Efficacy and safety of erlotinib in the treatment of metastatic non-small-cell lung cancer

Figures & data

Table 1 Survival results from BR.21: a phase III randomized, double-blind, placebo-controlled trial assessing the efficacy of erlotinib treatment of patients with advanced and chemotherapy-refractory NSCLC¹⁸

	Erlotinib (n = 488)	Placebo (n = 243)	P value
Progression-free survival (months)	2.2	1.8	<0.001
Overall survival (months)	6.7	4.7	<0.001
One-year survival (%)	31	22	NA

Table 2 Response rate to erlotinib in different patient subgroups in BR.21: gender, histologies, race, and smoker¹⁸

	Response rate (%)	P
Women vs men	14 vs 6	0.006
Adenocarcinoma vs other histologies	14 vs 4	<0.001
Asian vs non-Asian	19 vs 8	0.02
Nonsmoker vs current/former	25 vs 4	<0.001

Table 3 Erlotinib in combination with chemotherapy for the first-line treatment of NSCLC

Study	No of patients	Regimen	Median survival (months)	RR	Overall survival (%)
TALENT^Citation21	1,172	CT + placebo	10.2 vs 9.9	NR	NR
		CT + erlotinib	P = NS
TRIBUTE^Citation20	533	CT + placebo	10.5 vs 10.6	19.3 vs 21.5	44 vs 47
		CT + erlotinib	P = 0.95	P = 0.36

Abbreviations: RR, relative risk; CT, cisplatin.

Table 4 Ongoing phase I, II, and III trials with erlotiniba

Study phase	Treatment	Primary end point
II	Erlotinib plus R1507 in patients with IIIB/IV NSCLC with progressive disease after clinical benefit with erlotinib	PFS
I	Erlotinib plus Sorafenib in patients with pretreated unresectable stage III or IV NSCLC	Safety
III	Erlotinib vs docetaxel or pemetrexed	OS
II	Erlotinib in combination with chemoradiation in patients with stage IIIA/B	Time to disease progression
II	Erlotinib with concurrent whole brain radiation therapy in patients with brain metastases	OS
II	Erlotinib plus docetaxel in patients with advanced or metastatic NSCLC after failure of one chemotherapy regimen	PFS
II	Erlotinib in combination with chemoradiation in patients with stage IIIA/B NSCLC	Safety

a www.clinicaltrials.gov

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

ShepherdFARodrigues PereiraJCiuleanuTErlotinib in previously treated non-small cell lung cancerN Engl J Med200535312313216014882

 PubMed Web of Science ®Google Scholar

GatzemeierUPluzanskaASzczesnaAResults of a phase III trial of erlotinib (OSI-774) combined with cisplatin and GC chemotherapy in advanced non-small cell lung cancer (NSCLC)J Clin Oncol200422Suppl 14619s

 Web of Science ®Google Scholar

HerbstRSPragerDHermannRTRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancerJ Clin Oncol2005235892589916043829

 PubMed Web of Science ®Google Scholar