Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial
Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC.
However, several trials comparing platinum versus non-platinum based chemotherapy regimens
failed to demonstrate a statistically significant difference in terms of time to tumor
progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have
shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as
first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall
survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a
RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of
these two doublets, would be interesting.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Vassilis Georgoulias, MD
University Hospital of Crete, Dep of Medical Oncology
Greece: National Organization of Medicines