Intercalated combination of chemotherapy and erlotinib for stage IIIA non-small-cell lung cancer: a multicenter, open-label, single-arm, phase II study

Figures & data

Table 1 Patient demographic and baseline characteristics

Characteristic	Patients (n=39)
Age, years
Median	59
Range	52,63
Female gender, n(%)	10(25.64)
Smoking status, n(%)
Smokers^$	14(35.90)
Ever former smokers^	10(25.64)
Never smokers*	15(38.46)
Pathology, n(%)
Adenocarcinoma	18(46.15)
Adenosquamous carcinoma	13(33.33)
Others	8(20.51)
EGFR mutation status, n(%)
Positive	7(17.95)
Exon 19	5
Exon 20	1
Exon 19/21	1
Negative	9(23.08)
Unknown	23(58.97)
Brain CT or MRI abnormality, n(%)
Yes	19(48.72)
No	18(46.15)
Unknown	2(5.13)

Notes: ^$Smokers are defined as current smokers smoking >100 cigarettes/lifetime, or smoking >100 cigarettes/lifetime with abstinence from smoking for less than 1 year on the day before the start of therapy. ^Ever former smokers are defined as those who had abstained from smoking for at least 1 year on the day before the start of therapy and had a history of at least 100 cigarettes/lifetime. *Never smokers are defined as those smoking <100 cigarettes/lifetime.

Figure 1 Waterfall plot of the largest percentage changes from baseline in the sum of the longest tumor diameters for stage IIIA NSCLC patients.

Abbreviations: CR, complete response; NSCLC, non-small-cell lung cancer; PD, progressive disease; PR, partial response; SD, stable disease.

Figure 2 Kaplan-Meier curves for (A) disease-free survival (DFS) of the intention-to-treat population and (B) DFS of the intention-to-treat population stratified by EGFR mutational status.

Abbreviation: CI, confidence interval.

Table 2 Median DFS of stage IIIA NSCLC patients undergoing surgical resection, stratified by EGFR mutational status^&

	Wild-type EGFR	Mutated EGFR	Unknown EGFR status	Total (n=22)	P-value^
Events (censored)	6 (3)	5 (2)	3 (3)	14 (8)
Median DFS, months (95% CI)	24 (1.22, 50.61)	5 (1.92, *)	* (0.99, *)	20(5.26, 50.61)	0.3520

Notes: ^&calculated by the Kaplan-Meier method. ^Log-rank test for comparison of the three groups.

Abbreviations: DFS, disease free survival; NSCLC, non-small-cell lung cancer.

Figure 3 Kaplan-Meier curves for (A) overall survival (OS) of the intention-to-treat population, (B) OS of the intention-to-treat population stratified by surgical resection versus no surgical resection, (C) OS of the intention-to-treat population stratified by EGFR mutational status, and (D) OS of surgical patients stratified by EGFR mutational status.

Abbreviation: CI, confidence interval.

Table 3 Adverse events (all grades >10%); n(%)

AEs (all grades >10%)	No. of events	Cases, n(%)
Total AEs	99	27(69.2)
CTCAE Grade (3.0)
1	55	20(51.3)
2	39	18(46.2)
3	5	5(12.8)
4	0	0
AEs leading to interruption or dose reductions	11	7(17.9)
ADR	94	27(69.2)
SAE	0	0
AEs CTCAE grade ≥3	5	5(12.8)
Death	0	0

Abbreviations: ADR, adverse drug reaction; AEs, adverse events; CTCAE, CommonTerminology Criteria for Adverse Events; SAE, severe adverse event.

Table S1 Univariate analysis of determinants of the objective response rate in the intention-to-treat population

Variables	N(%)	95%CI*	P
Gender
Male	12 (41.38)	0.471 (0.101,2.004)	0.3133
Female	6 (60.00)
Smoking status, n(%)
Current smokers	4 (28.57)	0.400 (0.068,2.150)	0.2900
Ever former smokers	5 (50.00)
Never smokers	9 (60.00)	1.500 (0.296,7.831)	0.6224
Histopathology
Adenocarcinoma	8 (44.44)	0.880 (0.244,3.130)	0.8430
Others	10 (47.62)
Age, years
>60	7 (50.00)	1.273 (0.339,4.817)	0.7186
≤60	11 (44.00)
EGFR mutation
Yes	6 (85.71)	4.798 (0.497,111.595)	0.2174
No	5 (55.56)
Unknown	7 (30.43)	0.350 (0.067,1.697)	0.1947
ECOG
1	9 (45.00)	0.909 (0.255,3.230)	0.8821
0	9 (47.37)

Abbreviations: CI, confidence interval; N, number