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
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 etoposi...
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| Main Authors: | , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
September 2010
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| In: |
Annals of oncology
Year: 2010, Volume: 21, Issue: 9, Pages: 1810-1816 |
| ISSN: | 1569-8041 |
| DOI: | 10.1093/annonc/mdq036 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/annonc/mdq036 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753419400598 
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| Author Notes: | P. Zatloukal, F. Cardenal, A. Szczesna, V. Gorbunova, V. Moiseyenko, X. Zhang, L. Cisar, J. -C. Soria, M. Domine & M. Thomas |
| Summary: | 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. |
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| Item Description: | Gesehen am 17.04.2024 |
| Physical Description: | Online Resource |
| ISSN: | 1569-8041 |
| DOI: | 10.1093/annonc/mdq036 |