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| |  Erlotinib Maintenance Therapy Shows Survival Benefits Over Placebo for NSCLC, No Unexpected Safety Signals: Presented at ECCO-ESMO By Chris Berrie BERLIN -- October 1, 2009 -- Erlotinib maintenance therapy shows no unexpected safety signals and provides significant survival benefits over placebo as first-line maintenance therapy in patients with advanced non-small-cell lung cancer (NSCLC), according to an analysis presented here at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO). Survival data analysis from the randomised, double-blind, placebo-controlled, phase 3 Sequential Tarceva in Unresectable NSCLC (SATURN) study was presented on September 22 by principal investigator Federico Cappuzzo, MD, Istituto Clinico Humanitas, Milan, Italy. To determine the benefits of first-line erlotinib maintenance therapy, 1,949 chemotherapy-naïve patients with advanced NSCLC initially underwent 4 cycles of first-line platinum-doublet chemotherapy. Those not showing progressive disease (n = 889) were then randomised to placebo (n = 451) or erlotinib 150 mg/day (n = 438). Patient baseline characteristics were similar between groups. The coprimary endpoint of significantly improved progression-free survival (PFS) for the full intention-to-treat population for erlotinib over placebo was reached (P < .0001). “When we look at this progression-free survival for the different subgroups of patients according to clinical characteristics, we see no specific subgroups with a high risk benefit from the therapy,” noted Dr. Cappuzzo. Similarly, biomarker subgroup analysis was possible, particularly for epidermal growth factor receptor (EGFR) immunohistochemistry, and also for EGFR fluorescence in situ hybridisation, KRAS mutation, and EGFR polymorphism. Again, there was no selectivity in PFS across these biomarkers. When PFS analysis was extended according to EGFR mutation status, those with wild-type EGFR showed a slightly reduced significant benefit over placebo (P = .0185); in contrast, the fewer EGFR mutation-positive patients showed greatly enhanced benefit of erlotinib over placebo (P < .0001). The overall survival (OS) secondary endpoint was also reached, with significant benefit for erlotinib over placebo (P = .0088). A similar subgroup analysis for OS according to patient clinical characteristics and biomarker status again showed no specific subgroups driving these benefits of erlotinib. “In particular, when we look at the group of patients without and with EGFR mutations, it is important to note that the benefit in survival was not driven by patients with EGFR mutations,” Dr. Cappuzzo stressed. Adverse events occurring in >=10% of placebo-treated and erlotinib-treated patients included rash (9% vs 60%) and diarrhoea (4% vs 20%). Dr. Cappuzzo briefly indicated the significant benefits for erlotinib over placebo for the quality of life secondary endpoint as time to pain (P = .0080) and time to analgesic use (P = .0199). Funding for this study was provided by Roche. [Presentation title: Overall Survival Analyses From the SATURN Phase III Placebo-Controlled Study of Erlotinib as First-Line Maintenance Therapy in Advanced Non-Small-Cell Lung Cancer (NSCLC). Abstract P465]
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