Table 1.

Summary of first-line efficacy data of TKIs in patients with EGFR-mutated advanced NSCLC (results from randomized phase III trials of gefitinib/erlotinib versus standard chemotherapy).

Trial	patient selection	treatment/number of patients	ORR (%)	PFS (months)	OS (months)
IPASS	Asia	Carboplatin-Paclitaxel	47	6.3	21.9
(Mok et al. 2009)	never- or light ex-smoker	(n=608 total; n=129 EGFR M+) Gefitinib	71	9.5	21.6
	adenocarcinoma	(n=609 total; n=132 EGFR M+)	p < 0.001	HR 0.48; p<0.001	HR 1.00; p 0.99
WJTOG 3405	Asia	Cisplatin-Docetaxel	32	6.3	not reached
(Mitsudomi et al. 2010)	EGFR mutation	(n=86 EGFR M+) Gefitinib	62	9.2	30.9
		(n=86 EGFR M+)	p< 0.001	HR 0.49; p<0.0001	HR 1.64; p 0.211
NEJ 002	Asia	Carboplatin-Paclitaxel	31	5.4	23.6
(Maemondo et al. 2010)	EGFR mutation	(n=100 EGFR M+) Gefitinib	74	10.8	30.5
		(n=98 EGFR M+)	p< 0.001	HR 0.30; p<0.001	HR NR; p 0.31
OPTIMAL	Asia	Carboplatin-Gemcitabine	36	4.6	NA
(Zhou et al. 2011)	EGFR mutation	(n=72 EGFR M+) Erlotinib	83	13.1	NA
		(n=83 EGFR M+)	p< 0.0001	HR 0.16; p<0.0001	NA
EURTAC	Europe	Platinum-Gemcitabine/Docetaxel	15	5.2	19.5
(Rossell et al. 2012)	EGFR mutation	(n=87 EGFR M+) Erlotinib	58	9.7	19.3
		(n=86 EGFR M+)	OR 7.5; p<0.0001	HR 0.37; p<0.0001	HR 1.047; p 0.87

EGFR: epidermal growth factor receptor; ORR: objective response rate; PFS: progression-free survival; OS: overall survival; HR: hazard ratio; OR: odds ratio; NA: not available, NR: not reported.