EGFR testing and clinical management of advanced NSCLC: a Galician Lung Cancer Group study (GGCP 048-10)

Figures & data

Table 1 Patient demographic and clinical characteristics

Characteristics	Total (n=198)	EGFR mutation status (n=184)
		Positive (n=25)	Negative (n=159)	P-value
Median age (range), years	66 (59–76)	72 (34–85)	65 (38–84)	NS
Sex, n (%)
Male	151 (76.3)	8 (5.7)	132 (94.3)	,0.001
Female	47 (23.7)	17 (38.6)	27 (61.4)
Race, n (%)
Caucasian	197 (99.5)	25 (13.7)	158 (86.3)
Black	1 (0.5)	0 (0.0)	1 (100)
Smoking history, n (%)
Former smoker	90 (45.5)	6 (7.1)	79 (92.9)	,0.001
Current smoker	65 (32.8)	2 (3.4)	57 (96.6)
Never-smoker	43 (21.7)	17 (42.5)	23 (57.5)
ECOG PS, n (%)
0	27 (13.6)	2 (8.7)	21 (91.3)
1	106 (53.5)	15 (14.7)	87 (85.3)
2	49 (24.7)	5 (11.2)	40 (88.8)
≥3	16 (8.1)	3 (21.4)	11 (78.6)
Tumor histology, n (%)
Adenocarcinoma	136 (68.7)	25 (100)	101 (80.2)	,0.01
Squamous-cell carcinoma	43 (21.7)	0 (0.0)	41 (100)
Large-cell carcinoma	16 (8.1)	0 (0.0)	14 (100)
Adenosquamous-cell carcinoma	2 (1.0)	0 (0.0)	2 (100)
Carcinoma NOS	1 (0.5)	0 (0.0)	1 (100)

Abbreviations: ECOG PS, Eastern Cooperative Oncology Group Performance Status; EGFR, epidermal growth factor receptor; NOS, not otherwise specified; NS, not significant.

Figure 1 Patient and sample disposition flow diagram.

Abbreviations: NSLC, non-small-cell lung cancer; EGFR, epidermal growth factor receptor.

Table 2 Source and type of tumor samples for EGFR mutation testing (n=198)

Sample characteristics	N (%)
Biopsy	114 (57.6)
Tumor tissue source
Primary tumor	90 (78.9)
Metastatic sites	24 (21.1)
Biopsy sample type
FFPET	112 (98.2)
Fresh tissue	2 (1.8)
Cytology	84 (71.4)
Tumor tissue source
Primary tumor	60 (71.4)
Metastatic sites	24 (28.6)
Cytology type
FNA	53 (63.1)
Bronchoalveolar lavage	10 (11.9)
Bronchial brushing	6 (7.1)
Pleural effusion	6 (7.1)
Othera	9 (10.7)

Note:

a Other cytology types used in two or less patients.

Abbreviations: EGFR, epidermal growth factor receptor; FFPET, formalin-fixed, paraffin-embedded tissue; FNA, fine-needle aspiration.

Table 3 Type of EGFR mutations identified in tumor (N=25) and serum samples (N=14)

Type of mutations	Tumor sample	Serum sample
	N (%)	N (%)
Exon 18	0 (0)	0 (0)
Exon 19	11 (44)	5 (35.7)
Del 19	11 (44)	5 (35.7)
Exon 20	2 (8)	1 (7.1)
Insertion	1 (4)	1 (7.1)
Not specified	1 (4)	–
Exon 21	12 (48)	8 (57.1)
L858R	11 (44)	6 (42.9)
L861Q	1 (4)	1 (7.1)

Abbreviation: EGFR, epidermal growth factor receptor.

Table 4 Concordance analysis between tumor and serum samples regarding EGFR mutation rate (N=174)

	Tumor sample
	EGFR MND	EGFR MD	Total
Serum samplea
EGFR MND	148	12	160
EGFR MD	1	13	14
Total	149	25	174
P-valueb	<0.001

Notes:

a Increasing the detection cutoff by 20%;

b chi-square test. Concordance rate =92.5%; overall concordance (Cramer’s V coefficient) =0.6; specificity =99.3%; sensitivity =52.0%; positive predictive value =92.9%; negative predictive value =92.5%.

Abbreviations: MD, mutation detected; MND, mutation not detected; EGFR, epidermal growth factor receptor.

Figure 2 Kaplan–Meier curves for PFS (A) and OS (B) in patients with advanced or metastatic NSCLC carrying EGFR mutations.

Abbreviations: CI, confidence interval; OS, overall survival; PFS, progression-free survival.