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.