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Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial

Purpose: In the phase III INTEREST trial, 1,466 pretreated patients with advanced non-small cell lung cancer (NSCLC) were randomly assigned to receive gefitinib or docetaxel. As a preplanned analysis, we prospectively analyzed available tumor biopsies to investigate the relationship between biomarke...

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Hauptverfasser: Douillard, Jean-Yves (VerfasserIn) , Shepherd, Frances A. (VerfasserIn) , Hirsh, Vera (VerfasserIn) , Mok, Tony (VerfasserIn) , Socinski, Mark A. (VerfasserIn) , Gervais, Radj (VerfasserIn) , Liao, Mei-Lin (VerfasserIn) , Bischoff, Helge (VerfasserIn) , Reck, Martin (VerfasserIn) , Sellers, Mark V. (VerfasserIn) , Watkins, Claire L. (VerfasserIn) , Speake, Georgina (VerfasserIn) , Armour, Alison A. (VerfasserIn) , Kim, Edward S. (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 2010
In: Journal of clinical oncology
Year: 2010, Jahrgang: 28, Heft: 5, Pages: 744-752
ISSN:1527-7755
DOI:10.1200/JCO.2009.24.3030
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.2009.24.3030
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.2009.24.3030
Volltext
Verfasserangaben:Jean-Yves Douillard, Frances A. Shepherd, Vera Hirsh, Tony Mok, Mark A. Socinski, Radj Gervais, Mei-Lin Liao, Helge Bischoff, Martin Reck, Mark V. Sellers, Claire L. Watkins, Georgina Speake, Alison A. Armour, and Edward S. Kim
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Zusammenfassung:Purpose: In the phase III INTEREST trial, 1,466 pretreated patients with advanced non-small cell lung cancer (NSCLC) were randomly assigned to receive gefitinib or docetaxel. As a preplanned analysis, we prospectively analyzed available tumor biopsies to investigate the relationship between biomarkers and clinical outcomes. - Methods: Biomarkers included epidermal growth factor receptor (EGFR) copy number by fluorescent in situ hybridization (374 assessable samples), EGFR protein expression by immunohistochemistry (n = 380), and EGFR (n = 297) and KRAS (n = 275) mutations. - Results: For all biomarker subgroups analyzed, survival was similar for gefitinib and docetaxel, with no statistically significant differences between treatments and no significant treatment by biomarker status interaction tests. EGFR mutation-positive patients had longer progression-free survival (PFS; hazard ratio [HR], 0.16; 95% CI, 0.05 to 0.49; P = .001) and higher objective response rate (ORR; 42.1% v 21.1%; P = .04), and patients with high EGFR copy number had higher ORR (13.0% v 7.4%; P = .04) with gefitinib versus docetaxel. - Conclusion: These biomarkers do not appear to be predictive factors for differential survival between gefitinib and docetaxel in this setting of previously treated patients; however, subsequent treatments may have influenced the survival results. For secondary end points of PFS and ORR, some advantages for gefitinib over docetaxel were seen in EGFR mutation-positive and high EGFR copy number patients. There was no statistically significant difference between gefitinib and docetaxel in biomarker-negative patients. This suggests gefitinib can provide similar overall survival to docetaxel in patients across a broad range of clinical subgroups and that EGFR biomarkers such as mutation status may additionally identify which patients are likely to gain greatest PFS and ORR benefit from gefitinib.
Beschreibung:Published online ahead of print at www.jco.org on December 28, 2009
Gesehen am 16.02.2023
Beschreibung:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.2009.24.3030

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