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  • Title: Efficacy of erlotinib in patients with advanced non-small-cell lung cancer (NSCLC): analysis of the Australian subpopulation of the TRUST study.
    Author: Boyer M, Horwood K, Pavlakis N, De Souza P, Millward M, Stein B, Johnston M, Abell F, Rischin D.
    Journal: Asia Pac J Clin Oncol; 2012 Sep; 8(3):248-54. PubMed ID: 22898114.
    Abstract:
    AIMS: The efficacy of erlotinib (Tarceva, Roche Products, Dee Why, Australia) has been demonstrated in patients with advanced non-small-cell lung cancer (NSCLC). Tarceva lung cancer survival treatment (TRUST) is an open-label, single-arm, phase IV global trial which investigated erlotinib in advanced NSCLC patients who had failed prior therapy or were unsuitable for chemo/radiotherapy. The aim of this analysis was to report the safety and efficacy of erlotinib in the Australian patient subpopulation. METHODS: Patients with stage IIIB/IV NSCLC progressing after standard systemic chemotherapy or unsuitable to receive chemo/radiotherapy were eligible for the study. The patients were treated with erlotinib at 150 mg/day orally, until disease progression or unacceptable toxicity. RESULTS: In Australia, 460 patients were recruited. Erlotinib was given as first-line (16%), second-line (49%) or third-line (35%) treatment. In the intent-to-treat population (N = 460), the median progression-free survival was 2.7 months (95% CI 2.3-3.4), 1-year survival was 35% (95% CI 30-39%) and median overall survival was 6.9 months (95% CI 5.7-8.0). Tumor response rates were available for 363 patients, with a disease control rate of 58%. Of the 460 patients included in the safety analysis, 24% had one or more erlotinib-related adverse event (AE). Rash was reported in 77% of patients, most commonly grade 1/2 (63%). Treatment-related serious AE were reported in 7% of patients; most commonly diarrhea (2%). Dose modifications were required in 18% of patients. CONCLUSIONS: Outcomes for Australian patients confirmed the efficacy and tolerability of erlotinib for the treatment of advanced NSCLC in routine clinical practice.
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