0	0	0	4.8	0
Anemia	13	6	2	0	0	38.1	0
Nausea	15	4	2	0	0	28.6	0
Vomiting	16	3	2	0	0	23.8	0
Diarrhea	16	3	1	1	0	23.8	4.8
Liver dysfunction	10	7	2	2	0	52.4	9.5
Rash	4	14	3	0	0	81	0
Nail changes	16	5	0	0	0	23.8	0
Anorexia	15	6	0	0	0	28.6	0
Fatigue	11	8	2	0	0	47.6	0