Journal Article

PreJuSER-11439

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Erstellung einer Input-Output-Tabelle für Mecklenburg-Vorpommern

Kronenberg, T.FZJ*

2010
Springer Berlin

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Please use a persistent id in citations: doi:10.1007/s11943-010-0084-9

Abstract: The IRESSA Survival Evaluation in Lung Cancer (ISEL) phase III study compared the efficacy of gefitinib (IRESSA) versus placebo in patients with refractory advanced non-small cell lung cancer (NSCLC). Although a statistically significant difference in survival was not seen between gefitinib and placebo in the overall ISEL population, preplanned subset analyses demonstrated a significant survival benefit in patients who had never smoked and in patients of Asian origin.In ISEL, 1692 patients who were refractory to or intolerant of their latest chemotherapy were randomized to receive either gefitinib (250 mg/day) or placebo, plus best supportive care. Preplanned subgroup analyses included an assessment of patients who were of Asian origin (n = 342).Two hundred thirty-five patients of Asian origin received gefitinib, and 107 received placebo. In these patients, treatment with gefitinib significantly improved survival compared with placebo (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.48, 0.91; p = 0.010; median survival, 9.5 versus 5.5 months). Patients of Asian origin also experienced statistically significant improvements in time to treatment failure with gefitinib compared with placebo (HR, 0.69; 95% CI, 0.52, 0.91; p = 0.0084; 4.4 versus 2.2 months), and objective response rates were higher with gefitinib than with placebo (12 versus 2%). Gefitinib was generally well tolerated in patients of Asian origin, with rash and diarrhea being the most common adverse events. No unexpected adverse events were observed.Treatment with gefitinib was associated with a significant improvement in survival in a subgroup of patients of Asian origin with previously treated refractory advanced NSCLC.

Keyword(s): Adult (MeSH) ; Aged (MeSH) ; Aged, 80 and over (MeSH) ; Antineoplastic Agents: adverse effects (MeSH) ; Antineoplastic Agents: therapeutic use (MeSH) ; Asian Continental Ancestry Group (MeSH) ; Carcinoma, Non-Small-Cell Lung: drug therapy (MeSH) ; Carcinoma, Non-Small-Cell Lung: ethnology (MeSH) ; Carcinoma, Non-Small-Cell Lung: mortality (MeSH) ; Double-Blind Method (MeSH) ; Female (MeSH) ; Humans (MeSH) ; Lung Neoplasms: drug therapy (MeSH) ; Lung Neoplasms: ethnology (MeSH) ; Lung Neoplasms: mortality (MeSH) ; Male (MeSH) ; Middle Aged (MeSH) ; Protein Kinase Inhibitors: adverse effects (MeSH) ; Protein Kinase Inhibitors: therapeutic use (MeSH) ; Quinazolines: adverse effects (MeSH) ; Quinazolines: therapeutic use (MeSH) ; Receptor, Epidermal Growth Factor: antagonists & inhibitors (MeSH) ; Survival Rate (MeSH) ; Antineoplastic Agents ; Protein Kinase Inhibitors ; Quinazolines ; gefitinib ; Receptor, Epidermal Growth Factor

Note: Record converted from VDB: 12.11.2012

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Contributing Institute(s):

1. Systemforschung und Technologische Entwicklung (IEF-STE)

Research Program(s):

1. Nachhaltige Entwicklung und Technik (P26)

Appears in the scientific report 2010

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