. 2013 Apr;20(2):e150–e160. doi: 10.3747/co.20.1226

TABLE I.

Selected trials in the first-line setting

3.1.

Reference (study name)	Primary endpoint	Pts ( n )	Arms	Group	Progression-free survival (pfs)				Overall survival (os)				Post-protocol treatment

					Months	hr	95% cl	p Value	Months	hr	95% cl	p Value
Sandler et al., 2006²³ (ecog 4599)	os	878	Carboplatin–paclitaxel–bevacizumab	itt	6.4	0.66	0.57, 0.77	<0.001	12.3	0.80	0.69, 0.93	0.003	No crossover planned
Sandler et al., 2006²³ (ecog 4599)	os	878	Carboplatin–paclitaxel		4.8				10.3				No crossover planned
Scagliotti et al., 2008²⁷ (jmdb)	os	1725	Cisplatin–pemetrexed	itt	4.8	1.04	0.94, 1.15	ns	10.3	0.94	0.84, 1.05	ns	No crossover planned; post-protocol, 13.4% of patients in control arm received pemetrexed
		1725	Cisplatin–gemcitabine		5.1				10.3
		847	Cisplatin–pemetrexed	Subgroup: adenocarcinoma		0.90	0.79, 1.02	ns	11.8	0.84	0.71, 0.94	0.03
		847	Cisplatin–gemcitabine						10.4
Mok et al., 2009³ (ipass)	pfs	1217	Gefitinib Carboplatin–paclitaxel	itt	5.7	0.74	0.65, 0.85	<0.001	18.6	0.91	0.76, 1.10	ns	No crossover planned; post-protocol, 64% of patients in chemotherapy arm received an egfr tki
		1217	Gefitinib Carboplatin–paclitaxel		5.8				17.3
		261	Gefitinib Carboplatin–paclitaxel	Subgroup: egfr M+		0.48	0.36, 0.64	<0.001		0.78	0.50, 1.20	ns
Pirker et al., 2009²⁸ (flex)	os	1125	Cisplatin–vinorelbine–cetuximab	itt	4.8	0.94	0.83, 1.08	0.39	11.3	0.87	0.76, 1.00	0.044	No crossover planned
Pirker et al., 2009²⁸ (flex)	os	1125	Cisplatin–vinorelbine		4.8				10.1				No crossover planned
Mitsudomi et al., 2010³³ and 2012³⁴ (wjtog 3405)	pfs	172	Gefitinib Cisplatin–docetaxel	itt (egfr M+)	9.2	0.49	0.34, 0.71	<0.0001	36	1.19	0.77, 1.83	0.443	No crossover planned; post-protocol, 91% of patients in chemotherapy arm received an egfr tki
Mitsudomi et al., 2010³³ and 2012³⁴ (wjtog 3405)	pfs	172	Gefitinib Cisplatin–docetaxel		6.3				39
Reck et al., 2010²⁵ (avail)	pfs (originally os)	692	Cisplatin–gemcitabine–bevacizumab	itt (7.5 mg/kg bevacizumab)	6.7	0.75	0.64, 087	0.0003	13.6	0.93	0.78, 1.11	0.42	Crossover not permitted
		692	Cisplatin–gemcitabine		6.1				13.1
		698	Cisplatin–gemcitabine–bevacizumab	itt (15 mg/kg bevacizumab)	6.5	0.85	0.73, 1.00	0.0456	13.4	1.03	0.86, 1.23	0.761
		698	Cisplatin–gemcitabine		6.1				13.1
Zhou et al., 2011³⁰ (optimal)	pfs	154	Erlotinib Carboplatin–gemcitabine	Received 1 dose of drug (egfr M+)	13.1	0.16	0.10, 0.26	<0.0001	22.7	1.065		ns	No crossover planned; post-protocol, 71% of patients in chemotherapy arm received an egfr tki.
Zhou et al., 2011³⁰ (optimal)	pfs	154	Erlotinib Carboplatin–gemcitabine		4.6				28.9
Han et al., 2012³¹ (First-signal)	os	309	Gefitinib Cisplatin–gemcitabine	itt	5.8	1.2	0.94, 1.5	ns	22.3	0.932	0.72, 1.2	0.604	No crossover planned; post protocol, 75% of in patients chemotherapy arm received an egfr tki
		309	Gefitinib Cisplatin–gemcitabine		6.4				22.9
		96	Gefitinib Cisplatin–gemcitabine	Subgroup: egfr M+		0.38	0.21, 0.68	<0.001		1.043	0.50, 2.2	ns
Rosell et al., 2012³² (eurtac)	pfs	173	Erlotinib Standard chemotherapy	itt (egfr M+)	9.7	0.37	0.25, 0.54	<0.0001	19.3	1.04	0.65, 1.68	0.87	Crossover
Rosell et al., 2012³² (eurtac)	pfs	173	Erlotinib Standard chemotherapy		5.2				19.5				Crossover
Yang et al., 2012³⁵ (lux-Lung3)	pfs	345	Afatinib Cisplatin–pemetrexed	itt (egfr M+)	11.1	0.58	0.43, 0.78	0.0004					No crossover planned
Yang et al., 2012³⁵ (lux-Lung3)	pfs	345	Afatinib Cisplatin–pemetrexed		6.9								No crossover planned

Pts = patients; hr = hazard ratio; cl = confidence limits; ecog = Eastern Cooperative Oncology Group; itt = intention-to-treat; ns = nonsignificant; egfr = epidermal growth factor receptor; M+ = mutation positive; tki = tyrosine kinase inhibitor.