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

Background: 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. Patients and methods: 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. Results: 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. Conclusion: This analysis of the Italian TRUST results confirms the activity and favourable safety profile of erlotinib in unselected patients with advanced NSCLC. (C) 2008 Elsevier Ireland Ltd. All rights reserved.