A multicenter international randomized phase III study comparing cisplatin in combination with irinotecan or etoposide in previously untreated small-cell lung cancer patients with extensive disease

• Verfasst von: Zatloukal, Petr [VerfasserIn]
• Verfasst von: Cardenal, F. [VerfasserIn]
• Verfasst von: Szczesna, A. [VerfasserIn]
• Verfasst von: Gorbunova, V. [VerfasserIn]
• Verfasst von: Moiseyenko, V. [VerfasserIn]
• Verfasst von: Zhang, X. [VerfasserIn]
• Verfasst von: Cisar, L. [VerfasserIn]
• Verfasst von: Soria, J. -C. [VerfasserIn]
• Verfasst von: Domine, M. [VerfasserIn]
• Verfasst von: Thomas, Michael [VerfasserIn]
• Titel: A multicenter international randomized phase III study comparing cisplatin in combination with irinotecan or etoposide in previously untreated small-cell lung cancer patients with extensive disease
• Verf.angabe: P. Zatloukal, F. Cardenal, A. Szczesna, V. Gorbunova, V. Moiseyenko, X. Zhang, L. Cisar, J. -C. Soria, M. Domine & M. Thomas
• E-Jahr: 2010
• Jahr: September 2010
• Umfang: 7 S.
• Illustrationen: 1 Diagramm
• Fussnoten: Gesehen am 17.04.2024
• Titel Quelle: Enthalten in: Annals of oncology
• Ort Quelle: Amsterdam [u.a.] : Elsevier, 1990
• Jahr Quelle: 2010
• Band/Heft Quelle: 21(2010), 9 vom: Sept., Seite 1810-1816
• ISSN Quelle: 1569-8041
• DOI: doi:10.1093/annonc/mdq036
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: cisplatin
• Sach-SW: etoposide
• Sach-SW: irinotecan
• Sach-SW: small-cell lung cancer with extensive disease
• K10plus-PPN: 1886034699

Abstract

Background - This study compared irinotecan plus cisplatin (IP) with etoposide plus cisplatin (EP) in small-cell lung cancer patients with extensive disease. - Patients and methods - Patients were randomly assigned to receive cisplatin 80 mg/m2 and either irinotecan 65 mg/m2, days 1 and 8 or etoposide 100 mg/m2, days 1-3, every 3 weeks. - Results - Baseline characteristics were balanced between patients receiving IP (N = 202) or EP (N = 203). Median overall survival was nonsignificantly superior for patients receiving IP versus EP, 10.2 versus 9.7 months [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.65-1.01, P = 0.06] and 1- and 2-year survival rates were 41.9% versus 38.9% and 16.3% versus 8.2%, respectively. Noninferiority of IP versus EP was established, upper bound of the 95% CI of HR 1.01 (prespecified margin IP/EP <1.25). Overall response (39.1% versus 46.6%) and time to tumor progression (5.4 versus 6.2 months) were not superior for IP. Grade 3/4 vomiting (10.9% versus 4.4%) and diarrhea (15.4% versus 0.5%) were more common in the IP versus EP arm; grade 3/4 neutropenia was more frequent in the EP (59.6%) versus IP arm (38.1%). - Conclusions - Our data demonstrate the noninferiority of IP versus EP for survival in primarily Western patients with SCLC-ED. A meta-analysis is required to finally assess the role of irinotecan in this setting.