Erlotinib in non-small cell lung cancer (NSCLC): Interim safety analysis of the TRUST study

7645 Background: In patients (pts) with relapsed NSCLC, erlotinib 150 mg/d significantly prolonged survival, delayed symptom progression, and improved quality of life versus placebo (Shepherd et al, N Engl J Med 2005;353:123–32). TRUST is an open label, non- randomized trial initiated to provide erlotinib access to pts with advanced NSCLC. Methods: Eligible pts had stage IIIb/IV NSCLC, and had failed or were unsuitable for chemotherapy. Erlotinib (150 mg/d p.o.) was given until disease progression or unacceptable toxicity. Pts were monitored monthly. Results: In November 2006, data were available for 5,015 pts (ITT population) from 51 countries. Median age was 63y (range 19–95). Pt characteristics (%) were: male/female 62/38; Caucasian/Oriental/other 76/19/5; non-smoker/ex- or current-smoker 28/71 (no data 1); ECOG PS 0/1/2/3 21/53/20/6; adenocarcinoma/squamous cell/other 53/25/21; stage IIIb/IV 22/78; erlotinib 1st/2nd/3rd-line/other 14/48/37/1. Safety data were available for 4,423 pts, 55% of whom had a...