An expanded access program of erlotinib (Tarceva) in patients with advanced non-small cell lung cancer (NSCLC): data report from Italy.

Erlotinib demonstrated significantly prolonged survival versus placebo in patients with advanced NSCLC who had progressed after standard chemotherapy. TRUST is a phase IV trial initiated to provide erlotinib access to patients with advanced NSCLC. We report the interim analysis for patients enrolled in the TRUST trial in Italy.Eligible patients had stage IIIB/IV NSCLC and had failed or were unsuitable for chemotherapy. Erlotinib (150 mg/day orally) was given until disease progression or unacceptable toxicity. Patients were monitored monthly.At time of this analysis, data from 651 patients were available. Patient characteristics were: median age 66 years (range 30-87), male 69%, former or current smoker 71%, ECOG PS 0-1 81%, adenocarcinoma histology 52% and stage IV 82%. Erlotinib was administered as first-, second-, third- or other-line in 12, 45, 43 and <1% of patients, respectively. Response rate was 9%, with a disease-control rate of 63%. Median progression-free survival was 15 weeks and was longer in females (p<0.001), patients with adenocarcinoma (p=0.008), those with no smoking history (p<0.001) and patients who experienced skin toxicity (p<0.001). Safety data were available for 609 patients, 35% of whom had at least one adverse event (AE), but only 4% of patients discontinued treatment due to erlotinib-related AEs.This analysis of the Italian TRUST results confirms the activity and favourable safety profile of erlotinib in unselected patients with advanced NSCLC.