Molecularly targeted therapies for advanced or metastatic non-small-cell lung carcinoma

Table 1 Selected phase III and randomized phase II trials comparing epidermal growth factor receptor tyrosine kinase inhibitor and chemotherapy as first-line therapy in patients with advanced non-small cell lung cancer

Trial	n	Type of study	Study design	OS (mo)	P value	PFS (mo)	P value	ORR (%)	P value
				HR (95%CI)		HR (95%CI)		HR (95%CI)
Fukuoka et al[34]	261	Retrospective	Gefitinib vs PC	21.6 vs 21.9		9.6 vs 6.3		71.2 vs 47.3
				1.00 (0.76-1.33)	0.99	0.48 (0.36-0.64)	0.0001	2.75 (1.65-4.6)	0.0001
Han et al[98]	42	Retrospective	Gefitinib vs Cis + G	27.2 vs 25.6		8.0 vs 6.3		84.6 vs 37.5
				1.04 (0.49-2.18)	NA	0.54 (0.26-1.1)	0.086	9.16 (2.10-39.84)	0.002
Mitsudomi et al[99]	172	Prospective	Gefitinib vs Cis + D	35.5 vs 38.8		9.6 vs 6.6		62.1 vs 32.1
				1.18 (0.76-1.8)	0.44	0.52 (0.37-0.71)	0.001	3.44 (1.60-7.37)	0.0001
Maemondo et al[35], Inoue et al[100]	228	Prospective	Gefitinib vs PC	27.7 vs 26.6		10.8 vs 5.4		73.7 vs 30.7
				0.88 (0.63-1.24)	0.48	0.32 (0.23-0.43)	0.001	6.32 (3.55-11.25)	0.001
Chen et al[28]	154	Prospective	Erlotinib vs C + G	22.7 vs 28.85		13.7 vs 4.6		83 vs 36
				1.04 (0.69-1.58)	0.69	0.16 (0.10-0.26)	0.0001	NA	0.0001
Rosell et al[29]	173	Prospective	Erlotinib vs platinum-based doublets	19.3 vs 19.5		9.7 vs 5.2		581vs 151
				1.04 (0.65-1.68)	0.87	0.37 (0.25-0.54)	0.0001	NA	NA
Yang et a2l[101]	345	Prospective	Afatinib vs Cis + P	NM		11.13vs 6.93		56.13vs 22.63
						0.58 (0.43-0.78)	0.0004	NA	0.001
Jänne et al[102]	345	Prospective	Erlotinib vs erlotinib + PC	24.6 vs 19.8		5.0 vs 6.6		35 vs 46
				NA	NA	NA	NA	NA	NA

¹Intention-to-treat population;

²Only lung adenocarcinoma patients;

³By independent review. PC: Paclitaxel and carboplatin; Cis: Cisplatin; C: Carboplatin; G: Gemcitabine; D: Docetaxel; P: Pemetrexed; OS: Overall survival; HR: Hazard ratio; NM: Not yet mature; NA: Not available; PFS: Progression-free survival; ORR: Objective response rate; n: Number of patients enrolled in the study.