| Autor: |
Esteban, Emilio, Fra, Joaquin, Fernández, Yolanda, Corral, Norberto, Vieitez, José M., Palacio, Isabel, de Sande, José L., Fernández, José L., Muñiz, Isabel, Villanueva, Noemi, Estrada, Enrique, Mareque, Beatriz, Uña, Esther, Buesa, José M., Lacave, Angel J. |
| Zdroj: |
Investigational New Drugs; May 2006, Vol. 24 Issue: 3 p241-248, 8p |
| Abstrakt: |
The objective of this study was to assess whether adding cisplatin to gemcitabine/vinorelbine combination improves the clinical outcome in patients with non-small-cell lung cancer (NSCLC). Chemotherapy-naïve patients with advanced NSCLC; age ≤75 years: Karnofsky performance status ≥60%, and with adequate hematological, renal and hepatic function, were randomized into 2 treatment groups to receive Gemcitabine 1250 mg/m2+ vinorelbine 30 mg/m2(GV group), or cisplatin 50 mg/m2+ gemcitabine 1000 mg/m2+ vinorelbine 25 mg/m2(CGV group). All drugs were administered on days 1 and 8 every three weeks: From September 1999 to March 2003, 114 patients were enrolled. No statistically significant difference was observed in GV vs CGV group in objective response (37 versus 47%, respectively; P= 0.5), median time to progression (5 versus 5.8 months; P= 0.6), overall survival (9 versus 10 months; P= 0.9) and 1-year survival (26 versus 28%; P= 0.9). Conversely, toxicities were significantly higher for CGV, including grade 3–4 neutropenia (24 versus 45%); neutropenic fever (4 versus 14%, including one toxic death); grade 3–4 thrombocytopenia (2 versus 14%); and grade 3–4 emesis (2 versus 14%). Our results suggest that the combination of gemcitabine and vinorelbine is less toxic than three-drug combination with cisplatin while showing similar efficacy. |
| Databáze: |
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