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Efficacy of erlotinib in patients with advanced Non‐small‐cell Lung Cancer (NSCLC): Analysis of the Australian subpopulation of the TRUST study
Author(s) -
BOYER Michael,
HORWOOD Keith,
PAVLAKIS Nick,
DE SOUZA Paul,
MILLWARD Michael,
STEIN Brian,
JOHNSTON Michael,
ABELL Fiona,
RISCHIN Danny
Publication year - 2012
Publication title -
asia‐pacific journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.73
H-Index - 29
eISSN - 1743-7563
pISSN - 1743-7555
DOI - 10.1111/j.1743-7563.2012.01540.x
Subject(s) - erlotinib , medicine , lung cancer , rash , oncology , adverse effect , population , erlotinib hydrochloride , cancer , surgery , epidermal growth factor receptor , environmental health
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.