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| |  Erlotinib Doubles Progression-Free Survival in Western Patients With NSCLC: Presented at WCLC By Jenny Powers AMSTERDAM, Netherlands -- July 7, 2011 -- Erlotinib given as first-line therapy demonstrated significantly improved progression-free survival over platinum-based chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC), researchers said here July 4 at the 14th World Conference on Lung Cancer (WCLC). These results are in-line with other data that have been, for the most part, acquired in Asian populations that historically have responded differently from Western study groups to NSCLC treatments. Patients in the study were also screened to provide a genetically specific group of patients who had epidermal growth factor receptor (EGFR) mutations. This planned interim analysis done on data from 153 patients demonstrated that the response rate of patients in the erlotinib arm (n = 84) was 54.5% compared with 10.5% in patients who received chemotherapy (n = 87; P <.0001). Disease control was achieved by 68 (79%) erlotinib-treated patients compared with 57 (66%) chemotherapy-treated patients. Patients treated with erlotinib had longer progression-free survival of 9.4 versus 5.2 months (in patients who received chemotherapy, P <.0001). Median survival was 22.9 months and 18.8 months in the erlotinib arm and chemotherapy arms, respectively (P =.8702). Radj Gervais, MD, Centre François Baclesse, Caen, France, and colleagues conducted the randomised study to determine the efficacy of erlotinib in EGFR mutation positive patients. Over a 4-year period, 1,227 patients were screened for EGFR mutations, and of these, 174 were randomised to erlotinib or platinum-based chemotherapy. The primary endpoint was progression-free survival, with secondary endpoints of response, overall survival, and toxicity. Addressing the study population, Dr. Gervais commented that “although a growing body of evidence has been emerging about this type of lung cancer, almost all of the studies have been conducted in Asian patients. This is the first phase 3 study of first-line erlotinib in Western patients with this genetically distinct type of advanced NSCLC.” Erlotinib was better tolerated than chemotherapy; the most common toxicities experienced by patients in the erlotinib arm were diarrhoea (57.3%), asthenia (53.3%), and rash (49.3%), In the chemotherapy arm, the most common adverse events were asthenia (68.9%), anaemia (45.9%), nausea (40.5%), and neutropenia (36.5%). Funding for this study was provided by Roche. This conference is sponsored by the meeting of the International Association for the Study of Lung Cancer (IASLC). [Presentation title: The EURTAC (European Tarceva Versus Chemotherapy) Study: Interim Results of a Phase III Randomized Trial of Erlotinib versus Chemotherapy (CT) in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients (p) With Epidermal Growth Factor Receptor (EGFR) Activating Mut. Abstract O10.01]
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