Role of erlotinib in the targeted treatment of non-small-cell lung cancer in Chinese patients

Figures & data

Table 1 Erlotinib versus placebo or chemotherapy in second-line setting

Study	Study phase	Treatment	Population	ORR (%)	Median PFS/TTP (months)	HR PFS	Median OS (months)	HR OS
BR21	Phase III	Erlotinib	Overall ITT	8.9	2.2	HR 0.61	6.7	HR 0.70
		Placebo		<1 P<0.001	1.8	P<0.001	4.7	P<0.001
TRUST	Phase IV	Erlotinib	Overall ITT	13	3.25		7.9
			E/SE Asian	27	5.78	HR 0.66	14.7	HR 0.57
			Non-E/SE Asian	10 P<0.0001	2.92	P<0.0001	6.8	P<0.0001
			Chinese	26.7	TTP =6.44		15.37
DELTA	Phase III	Erlotinib	EGFR wild-type	NP	1.3		9.0
		Docetaxel			2.9 P=0.013		9.2 P=0.914
CTONG0806	Phase II	Gefitinib	EGFR wild-type	14.7	1.6	HR 0.51	NA
		Pemetrexed		13.3 P=0.814	4.8	P<0.001

Abbreviations: EGFR, epidermal growth factor receptor; ITT, intention to treat; ORR, objective response rate; PFS, progression-free survival; TTP, time to progression; OS, overall survival; HR, hazard ratio; E/SE, East/Southeast; NA, not available; NP, not present; TRUST, Tarceva Lung Cancer Survival Treatment; DELTA, Docetaxel and Erlotinib Lung Cancer Trial; CTONG, Chinese Thoracic Oncology Group.

Table 2 Erlotinib versus chemotherapy as first-line treatment for epidermal growth factor receptor-mutant patients

Study	Study phase	Treatment (number of patients)	ORR (%)	Median PFS (months)	HR PFS	Median OS (months)	HR OS
IPASS	Phase III	Gefitinib (132)	71.2	9.5	HR 0.48	21.6	HR 1.0, P=0.99
		Carbo + Pac (129)	47.3 P<0.001	6.3	P<0.001	21.9
OPTIMAL	Phase III	Erlotinib (82)	83	13.1	HR 0.16	28.85	HR 1.04, P=0.69
		Carbo + Gem (72)	36 P<0.0001	4.6	P<0.0001	22.68
EURTAC	Phase III	Erlotinib	58	9.7	HR 0.34	22.9	HR 1.36, P=0.71
		Carbo/Cis + Doc/Gem	15 P<0.0001	5.2	P<0.0001	18.8

Abbreviations: PFS, progression-free survival; ORR, objective response rate; OS, overall survival; Cis, cisplatin; Carbo, carboplatin; Pac, paclitaxel; Doc, docetaxel; Gem, gemcitabine; HR, hazard ratio; IPASS, Iressa Pan-Asia Study; EURTAC, EURopean TArceva vs Chemotherapy.

Table 3 Erlotinib versus placebo as maintenance therapy

Study	Study phase	Frontline therapy	Maintenance therapy	Population	Median PFS/TTP	HR PFS/TTP	Median OS (months)	HR OS
SATURN	Phase III	Platinum-based doublets	Erlotinib	Overall ITT	12.3 weeks	HR 0.71	12.0	HR 0.81, P=0.0088
			Placebo		11.1 weeks	P<0.0001	11.0
				Asian	17.9 weeks	HR 0.57	20.8	HR 0.67, P=0.0931
					11.4 weeks	P=0.0067	15.2
INFORM	Phase III	Platinum-based doublets	Gefitinib	Chinese	4.8 months	HR 0.42	18.7	HR 0.84
			Placebo		2.6 months	P<0.0001	16.9	P=0.26

Abbreviations: PFS, progression-free survival; ORR, objective response rate; OS, overall survival; HR, hazard ratio; ITT, intention to treat; SATURN, Sequential Tarceva in Unresectable NSCLC [non-small-cell lung cancer]; TTP, time to progression; INFORM, Gefitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer.