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Gemcitabine and vinorelbine (GV) versus cisplatin, gemcitabine and vinorelbine (CGV) as first-line treatment in advanced non small cell lung cancer: Results of a prospective randomized phase II study

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Summary

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.

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Authors and Affiliations

  1. Clinical Oncology Services of the Hospital Central de Asturias, (Oviedo), Asturias, Spain

    Emilio Esteban MD, Joaquin Fra, Yolanda Fernández, Norberto Corral, José M. Vieitez, Isabel Palacio, Isabel Muñiz, Noemi Villanueva, Enrique Estrada, Beatriz Mareque, Esther Uña, José M. Buesa & Angel J. Lacave

  2. Clinical Oncology Services of the Hospital de León, Asturias, Spain

    José L. de Sande

  3. Clinical Oncology Services of the Hospital de Ponferrada, Asturias, Spain

    José L. Fernández

  4. Clinical Oncology Services of the Hospital Central de Asturias, Julián Clavería s/n, 33006, Oviedo, Asturias, Spain

    Emilio Esteban MD

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Esteban, E., Fra, J., Fernández, Y. et al. Gemcitabine and vinorelbine (GV) versus cisplatin, gemcitabine and vinorelbine (CGV) as first-line treatment in advanced non small cell lung cancer: Results of a prospective randomized phase II study. Invest New Drugs 24, 241–248 (2006). https://doi.org/10.1007/s10637-005-2478-z

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